Should the ‘War on Stem Cells’ Be Fought in Court?

By A. Rahman Ford, Columnist

A recent article published in the journal Regenerative Medicine suggests that civil lawsuits should be used to protect patients and draw attention to unscrupulous stem cell clinics. 

The authors, Claire Horner, Evelyn Tennenbaum, Zubin Master and Douglas Sipp, contend that civil litigation would "convincingly show patients and society that there are real and significant harms from unproven SCIs (stem cell interventions), and this strategy may complement the arsenal of efforts focused on reining in this industry.” 

Horner, Tennenbaum and Master are academics in medical ethics at Baylor College of Medicine, Albany Law School and the Mayo Clinic, respectively; while Sipp is affiliated with RIKEN, a Japanese research institute that is developing stem cell technology.

Their use of the word “arsenal” sounds like a declaration of war, an unfortunate, fratricidal war against their fellow Americans who need stem cells to treat their pain and disability.  After reading their article, it’s clear that fearmongering is their best weapon.

The authors really don’t like clinics that use a patient’s own stem cells to heal themselves.  They lament that many industrialized countries are moving toward more openness in accelerated approval of stem cells and other regenerative therapies.  And they contend that inadequate enforcement and penalties at the U.S. federal level justify the need for lawsuits.

“In the absence of government oversight of private sector firms, patients and consumers may need to look elsewhere to protect their interests. Civil litigation provides a means for patients who feel they have been harmed by undergoing a SCI to seek redress and compensation from providers and may also motivate government and industry to address the issue on a larger scale,” they wrote.

The most stupefying part is that the authors go so far as to compare the issue to tobacco companies, gun violence and child molestation! 

The authors admit at the outset that the main goal of their campaign is to propagandize the public and policy-makers.  They state plainly that “stem cell lawsuits may help raise public awareness and influence public policy” and would help draw “attention to negative outcomes and engender moral outrage on the behalf of vulnerable and sympathetic plaintiffs.” 

This tactic would shift attention away from pesky patients’ rights advocates who support broader availability of the potentially life-saving treatments offered by stem cells.  They see this strategy as viable because it worked for consumers injured by the tobacco industry, victims of gun violence, and sexual abuse victims molested by Catholic priests.  The fact that the authors would put stem cell clinics – and by extension stem cell patients – in the same category as Philip Morris, AR-15 gun manufacturers and pedophile Catholic priests is simply ludicrous.

For the authors, civil litigation is essentially a propaganda tool in their misguided war against a non-existent enemy. They advocate using civil litigation to “attract public attention” and “shape the media narrative.” Information operations such as these are an age-old concept in international relations and warfare, that includes the collection of tactical information about an adversary as well as the dissemination of propaganda in the pursuit of a competitive advantage over an opponent. 

And how do the authors intend to collect their tactical information?  They will use the civil litigation discovery process to uncover “previously undisclosed information about a provider’s practices” that could potentially trigger FDA investigations. 

Overall, the tone of the authors’ proposal is that of combativeness and belligerence, not negotiation and reconciliation.  As with all misguided wars, it is civilians – those who the war is allegedly waged to protect – are the ones who suffer the most.

Little Evidence to Support ‘War on Stem Cells’

Even worse, they don’t show their “war on stem cells” is supported by any real-world evidence.  Their methodology is insufficiently rigorous; it lacks integrity to the point of being flimsy, porous and leaky.  The data which serve as the cornerstone of the authors’ argument are 9 court cases in which plaintiffs allege that the stem cell therapy they received was either ineffective or injurious.  

This sample is far too small to seriously support any meaningful conclusions, much less the authors’ conclusion that the number of legal claims is growing.  The 9 cases cited were filed between 2012 and 2017 for a wide variety of medical conditions and for a wide variety of causes of action.

Not only are we not told how many stem cell procedures were actually performed in American clinics over the same time span, but in none of the 9 cases cited was there a disposition in favor of the plaintiffs!  In fact, one was voluntarily dismissed by the plaintiffs and another was dismissed on appeal.  Of the remaining seven, 4 were settled and 4 have yet to be decided. 

So none of the claims of negligence, misrepresentation, fraud, lack of informed consent, or unfair trade practices were ever proven.  The authors acknowledge that this is a problem, and in desperation turn to a Japanese case to support their claims.  The problem is the authors openly admit that “the U.S. administrative and legal systems differ greatly from Japan’s.”  It’s never a good idea to undermine your own argument.

If the authors are truly motivated by the safety and welfare of stem cell patients, then perhaps their efforts would be better spent advocating for the increased democratization and liberalization of stem cell policy. 

This can be accomplished by supporting policies geared toward the availability and affordability of stem cell therapies, such as the patient-centered ethos of “Right to Try” legislation, the regenerative medicine provisions of the 21st Century Cures Act, and the constitutionally-protected privacy right in a patient’s use of their own stem cells. 

We need less antagonism and asymmetry in stem cell policy-making, and more alliance-building and acceptance of a new paradigm of progress. The solution is not more litigation against people, but more listening to the people.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.  

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

How Trump and Congress Can Champion Stem Cells

By A. Rahman Ford, Columnist

For the second straight year, President Trump has endorsed making life-saving treatments like stem cell therapies more available to more Americans.

In his 2017 Joint Address to Congress, Trump highlighted the case of Megan Crowley, a young woman whose father had to launch his own drug company to help treat her Pompe Disease.  Also in attendance that evening was Sarah hughes, who was forced to travel to Mexico to use her own stem cells to treat her systemic idiopathic juvenile arthritis.

In reference to both cases, the president lamented the pain and death caused by the “slow and burdensome approval process at the Food and Drug Administration” that “keeps too many advances … from reaching those in need.”  He argued that regulatory restraints at the FDA should be “slashed” so that more Americans could benefit from life-saving therapies.

President Trump is keeping up the pressure.  During this week's State of the Union address, he continued his theme of a patient-centered, less restrictive approach to medical treatment. 

He did so by voicing his clear support for “Right to Try” legislation, which would increase the medical options of the critically ill by helping them avoid the unduly burdensome and bureaucratic spider’s web of the FDA. 

In a seeming reference to Sarah Hughes and other stem cell medical tourists, Trump stated unequivocally that “patients with terminally conditions … should have access to experimental treatments immediately” and they “should not have to go from country to country to seek a cure.”  He then urged Congress to pass the Right to Try Act, so that Americans can get help “right here at home.”

How Right to Try Works

The language of the Right to Try legislation is simple, straightforward and offers protections for patients and manufacturers.  Under the Senate version, an “eligible patient” who has been diagnosed with a terminal illness may be prescribed an experimental drug or biological product to treat their illness, so long as the patient has a qualified physician certify that he or she has exhausted all other treatment options and is unable to participate in a clinical trial. The patient must also provide informed consent to the physician and the physician may not be compensated by the manufacturer of a treatment for certifying the patient.  The patient, physician and manufacturer must all agree on the treatment.

Furthermore, the medical product in question must have successfully completed a Phase 1 clinical trial and must be enrolled in an FDA clinical trial.  The treatment must be authorized by state law, which means that the state must have a Right to Try law – which 38 states currently have.

The manufacturers receive protection under Right to Try legislation, in that there can be no legal liability for injury that may result as a consequence of the medical product’s use, and adverse events that may occur during treatment will not negatively impact any eventual approval of the product by the FDA. 

In an overwhelming and increasingly rare bipartisan display (94-1), the Senate has already passed the Right to Try Act.  The House version is currently awaiting approval.

Critics Deny Democratic Choice 

Critics of Right to Try make several claims to undermine the expansion of choices it would bring to critically ill patients.  Some physicians and medical ethicists claim that the true goal of Right to Try is to weaken the FDA as the only objective and appropriate gatekeeper of drug approval and access.  Some also claim that the legislation is redundant because the FDA already fills this need through its expanded access program. 

Still other critics try to dissuade patients by surreptitiously noting that “scary” conservative and libertarian think tanks like Freedom Partners and Americans for Prosperity, which are partially funded by the Koch brothers, favor passage of Right to Try legislation.  These criticisms warrant thoughtful consideration, but are not substantive enough to overcome overarching concerns of patients literally dying from their pain.    

Ultimately, Right to Try and stem cell therapy are issues that embody the deepening and broadening of healthcare choice -- a choice that should be embraced by an informed American citizenry, a forward-thinking medical establishment and government agencies that must be by and for the people. 

Carefully curated expansions of choice -- that privilege the humane while also giving due consideration to patient protection – serve as the foundation of all truly democratic institutions.  The FDA should accept that it can better serve people by acceding some of its authority and become more lean and nimble in the process.  Bigger is not always better.

Right to Try will not solve all the problems associated with stem cell therapy.  There is no way to predict with any precision how the law will operate legally or logistically, whether for stem cell therapies or other drugs and medical products.  Additionally, the Trump administration must revisit and revise the FDA’s stem cell guidance, specifically its limits on stem cells which are harvested, processed and administered to the same person to relieve conditions such as chronic pain.    

However, for advocates of stem cell therapy and health choice in general, Right to Try is a step in the right direction.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.  

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Stem Cell Regulation and a Rule Too Many

By A. Rahman Ford, Columnist

The New England Journal of Medicine recently published an op/ed rather benignly entitled “Rejuvenating Regenerative Medicine Regulation.”  

The authors, R. Alta Claro and Douglas Sipp, argue that the Food and Drug Administration did not go far enough in regulating stem cell therapies in its recently released final guidance, and that further restrictions need to be placed on Americans seeking to use their own cells to heal themselves. Both authors are affiliated with RIKEN, a Japanese research institute that is developing stem cell technology.

Although clothed in the flowing garb of humaneness, medical ethics and protecting the sick and disabled, the authors’ posture reveals itself to be strikingly paternalistic.  Rather than “rejuvenate” regenerative medicine with ideas that would invigorate and fertilize a forward-thinking, democratic regulatory regime, Claro and Sipp instead articulate positions so extreme that they operate as more of a death knell to stem cell innovation.  Indeed, the authors seem to have issued a eulogy for a promising and precocious corpus of medicine that has barely attained its infancy.

In their view, the FDA guidance is “a positive step,” but more needs to be done.  To assist in the effort, they urge institutions at the state level to “crack down” on malfeasant clinics and agitate for state legislatures to pass stricter informed consent laws, as was recently done in California. 

To justify further restrictions on the availability of stem cell therapies, they claim that the “explosion of stem cell marketing in the United States” has led to “predatory” clinics offering “untested stem cell treatments [that have] exposed patients to unjustifiable risks.” 

They further claim that the FDA has fallen short in in its staged approach to enforcing the new rules against clinics deemed to be in violation.  The authors even go so far as to assail the 21st Century Cures Act because it created “a pathway to approval that is at risk of putting cell and tissue products on the market before they have been adequately tested.”

A bare endorsement of the FDA’s “minimal manipulation” and “homologous use” tests would have been troubling enough, and the authors do endorse those tests in their article.  As I wrote in an earlier column, the agency’s guidance is unduly burdensome when it comes to autologous therapies – which involve stem cells that are extracted from a person and administered to the same person to relieve conditions such as chronic pain. 

In Clara and Sipp’s view, those suffering from pain and other chronic illnesses are part of the problem, because it was largely “patient demand” that helped “drive the growth of unproven therapies.”  Such a placing of blame upon chronically ill patients is disappointing. 

Equally disappointing is the authors’ disregard of those same patients’ constitutionally-protected privacy interest in their own bodies and their own cells, an interest which – as with abortion rights – would require a compelling interest on the part of the federal government to justify excessive regulation.  Unfortunately, an uncited reference to “numerous documented reports of medical accidents” involving stem cells does not a compelling interest make.

Texas Should be the Model

However, the authors are correct that states must be more involved in setting stem cell policy.  The problem is that they chose the wrong example.  Rather than emulate the restrictive policies of California, the Texas example should be the model that other states follow.  Texas has passed legislation making autologous stem cell therapies more accessible to its residents and has even buttressed it with “right to try” legislation.  

The Texas effort was spearheaded by tireless patient advocates who were able to communicate to state lawmakers their truly human stories.  Lawmakers heard and felt that pain – some personally because of their own experiences with pain and disability.  The result was stem cell choice, in a state-led regulatory model that can hopefully be a nationwide blueprint, as Washington state was for marijuana legalization.

Stem cell policy-making must not be a strictly elite enterprise.  It must be democratic process, as embodied by the Congress when it overwhelmingly passed the Cures Act and its provisions which help expedite stem cell cures.  The people’s voice must be preponderant, and bolstered by thoughtful, reasonable rules that privilege choice, promote fairness, and protect us from physical and legal injury.

We should not seek rules that only preserve a place for the status quo in a rapidly advancing medical technology landscape that threatens to make a dusty relic out of old ways of thinking.  The orthodox "clinical trial" medical regulatory paradigm favored by the FDA simply does not work for regenerative medicine and stem cell therapies.  So rather than fear-mongering by focusing on a conjured-up phantom of rampant medical malfeasance, we should embrace the future. 

Fear of change is understandable and expected from certain quarters.  But the millions of Americans in chronic and intractable pain are not the ones who are afraid, and are not as docile and ignorant as they may be portrayed.

Although their argument is flawed, the title Charo and Sipp selected is resounding.  Regenerative medicine and stem cell policies must indeed be about rejuvenation, not more regulatory entanglement.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.  

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

How Stem Cells Can Reverse Opioid Tolerance

By A. Rahman Ford, Columnist

On January 10, Pennsylvania Governor Tom Wolf declared a disaster emergency to fight the scourge of heroin and opioid abuse in his state, which has one of the highest overdose rates in the country.

“Pennsylvania’s opioid crisis impacts all areas of the state – including urban, suburban and rural communities and all ages including both young people and older Pennsylvanians – and is unprejudiced in its reach and devastation,” the declaration says. Virginia and other states have issued similar declarations.

Gov. Wolf’s effort comes months after President Trump declared the opioid crisis a national public health emergency and the president’s opioid commission released its final report, recommending more federal funding for addiction treatment, further restrictions on opioid prescribing, and the development of new non-opioid painkillers.

However, the commission’s report spent little time discussing an issue that is key to confronting the problems of opioid addiction and overdose – opioid tolerance.  “Tolerance” is defined as a decrease in effect following repeated or prolonged use of a drug, which can result in the need for higher and higher doses to achieve the same result.  For patients suffering from acute or chronic pain, this means that they need more pills to alleviate their pain. 

Tolerance can lead to a dangerous cascade of consequences. According to researchers at the National Institutes of Health, “the repeated administration of any opioid  almost inevitably results in the development of tolerance and physical dependence.” 

Although not all who become opioid tolerant become addicted, the World Health Organization asserts that people dependent on opioids are the group most likely to suffer an overdose. Given the seriousness of the problem, researchers have been looking for a way to prevent opioid tolerance and keep opioid users in a state of analgesia.  In that quest, some have found an answer in stem cells. 

In a recent study, Dr. Jianguo Cheng and scientists at the Cleveland Clinic and the Affiliated Hospital of Qingdao University in China hypothesized that mesenchymal stem cells (MSCs) could prevent or reverse opioid tolerance and opioid-induced hyperalgesia because of their profound anti-inflammatory properties. 

To prove their hypothesis, they induced opioid tolerance in laboratory mice and rats by injecting them with morphine for four weeks.  Astoundingly, after administering MSC therapy to the opioid-tolerant rodents, tolerance was reversed within as little as 2 days. The injections appeared to be completely safe.  All of the rodents showed normal movement, food and fluid intake, and body weight gain.  Their livers, kidneys and other major organs continued to function normally.

The authors concluded that MSCs have “enormous potential to profoundly impact clinical practice and improve opioid efficacy and safety.”  Their study builds on previous research that found MSC therapy “does not produce unwanted side effects and is well tolerated and safe.”  Rejection of the stem cells was not an issue because MSCs are immune-privileged.

America’s opioid problem is as destructive as ever.  If the states and the president’s commission truly seek novel, innovative and readily-implementable solutions to the opioid crisis, tolerance is a critical target and stem cell therapy may be a viable solution.  Patients in pain need solutions now.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.  

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Stem Cells: Signs of Progress in a Rigged Game

By A. Rahman Ford, Columnist

The Wall Street Journal recently published an article on the use of stem cell therapies for knee problems, including arthritis.  Overall, the perspective of the piece was positive and it has several laudable aspects.  Physicians from large academic institutions, such as Harvard University and Stanford University, were interviewed to provide their opinions on the use of autologous stem cells derived from a patient’s own fat or bone marrow for certain painful orthopedic indications. 

The article rightly acknowledges the high patient demand for these autologous therapies. It also mentions how the U.S. lags behind other countries in offering them and the disturbing fact that this therapy is not covered by medical insurance.  The doctors who were interviewed also discussed how conventional approaches to osteoarthritis in knees – meniscus surgery, microfracture surgery, etc. – often fail to demonstrate long-term benefit.  These doctors, along with many others around the world, recognize that we need new therapies for orthopedic conditions.

Any positive portrayal of the clinical uses of stem cells should be welcomed. The unfortunate truth is that many potential patients are scared off by publications that focus their reporting on the alleged malfeasance of a few bad-actor stem cell clinics.  These same publications often neglect to cover the countless stem cell success stories from clinics in the U.S. and abroad. 

A focus on these promising results may help allay those fears and convince some of those fearful patients that stem cells are, in fact, a viable medical option for their chronic orthopedic pain. 

Less fear can lead to self-education and increased awareness of the safety and potential of stem cells.  Patients may even try stem cell therapy and become advocates.  In this sense, the WSJ piece is good public relations for stem cell therapies overall.

However, there is an unsettling undertone in the WSJ piece and media coverage in general of stem cells, which places too much emphasis on the opinions of clinicians from certain large institutions.  That diminishes the value of work being done in smaller stem cell clinics, which have been safely and effectively treating patients with orthopedic conditions for years. 

The unintended implication is that Harvard and Stanford physicians’ assessments are more legitimate because of the perceived prestige of their employers, and because they follow the guidelines that the FDA set forth for pursuing such treatments.  Of course, these institutions have millions of dollars in capital that it takes to conduct clinical studies and comply with these guidelines, while smaller clinics often do not.  We must take care to avoid creating or reinforcing illegitimate hierarchies that give some physicians more scientific authority than others, based solely on money, perceived prestige, or the ability to adhere to an unfair set of rules.

The sad truth is that the stem cell game is rigged.  The FDA’s rules regarding the use of autologous stem cell therapies favor those with more financial resources because they can afford expensive clinical trials.  Medical innovation cannot be strictly the domain of wealthy institutions with the finances to play on a tilted field.  The FDA’s “minimal manipulation” and “homologous use” regulatory standards for using stem cells are unduly burdensome and need to be relaxed for autologous stem cell uses. 

Recently, the FDA issued a warning letter to American Cryostem, a company involved in the manufacture of adipose stem cell products derived from a patient’s body fat.  In addition to manufacturing violations, the company was accused of violating the FDA’s “minimal manipulation” and “homologous use” standards. 

Setting the merits of the case aside, it is emblematic of the FDA’s crackdown on clinics that are much smaller than Harvard and Stanford, but which have been relieving patients’ pain with autologous therapies for years.  Their scientific contributions must not be subordinated or dismissed as illegitimate or inconsequential.

Stories of how stem cells are entering mainstream medicine can help us realize the goal of available, affordable stem cell therapy for all Americans.  However, valorization of those institutions with the means to “play within the rules” must not come at the expense of sounding the alarm that the rules themselves are patently unfair.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.  

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

FDA Warns New Jersey Stem Cell Company

By Pat Anson, Editor

The U.S. Food and Drug Administration has warned a New Jersey biotechnology company to stop producing and marketing a stem cell product, the latest in a series of steps the agency has taken to rein in the fast growing stem cell industry.

The FDA sent a warning letter to American CryoStem Corporation for marketing adipose derived stem cells without FDA approval and for “significant deviations” from manufacturing guidelines.

American CryoStem is using adipose tissue – a patient’s own body fat – to create a product called Atcell, which is promoted as a treatment for stroke, brain injuries, Parkinson’s disease, amyotrophic lateral sclerosis (ALS) and multiple sclerosis.

The FDA said there was “more than minimal manipulation” of adipose tissue in the manufacturing of Atcell, which introduced the potential for contamination. The agency said Atcell should undergo clinical trials and an FDA review to prove its safety and effectiveness before being marketed.

“The use of Atcell raises potential significant safety concerns, due in part to the fact that there is little basis on which to predict how the product will perform in a patient,” said Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research. “In addition, this product may also cause harm to patients who may put their trust in an unproven therapy and make the decision to delay or discontinue medical treatments proven to be safe and effective.”

The FDA issued new guidelines for stem cell therapy last November, a “risk-based approach” that critics say could slow the development of novel treatments for autoimmune diseases, cancer, diabetes, neuropathy, back pain and other illnesses.  

As PNN has reported, hundreds of stem cell clinics have opened around the country, often mixing hope with hype by making claims such as, “You don’t have to accept chronic pain as a fact of life.”  The treatments are expensive and usually not covered by insurance. 

Some patients receiving stem cell therapy have reported remarkable recoveries from chronic conditions once deemed untreatable.  Sara Bomar, for example, was confined to a wheelchair after being diagnosed with arachnoiditis, a painful inflammation of nerves in her spinal column. She started walking again after a high dose infusion of stem cells made from her adipose tissue.

The warning letter to American CryoStem was sent nearly six months after FDA investigators inspected the company’s laboratory in Monmouth Junction, New Jersey, finding “significant safety concerns” and “objectionable conditions.”  The firm has implemented changes at its lab to respond to the FDA’s concerns, however the agency said the response “inadequately addresses" the problems and failed to recognize that Atcell is an unlicensed product.  The FDA gave the company 15 working days to respond to its warning letter.

American CryoStem did not respond to PNN’s request for comment.  The company bills itself as a “biotechnology pioneer” in the use of adipose stem cells, and has laboratories in Hong Kong, mainland China and Japan. It recently licensed the patent rights to its stem cell technology in China and plans to expand its operations there.

The FDA Got it Wrong on Stem Cells

By A. Rahman Ford, Columnist

In August, FDA Commissioner Scott Gottlieb, MD, signaled that his agency would move in the direction of enhanced regulation of stem cell therapies.  He said the action was justified because of “unscrupulous actors” who deceive patients with what he described as “dangerously dubious products.” 

Although the FDA referred to its prospective actions benignly as “enforcement” and “protection,” the likely impact seemed obvious – safe and effective therapies that have been healing patients for years would become less available and more expensive. 

Those concerns have now been made real.

This week the FDA released its final guidance on regenerative medicine and stem cell therapy, an approach that relies extensively on more regulation.

“We’re at the beginning of a paradigm change in medicine with the promise of being able to facilitate regeneration of parts of the human body, where cells and tissues can be engineered to grow healthy, functional organs to replace diseased ones; new genes can be introduced into the body to combat disease; and adult stem cells can generate replacements for cells that are lost to injury or disease,” Gottlieb said in a statement.

“We’re adopting a risk-based and science-based approach that builds upon existing regulations to support innovative product development while clarifying the FDA’s authorities and enforcement priorities. This will protect patients from products that pose potential significant risks, while accelerating access to safe and effective new therapies.”

Unfortunately, from both a patient and policy perspective, the FDA’s guidance is distinctly retrograde, drifting backward against a cosmic tide of scientific discovery that should be propelling post-modern medicine forward.  Not only are the FDA’s actions potentially detrimental to the health of Americans who suffer from chronic illnesses that could be treated or even cured by stem cells, they could cripple the entrepreneurship, ingenuity and cost-effectiveness of regenerative medicine. 

For the next 36 months, Gottlieb says FDA will adopt a “risk-based approach” in enforcement of the new rules, “taking into account how products are being administered as well as the diseases and conditions for which they are being used.”  While this grace period seems reasonable, the final guidance makes clear that the FDA will prioritize the oversight of clinics that deliver stem cells via intravenous infusion, in part because “use of these unapproved products may cause users to delay or discontinue medical treatments that have been found safe and effective.”

But intravenous stem cell administration has been safely used to treat patients suffering from painful autoimmune diseases like multiple sclerosis.  I have personally had intravenous stem cell therapy, and found it to be both safe and effective. 

‘Minimal Manipulation’ Test Tough to Pass

While well intended, the FDA’s guidance suffers from unduly restrictive definitions of “minimally manipulated” and “homologous use” -- key standards that will determine the availability of future stem cell therapies. 

Stated simply, stem cells that are “minimally manipulated” will not need to be approved by the FDA via clinical trial.  But that’s a tough test to pass and would seem to rule out mesenchymal stem cells, which help reduce inflammation in orthopedic and autoimmune conditions, conditions that cause unbearable pain for countless Americans.  The FDA’s conception of “minimally manipulated” is simply too limited.

The “homologous use” definition is likewise flawed.  Even if a stem cell product passes the “minimally manipulated” test, the cells used must “perform one or more of the same basic functions in the recipient as the cells or tissues performed in the donor.”  Under this definition, blood stem cells can be transplanted into a person with a disorder affecting their blood system, but cannot be used to repair damaged tissue, as in the case of a child’s cerebral palsy or a wounded veteran’s traumatic brain injury.

However, in a cruel twist, adipose (fatty) tissue used for cosmetic procedures like breast reconstruction and augmentation do satisfy the “homologous use” test and do not require a clinical trial.

Essentially, under these guidelines, the FDA strong-arms the child with cerebral palsy and the war veteran to the back of the medical bus, while giving breast augmentation the VIP treatment and ushering it to the front.  Sorry FDA, big breasts are not more important than curing diseases. 

FDA Should Respect Privacy Rights

Additionally, as I have written about previously, Americans have a constitutionally-protected privacy right in their own cells.  The FDA’s new rules completely ignore this right.  It is a basic right that emanates from established Supreme Court case law and fundamental principles of personal liberty and autonomy, and protections against undue intrusions upon bodily integrity. 

One’s body and one’s health are indeed intimate and personal matters that federal agencies must respect.  Instead of being overly preoccupied with a cell’s “same basic function,” the FDA needs to be concerned with a person’s “fundamental basic right” to use their own cells as they see fit.

In fact, one could easily argue that sufficient government regulation and patient protections already exist in federal and state law, as well as medical ethics boards.  The truth is that additional federal regulations are unnecessary, unduly burdensome, and infringe upon the sanctity of the physician-patient relationship and our right to control our own bodies. 

Commissioner Gottlieb’s declaration that patient safety is of paramount concern is a pleasure to hear.  However, in practice, the FDA’s regulatory efforts will likely serve to retard medical innovation and force Americans to travel abroad for life-saving stem cell therapies. They also preserve a “clinical trial” approach to treatment that, when applied to stem cells, has proven itself to be unduly burdensome, unreasonably slow, and unbelievably expensive.

Ultimately, what is abundantly clear is that the American people have spoken.  Their voices are filled with pain and they must be heard.  Retrograde stem cell policy is inimical to curing disease and is an affront to the elimination of pain. 

A. Rahman Ford, PhD, is a freelance researcher and writer on the issues of politics, policy and health. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor in Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.  

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

4 Infusions That Can Help Relieve Chronic Pain

By Barby Ingle, Columnist

I am so excited to finally be to my favorite letter – "I" -- in my series on alternative pain treatments. The “I” stands for infusions.

There are many different types of infusions, but the four I will cover are ketamine, immunoglobulins, lidocaine and stem cells. I have done 3 of the 4, and one of my good friends has done the fourth with great success. So I feel comfortable sharing what I know about infusions based on my personal health journey.

Ketamine

I was afraid of ketamine when I first heard about it. Ketamine was created in 1962, when it was first synthesized by scientist Calvin Stevens at the Parke Davis Laboratories. Ketamine is a potent anesthetic that blocks pain by acting as a N-methyl-D-aspartate (NMDA) receptor antagonist. It can also reset glia nerve cells in the spine and brain.

Ketamine is not appropriate for everyone. For me, I saw it as a chance to reverse the Reflex Sympathetic Dystrophy (RSD) that I had been living with since 2002.  My excitement was great, along with my family’s. My regular treating doctors were not so optimistic about ketamine, but were not discouraging it either.

I began receiving ketamine infusions in 2009. They put me into remission and I continue with booster therapy as needed. I still have flares, but ketamine got me through the biggest challenges of living with RSD. Here is a video of me after my initial infusion treatments, which many find motivational.

Before I started getting ketamine infusions, they wanted me off opioids completely so that my nervous system would reboot better. Research showed that ketamine patients on opioids were not getting the same good results as people who stopped taking them. Since then, I have also learned that opioids also set off glia cells, which is not a good thing for nerve pain patients.

Immunoglobulins

Intravenous Immunoglobulin – known as IVIg --  is used to treat various autoimmune, infectious and idiopathic diseases. One of my best friends, who has multifocal motor neuropathy, uses it to stay functional.

I have not had IVIg yet, but if ketamine didn’t work for me, I would give it a try, insurance permitting. The cost per treatment is between $5,000 and $10,000, so for many it is not an option.

If you have the cash, the FDA has approved IVIg for graft disease and idiopathic thrombocytopenic purpura (ITP). It is also used to treat patients with Kawasaki disease, Guillain-Barre syndrome, and polymyositis/dermatomyositis. I know a number of people who have used it for RSD.

One of the complaints I have heard from friends who use IVIg is that it takes time before your feel any benefits – sometimes days or weeks. If it is a viable treatment for you, there should be some changes in your symptoms and pain levels within 4 weeks.

However, some people do not respond to IVIg and it is very expensive to try just to see what happens. The cost is high because immunoglobulin products come from the pooled human plasma of a thousand or more blood donors, who have to go through an extraction process themselves before it can be processed and ready for use in infusions.

Stem Cells

Stem cell research could pave the way for an entirely new approach to chronic pain that reduces the current reliance on opioids and other analgesics.

I tried two rounds of stem cell infusions for gastroparesis, intestinal ischemia, heart valve dysfunction, cardiac ischemia, and temporomandibular joint disorder (TMJD).

The infusions reversed my gastrointestinal issues within 24 hours and my heart issues in 7 days, but it took longer for my TMJD to feel any relief. I did get some, just not as much as the other areas of my body. I also got improved function in my ovaries, with an increase in estrogen production I did not have before stem cell therapy.

The providers I worked with said it would take 6 to 8 rounds of stem cell infusions to help my nerve pain. I don’t have the money for that, so I stopped after two treatments.

Stem cell studies I have seen show great promise for multiple sclerosis patients, and I will be watching closely to see if it works for RSD and other neuro-autoimmune diseases. Stem cells could also be used as a tool to reverse opioid tolerance and opioid-induced hyperalgesia, two problematic side effects of opioid therapy.

Lidocaine

Although my providers told me that lidocaine infusions are practically pain free, I can tell you they are not. The lidocaine infusions I was given were in conjunction with my stem cell therapy. I felt everything and came away feeling that lidocaine was not a good option for me.

My step sister did have good results from her 7-day infusions of lidocaine, so it goes to show that you have to check to see what works best for you.

Lidocaine is an amide anesthetic and has a wide range of mechanisms of action. Research has shown that lidocaine, when given in a low dose intravenous infusion, has successfully provided pain relief for several chronic pain conditions that have failed other treatment modalities. A recent study in Pain Medicine found that lidocaine provided pain relief to 41 percent of patients, most of whom had neuropathic pain. 

According to providers at Stanford University, the success of lidocaine infusion is dependent on the specific cause of your pain. Some patients report immediate and long lasting pain relief, while others say relief came slowly and only lasted while the medication is being infused. Some patients also report unpleasant side effects.

The only adverse reaction I had – besides the fact it didn’t work for me – is that the infusion itself was extremely painful. Physicians have no way of knowing how you’ll react until you try it. By the time I was begging for help during the infusion, it was too late.

PNN columnist Crystal Lindell has been getting lidocaine infusions and they’ve helped Crystal reduce her use of painkillers. A recent study in Pain Medicine found that lidocaine provided long-lasting pain relief in 41 percent of patients, most of whom had neuropathic pain. 

I would be glad to share more of my experiences with infusions for anyone who has questions from the patient perspective. I would also love to hear your stories about infusions and whether they worked for you. 

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

A Promising Solution to Lower Back Pain

By A. Rahman Ford, Columnist

As many of us can attest to, lower back pain (LBP) is a debilitating and painful medical condition that severely impacts quality of life.  An analysis of the Global Burden of Disease in 2010 showed that LBP ranked as the greatest contributor to disability out of nearly 300 conditions studied. 

Lower back pain tends to peak in older age groups; thus, regions with higher life expectancies are disproportionately impacted.  The number of people with LBP is projected to increase in the coming decades, especially in low- and middle-income countries.  About 149 million work days are lost every year in the U.S. because of LBP, at an estimated cost of $100-200 billion.  

Of course, the costs to the patient – both financial and emotional – can never be adequately quantified.

Tough Questions, Few Answers

Although the causes of LBP generally are multifarious, the National Institutes of Health maintains that the majority of cases are mechanical in nature.   The gradual degeneration of the spine as a result of normal wear and tear – referred to as spondylosis – can result in a myriad of painful conditions that range from simple sprains, to herniated or ruptured discs, to injuries caused by trauma. 

While the causes of lower back pain are rarely addressed, analgesic medications are routinely prescribed to treat its symptoms.  Commonly prescribed medications include opioids, NSAIDS, anticonvulsants, antidepressants, counter-irritants and epidural steroid injections.

However, these analgesic treatments have shortcomings: potentially dangerous side-effects, adverse drug interactions, addiction, organ damage or only temporary relief.  Other treatment options include physical therapy, transcutaneous electrical nerve stimulation (TENS), acupuncture and in extreme cases, surgery. 

Sadly, neither the conservative management nor the more invasive surgical options consistently yield satisfactory results, because they fail to address the underlying disease processes.  In fact, some treatments may actually lead to a worsening of the condition in the long term.  Undoubtedly, new approaches are needed to solve the problem.

Research Supports Stem Cells for LBP

Many cases of lower back pain involve structural damage to the intervertebral discs, either by way of a herniated disc or degenerative disc disease (DDD).  This condition is quite prevalent among older adults, with one study finding that 95% of older Americans exhibiting some degree of disc degeneration. 

In the search for treatments beyond analgesics and surgery, several researchers have demonstrated the effectiveness of stem cell therapy in treating disc injuries in both humans and animals. 

Leung et al. (2006) and Drazin et al. (2012) noted the potential for mesenchymal stem cells (MSC) to treat intravertebral disc degeneration in laboratory animals.  Orozco et al. (2011) used autologous bone marrow-derived MSCs to treat 10 patients with lumbar disc degeneration, who exhibited rapid improvement in pain and disability. 

Similarly, Pettine et al. (2015) reported significantly reduced pain scores in 26 patients who received autologous bone marrow-derived stem cells. 

Coming to a Clinic Near You?

Just this year, Centeno et al. successfully used an injection of autologous bone marrow derived MSCs to treat DDD in 33 patients with lower back pain.  The authors found “no safety issues, substantially reduced pain, increased function and reduced disc bulge size in most patients.”

That treatment utilized stem cell technology created by BioRestorative Therapies, which uses autologous bone marrow-derived MSCs to treat chronic lumbar disc disease.  According to the company’s website, “not only could this program potentially eliminate surgery in many cases, but it could also provide substantially more effective treatment than current non-invasive therapies with a design to be curative.”  The company has been cleared by the FDA for Phase 2 clinical trials to treat lower back pain due to DDD.

DiscGenics, a biotech company based in Utah, has also received FDA approval for a study of stem cell therapy to treat patients with intervertebral disc disease. DiscGenics’ approach is different, because it uses patented technology to derive its proprietary “discogenic cells” directly from adult human disc tissue.

“We believe it has the potential to offer pain relief and restored function to millions of patients suffering from the debilitating effects of lower back pain,” DiscGenics CEO Flagg Flanagan told The Salt Lake Tribune. “Receiving the go-ahead from the agency to begin in-human trials is a critical step forward for our clinical program.”

DiscGenics plans to begin enrolling 60 patients in the study before the end of the year.  

Although both BioRestorative and DiscGenics have therapies that look promising, it will be some time – likely years – before either treatment is publicly available. But these studies could be a major step forward in finding an actual cure for back pain, not just another treatment that masks the pain.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor in Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.  

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

How the FDA Can Help Solve the Overdose Crisis

By A. Rahman Ford, Columnist

As the U.S. Food and Drug Administration prepares to issue new guidelines on stem cell therapy, it must give due consideration to the ever-increasing number of Americans who suffer from intolerable chronic pain.

According to the National Institutes of Health, over 25 million American adults suffer from chronic pain and nearly 40 million have severe levels of pain.  To alleviate that pain, many turn to addictive opioid medications, sometimes with deadly consequences. 

Under former FDA Commissioner Robert Califf, the agency took several steps to reduce opioid addiction, including improved warning labels, enhanced education for prescribers, and the development of abuse-deterrent drug formulations. 

Unfortunately, those initiatives have had negligible success in stemming the tide of opioid overdose, perhaps because, as Califf himself put it, “financial incentives in the (pharmaceutical) industry can lead to a focus on short-term profits instead of patient well-being.”

Indeed, although opioid addiction has seeped into the public consciousness and ascended to the top of many politicians’ agendas, the attention has been largely rhetorical -- practical, immediate-term solutions to the overdose crisis remain few and far between.  Clearly, new approaches are needed. 

Stem cell therapy can be a meaningful intervention in the effort to eradicate chronic pain and end opioid deaths.  The fact is that many physicians are already using stem cells to treat chronic pain safely and effectively, and have been doing so for years. 

Stem cell therapy can be a meaningful intervention in the effort to eradicate chronic pain and end opioid deaths.  The fact is that many physicians are already using stem cells to treat chronic pain safely and effectively, and have been doing so for years.  But with the issuance of new guidelines, which are expected this fall, the FDA could very well limit access to stem cell therapy, even to stem cells that come from our own bodies. 

Current FDA Commissioner Scott Gottlieb recently said stem cells hold “significant promise for transformative and potentially curative treatments,” but some unscrupulous stem cell clinics were preying on sick people desperate to find cures. While cracking down on these bad actors, Gottlieb must not lose sight of the fact that stem cell therapy is a potential solution to everyday Americans’ chronic pain.

Science Supports Stem Cells for Pain

Let’s take a brief look at some of the recent scientific literature about stem cell therapy, and how it can attenuate or even eliminate the chronic pain that results from a myriad of medical conditions. 

A 2014 study in the Journal of Pain Research made the case for the use of adult stem cells to treat neuropathic pain.  Due to the "scarce response to the conventional analgesic therapy,” the authors said it was “mandatory to identify and propose novel approaches" to neuropathic pain. They noted the “fast onset and long-lasting effect on pain relief that one injection (of stem cells) could provide,” an outcome far superior to drugs which require chronic administration, have side effects, and require periodic dose increases.

That same year, an editorial in the British Journal of Medical Practitioners entitled “Stem Cell Therapy: The Future of Pain Medicine” claimed that “recent advancements for SCT (stem cell therapy) for pain due to degenerative diseases in the spine and joints are promising and indicative that SCT will undoubtedly play a major role in the future.” 

A 2015 review in the World Journal of Stem Cells examined the plausibility of using stem cells to treat acute, chronic and neuropathic musculoskeletal pain, concluding that stem cells “show promise for several chronic non-life-threatening yet disabling conditions.”

Just this year, in a review published in Frontiers in Immunology, researchers said stem cells derived from a patient’s bone marrow “may provide efficient, long-term, and safe therapy for patients with painful diseases” such as osteoarthritis, degenerative disc injuries, inflammatory bowel disease, neuropathic pain, and pain associated with cancer and radiotherapy.

Stem cells can alleviate pain in a myriad of ways.  A recent study published in Military Medicine found that a low-dose stem cell injection significantly attenuated neuropathic pain in injured rats, regardless of whether the cells were derived from bone marrow or adipose (fatty) tissue.  The authors concluded that the therapy “has great potential to emerge as an innovative, safe, efficacious, and cost-effective therapy for the treatment [of] neuropathic pain or other chronic pain conditions.”

A 2016 study published in International Orthopaedics followed 26 patients who suffered from chronic discogenic lower back pain who were injected with their own bone marrow concentrate.  All 26 patients had a significant decline in their pain and disability scores, and were able to avoid surgery. 

Stem Cells Can be a Remarkable Solution

As the above sampling of literature suggests, stem cells can treat chronic pain caused by several illnesses.  It is important to note that no subjects in any of the referenced studies experienced significant adverse effects.  Safety was simply not an issue.  The results regarding the use of autologous stem cells – a patient’s own stem cells -- are especially noteworthy because, so long as the cells are “minimally manipulated,” under current FDA regulations approval is not required.

If this were to change due or be restricted under new FDA guidelines, many patients would be left with no viable pain treatment options.  Let us not forget that former Texas governor and current Secretary of Energy Rick Perry once suffered from chronic back pain, and found no answer in surgery or pills.  Perry found relief in his own stem cells.  All of us deserve that chance.

On June 13 of this year, Commissioner Gottlieb made it clear that “everyone at the FDA is committed to focusing on all aspects of the [opioid] epidemic” and promised to seek input from the public “to share additional steps and information that the FDA should consider in addressing these challenges.” 

Commissioner Gottlieb, a growing number of Americans like Secretary Perry are already using stem cells to solve problems that current treatment modalities have failed to cure.  They're traveling to clinics at home and abroad because their pain is disabling and insufferable. 

Commissioner Gottlieb, by adopting a forward-thinking policy on stem cell therapy – specifically autologous stem cell therapy – you can fulfill your promise to the American people.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor in Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.  

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

NFL Players Tackle Pain with Regenerative Medicine

By A. Rahman Ford, Columnist

Several members of the Seattle Seahawks have opted for a regenerative medicine therapy called Regenokine to treat their pain and injuries, and the players believe it has made a big difference. 

The Seahawks were one of the NFL’s healthiest teams last season, ranking 5th out of 32 teams overall.  However, key players such as defensive back Earl Thomas and wide receiver Tyler Lockett had season ending injuries. Other players, like quarterback Russell Wilson and cornerback Richard Sherman, had nagging injuries that limited their effectiveness on the field. 

Unfortunately, serious injuries are all too common in the NFL.  According to NFL injury data, the incidence of anterior cruciate ligament (ACL) tears in the knee during the regular season has remained relatively consistent since 2012, with 36 reported in 2016. 

Likewise, the incidence of medial collateral ligament (MCL) tears has remained steady, with 143 incidents reported last season.  Suffice it to say, these injuries can require surgery, shorten playing careers and can be extremely painful, both physically and emotionally.

SEAHAWKS RECEIVER DOUG BALDWIN

Painkiller Use in the NFL

To cope with the pain, many NFL players resort to using opioid painkillers. According to the Washington Post, sealed court filings in a lawsuit filed by 1,800 former players asserted that the NFL violated federal law in prescribing painkillers to players.  Specifically, the players contended that the NFL disregarded DEA guidance on how to distribute controlled substances, and encouraged players to use powerful painkillers and anti-inflammatory drugs.  Team doctors who were deposed admitted to violating federal laws in prescribing painkillers. 

According to the filings, the average NFL team prescribed 5,777 doses of NSAIDs and 2,213 doses of controlled medications.  This amount averages to about 6-7 pain pills or injections per week per player. As a result, the players maintain that they suffered long-term organ and joint damage. 

In some cases, painkiller use in the NFL has led to addiction.  Hall of Fame quarterback Brett Farve, known for his durability and aggressive play, detailed how he would take 15 Vicodin at a time every day, and even resorted to asking teammates for their pills.

Regenerative Medicine as an Alternative to Existing Pain Therapies

In search of treatment options, several Seahawks traveled to England this year for a procedure known as Regenokine, or Orthokine.  The patented process was invented by Dr. Peter Wehling, Co-Director of the Center for Molecular Orthopaedics and Regenerative Medicine in Dusseldorf, Germany.  He, along with Klaus Wehling and biologist Dr. Julio Reinecke, founded the company Orthogen in 1993 to provide a joint-preserving alternative to traditional surgery. 

Orthokine works by using a patented syringe to incubate the “autologous conditioned serum” (ACS) in a patient's blood. In this phase, the blood is exposed to glass spheres, enriching the number of anti-inflammatory cytokines, interleukin agonists, and multiple growth factors.  After incubation, the blood is spun in a centrifuge to separate the solid components from the serum.  The ACS is later injected into the affected tissues. 

The therapy is not yet FDA approved, but is being offered by some clinics in the U.S. The cost of the procedure can vary.  Lloyd Sederer, MD, chief medical officer of the New York State Office of Mental Health, went to California in 2011 for ACS therapy of his arthritic knees and sore shoulders. He was charged $9,000 for the first joint and $3,000 for each subsequent joint.

Is the Treatment Effective?

Research on the effectiveness of the ACS/Orthokine/Regenokine treatment is scant but positive.  A 2015 study by Garcia-Escudero and Hernandez-Trilllos of 118 patients with unilateral knee osteoarthritis found significant improvements in pain over a two-year period.  These patients chose to forego surgery and instead opted for ACS and physiotherapy. 

A 2009 study had similar results with 376 osteoarthritis patients, concluding that the ACS therapy reduced pain and increased functional mobility for up to two years.  However, Rutgers et al. (2015) found no significant, long-term clinical improvement in 20 patients with osteoarthritis treated with ACS.  In 2009, Becker et al. used ACS successfully on patients with unilateral lumbar radiculopathy, or sciatica.  Ravi Kumar et al. (2015) replicated those results in 20 patients, leading the authors to conclude that “ACS can modify disease course in addition to reducing pain, disability and improving general health.”  In no study were there significant safety issues.

The reality is that interest in the therapy is largely driven by anecdotal, but promising evidence.  Dr. Sederer, who detailed his ACS treatment in an Atlantic article, was very happy with the results.  Seahawks linebacker K.J. Wright had ACS therapy to treat his nagging knee injury and told the Seattle Times he felt “1,000 percent better” than before.  Receiver Doug Baldwin, Defensive End Michael Bennett and several other Seahawks also traveled to Europe for ACS therapy.

Player reports have been so positive that Seahawks head coach Pete Carroll affectionately refers to receiving the therapy as “entering the circle.”  Other athletes have reported similar positive results, including MLB player Alex Rodriguez, NBA star Kobe Bryant and professional volleyball player Lindsay Berg.

Another Option in Tackling Chronic Pain

Overall, ACS/Orthokine/Regenokine therapy is very promising in treating pain.  However, the dearth of clinical data may cause some patients to choose a different option.  In addition, the cost – which is not covered by insurance – is likely prohibitive for most. 

To further complicate matters, there have been no published studies comparing the efficacy of ACS to other, better researched regenerative therapies such as platelet-rich plasma (PRP) therapy or stem cell therapy.  However, the good news for patients is that regenerative medicine alternatives to prescription painkillers are becoming more popular and more widely accepted.

A. Rahman Ford, PhD, is a lawyer and research professional who lives with chronic inflammation in his digestive tract. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor in Chief of the Howard Law Journal.

Rahman has received stem cell treatment and closely follows developments in regenerative medicine. He is not affiliated with any stem cell treatment provider.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

FDA Should Tread Carefully with Stem Cell Regulation

(Editor’s note: This week FDA commissioner Scott Gottlieb said the agency would crack down on clinics that offer experimental stem cell treatments. While acknowledging that stem cells offer “significant promise” for treating chronic pain and other chronic conditions, Gottlieb said some clinics were preying on sick people desperate to find cures.

A. Rahman Ford has received stem cell treatment and has been closely following developments in stem cell research and regenerative medicine.)

By A. Rahman Ford, Columnist

On its face, FDA Commissioner Gottlieb's statement seems like a reasonable approach to regulating stem cell therapies.  He emphasizes the need to balance costs and benefits, and the need to protect vulnerable consumers from exploitation. 

I think all can agree with the Commissioner when he states that "these technologies hold the potential to significantly alter the course of a broad range of diseases."  These diseases are often accompanied by intense physical pain that pharmaceuticals cannot relieve.

Specifically, the Commissioner makes three heartening observations. First, he acknowledges the "significant promise for transformative and potentially curative treatments" offered by regenerative medicine.  This is a promise that mainstream pharmaceutical medicine has yet to fulfill, and one that those suffering from chronic pain need addressed immediately. 

Second, it is without question that regulatory clarity and the resolution of legal uncertainty regarding these therapies' use can be a good thing.  If there are in fact an irresponsible "select few," or a minority of unscrupulous, exploitative "bad actors" as the Commissioner claims, then legal action by the FDA against them is reasonable. 

fda commissioner scott gottlieb

Finally, the Commissioner seems to implicitly recognize how critical it is for the FDA to respect the distinction between medical products subject to agency oversight, and those which fall under the "practice of medicine," a distinction which Commissioner Gottlieb acknowledges is fraught with "close calls."

That said, as an advocate for patients seeking stem cell therapies, upon reading Commissioner Gottlieb's statement I am overall circumspect.  It is well known that the FDA has a rather unsettling history of issuing regulations that unduly restrict patients' access to stem cell therapies, specifically autologous stem cell therapies.  These are therapies that use cells harvested from one person, are minimally manipulated, and then administered to the same person. 

I've previously made my position on this "personal" stem cell therapy known, particularly the privacy implications involved. 

Restrictions such as the unduly burdensome "minimally manipulated" federal standard and the "same basic function" requirement are clear evidence of an intent to restrict.  So, the fact that Commissioner Gottlieb's statement reiterates the "same basic function" standard as a factor in requiring that a stem cell therapy be approved through a clinical trial, rather than it being part of the "practice of medicine," seems to indicate more of the same federal overreach.

Make no mistake, the potential dangers of stem cell therapy are real, and proactive effort to protect patients is far better than any reactive effort.  However, the potential dangers should not be overstated or exaggerated ostensibly toward the end of more unnecessary restrictive regulation. 

The FDA has a history of doing this.  For example, the New England Journal of Medicine published a commentary in March by then FDA Commissioner Robert Califf arguing that, aside from a few indications, the clinical use of autologous stem cell therapies has not been proven effective and can even be dangerous. 

Not only did the article ignore years of clinical data from medical practitioners, the one cited example of the danger of autologous stem cells was actually an example of allogeneic stem cell use -- stem cells from another person!

Thus, when the Commissioner asserts that the FDA will "aid in the effort to bring novel therapies to patients as quickly, and as safely, as possible," it simply belies history.  Likewise, overtures made toward any potential regulations being congruent with the 21st Century Cures Act are dubious.  The spirit of the Cures Act is clear; it calls for the "accelerated approval for advanced regenerative therapies." 

More federal regulation rarely, if ever, leads to acceleration of anything.  In fact, it almost always tends to slow things down.  Thus, unnecessary and unreasonably burdensome regulation by the FDA could contravene the will of Congress, and thus the will of the American people.

Texas Legalizes 'Personal' Stem Cell Therapy

Furthermore, the FDA's prospective regulatory guidance must be viewed in the context of recent events in Texas.  On June 13, Texas governor Greg Abbot signed HB 810 into law, which made Texas the first state to legitimize the use of personal stem cell therapies statutorily. The signing of the bill was celebrated not only by stem cell advocates, but by the countless Americans who suffer from chronic, debilitating conditions for which the current medical services delivery model can offer only surgery and medication.  For many, it was a monumental step forward toward fulfilling the promise of regenerative medicine and realization of true health care.  

However, the FDA may have seen this move as reinforcing a "wild west" stem cell landscape, a landscape which it believes it must police.

All of us, including FDA officials, should be reminded that on February 28, at President Trump's first State of the Union speech (and on Rare Disease Day), the President took note of Sarah Hughes, a young attendee who had used her own stem cells to successfully treat Pompe’s Disease. The therapy normalized her immune system, alleviated her symptoms and helped reduce her medications from 22 to 8.

We must also remember the promise President Trump made to America's military veterans, many of whom suffer from painful, debilitating conditions that may be treated or cured by stem cells.  President Trump cares deeply about veterans' health.  He recently signed the Veterans Appeals Improvement and Modernization Act, which streamlines the process of veterans appealing claims over disability benefits.  He also signed a bill that will let more veterans bypass the Department of Veterans Affairs and instead receive treatment from private doctors. 

Finally, he signed legislation approving new tools to expand the VA's existing Telehealth Services, so veterans can schedule appointments and have video consultations from their mobile phones.  It seems obvious that President Trump would never support restricting veterans' access to the medical care they need, including stem cells.

I believe that President Trump, through his devotion to our veterans, the Congress through the Cures Act, and the American people through their need for medical alternatives, would strongly disagree with any unreasonable curtailment of stem cell therapies. 

The FDA must not defer to the opinion of "industry," and must prioritize the needs of Americans like Sarah Hughes and our suffering wounded warriors.  People are in pain and pills can’t always help them.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor in Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Dr. Ford is not affiliated with any stem cell treatment provider. He suffers from chronic inflammation in his digestive tract and is unable to eat solid food.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

FDA Expands Crackdown on Stem Cell Clinics

By Pat Anson, Editor

The Food and Drug Administration is stepping up its campaign against experimental stem cell therapies, which are increasingly being used to treat cancer, diabetes, neuropathy, back pain and other chronic illnesses.

On Friday, the FDA raided two stem cell clinics operated by California Stem Cell Treatment Centers, and seized five vials of a smallpox vaccine supplied by StemImmune in San Diego. The vaccine is mixed with stem cells derived from a patient’s body fat – known as adipose tissue -- and then injected back into the patient. The FDA considers that “an unapproved and potentially dangerous treatment” for cancer.

On Monday, the FDA also sent a warning letter to a stem cell clinic in Florida, which advertises stem cells derived from body fat to treat a variety of chronic illnesses, including rheumatoid arthritis, lupus and other autoimmune diseases. Three elderly women at the clinic went blind after having stem cells injected into their eyes in an attempt to treat macular degeneration.

in a lengthy statement announcing the crackdown,  FDA commissioner Scott Gottlieb, MD, said stem cell therapy and regenerative medicine hold “significant promise for transformative and potentially curative treatments,” but some “bad actors” were preying on sick people desperate to find cures.

“There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products,” Gottlieb warned.

“In such an environment a select few, often motivated by greed without regard to responsible patient care, are able to promote unproven, clearly illegal, and often expensive treatments that offer little hope, and, even worse, may pose significant risks to the health and safety of vulnerable patients.”

Dr. Mark Berman, a co-founder of California Stem Cell Treatment Centers, told the Los Angeles Times that Gottlieb’s comments were "disparaging and misrepresentative," and showed "a lack of understanding" of stem cell treatments. 

As PNN has reported, hundreds of stem cell clinics have opened around the country in recent years, often mixing hope with hype to make claims such as “You don’t have to accept chronic pain as a fact of life.”  The treatments are expensive and usually not covered by insurance.  A clinic in Sacramento, for example, charges $5,000 for a single joint injection and $6,000 for a spinal injection.

FDA officials say there is not enough evidence to support some of the newer stem cell therapies – particularly when cells are harvested from a patient’s own body fat (adipose tissue).

“Stem cells derived from sources such as adipose tissue are being used to treat multiple orthopedic, neurologic, and other diseases. Often, these cells are being used in practice on the basis of minimal clinical evidence of safety or efficacy,” wrote Robert Califf, MD, Gottlieb’s predecessor as FDA commissioner, in a commentary published in the New England Journal of Medicine.

Some patients, however, have reported remarkable recoveries from chronic conditions often deemed untreatable. Sara Bomar, for example, was confined to a wheelchair after being diagnosed with arachnoiditis, a painful inflammation of nerves in her spinal column. She started walking again after a high dose infusion of stem cells made from adipose tissue.

“I am able to walk. I am able to workout at the Y. I am still careful. It’s not like I don’t ever have any pain, I do have a little bit from time to time. But it is nothing compared to what I had before,” Bomar told PNN.

Gottlieb said the FDA would release new guidelines in the fall to outline what types of stem cell therapy and regenerative medicine would be allowed. And he warned that more enforcement actions were coming, like the ones in Florida and California.

“I will not allow these activities to go unchecked. I’ve directed the FDA to launch a new working group to pursue unscrupulous clinics through whatever legally enforceable means are necessary to protect the public health,” Gottlieb said.

Some patients who have the resources are heading to Europe to get regenerative treatments that can't get in the U.S.  The Seattle Seahawks this week sent five more players to Germany to have their blood processed and re-injected to treat nagging injuries. The procedure involves withdrawing blood from the patient and then spinning it to produce a high concentration of platelet cells. The plasma is then injected back into the patient at the injury site, speeding up the healing process. Two other Seahawks have already had the procedure, along with athletes such as Kobe Bryant and Alex Rodriguez.

Stem Cell Vaccine Could Reverse Arthritis

By Pat Anson, Editor

A team of researchers has successfully used gene-editing technology to “rewire” mouse stem cells to fight inflammation – a finding that could pave the way for a new class of biologic drug that replaces cartilage and protect joints from damage caused by arthritis.

The stem cells, known as “smart” cells (stem cells modified for autonomous regenerative therapy), were developed at Washington University School of Medicine and Shriners Hospitals for Children in St. Louis, in collaboration with investigators at Duke University and Cytex Therapeutics in North Carolina.

The research findings are published in the journal Stem Cell Reports.

"Our goal is to package the rewired stem cells as a vaccine for arthritis, which would deliver an anti-inflammatory drug to an arthritic joint but only when it is needed," said senior author Farshid Guilak, PhD, a professor of orthopedic surgery at Washington University School of Medicine.

Guilak and his colleagues grew mouse stem cells in a test tube and then used a gene-editing tool called CRISPR to remove a gene that plays a key role in inflammation. That gene was replaced with a gene that releases a biologic drug that combats inflammation.

Within a few days, the modified stem cells grew into cartilage cells and produced cartilage tissue. Further experiments showed that the engineered cartilage was protected from inflammation.

"We hijacked an inflammatory pathway to create cells that produced a protective drug," explained Jonathan Brunger, PhD, the paper's first author and a postdoctoral fellow in cellular and molecular pharmacology at the University of California, San Francisco.

IMAGE CREDIT: ELLA MARUSHCHENKO

Many current biologic drugs used to treat arthritis – such as Enbrel, Humira and Remicade -- attack an inflammation-promoting molecule called TNF-alpha. But the problem with these drugs is that they interfere with the immune system throughout the body and can make patients susceptible to side effects such as infections.

"We want to use our gene-editing technology as a way to deliver targeted therapy in response to localized inflammation in a joint, as opposed to current drug therapies that can interfere with the inflammatory response through the entire body," said Guilak. “If this strategy proves to be successful, the engineered cells only would block inflammation when inflammatory signals are released, such as during an arthritic flare in that joint."

Researchers have begun testing the engineered stem cells in mouse models of rheumatoid arthritis and other inflammatory diseases. If the work can be replicated in living laboratory animals and then developed into a clinical therapy, the cartilage grown from stem cells would respond to inflammation by releasing a drug that protects them from further damage.

"When these cells see TNF-alpha, they rapidly activate a therapy that reduces inflammation," Guilak explained. "We believe this strategy also may work for other systems that depend on a feedback loop. In diabetes, for example, it's possible we could make stem cells that would sense glucose and turn on insulin in response.

"The ability to build living tissues from 'smart' stem cells that precisely respond to their environment opens up exciting possibilities for investigation in regenerative medicine."

Farshid Guilak and co-author Vincent Willard have a financial interest in Cytex Therapeutics, a startup founded by some of the investigators. They may license the technology and realize financial gain if it is eventually is approved for clinical use.

Guilak and his colleagues at Cytex have also used stem cells to grow new cartilage that could someday be implanted into arthritic hips, delaying or eliminating the need for hip replacement surgery.

Stem cells are found throughout the body and are increasingly being used to develop new treatments to repair damaged tissue and reduce inflammation. The Food and Drug Administration considers most stem cell treatments experimental because their safety and efficacy haven’t been proven through clinical studies.

Can Stem Cells Treat Arachnoiditis?

By Pat Anson, PNN Editor

Sara Bomar thought she’d be spending the rest of her life in a wheelchair or bedridden.

sara bomar davis and husband george

But the 54-year old Tennessee woman is not only walking again, she’s been able to resume her career as a doctor after an experimental stem cell treatment for her chronic back pain.

What makes her recovery all the more remarkable is that Bomar has arachnoiditis, a spinal disease that leaves many patients permanently disabled.  

“I am able to walk. I am able to workout at the Y. I am still careful. It’s not like I don’t ever have any pain, I do have a little bit from time to time. But it is nothing compared to what I had before,” says Bomar, who practices general medicine in the Nashville area.

Bomar’s back problems started in 2000 with a ruptured disc. Surgery, physical therapy, epidural steroid injections and spinal cord stimulators all failed to stop the pain and her condition worsened. By 2008, she was in a wheelchair and diagnosed with arachnoiditis, an inflammation of the arachnoid membrane that surrounds the spinal cord.

The inflammation causes scar tissue to build around spinal nerves, which begin to adhere or stick together. That is known as adhesive arachnoiditis, which causes burning or stinging pain that can be felt from head to toe. The disease is progressive and thought to be incurable.

Or is it?

Two years ago Bomar heard about innovative stem cell treatments being offered by Todd Malan, MD, at the Center for Regenerative Cell Medicine in Scottsdale, Arizona. At the time, Malan had successfully treated only one other patient with arachnoiditis, but in that case the disease was still in its early stages. Bomar’s arachnoiditis was more advanced, but she thought stem cells were worth trying.

“It was kind of a shot in the dark,” she says. “There was really nothing else.”

Stem Cells as “Seeker Hunters”

Most people think stem cells can only be found in bone marrow or human embryos, but Malan uses fat-derived stem cells found in the patient’s adipose (fatty) tissue.  When injected into the blood stream, Malan says these stem cells are “incredible seeker hunters” that can locate and repair damaged tissue, while reducing inflammation and improving circulation.

“The key is to understand that these stem cells are designed by the body to do this repair process,” Malan said. “What we’re trying to do with these procedures is to enhance the normal process that the body uses.”

Malan enhances the process further with a high-dose infusion of as many as 100 million stem cells. For patients with spinal cord or brain injuries, he also injects mannitol, a drug used to treat head trauma that apparently helps the stem cells pass through the blood-brain barrier into the central nervous system.  

In August 2014, Bomar received a high-dose infusion of her own stem cells through an IV in her arm. Within a week, she noticed that the blood circulation in her left leg seemed to be improving.

“My mom came and visited me three days after I had the procedure and she said, ‘You know, I think your foot looks a little pinker.’ And I looked down and said, ‘Gosh mom, you’re right.’”

A few days later, Bomar noticed reduced swelling in her feet and could put on shoes that she wasn’t able to wear before. Months later, she was able to exercise on an underwater treadmill and then an elliptical machine. There was also less pain.

“The pain started to lessen. It was slow, it wasn’t all at once. But over months, which I think was fantastic progress, that pain did lessen,” she remembers. “Arachnoiditis is a pain that you deal with constantly. And it was really something not to have that constantly. I remember at first just thinking, wait a minute. I don’t have any pain right now. That was pretty amazing.”

sara and daughter anna

Bomar’s condition has improved so much that she was able to vacation with her family in California last summer, and go hiking and bike riding.

Because Bomar still has metal in a spinal cord stimulator implanted in her back, an MRI can’t be taken to confirm if the nerves in her spine are still encased in scar tissue. But Malan is confident the scar tissue is either gone or the stem cells have created enough healthy nerve tissue to bypass the problem.

“The studies have been well documented, especially for scar tissue breakdown,” he says.

Malan has now treated about two dozen patients with arachnoiditis, but is careful not to say that a cure or treatment has been found. He says more studies are needed to confirm if his stem cell therapies are safe and effective. 

“We have not had a patient yet who hasn’t had a clinical response,” he told Pain News Network. “The vast majority of the patients with adhesive arachnoiditis or chemical arachnoiditis have gotten to a point where they say their quality of life has significantly improved.” 

“I believe the doctor. I think it could be a breakthrough,” says Forest Tennant, MD, a California pain physician who is one of the world’s leading experts on arachnoiditis.

Tennant plans to begin using stem cell treatments himself, along with other experimental therapies such as growth hormones. But he doesn’t think stem cells will work on patients with advanced cases of arachnoiditis.

“I do have two patients who have tried it and it did not work. But their cases were so far along. They were already bed-bound and paralyzed, and you can’t expect a treatment like that to help,” he said. “The disease has to be in its fairly early stages for it to work, would be my guess. We don’t know enough. It’s the old story of one case does not make a treatment, but one good case certainly stimulates investigation into that treatment. And that’s where we’re at with this.”

More Clinical Studies Needed

One issue that’s been holding up investigation is that most stem cell treatments have not been approved by the Food and Drug Administration. FDA commissioner Robert Califf, MD, was openly skeptical of stem cells derived from body fat (adipose tissue) in a commentary recently published in the New England Journal of Medicine.

“Stem cells derived from sources such as adipose tissue are being used to treat multiple orthopedic, neurologic, and other diseases. Often, these cells are being used in practice on the basis of minimal clinical evidence of safety or efficacy,” Califf wrote.

Dr. Malan bristles at the notion there is not enough evidence and blames the FDA for holding up stem cell research.

“The FDA hasn’t approved a single stem cell technology in 16 years in the United States,” he said. “These are approved therapies in other countries. And to make statements that there is inadequate evidence is ridiculous. The reason there is inadequate evidence is because the FDA has not permitted us to do anything but Phase I studies.”

Until more advanced studies are conducted and new stem cell therapies approved, the treatment that appears to have worked so well on Sara Bomar will not be widely available for patients who suffer from arachnoiditis. Dr. Tennant estimates as many as one million Americans may have the disease, many of them misdiagnosed with “failed back syndrome” or other spinal problems.

“It certainly helped me,” Bomar says of stem cell therapy. “As far as I’m aware, there is nothing else out there could provide this kind of relief.”