Don’t Let Them Stop the Stem Cell Movement

By A. Rahman Ford, Columnist

Somewhat lost in Donald Trump’s presidential victory was the resounding statement made by voters that medical marijuana is here to stay.  Those people-driven victories were monumental for millions suffering from painful and debilitating illnesses -- people who could achieve a life-saving benefit from marijuana or its derivatives. 

It’s only a matter of time before the DEA changes its ridiculous classification of marijuana as a Schedule I controlled substance. 

I believe that one of the next challenges in the wellness movement is the FDA’s control over your own stem cells, or as I call them, personal stem cells.  Quite frankly, the DEA’s position on marijuana is about as misplaced as the FDA’s position on you using the cells God gave you to heal yourself. 

Some scientists have been pushing quite a bit of manufactured controversy around the issue.  Those same scientists tried the same thing with marijuana.  But now the people know the truth.

Personal stem cells are simple to understand.  I’m not talking about embryos, umbilical cords or artificial cells grown by some scientist in a lab.  When I talk about personal stem cells, I’m talking about master cells cultivated from your own bone marrow or fat. 

Yes, you have stem cells in your own body that can heal you.  

In marijuana terms, it’s like you’re your own stem cell “grow house.”  Your own cells can be used to heal any number of physical ailments, including orthopedic issues.  Orthopedists have been using the procedure for years, and there is also evidence that stem cells can be used to heal autoimmune diseases. 

Like marijuana, we really have no idea how many ailments can be improved or even cured with personal stem cells.

If you’re wondering whether personal stem cells can actually heal, look no further than professional sports.  Recently, Bartolo Colon, currently the oldest major league baseball player at 43 years of age, signed a $12.5 million pitching contract with the Atlanta Braves.  How in the world is he able to be so productive at an age where most players are long retired?  You guessed it – his own stem cells.

What about NFL Hall of Famer and two-time Super Bowl winner Peyton Manning, who literally broke his neck playing the game he loved?  Yes, his own stem cells.  International athletes like tennis champion Rafael Nadal have benefitted as well.  In fact, hundreds of professional athletes have healed from serious injuries by using their own stem cells. 

Personal stem cells can work.

Unfortunately, many athletes have to go overseas to use their own God-given healing potential, because the FDA doesn’t allow certain techniques to expand your really strong (mesenchymal) stem cells.  But these wealthy, well-connected athletes who earn their living by being fit -- often enduring severe injuries and pain -- know the truth.  Your own stem cells can heal you.

Just think how many wounded combat veterans could benefit from their own cells!  A 2014 University of Michigan study found that 60 percent of U.S. Army soldiers who were unable to return to a military career after an Iraq deployment couldn’t do so because of a muscle, bone or joint injury. The strongest predictors of inability to serve were fractures and chronic knee, shoulder, spine and back pain. 

But it’s not just musculoskeletal conditions.  Our troops also have crippling brain injuries from IED and other bomb blasts.  According to the Pittsburgh Tribune Review, tens of thousands of combat veterans returning from Iraq and Afghanistan with undiagnosed brain injuries “often were ‘thrown into a canyon’ – falling deeper into despair and sometimes flirting with suicide or addiction.”

It gets worse.  To cope with the pain and depression of injury, many wounded warriors turn to addictive pharmaceutical painkillers or illegal street drugs.  A 2011 American Public Health Association report found that the overdose rate for veterans on opioid painkillers was twice the national average, and that they are more likely to become addicted to heroin. 

Opioid abuse is such an epidemic that, in a recent letter to physicians, the Surgeon General called it a crisis and launched the “Turn the Tide” campaign to raise awareness about the issue. 

Fortunately, many wounded warriors have already begun turning the tide by replacing their toxic pills with medical marijuana.  Now, we owe it to our troops to help them turn the tide even further, by giving them another option – personal stem cells.

We celebrate our troops with parades and salutes on Veteran’s Day, Memorial Day and during just about every major sporting event, and justifiably so.  But maybe the best way to celebrate them is to allow them to heal themselves with their own cells so that they can once again be the parents, siblings and children we love.  Our government has a moral and ethical obligation to do so, and we the people have an ethical and moral obligation to make them do it.

Stem Cell Therapy Not FDA Approved

I want to be clear: clinical use of adult, embryonic and umbilical cord stem cells are not FDA approved, and any determination as to their safety or efficacy requires further research (although, in the interest of full disclosure, I have had umbilical cord stem cells in China and the therapy helped me greatly with no negative effects). These stem cells are properly under the domain of the FDA because they are biological agents that are taken from one person and injected into another person and intended to treat a disease. 

What I’m talking about are cells that go from YOU into YOU.  Personal stem cells are as natural as marijuana, and the federal government should acknowledge that your use of your own cells should be a transaction between you and a licensed physician, and regulated at the state level.

States like Colorado and Washington have already proven how safe and healing – not to mention lucrative – marijuana can be, despite what all of the “experts” were saying.  Your own stem cells are no different.

Right now, personal stem cells are technically legal, but the future regulatory landscape is so uncertain that few physicians offer it and few Americans can afford it.  Rather than expanding access to personal stem cells, the FDA has recently tried to restrict their use.

The proposed action by the FDA is wrong.  Unfortunately, it seems like the agency is refusing to hear the cries of persons with disabilities (like myself) and wounded warriors who come home crippled after serving abroad -- so that the children of federal agency bureaucrats can be safe here at home.

I believe marijuana legalization gives personal stem cell advocates hope.  The legalization movement succeeded despite federal intransigence because of the success of direct democracy. People voted at the state level in referendums, without elected officials operating as self-interested intermediaries. 

Given the important nature of this issue, and the apparent ineffectiveness of federal government lobbying and litigation alone, the personal stem cell movement may need to add a referendum component as well.  It may be difficult, but it can be done. 

Educate yourself, and then educate others.  Human beings are not drugs.  We need to keep it that way.

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.

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org.

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 Therapy: Hope or Hype for Pain Patients?

By Pat Anson, Editor

The testimonials sound so encouraging. Chronic pain from arthritis, neuropathy and degenerative disc disease begins to fade after a single injection of stem cells.

“The next day after a needle went in there, the next morning they felt better. Immediately,” says 93-year old Curtis Larson, who suffered from neuropathic pain in his feet and ankles for nearly a decade.  

"Pain’s all gone. Completely gone,” Larson says in a promotional video hosted on the website of Nervana Stem Cell Centers of Sacramento, California.     

“You don’t have to accept chronic joint pain as a fact of life. There’s still hope even if medications and other treatments haven’t worked for you. Our practitioners can explain to you how stem cell treatments work and whether you can benefit,” the Nervana website states. “Relief may be on its way!”

We’ve written before about experimental stem cell therapy and how injections of cells harvested from a patient’s bone marrow or blood are being used to treat chronic conditions such as low back pain.

Professional athletes such as Kobe Bryant and Peyton Manning have used one stem cell treatment – known as platelet rich plasma therapy -- to recover from nagging injuries and revitalize their careers.

But has stem cell therapy moved beyond the experimental stage? Is it ready for widespread use?

“Published data derived primarily from small, uncontrolled trials plus a few well-controlled, randomized trials have not reliably demonstrated the effectiveness of stem-cell treatments,” wrote FDA commissioner Robert Califf, MD, in a commentary recently published in the New England Journal of Medicine – an article clearly aimed at throwing cold water on some of the hype surrounding stem cell treatment.

Califf and two co-authors said there is simply not enough evidence to support some of the newer stem cell therapies – such as cells harvested from a patient’s body fat (adipose tissue).

“The safety and efficacy of the use of stem cells derived from peripheral blood or bone marrow for hematopoietic reconstitution are well established. Increasingly, however, hematopoietic stem cells and 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, sometimes with the claim that they constitute revolutionary treatments for various conditions,” they wrote.

But the lack of evidence and FDA approval haven’t stopped stem cell clinics from popping up all over the country. Over 570 such clinics now operate nationwide, with over a hundred of them in California alone, according to the Sacramento Bee. Some clinics – such as Nervana Stem Cells – are hosting free seminars for chronic pain patients, publicizing them with advertisements that read, “We want you to start living your life pain free!”

A Sacramento Bee reporter attended one seminar and listened to a former chiropractor who works for Nervana tell the audience that they can lower their pain scores from 8’s and 9’s to “mostly 0’s and 1’s” after 16 weeks of injections. He said the clinic has a 90 percent success rate.

Nervana does not use stems cells derived from bone marrow, blood or body fat, but uses a solution of embryonic stem cells from the “after-birth of healthy babies,” the Bee reported. Costs ranged from $5,000 for a single joint injection to $6,000 for a spinal injection. Stem cell therapy is not usually covered by insurance.

“It’s quite clear that these people are offering treatments that haven’t been tested in clinical trials. It’s a little concerning,” Kevin McCormack, a spokesman for the California Institute of Regenerative Medicine told the Bee.  

“There’s a gray zone where these clinics are operating,” he said. “The FDA needs to address the issue of these clinics and address this slow, onerous approval process for stem cell therapy.”

The FDA’s Califf says the agency is not trying to stifle research into a promising new field of medicine -- it’s just waiting for proof that the treatments work and don’t cause harmful side effects. He cited cases in which stem cell patients developed tumors or went blind after injections.

“Such adverse effects are probably more common than is appreciated, because there is no reporting requirement when these therapies are administered outside clinical investigations,” Califf wrote. “The occurrence of adverse events highlights the need to conduct controlled clinical studies to determine whether these and allogeneic cellular therapies are safe and effective for their intended uses. Without such studies, we will not be able ascertain whether the clinical benefits of such therapies outweigh any potential harms.”

Stem Cell Therapy Could Avoid Joint Replacement

By Pat Anson, Editor

An experimental stem cell treatment that grows new cartilage could someday help millions of arthritis patients avoid joint replacement surgery.

Researchers at Washington University School of Medicine in St. Louis and Cytex Therapeutics in Durham, N.C. have developed a 3-D, biodegradable synthetic scaffold that is molded into the precise shape of a patient’s hip joint.

The scaffold, which is covered with cartilage made from the patient’s own stem cells, is designed to be implanted onto the surface of an arthritic hip.

Resurfacing the hip joint with this “living” tissue could ease arthritis pain, and may delay or even eliminate the need for hip replacement surgery, according to researchers.

Joint replacement surgery is usually performed on the elderly to relieve pain from osteoarthritis, a painful and disabling condition caused by a loss of cartilage and the degradation of joints. Over a million hip and knee joint replacement surgeries are performed annually – a number expected to surpass four million by 2030 due to the aging of the U.S. population. 

WASHINGTON UNIVERSITY IMAGE

“We’ve developed a way to resurface an arthritic joint using a patient’s own stem cells to grow new cartilage, combined with gene therapy to release anti-inflammatory molecules to keep arthritis at bay. Our hope is to prevent, or at least delay, a standard metal and plastic prosthetic joint replacement,” said Farshid Guilak, PhD, a professor of orthopedic surgery at Washington University.

After inserting a gene into the newly grown cartilage and activating it with a drug, researchers say the gene will release anti-inflammatory molecules to fight arthritis.

“When there is inflammation, we can give a patient a simple drug, which activates the gene we’ve implanted, to lower inflammation in the joint,” said Guilak. “We can stop giving the drug at any time, which turns off the gene.”

By adding gene therapy to the stem cell and scaffold technique, Guilak and his colleagues believe it will be possible to coax patients’ joints to fend off arthritis, preserve cartilage, and function better for a longer time.

The 3-D scaffold is built using a weaving pattern that gives the device the structure and properties of normal cartilage. It is made with hundreds of biodegradable fiber bundles that are woven together to create a high-performance fabric that functions like normal cartilage.

“The woven implants are strong enough to withstand loads up to 10 times a patient’s body weight, which is typically what our joints must bear when we exercise,” said Franklin Moutos, PhD, vice president of technology development at Cytex.

Scientists have tested the tissue engineering in cell culture, and some customized implants are being tested in laboratory animals. If all goes well, such devices could be ready for testing in humans in three to five years.

Currently, there are about 30 million Americans who have osteoarthritis. That number includes a growing number of younger patients — ages 40 to 65 — who have limited treatment options.  Doctors are often reluctant to perform hip replacement surgery on patients under age 50 because prosthetic joints typically last for less than 20 years. A second surgery to remove a worn prosthetic can destroy bone and put patients at risk for infection and other complications.

“We envision in the future that this population of younger patients may be ideal candidates for this type of biological joint replacement,” said Bradley Estes, PhD, vice president of research and development at Cytex.

The research findings, which are published in the Proceedings of the National Academy of Sciences, are supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institute on Aging, which are both part of the National Institutes of Health (NIH).

Study Tests Stem Cells for Degenerative Disc Disease

By Pat Anson, Editor

An Australian biotech company is testing a new stem cell treatment for degenerative disc disease.

Mesoblast is enrolling patients in a Phase 3 study to see if a single injection of mesenchymal precursor cells (MPCs) taken from the bone marrow of healthy donors can relieve back pain and improve the mobility of patients with disc disease, which occurs when the cushions between vertebrae wear down because of aging, genetics or injuries.

Millions of MPCs are injected directly into the damaged disc in an outpatient procedure. Previous studies have found that MPCs have anti-inflammatory effects, and help strengthen and improve the stability of damaged discs. The treatment is being developed for patients who have exhausted other options for their back pain.

“Patients with this level of degeneration often try multiple treatments for relief, including pain medication, massage, physical therapy, chiropractic adjustments and acupuncture,” says lead investigator Kee Kim, MD, professor of neurological surgery and co-director of the University of California Davis Spine Center.

“For some of them, nothing seems to help, and we end up operating to remove the degenerated disc and fuse the spine to eliminate motion that may cause increased pain. We want to know if a single dose of this investigational therapy can offer relief without the need for surgery.”

UC Davis is one of 28 sites in the United States and Australia involved in the study. Participants with degenerative disc disease in the lower back will receive injections of either MPCs, MPCs with a carrier material (hyaluronic acid) or a placebo. Although the MPCs are collected from donors, tissue matching is not necessary.

Following treatment, participants will be evaluated by researchers six times over the course of a year. They also will be given the option to participate in an extension of the study to track their progress for three years after the initial injection.

Previous studies have found that MPCs have anti-inflammatory effects, and help strengthen and improve the stability of damaged discs. Researchers caution, however, that the treatment may not be effective for everyone.

“Many patients with back pain will not benefit from this stem cell therapy and may still require surgery,” Kim said. “For some patients, it could offer improvement. For these patients, it is worth exploring this alternative.”

You can find out more about the study by clicking here.

Stem Cell Study for Back Pain Begins

By Pat Anson, Editor

Enrollment has begun in a clinical study of an experimental stem cell therapy that could – if proven successful – revolutionize the treatment of low back pain caused by degenerative disc disease.

About 330 adults with chronic low back pain who have not responded to conventional therapy will be enrolled in the Phase III “Cascade” study at over two dozen medical centers in the United States. Participants will be injected in the lumbar disc with millions of Mesenchymal Precursor Cells (MPCs) – adult stem cells derived from donated bone marrow.

An earlier Phase II study showed that a single injection of a 6 million cell dose of MPCs reduced low back pain and improved function for at least 12 months. Participants also used fewer opioids for pain relief and required less treatment.

“If you look at the study as a whole, people who received the 6 million stem cell injection into the disc, 70 percent of them had a reduction of their pain of 50% or greater. These were clinically relevant changes,” said J. Scott Bainbridge, MD, lead investigator at Denver Back Pain Specialists, one of the clinics participating in the Cascade study.

"The clinical program is the first of its kind in the United States and we are very excited by the potential of these adult stem cells to provide a novel therapeutic approach."

Bainbridge says the stem cell injection takes up to two months to stop the pain and inflammation triggered by degenerative disc disease.

“It takes time for the stems cells to normalize the inflammatory condition,” Bainbridge told Pain News Network. “You’re taking a disc that is on a degenerative cascade or path. The stem cells regulate that, they change it from an inflammatory stage to an anti-inflammatory, homeostatic state. It turns on the engine, if you will, to start building and producing some of the things that will help the disc become hydrated and build back some of its structural integrity.”    

Degenerative disc disease is the most common cause of low back pain, which develops with the gradual loss of proteoglycan, a substance that cushions the bones of the spine and enables normal motion.

Conventional treatment includes pain medication, physical therapy or surgical intervention such as a spinal fusion. Bainbridge says stem cell injections have the potential to become a frontline treatment, to be used before a riskier treatment such as surgery.

The Cascade study is sponsored by Mesoblast Limited, an Australian company focused on cell-based regenerative medicine. Mesoblast is also developing stem cell treatments for rheumatoid arthritis and diabetic neuropathy, using “off-the-shelf” stem cells from healthy adult donors that do not require tissue matching.

“(There) is compelling evidence that Mesoblast’s stem cell technology has the potential to change the treatment of spinal disease from focusing on surgical reconstruction to biologic regeneration. Physicians and patients are seeking access to a new modality to treat patients with this highly debilitating disease for whom there are limited options,” said Hyun Bae, MD, Medical Director at the Cedars-Sinai Spine Center in Los Angeles, which participated in the Phase II study.

Unfortunately, it could take years for the therapy to win approval from the U.S. Food and Drug Administration. The Cascade study alone is expected to take about three years. For further information about the study and a list of the 25 clinics that are recruiting participants, click here.

‘Amazing’ New Stem Cell Treatment for Neuropathy

By Pat Anson, Editor

Researchers at Duke University say an experimental stem cell therapy being tested on animals shows great potential to provide long-lasting pain relief for people suffering from diabetic neuropathy or other types of nerve damage.

In a study published in the Journal of Clinical Investigation, researchers said mice injected with a type of stem cell known as bone marrow stromal cells (BMSCs) were much less sensitive to nerve pain.

"This analgesic effect was amazing," said Ru-Rong Ji, PhD, a professor of anesthesiology and neurobiology in the Duke School of Medicine. "Normally, if you give an analgesic, you see pain relief for a few hours, at most a few days. But with bone marrow stem cells, after a single injection we saw pain relief over four to five weeks."

BMSCs are known to produce an array of healing factors and can be coaxed into forming other types of cells in the body. They are already being used to treat people with serious burns, inflammatory bowel disease, heart damage and stroke.  

"Based on these new results, we have the know-how and we can further engineer and improve the cells to maximize their beneficial effects," said Ji.

Researchers injected the mice with stem cells through a lumbar puncture, infusing them into the fluid that bathes the spinal cord.

The picture on the right shows how the injected stem cells (in red) migrated to the site of the nerve injury and were still present four weeks after treatment.

A molecule emitted from the injured nerve cells -- which has previously been linked to neuropathic pain – is believed to act as a “homing signal” and attract the stem cells.

Researchers measured levels of anti-inflammatory molecules in the mice and found that one in particular, TGF-β1, was present in higher amounts in the spinal fluid of the stem cell-treated animals.

TGF-β1 is a protein that is secreted by immune cells and is common throughout the body. Research has shown that people with chronic pain have too little TGF-β1.

courtesy duke university

Injecting TGF-β1 directly into spinal cord fluid provides pain relief, but only for a few hours, according to Ji. By contrast, bone marrow stromal cells stay on site for as much as three months after the infusion.

Ji’s research team is working to identify stem cells that produce more TGF-β1, as well as other types of pain relieving molecules. In addition to diabetic neuropathy, researchers believe stem cell therapy could also be used to treat pain from chemotherapy, surgical amputation, lower back pain and spinal cord injuries.

Nearly 26 million people in the United States have diabetes and about half have some form of neuropathy, according to the American Diabetes Association.  Diabetic peripheral neuropathy causes nerves to send out abnormal signals. Patients feel pain or loss of feeling in their toes, feet, legs, hands and arms. It may also include a persistent burning, tingling or prickling sensation. The condition can lead to injuries, chronic foot ulcers and even amputations.

Another recent animal study by researchers in the U.S. and South Korea found that diabetic rats given intramuscular injections of bone marrow stromal cells experienced both angiogenesis (blood vessel growth) and a restoration of the myelin sheath -- a protective covering over nerve cells damaged by neuropathy.

"Currently, the only treatment options available for DN (diabetic neuropathy) are palliative in nature, or are directed at slowing the progression of the disease by tightly controlling blood sugar levels," said Dr. John Sladek, Jr., Professor of Neurology, Pediatrics, and Neuroscience, Department of Neurology at the University of Colorado School of Medicine.

"This study offers new insight into the benefits of cell therapy as a possible treatment option for a disease that significantly diminishes quality of life for diabetic patients.”

The study is being published in the journal Cell Transplantation.