Stem Cell Clinic in Colombia Offers Hope to International Pain Patients

By A. Rahman Ford, PNN Columnist

As the U.S. Food and Drug Administration continues to restrict access to stem cell therapy with its overly burdensome regulations, Americans with chronic pain continue to suffer needlessly.

Although many clinics in the U.S. use stem cells to treat arthritis, degenerative disc disease and other pain conditions, FDA regulatory restrictions make affordable access to these therapies inordinately difficult, if not downright impossible, for the average patient. As a result, many Americans are traveling to other countries to receive the pain treatment they need.

The BioXcellerator stem cell clinic in Medellin, Colombia is one of those destinations. Although its corporate headquarters is located in Arizona, BioXcellerator is not constrained by excessive regulations in Colombia, where it has used regenerative medicine for years to treat pain, often with remarkable results.

BioXcellerator CEO Karolynn Halpert, MD, has made it her mission to help pioneer stem cell therapy in Colombia. Dr. Halpert was an emergency room physician and administrator at a Medellin clinic before joining BioXcellerator, following the same career path as her parents, who are both physicians. As Halpert likes to joke about her interest in cellular science, “I guess you could say it’s in my DNA.”

“Not only do I get to work on the frontiers of scientific discoveries we couldn’t even envision a decade ago, I also get a chance to meet patients, help them heal, see the results, and share in their joy as they suffer less pain and enjoy healthier lives,” Halpert said in an email.

“Getting to know patients is what makes you become a ‘real’ doctor, something I think is lost with so much access to technology today.”

BioXcellerator uses mesenchymal stem cells (MSCs) derived from umbilical cord blood, a patient’s own adipose (fat) tissue or their own bone marrow. Treatment protocols are unique to each patient, with stem cells injected into parts of the body where they are most needed.

“For example, if we’re treating a spinal disorder, we inject cells directly into the spinal fluid or intrathecal space,” Halpert explained. “We often see quick results, but mostly the major benefit takes months to develop.”

DR. Karolynn Halpert

BioXcellerator tracks its patients for 12-19 months to confirm results, and to observe how the body uses stem cells to repair and regenerate tissues and joints. Halpert says she gets positive results in about 80 to 90 percent of patients, in large part because she only accepts patients who she believes can benefit from the therapy.

Most of BioXcellerator’s patients suffer from chronic pain. Halpert has treated many conditions, including osteoarthritis, rheumatoid arthritis, joint injuries, spinal damage, autoimmune conditions, orthopedic disorders and neurological conditions. She cites the example of a woman who recently came to her seeking stem cell therapy for a severely and consistently painful spinal condition.

“The day after we injected stem cells into her compressed and degenerated disc, she was here in the office jumping, dancing, hugging all of us, crying in joy, because it was the first day in years that she had suffered no pain,” Halpert recalled.

Another patient had been in a car accident that left him disabled, unable to work and in such excruciating pain that he considered suicide. “Just a few months after treatment he was no longer in pain, went back to work and enjoys life once again,” said Helpert.

Many of BioXcellerator’s patients are professional athletes, including mixed martial art competitors like Ken Shamrock, Chuck Liddell, Chris Cyborg, Frank Mir, Frankie Edgar, Kamaru Usman, Chael Sonnen and Henry Cejudo.

Others who have traveled for treatment in Colombia include professional wrestlers such as Ryback Reeves, Kevin Nash and Bobby Lashley. Other noteworthy patients include social media influencers Amberley Snyder, Jesse Golden and Brian Goldstein.

Response to Stem Cell Critics

Unlike stem cell clinics in the U.S. that are demonized as “bad actors” and “predatory,” BioXcellerator enjoys a good working relationship with INVIMA, Colombia’s equivalent to the FDA. Halpert notes that INVIMA recently approved BioXcellerator’s proposal for a clinical trial to use stem cells to treat COVID-19.

Halpert acknowledges there is a worldwide veil of ignorance among physicians about the therapeutic efficacy and potential of stem cells.  She believes Colombia may be more progressive than other countries, which is why the BioXcellerator clinic in Medellin attracts so many international patients.

As for critics who say stem cell treatments are “unproven” and “risky,” Halpert’s response is unequivocal.

“Let me be clear. We don’t put anyone at risk. Our goal is to help patients live better and stay healthy. If we put patients at risk, not only would our reputation suffer, but skepticism would grow about the entire field of regenerative medicine, and nobody wants that,” she said.

“Those who claim that our therapies are unproven are simply ignorant. Anyone who looks at the evidence with an open mind can see the proof for themselves. I don’t know what ‘critics’ you are referring to but I suspect they are not medical doctors with real experience in the field or PhD’s in biotechnology.”

As for the cost of stem cell treatment, which is usually not covered by insurance, Halpert asserts that cellular therapy is not a routine procedure and its costs are in line with those of other complex treatments such as surgery.

Medical treatment in Colombia is often cheaper than in the United States, and although international patients may be skeptical about traveling to Medellin – where drug cartels openly warred with each other in the 1980’s -- it is now ranked as one of the most innovative and smartest cities in the world.

As for the future of stem cell therapy (SCT), Halpert is optimistic.

“It’s part of a new approach that doesn’t simply mask symptoms with medications or repair structures through surgery,” she told me. “SCT really embraces a wider perspective that recognizes that the body knows how to heal itself. As we learn more about how this process works, we can make significant progress that will lead to a new age in medicine that focuses less on curing sickness and far more on health optimization, immunity, and longevity.”

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

Report Calls for Overhaul of Sickle Cell Treatment

By Pat Anson, PNN Editor

A new report by the National Academies of Sciences, Engineering, and Medicine is calling for major changes in the way sickle cell disease is treated in the United States, including an end to the discrimination and stigma that many sickle cell patients face while navigating the healthcare system.

About 100,000 Americans live with sickle cell disease (SCD), a genetic disorder that mainly affects people of African or Hispanic descent. SCD causes red blood cells to form in a crescent or sickle shape, which can create blockages in blood vessels that prevent the normal delivery of oxygen throughout the body. As a result, sickle cell patients often suffer from chronic pain, anemia, infections, strokes and organ failure.

Compared to other chronic illnesses, SCD has received little attention from the healthcare community, resulting in a lag in the development of new treatments. Until 2018, only one drug was approved by the Food and Drug Administration to treat sickle cell patients. Bone marrow and stem cell transplants are currently the only curative therapies for SCD.

“People with sickle cell disease show incredible resilience. They often have to become their own advocate to get the treatment and services they deserve — whether in the health care system, at school, at work, or in the community,” said Marie McCormick, MD, a pediatrician and professor at the Harvard School of Public Health, who chaired the committee that wrote the report.

Addressing Sickle Cell Disease: A Strategic Plan and Blueprint for Action calls for the National Institutes of Health to designate SCD as a “health disparity” to incentivize more research, and for the Department of Health and Human Services to fund efforts to identify and mitigate disparities in health outcomes for sickle cell patients.

Lack of Compatible Donors

Although stem cell and bone marrow transplants are the only cures for SCD, it’s often difficult to find compatible donors, especially for children who can benefit the most from treatment.

“Unfortunately, less than one in five individuals with sickle cell disease have compatible donors. Those children fortunate to have a fully matched sibling as a donor enjoy very high success rates with very few complications after transplantation,” said Enrico Novelli, MD, an Associate Professor of Medicine and Director of the Adult Sickle Cell Disease Program at University of Pittsburgh Medical Center.

“The success of the procedure decreases as people get older. For many adults living with sickle cell disease, stem cell transplantation is not an option, either because they are too ill to undergo the procedure, or because of a lack of donor,” Novelli said in an email to PNN.  

“And for those who are cured by transplantation and no longer have sickle cell disease, some challenges remain; for instance, the treatments to prepare the recipient for the donor stem cells may cause infertility, and years of exposure to the disease may leave a mark in terms of organ dysfunction and chronic pain. Thus, it may take a while for some patients to overcome their sickle cell-related chronic pain after a successful stem cell transplant.”

The report recommends that the Centers for Medicare & Medicaid Services and state Medicaid programs, as the lead insurers for most sickle cell patients, explore new payment methods to encourage and pay for coordinated care delivered by certified SCD centers. Insurance coverage is also needed to finance the cost of experimental new treatments, such as gene therapy.

The report calls for more diversity and “cultural competency training” for SCD care providers, as well as better training in managing acute and chronic pain. It also recommends that federal health agencies work with states to standardize newborn screening for SCD and to develop a national registry of people living with sickle cell disease.

Why Stem Cell Critics Are Wrong

By A. Rahman Ford, PNN Columnist

In a recent and rather lengthy New York Times article entitled “Stem Cell Treatments Flourish With Little Evidence That They Work,” authors Denise Grady and Reed Ableson do their absolute best to convince their readers that stem cell therapy (SCT) is based on strange, magical hocus-pocus, and its practitioners are all mad scientists. 

They portray stem cell clinics as shadowy castle dungeons lit only by the occasional lightning strike, and filled with glass beakers that froth with fluorescent-colored liquids.  The authors even use the phrase “unproven cell cocktails.”  That little piece of anti-SCT propaganda even scares me a little, and I’ve had SCT.

In the article, the authors trot out the same tired, empty and underhanded tropes that all articles of its ilk like to employ:

• “no clear evidence that these treatments work”

• “gotten way ahead of the science”

• “no regulatory oversight”

• “rogue clinics”

• “scant data”

• “not covered by insurance”

• “high risk”  

• “lack of solid medical evidence”

• “snake oil”

A recent New Yorker article isn’t much different.  Both articles do contain some valid points, but those points are obscured by the scare tactics, fear-charged language and cherry-picked patient cases.

These SCT hit pieces appear from time-to-time, but rarely in publications with the broad readership of the New York Times and the New Yorker.  After reading so many of them over the years, I began to wonder – if stem cell clinics are flourishing, then isn’t that a tacit admission that the fear-mongering isn’t working? 

And if the fear-mongering isn’t working, why do they keep publishing these less-than-objective articles?  

Maybe it’s because they feel like they are part of some consumer protection vanguard to protect Americans from sleazy medical charlatans.  Or maybe it’s because the scare tactics have failed and they have no idea what else to do. 

The fact is, as I wrote in a recent PNN column, the SCT tipping point appears to have been reached. The American public simply isn’t buying what the critics are selling. As many as 1,000 stem cell clinics are now operating in the United States, according to The Washington Post, which predicts the industry is “likely to flourish” despite a judge’s ruling that upheld the FDA’s authority to regulate — and stifle — the industry.    

The Basquiat Effect

But it gets even worse for the anti-SCT purveyors. They may be suffering from what I refer to as the Basquiat Effect.  Jean-Michel Basquiat was a graffiti-inspired painter, sculptor and musician who rose to prominence in the 1980s in New York City. 

Basquiat’s work is laden with social and political commentary, with primordial figures, abstract arrangements and linguistic devices.  One of his more popular motifs was to write words and cross them out. 

Why did he do this?  As quoted from the documentary Jean-Michel Basquiat: Radiant Child, “I cross out words so you will see them more.  The fact that they are obscured makes you want to read them.”

One of Basquiat’s paintings recently sold for $110.5 million.  He was clearly on to something.

Put simply, the Basquiat Effect holds that the more one tries to hide something, the more the people they are trying to hide it from pay attention to it.  This effect becomes even more powerful after the phenomenon that is attempting to be hidden reaches it tipping point. 

Because the American public’s curiosity is already piqued, any mention of the phenomenon, regardless of context, compels the reader to look into it. The principle seems counter intuitive, but SCT critics may have provided a perfect example.  The New York Times and New Yorker articles may actually drive more people toward SCT rather than away. 

One of Basquiat’s trademark graffiti tags was “SAMO,” short for “Same Old.”  It essentially illustrated his disenchantment with the prevailing cultural orthodoxy and his intention to introduce something new, radical and revolutionary as a solution. 

In the same way, SCT is a radical response to the failures of medical orthodoxy. The “SAMO” pills and surgeries that exemplify the “treatment” approach to healthcare have given way to an expanding desire by the American people for procedures that actually “cure” chronic conditions and don’t just mask their symptoms.

The best approach for the anti-SCT purveyors may be to join a pro-cure movement that is clearly succeeding despite their efforts.  Or, they can continue to publish their criticism.  Either way, stem cell therapy will flourish.

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.

Experimental Stem Cell Therapy Reverses MS

By Steve Weakley

A small but promising study has shown that an experimental stem cell therapy can dramatically slow the progression of multiple sclerosis. Some MS patients treated with their own stem cells even experienced a reversal of their symptoms that has lasted for years.

MS is a chronic, incurable and progressive disease that attacks the body’s central nervous system, causing numbness in the limbs, difficulty walking, paralysis, loss of vision, fatigue and pain. The disease affects over 2 million people around the world.

An international team of researchers enrolled 110 patients in the study with relapsing-remitting MS, a version of the disease where symptoms appear for a few days or weeks, followed by periods of remission.

Half of the patients were treated with standard MS medications as a control group, while the other half went through a four-step experimental procedure.

The experimental group was given chemotherapy to stimulate the production of hematopoietic stem cells that recharge the immune system. Those stem cells were then removed from the patients’ blood and frozen.  After that, a more powerful round of chemotherapy was used to wipe out the patients’ damaged immune systems, and the thawed stem cells were put back into their bodies by transfusion.

Over half of the 55 patients in the control group continued to see their disease progress, while only three patients got worse in the experimental stem cell group. The other 52 had fewer symptoms and a better quality of life. The findings were reported in the journal JAMA.

“It’s the best evidence comparing stem cell transplants to standard therapy,” Harry Atkins, MD, a stem cell scientist at Ottawa Hospital in Canada told Vox . “This is one of the first pieces of proof that, yes, patients who have aggressive MS do better after a transplant than with the standard therapy.”

“The stem cell therapy gets patients off lifelong treatments and gives them results that have never been seen before with this disease,” said lead author Richard Burt, MD, a stem cell researcher and physician at Northwestern University.

One of Burt’s patients who benefited from the stem cell transplant is 28-year old Amanda Loy, who told Vox that prior to treatment she needed a cane to walk and was unable to work.  Within a year of treatment her symptoms had disappeared.

“It sounds so dramatic, but (the treatment) gave me my life back,” said Loy, who now works as a full-time teacher, runs half marathons and plays soccer with her 10-year-old son. She no longer takes MS medication.

Researchers still don’t know if the stem cell therapy will work with other forms of MS or how long the benefits will last. But it’s the first treatment that has shown the potential to actually reverse the disease.

“I do think it’s going to change the natural history of MS,” says Burt. “When you use it in the right group of patients with MS, you get these really gratifying results.”

A recent study by Australian researchers found that another experimental stem cell therapy shows promise in treating patients with progressive multiple MS, the most difficult-to-treat form of the disease.

Scientists at the University of Queensland extracted immune cells from patients who had either primary or secondary progressive MS. The cells – known as T-cells – were then “trained” in a laboratory to target and kill cells infected with the Epstein Barr virus, which has long been associated with MS.

When the altered T-cells were injected back into the bloodstream of 10 patients, seven said their symptoms improved. They had more energy, improved concentration, slept better, and had improved vision and balance. There were no serious side effects.