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. 

David vs. Goliath: California’s Stem Cell Program Demonizes Small Clinics

By A. Rahman Ford, PNN Columnist

In a recent article published in Stem Cells Translational Medicine, officials with the California Institute for Regenerative Medicine (CIRM) call for nationally uniform standards for stem cell products to facilitate the ”responsible delivery of regenerative medicine.”

Some of their recommendations are reasonable. However, CIRM’s insistence upon uniformity and their demonization of small stem cell clinics in a contrived narrative is sophomoric, disingenuous and counterproductive.

CIRM was created in 2004 when California voters passed Proposition 71, the California Stem Cell Research and Cures Initiative. Supporters of Prop 71 lamented how the federal government had failed to provide adequate funding for stem cell research, so the state needed to step in and provide $295 million in bonds to advance stem cell treatments to patients with unmet medical needs.

CIRM is currently at a financial crossroads. To date, CIRM has funded over 1,000 research, training and community engagement projects. However, with its initial funding almost gone, it is now seeking an additional $5.5 billion through a ballot initiative. While CIRM has been strong in research, no CIRM-funded trial has won FDA approval. According to Nature, CIRM has funded 55 clinical trials but only one therapy is likely to hit the market any time soon.

Indeed, a 2018 San Francisco Chronicle investigation found that CIRM’s achievements “fall far short of what Prop. 71’s promoters promised.” Furthermore, “the bulk of CIRM grants have gone to basic research, training programs and building new laboratories, not to clinical trials testing the kind of potential cures and therapies the billions of dollars were supposed to deliver.”

Thus, while it’s noteworthy that CIRM-funded scientists have published over 330 scholarly articles in some of the top academic journals, practical results remain negligible to non-existent.

Promises Laid Upon False Premises

California’s scientific and physical infrastructure has benefited greatly from CIRM, but sick and disabled Californians have not. The fact that CIRM’s accomplishments have been so minimal makes their claims about acting in “the best interest of the patient” all the more curious.

Lead author Geoffrey Lomax, PhD, a Program Manager at CIRM, and colleagues argue that clinics offering stem cell treatments are in need of increased regulatory oversight. Toward that end, they recommend a new policy framework with technical, organizational and ethical benchmarks aimed at developing a standard of care for the stem cell industry. It pledges adherence to the FDA clinical trial process and chastises clinics for flaunting long-established rules for drug approval.

“There are documented examples of unproven stem cell interventions causing harm to patients. In the majority of examples, the intervention deviates from the norms of responsible medical practice. Numerous authoritative bodies have raised concerns over the potential for medical and financial harm to result from these practices,” Lomax wrote.

Generally speaking, some of their recommendations make sense. For example, they recommend that doctors, nurses and technicians providing stem cell treatments possess specialized training and expertise. They also recommend that providers educate and evaluate patents throughout the treatment process. Finally, the authors support the creation of a stem cell registry to facilitate the reporting of adverse events resulting from stem cell treatments.

However, these common-sense recommendations are overlaid by a rigid, forced adherence to an anachronistic model of medical treatment. This model is the FDA clinical trial process, which treats a patient’s own stem cells as “drugs.” That is unfortunate, because stem cell therapies are revolutionary, paradigm-shifting and defy old conceptions about drugs and medicine.

Perhaps the most glaring sin is CIRM’s demonization of small clinics offering stem cell treatments. These clinics are producing the real-world results that CIRM has not. This “us vs. them” approach occludes truth and impedes progress to the detriment of those most in need. It is unnecessary to diminish the value of others’ efforts to bolster or justify one’s own. Cooperation, not contrived competition, is in the best interest of patients.

Furthermore, forced uniformity in stem cell policy standards may not be the answer. Let us not forget that it was the state of California in 1996 that led the way on medical marijuana, amidst a cacophony of marijuana opponents who decried the potential for a “wild west” of rogue marijuana dispensaries that would prey upon desperate patients.

Now, years later, we see that none of those calamities materialized. For CIRM to now use the same argument and same invective toward stem cell clinics seems disingenuous and hypocritical.

Lomax fails to see that from the patient perspective the narrative is not “heroic” CIRM vs. the “villain” clinics, but more of a story of the “Goliath” CIRM vs. the “David” clinics. We all know how that story turned out.

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.