Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News
Until the scientific evidence for both safety and efficacy is determined, these alternative treatments will be heavily scrutinized.
Tired of pain from a rotator cuff tear that knocked him out of baseball a year earlier, pitcher Bartolo Colón jumped at the chance in 2010 when the medical director of a Florida clinic invited him to undergo a procedure the clinic said involved adult stem cells in his native Dominican Republic. Doctors extracted bone marrow and fatty tissue from his hip, put it through a process the clinic said increased the concentration of his stem cells, then injected the mix into his aching right shoulder.
Colón bounced back last year to an 8–10 record with the New York Yankees. This year with the Oakland Athletics, he started 3–1, but is now 9–9. He pitched six shutout innings in a 10–4 win over the Los Angeles Angels on August 7, but struggled five days later against the Chicago White Sox, surrendering five earned runs in a 7–3 loss.
Up-and-down might also describe prospects for the “stem cell” treatment industry. Anecdotes abound in which patients are cured of diseases that defy conventional medicine. But the field also has numerous patients who have not recovered—or whose deaths followed expensive procedures, often performed overseas in industry-friendly havens, through clinics affiliated with U.S. doctors relying on the Internet to draw patients.
Those clinics can expect more FDA scrutiny. A July 23 federal court decision allows the agency to regulate as drugs clinical treatments produced from patients’ stem cells processed beyond “minimal” manipulation. The U.S. District Court in Washington, DC, upheld an FDA injunction shutting down Regenerative Sciences, contending its Regenexx-C stem-cell therapy entails more-than- “minimal” manipulation and is thus a drug requiring agency approval.
Regenexx-C takes bone marrow aspirate, isolates mesenchymal stem cells, and grows those in culture, then injects it into patients with bone, cartilage, and other orthopedic problems. The company cites two multi-year case series — one of 227 patients, the other 339 patients — as well as several case studies published by its medical director, Christopher J. Centeno, M.D. He told GEN that clinical trials will be launhed soon. Regenerative Sciences vows to appeal, noting that FDA defines as routine medical practice the harvesting of a patient’s stem cells for autologous injection.
“If it does effectively disappear from the U.S. and only remains overseas, then it will probably shrink the size of the clientele, which is a positive thing for treatments that don’t have a scientific basis—scientific evidence for both safety and efficacy,” Douglas Sipp, who leads the Science Policy and Ethics Studies unit at RIKEN Center for Developmental Biology, told GEN.
Sipp correctly notes the “stem cell” procedures pose risks to both health and finances. While researchers don’t rule out a future medical use for stem cells, it’s still at the research phase: “The scientific community agrees that they are not ready for that level of widespread use in the clinic, particularly in cases where things are done by unregulated private companies that have this very strong conflict—they have an additional interest, which is to make money.”
The Florida clinic whose medical director performed Colón’s procedure, Regenocyte Therapeutic, says in a video clip on its website that treatments range from $15,000 to $54,000. That’s higher than many clinics are now charging, Sipp says, thanks to price competition by the growing number of “stem cell” centers worldwide. While clinics until recently charged from the high $20,000s to around $30,000, Sipp says, “Now I would say there are a lot of clinics that are down under $10,000 for an injection of what they claim to be stem cells for various conditions.”
Sipp, who is also editor of the blog Stem Cell Treatment Monitor, adds, “They are an expensive form of alternative medicine, if you define alternative medicine as medicine that isn’t accepted by the mainstream of the medical community.”
Regenocyte declares on its website it can treat patients with cardiac, pulmonary, and vascular health problems: “Regenocyte’s Adult Stem Cell Therapy is safe, highly effective, and presents minimal risk.”
Florida’s health department remains unconvinced. Last year, it restricted the medical license of Regenocyte’s director of cardiology and vascular diseases, Zannos Grekos, M.D., barring him from performing stem-cell procedures after a 69-year-old woman fell at home and died of brain injuries in 2010, following treatment for neurological damage after chemotherapy for breast cancer. In March, the department suspended Dr. Grekos’ license after a 77-year-old man died following liposuction performed at Regenocyte by an assisting doctor.
Neither Dr. Grekos nor his lawyer, Richard Ozelie, responded to a GEN email with questions arising from the cases. Ozelie issued a statement in March saying the procedure on the man did not involve stem cell treatment, and that Dr. Grekos and affiliated personnel in the U.S. and Dominican Republic have performed more than 300 “stem cell” treatments and/or procedures since 2006.
Dr. Grekos, who is appealing the suspension, scored a partial victory when Florida had to re-file its complaint against him to remove a claim that Regenocyte’s procedure was not FDA-approved. The state still argues that Dr. Grekos failed to justify the treatment, which it said lacked “substantial medical and scientific value.”
“We are confident that ultimately Dr. Grekos will have his medical license reinstated,” Ozelie said in a statement.
Driving patient demand for stem cell treatments, Sipp says, is growing demand for pain relief through prolotherapy, and for orthopedics and plastic surgery procedures, despite opposition from groups such as the American Society of Plastic Surgeons.
“There’s a lot of hype around stem cells and stem cell therapies,” Insoo Hyun, Ph.D., associate professor of bioethics at Case Western Reserve University School of Medicine, told GEN. “They typically involve really intractable types of diseases for which there are not very good alternative standard medical treatments, so patients at the end of their rope start to look elsewhere for a possible hope and therapy. That’s where the stem cell purveyors are swooping in, finding patients who fit that kind of profile.”
U.S. activity by stem cell clinics faces further challenge. Last month, six Los Angeles patients filed a civil lawsuit alleging that Human Biostar, the California subsidiary of South Korea-based RNL Bio, and co-defendants fraudulently persuaded them to pay $75,000 for clinic visits in China, Mexico, and South Korea, where cures were promised for aging and illnesses including diabetes, hypertension, and insomnia. Patients said they saw no improvement after donating fatty tissue from which stem cells were to be extracted, processed, and reinjected into the six. Plaintiffs also question whether the cells were properly transported.
“It is just one example of what I think is going to be just a flood of litigation moving forward,” Bernard Siegel, executive director of the nonprofit Genetics Policy Institute, told GEN.
Sipp says RNL Bio may well survive the lawsuit: “The U.S. is not the home of their operations, and it’s not one of their main venues for treating people. So, it may be a difficult case for the patients to win in a meaningful way.”
While RNL Bio may survive, the U.S. stem-cell treatment industry will be harder-pressed to withstand growing scrutiny by FDA, reinforced by exposes like the two aired by TV’s “60 Minutes.” That may well move most activity overseas, until international health agencies finally crack down on clinic abuses—something unlikely to occur short-term.