The FDA has asked a federal judge to stop the Denver-area doctors from performing a Regenexx procedure, which involves removing stem cells from a patient's bone marrow, expanding them in a special solution and re-injecting the cells at the site of an injury.
The federal lawsuit, which was filed in August 2010 and is ongoing, contends that Regenerative Sciences is selling an unapproved product that has not been prepared in a safe manner.
Physicians from Regenerative Sciences in Colorado have said in court papers that they agreed to stop performing the procedure while the case is argued in court. Attorneys for Dr. Christopher Centeno, director of the Colorado group, and his partners say the FDA lawsuit should be stricken because the procedure constitutes the "practice of medicine," which is not regulated by the FDA.
The Health Link Medical Center, an Oceanside clinic, is advertising on its website that as of January, its doctors are "trained and certified" by the Colorado team. For its part, the Colorado clinic lists the Oceanside facility as part of its Regenexx Procedure Network, which also includes clinics in New Jersey, New York and Pennsylvania.
The Health Link website says the California clinic is the first in the state to be "licensed" to perform the Regenexx procedures by the Colorado team.
"Their stem cell orthopedics experience is unrivaled and they are physician leaders in stem cell therapy for orthopedic injuries in terms of research presentations, publications, and academic achievements," the website says.
The California clinic says its Regenexx services are for patients in chronic pain who are seeking an alternative to surgery.
Andrew Ittleman, a Miami attorney who is representing Regenerative Sciences, emphasized that the FDA is suing the firm over one procedure that is not being performed in California. Ittleman said the FDA is concerned about the group's process of adding a growth enhancer to increase the number of stem cells taken from a patient before re-implanting them. He said the California procedure does not include use of the growth enhancer.
The California treatment, he said, "has very little, if anything, to do with the procedure" that's subject to the FDA lawsuit.
Ed Anselmo, manager of the Health Link clinic, also said the California group plans to draw tissue from patients' bone marrow, separate the stem cells and re-inject them at the site of an injury. He said the team will not perform the procedure that involves expansion of patient cells in a solution, which is being done at a Regenexx-licensed Cayman Islands clinic. "You can't do that in the U.S.," Anselmo said.
An FDA spokeswoman asked about Regenerative Sciences and licensee Health Link said the agency doesn't comment on open investigations.
While promising stem cell treatments are making headlines nationwide on a weekly basis, most of them are part of highly structured clinical studies affiliated with major universities. The studies take years and cost millions of dollars, and they are aimed at proving that new therapies are safe and more effective than a placebo.
Stem cell treatments for leukemia patients are among the only FDA-approved and commonly used therapies.
Widespread criticism has cropped up around stem cell tourism, or the sales of promising ? but unproven and expensive ? treatments, usually overseas. Critics say those offering the services exploit the hopes and fears of vulnerable patients who are desperate for a miracle. Supporters of such therapies, though, are critical of the painstaking and costly process of proving medications safe and effective in America.
The Regenexx lawsuit is among the first the FDA has brought regarding a stem cell therapy offered in the U.S. An expert who filed a declaration for the FDA wrote that the Regenexx procedures did not go through the kind of rigorous testing that leads to widespread acceptance in medicine.
George F. Muschler, an orthopedic surgeon and professor at Case Western Reserve University in Ohio, reviewed several case studies and a safety study that Regenexx doctor Centeno published in scientific journals. The studies reported the benefits of his treatments, which are meant to remedy unhealed fractures and torn muscles or tendons.
Muschler found faults with the reports' methodology, scope and oversight, noting that the series of studies "may be degenerating into an undisciplined and unfocused and even groping and wishful fishing expedition."
He concluded that the "cultured cell product has not been tested in a single adequate and well-controlled clinical study for any of the indications for which it is being promoted and used. ? It is my strongly held view that (Regenerative Sciences) is exposing patients to medical risk without any reliable scientific evidence of therapeutic benefit."
The FDA has issued criticisms of its own, calling the Regenexx product "adulterated" because of shortcomings it uncovered during facility inspections. The FDA also says the sales and transport of the cells violates a federal law regulating prescription medications.
Attorneys for Regenerative Sciences say in legal documents that the procedure falls under state powers because it "constitutes the practice of medicine," overseen by the medical board.
"Additionally, the Procedure has been examined by the Colorado Board of Medicine and has been determined to be fully compliant with Colorado-state law," court records say. The Regenerative Sciences website includes the testimonials of patients who say they benefited from the treatment.
Dan Wood, a spokesman for the California Medical Board, said physician use of stem cell treatments falls under the purview of the FDA.
Story courtesy of our media partners at California Watch (A Project of the Center for Investigative Reporting)