Is Regenexx Effective & Safe? Or is it a Scam & Illegal?
Facing FDA suit, stem cell firm goes on with illegal cure
The United States Justice Department and the Food and Drug Administration have ordered doctors from a Denver, Colorado company to stop performing an illegal mesenchymal stem cell-treatment. But physicians at its Southern California affiliate have gone ahead and announced recently that they are “licensed and trained” to perform the procedure.
The FDA has asked a federal judge to stop doctors from Regenerative Sciences Inc from performing what it calls a “Regenexx” procedure marketed as a “ breakthrough, non-surgical treatment option for people suffering moderate to severe pain from joint, tendon, ligament, or bone injury.
The procedure entails removing stem cells from a patient’s bone marrow, propagating them in a special solution, then re-injecting the cells at the site of an injury.
The ongoing federal lawsuit, filed in August 2010, takes Regenerative Sciences to task for selling an unapproved drug that hasn’t been prepared in a safe manner.
In order to introduce or deliver a drug “that is also a biological product” into interstate commerce, a valid biologic license must be in effect, says FDA’s Mary A. Malarkey in a warning letter to Dr. Christopher Centeno, Regenerative Sciences medical director on July 2008.
“Such licenses are issued only after a showing of safety and efficacy for the product’s intended use,” she writes. Malarkey is the director of the FDA’s Office of Compliance and Biologics Quality at the Center for Biologics Evaluation and Research.
Malarkey says that drugs being developed may be “distributed for clinical use in humans only if the sponsor has an investigational new drug application in effect as specified by FDA regulations (21 U.S.C. 355(i); 21 CFR Part 312),”
The drug regulator also says the sales and transport of the stem cells violates a federal law regulating prescription medications.
Stem Cell Therapy Review Journal checked the website of The Health Link Medical Center, an Oceanside clinic, and found it still advertises that its doctors are “trained and certified” by the Regenerative Sciences’ Colorado team.
For its part, the Colorado clinic lists the Oceanside facility as part of its Regenexx Procedure Network, which also includes clinics in Pennsylvania, New Jersey and New York.
Few approved treatments, some clinical studies
The FDA has not approved any stem cell treatments for orthopedic injuries. The only FDA-approved stem cell treatments involve those for leukemia patients, which are now commonly used therapies.
While promising stem cell treatments often hog the headlines, these are part of highly structured clinical studies conducted in major universities. Aimed to prove that new therapies are safe and to gather more evidence that treatments are more effective than placebos, such studies take years and cost millions of dollars.
By contrast, the mesenchymal stem cells used in the Regenexx procedure are not the subject of an approved biologics license application (BLA) or part of a clinical trial or an investigational new drug application (IND) in effect, Malarkay says in her warning letter.
No science behind Regenexx
Before the FDA filed its declaration, it asked an expert to review the studies that Regenexx physician Dr. Centeno published in scientific journals.
The Regenexx procedures did not go through the kind of rigorous testing that leads to widespread acceptance in medicine, concludes George F. Muschler, an orthopedic surgeon and professor at Ohio’s Case Western Reserve University who reviewed several case studies and a safety study by Dr. Centeno.
The studies merely reported the alleged benefits of his treatments that meant to remedy unhealed fractures and torn muscles or tendons.
Altogether, the series of studies “may be degenerating into an undisciplined and unfocused and even groping and wishful fishing expedition,” Muschler said. He also found faults with the reports’ methodology, scope and oversight.
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, he says, concluding “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 also inspected the company’s facilities and uncovered shortcomings that led it to criticized the Regenexx product as being “adulterated.”
The Regenexx lawsuit is one of the first the FDA has filed over a stem cell therapy offered within the U.S.
Meanwhile, “stem cell tourism” is a growing global illicit industry that sells hope to people suffering from Parkinson’s disease, amyotrophic lateral sclerosis, spinal cord injury, severe burns, heart disease, diabetes and other severely debilitating and disabling conditions—and puts instead puts them in danger. Most of these procedures are conducted outside the U.S., in China, Russia, the Dominican Republic, Ukraine and other countries in Europe and elsewhere.
Over the years, FDA has issued several warnings over these dangerous and illegal procedures, but it does have its supporters. Many people, especially those suffering from incurable ailments themselves and those who take care of them, are critical of the painstaking and costly process of proving medications safe and effective in America.
On its website, Health Link, Regenerative Sciences’s California associate clinic boasted that it was the first in the state to be “licensed” to perform the Regenexx procedures.
“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.
So far, Regenerative Sciences doctors have agreed to stop performing the Regenexx procedure while the case is argued in court. But Andrew Ittleman, a Miami attorney who is representing Regenerative Sciences, told California Watch, a news site funded by the Center for Investigative Reporting, the FDA is suing the firm over a procedure that is not being performed in California.
Ittleman claims 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 — but this technique is not practiced by the California group, he says.
The California treatment, he argues, “has very little, if anything, to do with the procedure” that’s subject to the FDA lawsuit.
Attorneys for Dr. Centeno and his partners also say the FDA lawsuit should be stricken because the procedure constitutes the “practice of medicine.”
In legal documents reviewed by California Watch, attorneys for Regenerative Sciences say that the procedure falls under state powers because it “constitutes the practice of medicine” — and this is overseen by the medical board. Medical practice isn’t regulated by the FDA, they argue.
But according to Dan Wood, a spokesman for the California Medical Board, the use of stem cell treatments falls under the purview of the FDA.