Two large, recent reports in The Washington Post have reported the dangers to patients posed by practitioners at stem cell clinics. These clinics, some of which are largely unregulated and independent, have been involved in various forms of litigation, ranging from lawsuits over medical malpractice, product liability and lack of sterile products and procedures. One particularly blatant suit described how a woman was supposedly treated for macular degeneration with injections of her own reprocessed adipose tissue into her eyes. The result has almost left her completely blind.
The FDA and other regulatory agencies have been remiss in regulating this widely growing area of medicine. Some regulators and observers have gone so far as to say that some practices border on human experimentation. Indeed, the Post article quoted Charles Murry, director of The Institute for Stem Cell and Regenerative Medicine at The University of Washington as saying, “We’re afraid that these charlatans will besmirch the reputation of legitimate work we have spent decades trying to bring to the clinic.”
In theory, clinic operators say treatments work like this: fat tissue is extracted from the patient, and physical and chemical processing refines down the material to isolate stem cells, which is then injected back into the patient in certain problem target areas. But stem cell researchers refute this type of elementary process, saying in criticism that the material extracted contains little-to-no stem cells and that this reinjected material does not do the regenerative work purported. Also, the FDA notes that few stem cell therapies have been approved, with products derived from umbilical cord and placental blood. These therapies are most promising in leukemia and other blood diseases.
Many stem cell clinics have opened claiming to treat conditions as diverse as heart disease, Parkinson’s, stroke, vision problems, arthritis, autism and more. But Timothy Caufield, a health law professor at University of Alberta (Canada) said in the Post article: “What they’re really selling is false hope…they’re taking a legitimate and developing field of science and using it to prey on patients who are desperate for a cure.”
And the “false hope” they are selling can be quite expensive. Insurance seldom covers this type of “care,” and patients can pay large sums out of pocket. So large that the people peddling this can make big money…money that they’ve attempted to woo me with. In my recent professional life, I have received multiple offers of high-paying and even partnership arrangements by these types of clinics. I did my research, looked at what they were doing, and turned each one down. For various reasons, including the personalities of the principals, the procedures performed and the ancillary quasi-medical marketing being offered (supplements and pain therapies of unproven value and more). The set-up just didn’t pass the sniff-test.
Since reports of patients being blinded have emerged, the FDA finally acted to stop two companies involved in alleged stem cell therapy, US Stem Cell Clinic and Cell Surgical Network. Both companies disagree with the ruling and one has vowed to fight it. But the more than 700 stem cell clinics across the country may now come under closer scrutiny since Leigh Turner, a bioethicist at University of Minnesota, described the two above-mentioned companies in another Washington Post article as “the most notorious in the industry for marketing unproven treatments for incurable diseases.”
My advice to you: steer clear of all freestanding, non-university or medical school-affiliated clinics hawking these treatments. Until the FDA and scientific literature prove the efficacy and safety of these procedures, I’d exercise caution. These treatments are very much revenue driven and can be very expensive. We’ve already seen scores of patients being hurt. Don’t be one of them.