Hundreds of stem cell treatment clinics are popping up all over the country, including many in Jacksonville, and they are posing an alarming potential health threat. The U.S. Food and Drug Administration is warning the public that these clinics may be misleading consumers with promises of cures for everything from orthopedic injuries to auto-immune diseases. In some cases, patients have been blinded and there are even some deaths associated with the treatments.
The FDA recently inspected US Stem Cell Clinic of Sunrise, Florida and found that the clinic was administering stem cells derived from body fat intravenously or directly into the spinal cord of patients to treat a variety of serious diseases or conditions. Among those being treated were patients with Parkinson’s disease, ALS, and COPD. The FDA has not reviewed or approved these products for any use.
“There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt assurances to patients based on unproven and, in some cases, dangerously dubious products,” FDA Commissioner Scott Gottlieb warned last year.
According to the New England Journal of Medicine, there are three documented cases of elderly women who were blinded after having stem cells injected into their eyes. The treatment was marketed for macular degeneration.
There are a handful of stem cell treatment clinics in Jacksonville. Some of their websites tout a high success rate with zero side effects. However, on one of the local websites there is the following disclaimer: “[We]….are not offering stem cell therapy as a cure for any condition, disease, or injury. No statements or implied treatments on this website have been evaluated or approved by the FDA.”
Medical and legal experts around the world have called for better regulation of stem cell therapies. This comes after a number of deaths associated with these treatments, including a woman who died just hours after an unproven liposuction stem-cell therapy.
“There are very few stem cell therapies that have been proven, at this point, to be efficacious,” said Timothy Caulfield, research director of the Health Law Institute at the University of Alberta. “Lots of exciting work is going on — they’re in clinical trials right now — but for most conditions we simply aren’t there yet.”
Caulfield explained the lack of regulations leaves too many questions unanswered. “Are they actually using stem cells? How are they getting the stem cells into people? Those are all open questions, because it is such an unregulated field,” he said.
While there is a great deal of promise on the horizon for stem-cell treatments to offer cures or relief for those suffering from a variety of ailments, there are still many unknown factors. If you suffer any adverse consequences as a result of stem-cell treatments, you may need to seek legal help.