Stem Cell Treatments Pose Risks to Patients: FDA Investigates

Stem cell clinics have been steadily growing in number in recent years, and their popularity can be attributed to their claim that they can treat ailments not curable by traditional medicine.  This claim, however, remains poorly substantiated, and the use of stem cell therapy has drawn criticism from the FDA, which considers stem cell therapy to pose a high risk to patient health.  Despite scrutiny from the FDA, stem cell clinics seem to occupy a regulatory grey area, and continue to purport that they are not under FDA authority.

Are Stem Cell Clinics Under FDA Jurisdiction?

Stem cell clinics have attempted to sidestep FDA regulations by claiming that their procedures fall under ‘practicing medicine’ as opposed to developing a product that the FDA would then have jurisdiction over.  Some clinics have also gone on to falsely claim that they are performing research–not offering treatment options–in an effort to escape FDA oversight. Despite this, the FDA has gone on to approve certain procedures including those for blood disorders, however the vast majority of stem cell procedures remain unproven. Some examples of these unproven procedures include the extraction of stem cells through the process of liposuction and the placement of these cells in different parts of the body.  This process, according to the FDA, poses a certain amount of risk to the patient, who is in danger of injection site reactions in addition to side effects including tumors and blindness. In one instance, during a clinical trial conducted by U.S. Stem Cell, three patients lost all or most of their sight as a consequence of participating in the treatment plan—raising questions about the safety of these procedures.

FDA Regulation

The FDA has taken several measures to ensure proper regulation of these stem cell clinics.  When conducting the FDA review, for instance, investigators must show how each product will be manufactured to make sure that steps are being taken to guarantee product safety, as well as testing for potency and evaluating risks based on data taken from animal studies.  All of these steps are taken into account when determining whether or not a certain product is granted FDA approval.

The FDA sent out a warning letter in 2017 to stem cell clinics for marketing unapproved products as well as violating good manufacturing practices.  Despite these clinics’ claims that they were not subject to FDA jurisdiction, the FDA went ahead with their prosecution—indicating that the FDA considers stem cell claims a high enough risk to justify spending money for the prosecution and investigation of these clinics.

What the Future Holds

Although stem cell clinics have faced significant scrutiny from the FDA, a spokeswoman for one stem cell clinic stated that her company would continue offering stem cell treatments derived from other tissue.  It remains an ongoing struggle on behalf of the FDA to keep up with the regulation of stem cell clinics, as the industry continues to grow at an exponential pace.  At present, it seems that the FDA will continue issuing warning letters and initiating court cases against unscrupulous clinics, and keep a close watch over these companies.

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