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Regulating stem cell therapy

July 28, 2017

Earlier this week MedPage Today reported on an influx of centers offering stem cell therapies for patients with heart failure. However, this treatment — which is marketed for a variety of conditions — can cost a pretty penny and is often without substantial regulation or evidence of real benefit.

Leigh Turner, PhD, of University of Minnesota, who has published research on selling stem cells and pay-to-participate stem cell studies, shared his thoughts on the current state of stem cell therapy.

What level of regulation is appropriate for stem cell therapy centers? Should they be required to demonstrate a clinical benefit through FDA-approved randomized trials, for example?

Turner: Many of the stem cell clinics currently operating in the U.S. should be investigated by the FDA, issued warning letters, and prohibited from making misleading marketing claims and selling unapproved medical products. Stem cell therapies should be allowed into the marketplace following development of conclusive evidence of safety and efficacy. Randomized controlled trials conducted with Investigational New Drug applications cleared by the FDA and approved by institutional review boards are key tools for generating such data. Expanded access (also known as “compassionate use”) programs should be used to provide patients with stem cell interventions that have promising data backing them though they are not yet approved by the FDA. Patients should not assume that businesses promoting “stem cell treatments” are selling safe and effective stem cell therapies. In many cases, there is no way to know what such businesses are injecting or infusing into their customers in exchange for thousands or tens of thousands of dollars.

Advocates of personal liberty argue that it’s none of the government’s business if patients want to seek such therapies. Do you agree or disagree, and why?

Turner: Notwithstanding claims made by hard-core libertarian ideologies, it is the government’s business to prevent transmission of infectious diseases, promote patient safety and public health, regulate the conduct of human subjects research, and provide pre-marketing authorization for drugs, biologics, and medical devices. Focusing only on personal liberty is a recipe for enabling fraud and increasing the likelihood that vulnerable individuals will be exposed to unnecessary risks and suffer serious harms. Those harms can take the form of spending thousands of dollars without any reasonable prospect of improved health, physical injuries, betrayal of hope and trust, and even fatal outcomes. These risks are not speculative or theoretical. Two patients died after undergoing stem cell procedures at one Florida clinic and three women were blinded after having “stem cell treatments” at another clinic in Florida. Other patients have sued such businesses for fraud. The exercise of personal liberty requires being able to select meaningful options rather than making decisions based on inaccurate sales pitches.

Because many stem cell therapies rely on autologous cells, private investment is often not available to support formal clinical trials. How can stem cell medicine progress if not through individual treatment centers such as these?

Turner: Private investment and public funding are available for both autologous stem cell interventions and testing of allogeneic stem cell products. There is also funding available for testing the medical devices used to produce such cellular products. True progress in stem cell research and the development of cellular therapies is not going to result from clinics making dramatic marketing claims. Real progress requires conducting rigorous basic and pre-clinical research followed by carefully designed and properly conducted clinical trials that are subject to regulatory oversight and generate high-quality safety and efficacy data. Conducting such research in an ethical, scientific, and legal manner is difficult, costly, time-consuming, and necessary. Hundreds of U.S. clinics are making dramatic advertising claims about stem cell treatments, but in most cases they have no evidence to support their hard-sell marketing. They use extreme forms of stem cell hype to sell the illusion of innovative medical therapies.

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