FDA puts pressure on US stem cell clinics


The FDA says that there is no room for companies that place patients at risk through products that violate the statutes and regulations. It is very concerned that several clinics across the country continue to market invasive stem cell products to patients, wrongly claiming that they don’t fall under the regulatory provisions.

FDA commissioner Scott Gottlieb says; "Stem cell therapies offer the potential to treat or even cure diseases or conditions for which few effective treatment options exist. Cell based therapies are one of the most promising new fields of science and medicine. These products hold tremendous potential for transformative and potentially curative treatments for some of the most devastating diseases and conditions challenging us today”.

Gottleib continues, "But most forms of regenerative medicine are still in early stages of development and adult stem cells and stem cells from birthing tissues have not yet been shown to be safe and effective for use in the treatment of any other diseases or conditions. Legitimate firms are doing the essential groundwork to develop such products, fully in keeping with our statutes and regulations, examining their safety and potential benefits in a range of diseases and conditions, including cancer, heart failure, stroke and amyotrophic lateral sclerosis. Certain stem cell therapies are subject to careful development requirements under the FDA’s existing regulations."

He warns: "Some clinics and doctors are taking advantage of the widespread belief in the eventual promise of these products, flouting the statutes and our regulations, and deceiving patients by illegally manufacturing or selling purported therapies, and falsely promoting their benefits. This ultimately puts at risk the very patients they claim to want to help. There is a false premise being asserted by some that a product derived from a person’s own body and then manipulated and reinserted for another use different from the one it played in its original location is not subject to FDA regulation just because it originated from the person it was given back to. But stem cell products can create unique and serious risks depending on how they’re manipulated once they’re taken from the body and how they are used once they’re reinserted in the body. When a product undergoes more than minimal manipulation, its characteristics may be changed in a way that are novel, and its risks and potential benefits unique."

He adds: "We have seen too many cases of sponsors claiming that cells aren’t subject to FDA regulation just because the cells originated from the same patient to whom the eventual manufactured product is being given. And we’ve seen too many cases of companies making unsubstantiated claims that these treatments prevent, treat, cure or mitigate disease where the products have sometimes led to serious patient harm. Patient safety is our first priority. These invasive procedures create a direct risk to patients. They also create indirect risks by potentially encouraging them to forgo otherwise effective, available treatments, and opt instead for purported treatments that create risks and offer no demonstrated benefits. False claims do a tremendous disservice to innovators who are working to legitimately develop safe and effective stem cell therapies by casting doubt across the entire field."

The FDA only has power in the USA, so an unfortunate side effect of tighter regulation is that desperate patients are potentially persuaded overseas to other clinics making unsubstantiated claims.



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