Era of unregulated stem cell therapies may be coming to an end


Is the Wild West of stem cell therapies coming to an end? Newly released guidelines from the U.S. Food and Drug Administration (FDA) suggest illegitimate, unproven uses might become a thing of the past. The latest statement by the FDA announces “a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies.”

FDA Commissioner Scott Gottlieb, M.D. recognizes that “Alongside all the promise, we’ve also seen products marketed that are dangerous and have harmed people. With the policy framework the FDA is announcing today, we’re adopting a risk-based and science-based approach that builds upon existing regulations to support innovative product development while clarifying the FDA’s authorities and enforcement priorities. This will protect patients from products that pose potential significant risks, while accelerating access to safe and effective new therapies.” This is long overdue.


With high price tags, so-called “stem-cell” clinics are designing therapies without evidence that serve to do harm, are ineffective, prey on the most vulnerable—potentially curtailing their ultimate treatment choices, and threaten the legitimate work being done that holds great promise for devastating and serious disease.

With an explosion of developments in regenerative medicine, in general, regulatory bodies need walk a fine line between implementing some restrictions while still fostering innovation.

Read full, original post: Is The Wild West Of Stem Cell Therapies Coming To An End?



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