T

he Food and Drug Administration on Thursday unveiled a series of guidelines that aim to encourage the development of promising and legitimate stem cell therapies while distinguishing them from the largely untested stem cell treatments hawked by unregulated clinics around the country.

The FDA’s guidelines have been expected and eagerly awaited by the stem cell community given the rapid proliferation of untested — and potentially unsafe — therapies around the country. Clinics promoting these therapies claim to be able to treat ailments from autism to neurodegenerative disorders to erectile dysfunction.

This is a STAT Plus article and you can unlock it by subscribing to STAT Plus today. It's easy! Your first 30 days are free and if you don't enjoy your subscription you can cancel any time.
Already a subscriber? Log in here.

Leave a Reply to Joel B Singer MD Cancel reply

Please enter your name.
Please enter a comment.

  • The FDA has still not clarified its position because it is tied up in trying to define the undefinable as far as homologous vs. autologous use. The FDA position flies in the face of long held surgical traditions such as fat transplant to the sinuses or brain, use of veins to reconstruct arteries, use of skin tubes to reconstruct the urethra and esophagus and many other examples of surgical procedures used fir the past 50〜60 years.

Sign up for our Biotech newsletter — The Readout

Your daily guide to what’s new in biotech.