July 14, 2020

The Niche

Knoepfler lab stem cell blog

REGROW Act critique

3 min read

The biggest debate today in the stem cell world is over how much regulation is needed for new, investigational stem cell therapies that are not as yet approved. Sometimes it feels very lonely being out there publicly advocating for appropriately thorough regulation of stem cell therapies and at times I get a lot of heat for that, especially from stem cell clinics. For instance, I am publicly opposed to the REGROW Act, a piece of legislation that would dangerously weaken oversight of experimental stem cell therapies. …Read More

2 min read

Senators Mark Kirk, Joe Manchin, and Susan Collins have proposed new legislation in the form of the REGROW Act that would substantially interfere with the FDA’s ability to properly regulate the development of new stem cell and regenerative medicine therapies based on hard science. The REGROW Act would force the FDA to allow rushed introduction of experimental stem cell interventions into patients even if the science did not support that these were safe or effective at that time. From the Kirk press release: “Unfortunately the Food and …Read More