ISCT comments on recent FDA statement on regulation of cell therapies

The International Society for Cellular Therapy responded to the FDA’s recent state in a letter to Commissioner Scott Gottlieb.

The International Society for Cellular Therapy (ISCT) has enthusiastically welcomed the FDA’s new stance on enforcing regulation of stem cell and regenerative medicine therapy. In a public statement, the FDA Commissioner Scott Gottlieb denounced “unscrupulous actors who have seized on the clinical promise of regenerative medicine” and promised “a comprehensive policy framework that will more clearly describe the rules of the road in this new field.” 

In a letter to Gottlieb, Massimo Dominici, immediate past President of ISCT and Chair of the Presidential Task Force (PTF) on the Use of Unproven Cellular Therapies, and Catherine Bollard, current ISCT President, praised the statement, sharing some of the significant efforts undertaken by the PTF.

“The Task Force continues to be a prominent and leading voice in the industry”, Dominici and Bollard commented in the letter.

“We strongly applaud today’s media announcements”, the letter stated, concluding: “We would be delighted to work with the FDA in its continuing efforts to ensure safe and effective treatment for cellular therapy patients.”

Source: Letter to FDA Commissioner Scott Gottlieb; ISCT press release