News & Press: Breaking News

ISCT Response to Aug 28th FDA Statement Concerning Regulatory Oversight of Cellular Therapies

Wednesday, August 30, 2017  
Share |

Dr. Gottlieb’s recent statement on August 28th, 2017, set a new tone for enforcement of stem cell and regenerative medicine practices. In his public statement, Dr. Gottlieb denounces the “unscrupulous actors who have seized on the clinical promise of regenerative medicine” and promises “a comprehensive policy framework that will more clearly describe the rules of the road in this new field.”  This stance is enthusiastically welcomed by the cellular therapy field and strongly commended by the International Society for Cellular Therapy (ISCT).

Massimo Dominici, MD, immediate past President of ISCT and Chair of the Presidential Task Force (PTF) on the Use of Unproven Cellular Therapies, and Catherine Bollard, MD, MBChB, current ISCT President, responded to Dr. Gottlieb on August 29 via letter. The ISCT leaders lauded the statement and shared some of the significant efforts the PTF has undertaken. Dr. Dominici stated “ISCT is a leader in educating the range of stakeholders affected by this issue. We strongly applaud today’s media announcements.”

ISCT looks forward to the continued efforts of the FDA and ISCT PTF to educate the community and provide feedback for the regulation of stem cell and regenerative medicine.


© 2017 International Society for Cellular Therapy. All rights reserved.
ISCT, International Society for Cellular Therapy, and the ISCT logo are registered service marks of The International Society for Cellular Therapy.
The BEACON and lighthouse logo is a service mark of The International Society for Cellular Therapy.