About Us

Who We Are

The ISCT Presidential Task Force (PTF) on the Use of Unproven and/or Unethical Cell and Gene Therapy is composed of prominent experts in the cell and gene therapy field. Their leadership spans academia, industry, and regulation. The Task Force strives to characterize unproven and unethical cell and gene interventions, and promote safe and effective practices worldwide.

Learn more about the Task Force – Click here to view  


December 6, 2019 US FDA Public Safety Notification on Exosome Products
November 18, 2019 ISCT PTF tackling borderless issue of unproven cell banking
October 21, 2019 ISCT forms sector-wide coalition to combat the rise of unproven commercial cell banking services
August 2019

Bruce Levine, ISCT President Elect speaks at the first meeting of the International Commission on the Clinical Use of Human Germline Genome Editing – Meeting Agenda

Scientists Seek Better Guidelines for Editing Genes in Human Embryos – Scientific American

June 6, 2019  US FDA Wins Landmark Court Decision Against For-Profit Stem Cell Clinic
April 3, 2019 Statement by FDA Commissioner Scott Gottlieb, M.D., and Biologics Center Director Peter Marks, M.D., Ph.D. on FDA’s continued efforts to stop stem cell clinics and manufacturers from marketing unapproved products that put patients at risk, while progressing the agency’s commitment to help advance legitimate stem cell product development under existing agency regulations
March 27, 2019

Recent publication co-authored by members of the ISCT Presidential Task Force critically discusses the current status of cell therapies for lung disease:

Translating Basic Research into Safe and Effective Cell-based Treatments for Respiratory Diseases 

March 2019

Japan’s approval of stem-cell treatment for spinal-cord injury concerns scientists – Nature

Japan should put the brakes on stem cell sales – Nature

January 2019

FDA issues press release on reported safety concerns with Genetech, Inc umbilical cord blood-derived products.

’12 People Hospitalized with Infections from Stem Cell Shots’ – The New York Times

‘FDA Cracks Down on Purveyors of Stem Cell Treatments’ – The Scientist

November 2018 ISCT publishes annual report on cell and gene therapy market authorizations
October 18, 2018 FTC enforcement action against unproven cell therapies:

Stemming unproven stem cell therapy claims

FTC takes aim at deceptive stem cell therapy claims

June 2018 Speakers from ISCT’s 2018 Annual Meeting Presidential Task Force Session on UCTs referenced in The Medicine Maker: Peter Marks, Massimo Dominici
June 20, 2018 ISCT Presidential Task Force on UCT Committee Members publish in Lancet Respiratory Medicine:  Leigh Turner, Dan Weiss, Laertis Ikonomou
August 30, 2017 ISCT Response to Aug 28th FDA Statement Concerning Regulatory Oversight of Cellular Therapies
August 28, 2017 US FDA Commissioner Scott Gottlieb, M.D., issues statement on the FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine
July 7, 2017 Global interest in report co-authored by members of ISCT Presidential Task Force on UCT
December 2, 2016 ISCT Publishes Article in Translational Scientist Concerning the US REGROW Act
October 19, 2016 ISCT Presidential Task Force Publishes Article in Brain Circulation Journal