About Us

Who We Are

The ISCT Presidential Task Force (PTF) on the Use of Unproven and/or Unethical Cell and Gene Therapies 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.

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News

June 7, 2021 Legislature enacted by the General Assembly of the State of Vermont relating to health care practitioners administering stem cell products not approved by the U.S. Food and Drug Administration
April 7, 2021 S. 22 – An act relating to health care practitioners administering stem cell products not approved by the U.S. Food and Drug Administration: House Health Care Committee Meeting
October, 2020 Advertisement of Unproven CGT: Dialogue with Google
August 18, 2020 Stat News publishes How do you separate scientifically sound stem cell therapies from scams?
June 23, 2020 The National Law Review publishes Update on FDA’s Comprehensive Regenerative Medicine Framework: Looming November 2020 Deadline Preceded by a Flurry of Letters from CBER and a New JAMA Editorial
June 17, 2020 The Journal of the American Medical Association publishes article on Identifying the Risks of Unproven Regenerative Medicine Therapies

Marks PW, Hahn S. Identifying the Risks of Unproven Regenerative Medicine Therapies. JAMA. Published online June 17, 2020. doi:10.1001/jama.2020.9375. Copyright © (2020) American Medical Association.  All rights reserved.
May 11, 2020 Press Release: ISCT demands proper clinical investigation for COVID-19 therapies

Following up on its announcement on March 25, 2020 that it is working with scientific and industry organizations and regulators on a range of actions against the proliferation of unproven and untested ‘stem cell’–based therapies with claims to treat COVID-19, ISCT has detailed in a press announcement a series of significant publications, authored by ISCT leaders, which uphold scientific standards while contributing important research developments concerning COVID-19.
March 25, 2020 ISCT takes a stand against organizations marketing unproven COVID-19 cell and gene therapies
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