Who We Are
The ISCT Committee on the Ethics of Cell and Gene Therapy (ECGT) is composed of prominent experts in the cell and gene therapy field. Their leadership spans academia, industry, and regulation. The Committee strives to characterize unproven and unethical cell and gene interventions, and promote safe and effective practices worldwide.
Learn more about the Committee –Click here to view
Formerly known as the ISCT Presidential Task Force on the Use of Unproven and/or Unethical Cell and Gene Therapies (PTF)
News
October 5, 2023 | The International Society for Cell & Gene Therapy (ISCT) published a comprehensive guide to safeguard patients against unproven cell and gene therapies. The guide aims to educate ISCT members, healthcare professionals, and the public about the risks related to the direct-to-consumer regenerative therapy industry, exposing common deceptive marketing tactics and highlighting channels to report these practices. Access the full paper. |
June 2, 2023 | The International Society for Cell & Gene Therapy (ISCT) has filed an amicus curiae brief to support the U.S. government’s appeal in U.S.A. v. California Stem Cell Treatment Center, Inc., a case that ruled against the Food and Drug Administration (FDA) regulation of stromal vascular fraction (SVF) products and SVF expanded products thus jeopardizing the safety of patients. The amicus brief is filed jointly by the International Society for Cell & Gene Therapy (ISCT) and the International Society for Stem Cell Research (ISSCR). Download the brief. |
July 1, 2022 | ECGT Chair, Laertis Ikonomou, is interviewed by RELIAS MEDIA about ethical concerns of speculative cell banking services |
September 30, 2021 | Associated Press publishes an article on growth of US stem cell clinics during FDA’s Enforcement Discretion Period |
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: |
| 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 |
| January 2019 | ’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: |
| 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 |