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<div id="primary" class="main content-area"> <main id="main" class="site-main" role="main"> <article id="post-78" class="zita-article post-78 page type-page status-publish hentry"> <div class="entry-header entry-page"> <h1 class='entry-title'>About Us</h1> </div> <div class="entry-content"> <div data-elementor-type="wp-page" data-elementor-id="78" class="elementor elementor-78"> <section class="elementor-section elementor-top-section elementor-element elementor-element-2ac0a455 elementor-section-boxed elementor-section-height-default elementor-section-height-default" data-id="2ac0a455" data-element_type="section"> <div class="elementor-container elementor-column-gap-default"> <div class="elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-318747f1" data-id="318747f1" data-element_type="column"> <div class="elementor-widget-wrap elementor-element-populated"> <div class="elementor-element elementor-element-367380cf elementor-widget elementor-widget-text-editor" data-id="367380cf" data-element_type="widget" data-widget_type="text-editor.default"> <div class="elementor-widget-container"> <h2><strong><span style="color: #003366;">Who We Are</span></strong></h2><p>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.</p><p><span style="color: #003366;"><em><strong>Learn more about the </strong></em></span><em style="color: #003366;"><strong>Committee –<span style="color: #f29925;"><a style="color: #f29925;" href="https://www.isctglobal.org/about/isct-committees/ecgt" target="_blank" rel="noopener">Click here to view</a></span></strong><span style="color: #f29926;"><strong><br /></strong></span></em><span style="font-size: 10pt; color: #003366;"><em><strong>Formerly known as the ISCT Presidential Task Force on the Use of Unproven and/or Unethical Cell and Gene Therapies (PTF)</strong></em></span></p><h2><span style="color: #003366;"><strong>News</strong></span></h2><table style="width: 95.6606%; height: 2739px;" width="579"><tbody><tr><td style="text-align: center; width: 113.844px;"><p><span style="color: #003366;">October 5, 2023</span></p></td><td style="text-align: left; width: 449.156px;"><p><span style="color: #000000;">The International Society for Cell & Gene Therapy (ISCT) published a comprehensive guide to safeguard patients against unproven cell and gene therapies. </span></p><p><span style="color: #000000;">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. <span style="color: #ff9900;"><a style="color: #ff9900;" href="https://www.isct-cytotherapy.org/article/S1465-3249(23)00064-6/fulltext">Access the full paper</a></span>.</span></p></td></tr><tr style="height: 179px;"><td style="text-align: center; width: 113.844px; height: 179px;"><p><span style="color: #003366;">June 2, 2023</span></p></td><td style="text-align: left; width: 449.156px; height: 179px;"><p><span style="color: #000000;">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.</span></p><p><span style="color: #000000;">The amicus brief is filed jointly by the International Society for Cell & Gene Therapy (ISCT) and the International Society for Stem Cell Research (ISSCR). <span style="color: #ff9900;"><a style="color: #ff9900;" href="https://higherlogicdownload.s3.amazonaws.com/ISCT/09ae5313-7da9-4214-9f20-bb56f676e42f/UploadedImages/_22-56014__-_Amicus_Brief_-_SUBMITTED.pdf">Download the brief</a></span>.</span></p></td></tr><tr style="height: 72px;"><td style="text-align: center; width: 113.844px; height: 72px;"><p><span style="color: #003366;">July 1, 2022</span></p></td><td style="text-align: left; width: 449.156px; height: 72px;"><span style="color: #000000;">ECGT Chair, Laertis Ikonomou, is interviewed by RELIAS MEDIA about </span><span style="color: #ff9900;"><a style="color: #ff9900;" href="https://www.reliasmedia.com/articles/149564-ethical-concerns-persist-with-speculative-cell-banking">ethical concerns of speculative cell banking services</a></span></td></tr><tr style="height: 80px;"><td style="text-align: center; width: 113.844px; height: 80px;"><p><span style="color: #003366;">September 30, 2021</span></p></td><td style="text-align: left; width: 449.156px; height: 80px;"><span style="color: #000000;">Associated Press publishes an <span style="color: #ff9900;"><a style="color: #ff9900;" href="https://apnews.com/article/coronavirus-pandemic-business-science-health-california-106808694cb797a59db366df54e85692" target="_blank" rel="noopener">article on growth of US stem cell clinics</a></span> during FDA’s Enforcement Discretion Period </span></td></tr><tr style="height: 96px;"><td style="text-align: center; width: 113.844px; height: 96px;"><p><span style="color: #003366;">June 7, 2021</span></p></td><td style="text-align: left; width: 449.156px; height: 96px;"><span style="color: #003366;"><a href="https://legislature.vermont.gov/Documents/2022/Docs/BILLS/S-0022/S-0022%20As%20Passed%20by%20Both%20House%20and%20Senate%20Unofficial.pdf" target="_blank" rel="noopener"><span style="color: #ff9900;">Legislature enacted by the General Assembly of the State of Vermont</span></a> <span style="color: #000000;">relating to health care practitioners administering stem cell products not approved by the U.S. Food and Drug Administration</span></span></td></tr><tr style="height: 96px;"><td style="text-align: center; width: 113.844px; height: 96px;"><span style="color: #000000;">April 7, 2021</span></td><td style="text-align: left; width: 449.156px; height: 96px;"><span style="color: #003366;"><span style="color: #000000;">S. 22 – An act relating to health care practitioners administering stem cell products not approved by the U.S. Food and Drug Administration:</span> <a href="https://www.youtube.com/watch?v=6L96jDH81Iw" target="_blank" rel="noopener"><span style="color: #ff9900;">House Health Care Committee Meeting</span></a></span></td></tr><tr style="height: 24px;"><td style="text-align: center; width: 113.844px; height: 24px;"><span style="color: #000000;">October, 2020</span></td><td style="text-align: left; width: 449.156px; height: 24px;"><span style="color: #000000;">Advertisement of Unproven CGT:</span></td></tr><tr style="height: 48px;"><td style="text-align: center; width: 113.844px; height: 48px;"><span style="color: #000000;">August 18, 2020</span></td><td style="text-align: left; width: 449.156px; height: 48px;"><span style="color: #003366;"><span style="color: #000000;">Stat News publishes</span> <span style="color: #ff9900;"><a style="color: #ff9900;" href="https://www.statnews.com/2020/08/18/separate-scientific-scam-stem-cell/">How do you separate scientifically sound stem cell therapies from scams?</a></span></span></td></tr><tr style="height: 96px;"><td style="text-align: center; width: 113.844px; height: 96px;"><span style="color: #000000;">June 23, 2020</span></td><td style="text-align: left; width: 449.156px; height: 96px;"><span style="color: #003366;"><span style="color: #000000;">The National Law Review publishes</span> <a style="color: #f29925;" href="https://www.natlawreview.com/article/update-fda-s-comprehensive-regenerative-medicine-framework-looming-november-2020">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</a></span></td></tr><tr style="height: 216px;"><td style="text-align: center; width: 113.844px; height: 216px;"><span style="color: #000000;">June 17, 2020</span></td><td style="text-align: left; width: 449.156px; height: 216px;"><p><span style="color: #003366;"><span style="color: #000000;">The Journal of the American Medical Association publishes article on</span> <a style="color: #f29925;" href="https://jamanetwork.com/journals/jama/fullarticle/2767586?resultClick=1">Identifying the Risks of Unproven Regenerative Medicine Therapies</a></span></p><p><span style="color: #000000;"> Marks PW, Hahn S. Identifying the Risks of Unproven Regenerative Medicine Therapies. <em>JAMA.</em> Published online June 17, 2020. doi:10.1001/jama.2020.9375. Copyright © (2020) American Medical Association. All rights reserved.</span></p></td></tr><tr style="height: 288px;"><td style="text-align: center; width: 113.844px; height: 120px;"><span style="color: #000000;">May 11, 2020</span></td><td style="text-align: left; width: 449.156px; height: 120px;"><p><a style="color: #f29925;" href="https://community.isctglobal.org/blogs/isct-head-office1/2020/05/11/isct-demands-proper-clinical-investigation-for-cov">Press Release: ISCT demands proper clinical investigation for COVID-19 therapies</a></p><p><span style="color: #000000;">Following up on its</span> <a style="color: #f29925;" href="https://community.isctglobal.org/blogs/isct-head-office1/2020/03/25/isct-takes-a-stand-against-organizations-pr">announcement on March 25, 2020</a> <span style="color: #000000;">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.</span></p></td></tr><tr style="height: 48px;"><td style="text-align: center; width: 113.844px; height: 48px;"><span style="color: #000000;">March 25, 2020</span></td><td style="text-align: left; width: 449.156px; height: 48px;"><a style="color: #f29925;" href="https://community.isctglobal.org/blogs/isct-head-office1/2020/03/25/isct-takes-a-stand-against-organizations-pr">ISCT takes a stand against organizations marketing unproven COVID-19 cell and gene therapies</a></td></tr><tr style="height: 48px;"><td style="width: 113.844px; height: 48px;"><span style="color: #000000;">December 6, 2019</span></td><td style="text-align: left; width: 449.156px; height: 48px;"><a style="color: #f29925;" href="https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/public-safety-notification-exosome-products" target="_blank" rel="noopener"><em>US FDA Public Safety Notification on Exosome Products</em></a></td></tr><tr style="height: 48px;"><td style="width: 113.844px; height: 48px;"><span style="color: #000000;">November 18, 2019</span></td><td style="text-align: left; width: 449.156px; height: 48px;"><em><a style="color: #f29925;" href="https://community.isctglobal.org/blogs/isct-head-office1/2019/11/18/isct-ptf-tackling-borderless-issue-of-unproven-cel" target="_blank" rel="noopener">ISCT PTF tackling borderless issue of unproven cell banking</a></em></td></tr><tr style="height: 48px;"><td style="width: 113.844px; height: 48px;"><span style="color: #000000;">October 21, 2019</span></td><td style="text-align: left; width: 449.156px; height: 48px;"><em><a style="color: #f29925;" href="https://community.isctglobal.org/blogs/isct-head-office1/2019/10/21/isct-forms-sector-wide-coalition-to-combat-the-ris" target="_blank" rel="noopener">ISCT forms sector-wide coalition to combat the rise of unproven commercial cell banking services</a></em></td></tr><tr style="height: 168px;"><td style="width: 113.844px; height: 168px;"><span style="color: #000000;">August 2019</span></td><td style="width: 449.156px; height: 168px;"><p style="text-align: left;"><span style="color: #000000;">Bruce Levine, ISCT President Elect speaks at the first meeting of the International Commission on the Clinical Use of Human Germline Genome Editing</span> –<em> <a style="color: #f29925;" href="https://cdn.ymaws.com/my.isctglobal.org/resource/resmgr/ptf2019/final_public_agenda.pdf" target="_blank" rel="noopener">Meeting Agenda</a></em></p><p style="text-align: left;"><em><a style="color: #f29925;" href="https://www.scientificamerican.com/article/scientists-seek-better-guidelines-for-editing-genes-in-human-embryos/" target="_blank" rel="noopener">Scientists Seek Better Guidelines for Editing Genes in Human Embryos</a> <span style="color: #000000;">– Scientific American</span></em></p></td></tr><tr style="height: 48px;"><td style="width: 113.844px; height: 48px;"><span style="color: #000000;">June 6, 2019</span></td><td style="text-align: left; width: 449.156px; height: 48px;"><em> <a style="color: #f29925;" href="https://www.celltherapysociety.org/news/454739/US-FDA-Wins-Landmark-Court-Decision-Against-For-Profit-Stem-Cell-Clinic.htm" target="_blank" rel="noopener">US FDA Wins Landmark Court Decision Against For-Profit Stem Cell Clinic</a></em></td></tr><tr style="height: 168px;"><td style="width: 113.844px; height: 168px;"><span style="color: #000000;">April 3, 2019</span></td><td style="text-align: left; width: 449.156px; height: 168px;"><em><a style="color: #f29925;" href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635165.htm" target="_blank" rel="noopener">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</a></em></td></tr><tr style="height: 168px;"><td style="width: 113.844px; height: 168px;"><span style="color: #000000;">March 27, 2019</span></td><td style="width: 449.156px; height: 168px;"><p style="text-align: left;"><span style="color: #000000;">Recent publication co-authored by members of the ISCT Presidential Task Force critically discusses the current status of cell therapies for lung disease:</span></p><p style="text-align: left;"><a style="color: #f29925;" href="https://www.atsjournals.org/doi/abs/10.1513/AnnalsATS.201812-890CME" target="_blank" rel="noopener"><em>Translating Basic Research into Safe and Effective Cell-based Treatments for Respiratory Diseases </em></a></p></td></tr><tr style="height: 120px;"><td style="width: 113.844px; height: 120px;"><span style="color: #000000;">March 2019</span></td><td style="width: 449.156px; height: 120px;"><p style="text-align: left;"><em><a style="color: #f29925;" href="https://www.nature.com/articles/d41586-019-00178-x" target="_blank" rel="noopener">Japan’s approval of stem-cell treatment for spinal-cord injury concerns scientists</a></em> <span style="color: #000000;"><em>– Nature</em></span></p><p style="text-align: left;"><em><a style="color: #f29925;" href="https://www.nature.com/articles/d41586-019-00332-5" target="_blank" rel="noopener">Japan should put the brakes on stem cell sales</a> <span style="color: #000000;">– Nature</span></em></p></td></tr><tr style="height: 208px;"><td style="width: 113.844px; height: 208px;"><span style="color: #000000;">January 2019</span></td><td style="width: 449.156px; height: 208px;"><p style="text-align: left;"><a style="color: #f29925;" href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628918.htm" target="_blank" rel="noopener"><em>FDA issues press release on reported safety concerns with Genetech, Inc umbilical cord blood-derived products.</em></a></p><p style="text-align: left;"><em><a style="color: #f29925;" href="https://www.nytimes.com/2018/12/20/health/stem-cell-shots-bacteria-fda.html" target="_blank" rel="noopener">’12 People Hospitalized with Infections from Stem Cell Shots’</a> <span style="color: #000000;">– The New York Times</span></em></p><p style="text-align: left;"><em><a style="color: #f29925;" href="https://www.the-scientist.com/news-opinion/fda-cracks-down-on-purveyors-of-stem-cell-treatments-65268?utm_campaign=TS_DAILY%20NEWSLETTER_2018&utm_source=hs_email&utm_medium=email&utm_content=68600167&_hsenc=p2ANqtz--KW7QCdVF9SAWiZoHgs9n5GjV2EEoZ0Ie7xQ4g9jYVXixXm2WMSfuRA7E34F-dtmJicD9hJXgzGM49VitmjvAO-y2Y_hB08GOFivqN0z0WrpJQYzI&_hsmi=68600167" target="_blank" rel="noopener">‘FDA Cracks Down on Purveyors of Stem Cell Treatments’</a> <span style="color: #000000;">– The Scientist</span></em></p></td></tr><tr style="height: 48px;"><td style="width: 113.844px; height: 48px;"><span style="color: #000000;">November 2018</span></td><td style="text-align: left; width: 449.156px; height: 48px;"><em><a style="color: #f29925;" href="https://www.celltherapysociety.org/news/427533/ISCT-publishes-annual-report-on-cell-and-gene-therapy-market-authorizations.htm" target="_blank" rel="noopener">ISCT publishes annual report on cell and gene therapy market authorizations</a></em></td></tr><tr style="height: 136px;"><td style="width: 113.844px; height: 136px;"><span style="color: #000000;">October 18, 2018</span></td><td style="text-align: left; width: 449.156px; height: 136px;"><p><span style="color: #000000;">FTC enforcement action against unproven cell therapies:</span></p><p><em><a style="color: #f29925;" href="https://www.ftc.gov/news-events/blogs/business-blog/2018/10/stemming-unproven-stem-cell-therapy-claims" target="_blank" rel="noopener">Stemming unproven stem cell therapy claims</a></em></p><p><em><a style="color: #f29925;" href="https://www.consumer.ftc.gov/blog/2018/10/ftc-takes-aim-deceptive-stem-cell-therapy-claims" target="_blank" rel="noopener">FTC takes aim at deceptive stem cell therapy claims</a></em></p></td></tr><tr style="height: 72px;"><td style="width: 113.844px; height: 72px;"><span style="color: #000000;">June 2018</span></td><td style="text-align: left; width: 449.156px; height: 72px;"><em><a style="color: #f29925;" href="https://cdn.ymaws.com/my.isctglobal.org/resource/resmgr/media/fdaquackdown.pdf" target="_blank" rel="noopener">Speakers from ISCT’s 2018 Annual Meeting Presidential Task Force Session on UCTs referenced in The Medicine Maker: Peter Marks, Massimo Dominici</a></em></td></tr><tr style="height: 72px;"><td style="width: 113.844px; height: 72px;"><span style="color: #000000;">June 20, 2018</span></td><td style="text-align: left; width: 449.156px; height: 72px;"><em><a style="color: #f29925;" href="https://community.isctglobal.org/blogs/isct-head-office1/2018/06/21/isct-presidential-task-force-on-uct-committee-memb" target="_blank" rel="noopener">ISCT Presidential Task Force on UCT Committee Members publish in Lancet Respiratory Medicine: Leigh Turner, Dan Weiss, Laertis Ikonomou</a></em></td></tr><tr style="height: 48px;"><td style="width: 113.844px; height: 48px;"><span style="color: #000000;">August 30, 2017</span></td><td style="text-align: left; width: 449.156px; height: 48px;"><em><a style="color: #f29925;" href="http://www.celltherapysociety.org/news/361520/ISCT-Response-to-Aug-28th-FDA-Statement-Concerning-Regulatory-Oversight-of-Cellular-Therapies.htm" target="_blank" rel="noopener">ISCT Response to Aug 28th FDA Statement Concerning Regulatory Oversight of Cellular Therapies</a></em></td></tr><tr style="height: 96px;"><td style="width: 113.844px; height: 96px;"><span style="color: #000000;">August 28, 2017</span></td><td style="text-align: left; width: 449.156px; height: 96px;"><em><a style="color: #f29925;" href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573443.htm" target="_blank" rel="noopener">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</a></em></td></tr><tr style="height: 48px;"><td style="width: 113.844px; height: 48px;"><span style="color: #000000;">July 7, 2017</span></td><td style="text-align: left; width: 449.156px; height: 48px;"><em><a style="color: #f29925;" href="http://www.celltherapysociety.org/news/353561/Global-interest-in-report-co-authored-by-members-of-ISCT-Presidential-Task-Force-on-UCT.htm" target="_blank" rel="noopener">Global interest in report co-authored by members of ISCT Presidential Task Force on UCT</a></em></td></tr><tr style="height: 48px;"><td style="width: 113.844px; height: 48px;"><span style="color: #000000;">December 2, 2016</span></td><td style="text-align: left; width: 449.156px; height: 48px;"><em><a style="color: #f29925;" href="http://www.celltherapysociety.org/news/320268/ISCT-Publishes-Article-in-Translational-Scientist-Concerning-the-US-REGROW-Act.htm" target="_blank" rel="noopener">ISCT Publishes Article in Translational Scientist Concerning the US REGROW Act</a></em></td></tr><tr style="height: 48px;"><td style="width: 113.844px; height: 48px;"><span style="color: #000000;">October 19, 2016</span></td><td style="text-align: left; width: 449.156px; height: 48px;"><em><a style="color: #f29925;" href="http://www.celltherapysociety.org/news/313876/ISCT-Presidential-Task-Force-Publishes-Article-in-Brain-Circulation-Journal.htm" target="_blank" rel="noopener">ISCT Presidential Task Force Publishes Article in Brain Circulation Journal</a></em></td></tr><tr style="height: 24px;"><td style="width: 113.844px; height: 24px;"> </td><td style="text-align: left; width: 449.156px; height: 24px;"> </td></tr></tbody></table> </div> </div> </div> </div> </div> </section> </div> </div> </article> </main> </div> </div> </div> <footer id="zita-footer"> <div class="footer-wrap widget-area"> <div class="bottom-footer"> <div class="bottom-footer-bar ft-btm-one"> <div class="container"> <div class="bottom-footer-container"> <div class="bottom-footer-col1"> <div class='content-html'> © 2019 ISCT. 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