Informational Resources – ISCT ECGT Committee

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content</a>    <div class="top-header"> <div class="top-header-bar abv-three"> <div class="container"> <div class="top-header-container"> <div class="top-header-col1"> <div class='content-html'> </div> </div> <div class="top-header-col2"> <div class='content-html'> </div> </div> <div class="top-header-col3"> <div class="content-social"> <ul class="social-icon "><li><a target="_blank" href="https://www.linkedin.com/company/international-society-for-cellular-therapy/"><i class="fa fa-linkedin"></i></a></li><li><a target="_blank" href="https://twitter.com/isctglobal?lang=en"><i class="fa fa-twitter"></i></a></li></ul></div> </div> </div> </div> </div> </div> <div class="main-header mhdrleft inline right-menu linkeffect-none"> <div class="main-header-bar two"> <div class="container"> <div class="main-header-container"> <div class="main-header-col1"> <div class="zita-logo"> <a href="http://www.isct-unprovencellulartherapies.org/" class="custom-logo-link" rel="home"><img width="610" 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id="container" class="site-container no-sidebar"> <div id="primary" class="main content-area"> <main id="main" class="site-main" role="main"> <article id="post-89" class="zita-article post-89 page type-page status-publish hentry"> <div class="entry-header entry-page"> <h1 class='entry-title'>Informational Resources</h1> </div> <div class="entry-content"> <p style="background: #003366; text-align: center;"><span style="color: #ffffff;"><strong>COVID-19 RESEARCH SPOTLIGHT</strong></span></p> <table border="1" cellspacing="5" cellpadding="5"> <tbody> <tr> <td style="vertical-align: top; width: 208px; text-align: left;"><strong>Cell-based treatments for COVID-19<br /> </strong><em><i>By Laertis Ikonomou, PhD</i></em></p> <p style="color: #000000;"><em><i>The COVID-19 pandemic has produced a rush of candidate treatments, currently evaluated worldwide for safety and efficacy. We discuss issues related to the development of cell-based interventions for COVID-19.</i></em></p> <p style="text-align: center;"><strong><a href="https://cdn.ymaws.com/my.isctglobal.org/resource/resmgr/telegraft_april_2020/telegraft_27.2_covid-19.pdf" target="_blank" rel="noopener"><img style="border: 0px; width: 104px; height: 42px; margin: 0px;" src="https://gallery.mailchimp.com/ccb354a28cdbeb6aa4265a3d0/images/4c59114f-c22e-40d1-9c0e-aca8040c4c34.png" alt="" width="104" height="42" data-file-id="1094183" /></a></strong></p> </td> <td style="vertical-align: top; width: 208px; text-align: left;"><strong>Current Status of Cell-Based Therapies for Respiratory Virus Infections: Applicability to COVID-19<br /> </strong><em><i>Maroun Khoury, Jimena Cuenca, Fernanda F. Cruz, Fernando E. Figueroa, Patricia R. M. Rocco, Daniel J. Weiss<br /> </i></em></p> <p style="text-align: center;"><a href="https://erj.ersjournals.com/content/early/2020/04/01/13993003.00858-2020"><img loading="lazy" style="border: 0px initial; width: 104px; height: 42px; margin: 0px;" src="https://gallery.mailchimp.com/ccb354a28cdbeb6aa4265a3d0/images/4c59114f-c22e-40d1-9c0e-aca8040c4c34.png" alt="" width="104" height="42" data-file-id="1094183" /></a></p> <p><em>Published in the <strong><i>European Respiratory Journal</i></strong></em></td> <td style="vertical-align: top; width: 208px; text-align: left;"><strong>Cell-Based Therapies for COVID-19: Proper Clinical Investigations are Essential</strong><br /> <em><i>Maroun Khoury, Patricia R.M. Rocco, Mauro Krampera, Ivan Martin, Sowmya Viswanathan, Donald G Phinney, Jan A. Nolta, Katarina LeBlanc, Jacques Galipeau and Daniel J. Weiss</i></em></p> <p style="text-align: center;"><a href="https://www.isct-cytotherapy.org/article/S1465-3249(20)30616-2/fulltext"><img style="border: 0px; width: 104px; height: 42px; margin: 0px;" src="https://gallery.mailchimp.com/ccb354a28cdbeb6aa4265a3d0/images/4c59114f-c22e-40d1-9c0e-aca8040c4c34.png" alt="" width="104" height="42" data-file-id="1094183" /></a></p> <p><em>Published in <strong><i>Cytotherapy</i></strong> </em></td> </tr> <tr> <td style="vertical-align: top; width: 208px; text-align: left;"><strong>ISCT takes a stand against organizations marketing unproven COVID-19 cell and gene therapies</strong><br /> Wednesday, March 25, 2020</p> <p style="color: #000000;"><em><i>Following up on a <a href="https://isctglobal.org/news/494824/ISCT-Releases-Statement-on-Unproven-Stem-Cell-Treatments-for-COVID-19.htm" target="_blank" rel="noopener">statement made on March 20th</a>, ISCT has issued a press release taking a stand against organizations marketing unproven COVID-19 cell and gene therapies.</i></em></p> <p style="text-align: center;"><a href="https://my.isctglobal.org/news/497106/isct-takes-a-stand-against-organizations-marketing-unproven-covid-19-cell-and-gene-therapies.htm"><img loading="lazy" style="border: 0px initial; width: 104px; height: 42px; margin: 0px;" src="https://gallery.mailchimp.com/ccb354a28cdbeb6aa4265a3d0/images/4c59114f-c22e-40d1-9c0e-aca8040c4c34.png" alt="" width="104" height="42" data-file-id="1094183" /></a></p> </td> <td style="vertical-align: top; width: 208px; text-align: left;"><strong>LIVE at ISCT 2020 Paris Virtual – ISCT </strong><strong>CSO Global Showcase on COVID-19 </strong></p> <p><strong>Part I: “The Force Awakens”</strong></p> <ul> <li><em><i>Review of Current Understanding of COVID-19 Pathogenesis<br /> </i></em></li> <li><em><i>Reports from the Front Lines</i></em></li> <li><em><i>Supply Chain Issues<br /> </i></em></li> </ul> <p><a href="http://www.isct2020.com/sessions-descriptions/" target="_blank" rel="noopener"><strong><img loading="lazy" style="border: 0px initial; width: 104px; height: 42px; margin: 0px;" src="https://gallery.mailchimp.com/ccb354a28cdbeb6aa4265a3d0/images/4c59114f-c22e-40d1-9c0e-aca8040c4c34.png" width="104" height="42" data-file-id="1094183" /></strong></a></td> <td style="vertical-align: top; width: 208px; text-align: left;"><strong>LIVE at ISCT 2020 Paris Virtual – ISCT C</strong><strong>SO Global Showcase on COVID-19 </strong></p> <p><strong>Part II: “A New Hope”</strong></p> <ul> <li><em><i>MSC-based Approaches</i></em></li> <li><em><i>Immuno-Gene Therapy Approaches</i></em></li> </ul> <p><a href="http://www.isct2020.com/sessions-descriptions/" target="_blank" rel="noopener"><strong><img loading="lazy" style="border: 0px initial; width: 104px; height: 42px; margin: 0px;" src="https://gallery.mailchimp.com/ccb354a28cdbeb6aa4265a3d0/images/4c59114f-c22e-40d1-9c0e-aca8040c4c34.png" width="104" height="42" data-file-id="1094183" /></strong></a></td> </tr> <tr> <td style="vertical-align: top; width: 208px; text-align: left;"><b>ISCT Presidential Task Force Members Laertis Ikonomou, Daniel J. Weiss, and Megan Munsie interviewed by <em>The Medical Republic</em> regarding concerns about the marketing of unproven therapies during the pandemic. </b></p> <p style="text-align: center;"><strong><a href="http://medicalrepublic.com.au/warnings-on-stem-cells-touted-as-covid-therapy/28460" target="_blank" rel="noopener"><img loading="lazy" style="border: 0px; width: 104px; height: 42px; margin: 0px;" src="https://gallery.mailchimp.com/ccb354a28cdbeb6aa4265a3d0/images/4c59114f-c22e-40d1-9c0e-aca8040c4c34.png" width="104" height="42" data-file-id="1094183" /></a></strong></p> </td> <td style="vertical-align: top; width: 208px; text-align: left;"><b>ISCT CSO Daniel J. Weiss moderates Webinar on Potential COVID-19 Treatments Using Cell Therapies </b></p> <p><em>Hosted by ARM, ARMF, and ISCT</em></p> <p style="text-align: center;"><strong><a href="https://my.isctglobal.org/page/Webinar-ARM-ARMF-ISCT" target="_blank" rel="noopener"><img style="border: 0px; width: 104px; height: 42px; margin: 0px;" src="https://gallery.mailchimp.com/ccb354a28cdbeb6aa4265a3d0/images/4c59114f-c22e-40d1-9c0e-aca8040c4c34.png" alt="" width="104" height="42" data-file-id="1094183" /></a></strong></p> </td> <td style="vertical-align: top; width: 208px; text-align: left;"><b>Preying on Public Fears and Anxieties in a Pandemic: Businesses Selling Unproven and Unlicensed “Stem Cell Treatments” for COVID-19</b></p> <p><em>By Leigh Turner, PhD</em></p> <p style="text-align: center;"><strong><a href="https://www.cell.com/cell-stem-cell/fulltext/S1934-5909(20)30201-0" target="_blank" rel="noopener"><img style="border: 0px; width: 104px; height: 42px; margin: 0px;" src="https://gallery.mailchimp.com/ccb354a28cdbeb6aa4265a3d0/images/4c59114f-c22e-40d1-9c0e-aca8040c4c34.png" alt="" width="104" height="42" data-file-id="1094183" /></a></strong></p> </td> </tr> </tbody> </table> <p style="background: #003366; text-align: center;"><span style="color: #ffffff;"><strong>LISTINGS OF APPROVED PRODUCTS & OTHER USEFUL RESOURCES</strong></span></p> <div id="mapplic-id19" data-mapdata="{"mapwidth":"2400","mapheight":"1520","minimap":false,"zoombuttons":true,"sidebar":false,"search":false,"hovertip":true,"fullscreen":false,"zoomlimit":"4","mapfill":false,"zoom":true,"alphabetic":false,"categories":[{"id":"eu","title":"Europe","color":"#1e73be"}],"levels":[{"id":"world","title":"World","map":"//www.isct-unprovencellulartherapies.org/wp-content/plugins/mapplic/maps/world.svg","minimap":"","locations":[{"id":"us","title":"United States (31)","description":"<p>Regulatory Agency: <a href=\"https://www.fda.gov/\">Food and Drug Administration (FDA)</a></p><p>CARVYKTI (ciltacabtagene autoleucel) (Janssen Biotech, Inc.)<br />RETHYMIC (Enzyvant Therapeutics GmbH)<br />STRATAGRAFT (Stratatech Corporation)<br />ABECMA (idecabtagene vicleucel) (Celgene Corporation)<br />BREYANZI (lisocabtagene maraleucel) (Juno Therapeutics, Inc.)<br />TECARTUS (brexucabtagene autoleucel) (Kite Pharma, Inc.)<br />ZOLGENSMA (AveXis, Inc)<br />HPC, Cord Blood (MD Anderson Cord Blood Bank)<br />LUXTURNA (voretigene neparvovec-rzyl) (Spark Therapeutics, Inc.)<br />YESCARTA (axicabtagene ciloleucel) (Kite Pharma, Incorporated)<br />KYMRIAH (tisagenlecleucel) (Novartis Pharmaceuticals Corporation)<br />MACI (Vericel Corporation)<br />Clevecord (HPC, Cord Blood) (Cleveland Cord Blood Center)<br />HPC, Cord Blood (Bloodworks)<br />IMLYGIC (talimogene laherparepvec) (Amgen Inc.)<br />HPC, Cord Blood (LifeSouth Community Blood Centers, Inc.)<br />ALLOCORD (SSM Cardinal Glennon Children's Medical Center)<br />Ducord (HPC, Cord Blood) (Duke University School of Medicine)<br />HPC, Cord Blood (Clinimmune Labs, University of Colorado Cord Blood Bank)<br />GINTUIT (Organogenesis, Inc.)<br />Hemacord (HPC, Cord Blood) (New York Blood Center, Inc.)<br />Laviv® (Azficel-T) (Fibrocell Technologies, Inc.)<br />ADSTILADRIN (nadofaragene firadenovec) (Ferring Pharmaceuticals)<br />HEMGENIX (etranacogene dezaparvovec-drlb) (CSL Behring LLC)<br />SKYSONA (elivaldogene autotemcel) (Bluebird Bio, Inc.)<br />ZYNTEGLO (betibeglogene autotemcel) (Bluebird Bio, Inc.)<br />ROCTAVIAN (valoctocogene roxaparvovec-rvox) (BioMarin Pharmaceutical Inc.)<br />LANTIDRA (donislecel-jujn) (CellTrans Inc.)<br />ELEVIDYS (delandistrogene moxeparvovec-rokl) (Sarepta Therapeutics, Inc.)<br />VYJUVEK (beremagene geperpavec-svdt) (Krystal Biotech, Inc.)<br />OMISIRGE (omidubicel-onlv) (Gamida Cell Ltd.)</p>","category":"false","action":"tooltip","pin":"circular pin-md pin-pulse pin-label","x":"0.2284","y":"0.5134","fill":"#003366"},{"id":"kr","title":"South Korea (19)","description":"<p>Regulatory Agency: <a href=\"https://www.mfds.go.kr/eng/index.do\">Ministry of Food and Drug Safety (MFDS)</a></p><p>Cartilife® (Biosolution Co., Ltd.)<br />Rosmir® (Tego Science, Inc)<br />KeraHeal-Allo™ (Biosolution Co., Ltd.)<br />NEURONATA-R® (Corestem, Inc.)<br />Cupistem® (Anterogen)<br />CARTISTEM® (Medipost Co., Ltd.)<br />Cellgram®-AMI (Pharmicell Co., Ltd.)<br />CureSkin Inj. (S.Biomedics Co., Ltd.)<br />Queencell® (Anterogen)<br />RMS OssronTM (Sewon Cellontech Co., Ltd.)<br />Immuncell-LC (GC Cell Corp.)<br />CreaVax-RCC® (JW CreaGene Corporation)<br />KeraHeal® (Biosolution Co., Ltd.)<br />Kaloderm® (Tego Science, Inc)<br />Holoderm® (Tego Science, Inc)<br />ChondronTM (Sewon Cellontech Co., Ltd.)<br />Kymriah (Novartis Korea Limited)<br />Luxturna (Novartis Korea Limited)<br />Zolgensma (Novartis Korea Limited)</p>","pin":"circular pin-md pin-pulse pin-label","fill":"#003366","category":"false","action":"default","x":"0.8350","y":"0.5311"},{"id":"se","title":"European Union (18)","description":"<p>Regulatory Agency: <a href=\"https://www.ema.europa.eu/en\">European Medicines Agency (EMA)</a></p><p>HOLOCLAR (Holostem Terapie Avanzate s.r.l.)<br />IMLYGIC (Amgen Europe B.V.)<br />STRIMVELIS (Orchard Therapeutics [Netherlands] B.V.)<br />SPHEROX (CO.DON AG)<br />ALOFISEL (Takeda Pharma A/S)<br />YESCARTA (Kite Pharma EU B.V.)<br />KYMRIAH (Novartis Europharm Limited)<br />LUXTURNA (Novartis Europharm Limited)<br />ZOLGENSMA (Novartis Europharm Limited)<br />LIBMELDY (Orchard Therapeutics [Netherlands] B.V.)<br />TECARTUS (Kite Pharma EU B.V.)<br />ABECMA (Bristol-Myers Squibb Pharma EEIG)<br />BREYANZI (Bristol-Myers Squibb Pharma EEIG)<br />CARVYKTI (Janssen-Cilag International NV)<br />UPSTAZA (PTC Therapeutics International Limited)<br />ROCTAVIAN (BioMarin International Limited)<br />EBVALLO (Pierre Fabre Medicament)<br />HEMGENIX (CSL Behring GmbH)</p>","pin":"circular pin-md pin-pulse pin-label","fill":"#004bce","category":"false","action":"default","x":"0.5290","y":"0.4517"},{"id":"ca","title":"Canada (7)","description":"<p>Regulatory Agency: <a href=\"https://www.canada.ca/en/health-canada.html\">Health Canada</a> </p><p>ZOLGENSMA (NOVARTIS PHARMACEUTICALS CANADA INC)<br />LUXTURNA (NOVARTIS PHARMACEUTICALS CANADA INC)<br />YESCARTA (GILEAD SCIENCES CANADA INC)<br />KYMRIAH (NOVARTIS PHARMACEUTICALS CANADA INC)<br />PROCHYMAL (MESOBLAST INTERNATIONAL SARL)<br />TECARTUS (GILEAD SCIENCES CANADA INC)<br />ABECMA (CELGENE INC)</p>","pin":"circular pin-md pin-pulse pin-label","fill":"#5b8dbf","category":"false","action":"default","x":"0.2115","y":"0.3895"},{"id":"cn","title":"China (5)","description":"<p>Regulatory Agency: <a href=\"http://english.nmpa.gov.cn/\">National Medical Products Administration (NMPA)</a></p><p>Oncorine (Shanghai Sunway Biotech Co.)<br />Gendicine (Shenzhen SiBiono GeneTech Co. Ltd.)<br />Yescarta (Shanghai Fosun Pharmaceutical Group)<br />Carteyva (JW Therapeutics)<br />FUCASO<sup>®</sup> (Innovent Biologics &amp; IASO Bio)</p>","pin":"circular pin-md pin-pulse pin-label","category":"false","action":"default","x":"0.7739","y":"0.5415","fill":"#7e9ebf"},{"id":"au","title":"Australia (10)","description":"<p>Regulatory Agency: <a href=\"https://www.tga.gov.au/\">Therapeutic Goods Administration (TGA)</a></p><p>LUXTURNA (voretigene neparvovec) (Novartis Pharmaceuticals Australia Pty Ltd)<br />YESCARTA (axicabtagene ciloleucel) (Gilead Sciences Pty Ltd)<br />KYMRIAH (T cells - tisagenlecleucel) (Novartis Pharmaceuticals Australia Pty Ltd)<br />SPINRAZA (nusinersen (as heptadecasodium)) (Biogen Australia Pty Ltd)<br />Chondrocytes - T - Ortho-ACI (Orthocell Pty Ltd)<br />ZOLGENSMA (Novartis Pharmaceuticals Australia Pty Ltd)<br />TECARTUS (brexucabtagene autoleucel) (Gilead Sciences Pty Ltd)<br />CARVYKTI (Ciltacabtagene autoleucel) (Janssen-Cilag Pty Ltd)<br />IMLYGIC (Talimogene laherparepvec) (Amgen Australia Pty Ltd)<br />HEMGENIX (etranacogene dezaparvovec) (CSL Behring Australia Pty Ltd)</p>","pin":"circular pin-md pin-pulse pin-label","fill":"#82a0bf","category":"false","action":"default","x":"0.8609","y":"0.8004"},{"id":"in","title":"India (8)","description":"<p>Regulatory Agency: <a href=\"https://cdsco.gov.in/opencms/opencms/en/Home\">Central Drugs Standard Control Organization (CDSCO)</a></p><p><a href=\"http://www.pharmabiz.com/NewsDetails.aspx?aid=101415&amp;sid=2\">CARTIGROW™ (Chondron ACI) (RMS Regrow)</a></p><p>OSSGROW™ (Ossron ABI) (RMS Regrow)</p><p><a href=\"https://business.medicaldialogues.in/apac-biotech-gets-indian-fda-approval-for-autologous-dendritic-cell-based-immuno-oncology-product-apceden/\">APCEDEN (APAC Biotech)</a></p><p><a href=\"https://www.natureasia.com/en/nindia/article/10.1038/nindia.2016.61\">Stempeucel® (Stempeutics Research)</a></p><p>Trichosera® (Hair care) (SPRL)</p><p>Cutisera® (Skin care) (SPRL) </p><p>Perioptisera® (Under eye care) (SPRL)</p><p>StemOne (Stempeutics Research)</p>","pin":"circular pin-md pin-pulse pin-label","fill":"#1e73be","category":"false","action":"default","x":"0.7040","y":"0.5859"},{"id":"jp","title":"Japan (19)","description":"<p>Regulatory Agency: <a href=\"https://www.pmda.go.jp/english/\">Pharmaceuticals and Medical Devices Agency (PMDA)</a></p><p>Alofisel (Takeda Pharmaceutical Company Limited)<br />Ocural (Japan Tissue Engineering Co., Ltd.)<br />Delytact (Daiichi Sankyo Company, Limited)<br />Breyanzi (Celgene Corporation)<br />Yescarta (Daiichi Sankyo Company, Limited)<br />Zolgensma (Novartis Pharma K.K.)<br />Nepic (Japan Tissue Engineering Co.,Ltd.)<br />Kymriah (Novartis Pharma K.K.) <br />Collategene (AnGes, Inc.)<br />Stemirac (Nipro Corporation)<br />Temcell HS (JCR Pharmaceuticals Co. Ltd.)<br />HeartSheet (Terumo Corporation, Ltd.)<br />JACC (J-TEC)<br />JACE (J-TEC)<br />Abecma (Bristol-Myers Squibb K.K)<br />Carvykti (Janssen Pharmaceutical K.K)<br />JACEMIN (Japan Tissue Engineering Co., Ltd.)<br />Sakracy (Hirosaki Lifescience Innovation, Inc.)<br />Vyznova (Aurion Biotech Japan, LLC)</p>","pin":"circular pin-md pin-pulse pin-label","fill":"#116ebf","category":"false","action":"default","x":"0.8702","y":"0.5368"},{"id":"ch","title":"Switzerland (14)","pin":"circular pin-md pin-pulse pin-label","fill":"#1e73be","category":"false","action":"default","x":"0.5239","y":"0.4761","description":"<p>Regulatory Agency: <a href=\"https://www.swissmedic.ch/swissmedic/en/home.html\">Swissmedic</a></p><p>Tecartus (Gilead Sciences Switzerland Sàrl)<br />ABECMA (Celgene GmbH)<br />Zolgensma (Novartis Pharma Schweiz AG)<br />Luxturna (Novartis Pharma Schweiz AG)<br />Yescarta (Gilead Sciences Switzerland Sàrl)<br />Spherox (co.don schweiz GmbH)<br />Alofisel (Takeda Pharma AG)<br />Kymriah (Novartis Pharma)<br />Spinraza (Biogen Switzerland AG)<br />Imlygic (AMGEN Switzerland AG)<br />Apligraf (Organogenesis Switzerland GmbH)<br />Breyanzi (Bristol-Myers Squibb Pharma EEIG)<br />Carvykti (Janssen-Cilag International NV)<br />Novocart 3D (B. Braun Medical)</p>"},{"id":"ir","title":"Iran (7)","description":"<p>Regulatory Agency: <a href=\"https://www.fda.gov.ir/en\">Iran Food &amp; Drug Administration</a></p><p>Amniodisk (SinaCell)<br />Wartocell (Celltechphamed Co.)<br />Recallercell (Celltechphamed Co.)<br />Renodermcell (Celltechphamed Co.)<br />Mesestrocell (Celltechphamed Co.)<br />Cell Amniosin (SinaCell)<br />Amniosin (SinaCell)</p>","pin":"circular pin-md pin-pulse pin-label","category":"false","action":"default","x":"0.6377","y":"0.5550","fill":"#1b45ad"},{"id":"sp","title":"Singapore (4)","description":"<p>Regulatory Agency: <a href=\"https://www.hsa.gov.sg/\">Health Sciences Authority (HSA)</a></p><p>KYMRIAH (Tisagenlecleucel) (Novartis (Singapore) Pte Ltd)</p><p>LUXTURNA (Voretigene neparvovec) (Novartis (Singapore) Pte Ltd)</p><p>YESCARTA (Axicabtagene ciloleucel) (Gilead Sciences Singapore Pte Ltd)</p><p>ZOLGENSMA (Onasemnogene abeparvovec) (Novartis (Singapore) Pte Ltd)</p>","pin":"circular pin-md pin-pulse pin-label","fill":"#0367bf","category":"false","action":"default","x":"0.7713","y":"0.6874"},{"id":"bz","title":"Brazil (3)","description":"<p>Regulatory Agency: <a href=\"https://www.gov.br/anvisa/pt-br\">Agência Nacional de Vigilância Sanitária (ANVISA)</a></p><p>ZOLGENSMA (AveXis, Inc)<br />LUXTURNA (voretigene neparvovec-rzyl) (Spark Therapeutics, Inc.)<br />YESCARTA (axicabtagene ciloleucel) (Gilead Sciences)</p><p> </p>","pin":"circular pin-md pin-pulse pin-label","fill":"#0040a8","category":"false","action":"default","x":"0.3598","y":"0.7463"},{"id":"gb","title":"United Kingdom (18)","pin":"circular pin-md pin-pulse pin-label","fill":"#1e73be","category":"false","action":"default","x":"0.4977","y":"0.4372","description":"<p>Regulatory Agency: <a href=\"https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency\">Medicines and Healthcare products Regulatory Agency (MHRA)</a></p><p>HOLOCLAR (Holostem Terapie Avanzate s.r.l.)<br />IMLYGIC (Amgen Europe B.V.)<br />STRIMVELIS (Orchard Therapeutics [Netherlands] B.V.)<br />SPHEROX (CO.DON AG)<br />ALOFISEL (Takeda Pharma A/S)<br />YESCARTA (Kite Pharma EU B.V.)<br />KYMRIAH (Novartis Europharm Limited)<br />LUXTURNA (Novartis Europharm Limited)<br />ZOLGENSMA (Novartis Europharm Limited)<br />LIBMELDY (Orchard Therapeutics [Netherlands] B.V.)<br />TECARTUS (Kite Pharma EU B.V.)<br />ABECMA (Bristol-Myers Squibb Pharma EEIG)<br />BREYANZI (Bristol-Myers Squibb Pharma EEIG)<br />CARVYKTI (Janssen-Cilag International NV)<br />UPSTAZA (PTC Therapeutics International Limited)<br />ROCTAVIAN (BioMarin International Limited)<br />EBVALLO (Pierre Fabre Medicament)<br />HEMGENIX (CSL Behring GmbH)</p>"},{"id":"nz","title":"New Zealand (1)","description":"<p>Regulatory Agency: <a href=\"https://www.medsafe.govt.nz/index.asp\">Medicines and Medical Devices Safety Authority (MEDSAFE)</a> &amp; <a href=\"https://www.epa.govt.nz/\">Environmental Protection Authority (EPA)</a></p><p>CARVYKTI (Ciltacabtagene autoleucel) (Janssen-Cilag Pty Limited)</p>","pin":"transparent pin-md pin-label","fill":"#0367bf","category":"false","action":"default","x":"0.9517","y":"0.8868"},{"id":"tw","title":"Taiwan (1)","description":"<p>Regulatory Agency: <a href=\"https://www.fda.gov.tw/eng/index.aspx\">Taiwan Food and Drug Administration</a></p><p>Zolgensma (AveXis, Inc.)</p>","pin":"transparent pin-md pin-label","fill":"#0367bf","category":"false","action":"default","x":"0.8170","y":"0.5948"},{"id":"il","title":"Israel (2)","description":"<p>Regulatory Agency: <a href=\"https://www.gov.il/en/departments/ministry_of_health/govil-landing-page\">Israel Ministry of Health</a></p><p>Zolgensma (AveXis, Inc.)</p><p>Alofisel (Takeda Israel Ltd.)</p>","pin":"transparent pin-md pin-label","fill":"#0367bf","category":"false","action":"default","x":"0.5924","y":"0.5596"}]}],"maxscale":4,"clearbutton":true,"mousewheel":true,"deeplinking":true,"fillcolor":"#343f4b","action":"tooltip","smartip":false,"zoomoutclose":true,"thumbholder":false,"topLat":"","leftLng":"","bottomLat":"","rightLng":""}"></div> <p style="text-align: center;"><a style="color: #003366;" href="https://higherlogicdownload.s3.amazonaws.com/ISCT/15175d29-b676-4bb3-8e1a-f7de41062a62/UploadedImages/Regulatory_Report.pdf" target="_blank" rel="noopener">Cell, Tissue and gene products with marketing authorization in 2023 worldwide</a></p> <table style="width: 100.394%;" width="579"> <tbody> <tr> <td style="width: 24.0069%;"> <h2 style="text-align: left;">Author</h2> </td> <td style="width: 177.312%;"> <h2 style="text-align: left;">Resource</h2> </td> </tr> <tr> <td style="text-align: left; width: 24.0069%;">Food and Drug Administration</td> <td style="width: 177.312%;"> <p style="text-align: left;"> <a href="https://www.dropbox.com/sh/dn9hq1gxvhdmek9/AADXcsI0B4-eV-PVFK5GOGPJa?dl=0" target="_blank" rel="noopener">FDA Warning Letters</a></p> </td> </tr> <tr> <td style="text-align: left; width: 24.0069%;">General Assembly of the State of Vermont</td> <td style="width: 177.312%;"> <p style="text-align: left;"><a style="color: #ff9900;" 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">Legislature</a> relating to health care practitioners administering stem cell products not approved by the U.S. Food and Drug Administration</p> </td> </tr> <tr> <td style="text-align: left; width: 24.0069%;">ISCT PTF on the Use of Unproven and/or Unethical Cell & Gene Therapies</td> <td style="width: 177.312%;"> <p style="text-align: left;">Annual Report – <a href="https://www.celltherapyjournal.org/article/S1465-3249(18)30619-4/fulltext" target="_blank" rel="noopener">Cell, Tissue and Gene Products with Marketing Authorization in 2018 worldwide</a></p> <p style="text-align: left;"><a href="https://my.isctglobal.org/resource/resmgr/Patient_Resource_Tables_Webs.pdf" target="_blank" rel="noopener">List of cell/tissue/gene products with marketing authorization</a> – updated November 2022</p> </td> </tr> <tr> <td style="text-align: left; width: 24.0069%;">ISCT PTF on the Use of Unproven and/or Unethical Cell & Gene Therapies</td> <td style="width: 177.312%;"> <p style="text-align: left;">Positioning a Scientific Community on Unproven Cellular Therapies (Multiple Languages)</p> <p style="text-align: left;"><a style="color: #f29925;" href="https://www.celltherapyjournal.org/article/S1465-3249(15)01081-6/pdf" target="_blank" rel="noopener">English</a> – <a style="color: #ff9900;" href="https://cdn.ymaws.com/my.isctglobal.org/resource/resmgr/ptf2018/ptf-article-it_v03.pdf" target="_blank" rel="noopener">Italiano</a> – <a style="color: #f29925;" href="https://cdn.ymaws.com/my.isctglobal.org/resource/resmgr/ptf2018/ptf-article-sp_v02.pdf" target="_blank" rel="noopener">Español</a> – <a style="color: #f29925;" href="https://cdn.ymaws.com/my.isctglobal.org/resource/resmgr/ptf2018/ptf-article-pg_v03.pdf" target="_blank" rel="noopener">Português</a> – <a style="color: #f29925;" href="https://cdn.ymaws.com/my.isctglobal.org/resource/resmgr/ptf2018/ptf-article-ch-simplified_v0.pdf" target="_blank" rel="noopener">简体中文 (Simplified Chinese)</a> – <a style="color: #f29925;" href="https://cdn.ymaws.com/my.isctglobal.org/resource/resmgr/ptf2018/ptf-article-ch-mandarin_v03.pdf" target="_blank" rel="noopener">繁體中文 (Traditional Chinese)</a> – <a href="https://cdn.ymaws.com/my.isctglobal.org/resource/resmgr/ptf2018/ptf-article-korean_v06.pdf" target="_blank" rel="noopener">한글 </a>(Korean) – <a style="color: #f29925;" href="https://cdn.ymaws.com/my.isctglobal.org/resource/resmgr/ptf2018/ptf-article-fr_v02.pdf" target="_blank" rel="noopener">Français</a> – <a style="color: #f29925;" href="https://cdn.ymaws.com/my.isctglobal.org/resource/resmgr/ptf2018/ptf-article-de_v01.pdf" target="_blank" rel="noopener">Deutsch</a> – <a style="color: #f29925;" href="https://cdn.ymaws.com/my.isctglobal.org/resource/resmgr/ptf2018/ptf-article-hindi_v01.pdf" target="_blank" rel="noopener">हिंदी (Hindi) </a>– <a style="color: #f29925;" href="https://cdn.ymaws.com/my.isctglobal.org/resource/resmgr/ptf2019/ptf-article-farsi_v03.pdf" target="_blank" rel="noopener">فارسی (Farsi)</a></p> </td> </tr> <tr> <td style="text-align: left; width: 24.0069%;">ISCT PTF on the Use of Unproven and/or Unethical Cell & Gene Therapies</td> <td style="text-align: left; width: 177.312%;"><a style="color: #f29925;" href="https://www.isctglobal.org/about/isct-committees/ptf-unproven-cell/ptfreferenceguide" target="_blank" rel="noopener">Reference Guide – Talking About Unproven Cell-Based Interventions</a></td> </tr> <tr> <td style="text-align: left; width: 24.0069%;">ISCT PTF on the Use of Unproven and/or Unethical Cell & Gene Therapies</td> <td style="text-align: left; width: 177.312%;"><a style="color: #f29925;" href="http://www.celltherapyjournal.org/article/S1465-3249(17)30714-4/fulltext" target="_blank" rel="noopener">Medical Societies, Patient Education Initiatives, Public Debate and Marketing of Unproven Stem Cell Interventions</a></td> </tr> <tr> <td style="text-align: left; width: 24.0069%;">The Journal of the American Medical Association (JAMA)</td> <td style="text-align: left; width: 177.312%;"><a style="color: #f29925;" href="https://jamanetwork.com/journals/jama/fullarticle/2767586?resultClick=1">Identifying the Risks of Unproven Regenerative Medicine Therapies</a></p> <p>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.</td> </tr> <tr> <td style="text-align: left; width: 24.0069%;">Wondery</td> <td style="text-align: left; width: 177.312%;"><a style="color: #f29925;" href="https://podcasts.apple.com/podcast/id1482851200" target="_blank" rel="noopener">Bad Batch Podcast</a>**</p> <p>Patients in search of a miracle cure end up in critical condition. The race is on to find out what went wrong before more people get hurt. The trail leads back to a medical company with slick marketing and a charismatic CEO. And to a multibillion dollar stem cell industry where greed and desperation collide. Laura Beil, the award-winning host and reporter of “Dr Death,” returns for this six-part investigative series from Wondery, the makers of “Dirty John” and “The Shrink Next Door.”</p> <p>**These links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by ISCT of any of the products, services or opinions of the corporation or organization or individual. ISCT bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.</td> </tr> <tr> <td style="text-align: left; width: 24.0069%;">The Journal of the American Medical Association (JAMA)</td> <td style="text-align: left; width: 177.312%;"><a style="color: #f29925;" href="https://c.ymcdn.com/sites/isct.site-ym.com/resource/resmgr/communityresources/JAMA_Patient_Page_-_Stem_Cel.pdf" target="_blank" rel="noopener">Information Fact Sheet</a></td> </tr> <tr> <td style="text-align: left; width: 24.0069%;">Joint Statement from Prominent Professional Organizations</td> <td style="text-align: left; width: 177.312%;"><a style="color: #f29925;" href="https://cdn.ymaws.com/my.isctglobal.org/resource/resmgr/communityresources/patient_advisory_sctandmt.pdf" target="_blank" rel="noopener">Patient Advisory for Stem Cell Therapy and Medical Tourism</a></td> </tr> <tr> <td style="text-align: left; width: 24.0069%;">ISCT PTF on the Use of Unproven and/or Unethical Cell & Gene Therapies</td> <td style="text-align: left; width: 177.312%;"><a style="color: #f29925;" href="https://cdn.ymaws.com/my.isctglobal.org/resource/resmgr/ptf2019/cell_therapy_medical_tourism.pdf" target="_blank" rel="noopener">Cell Therapy Medical Tourism: Time for Action</a></td> </tr> <tr> <td style="text-align: left; width: 24.0069%;">ISCT Immuno-Gene Therapy Committee</td> <td style="text-align: left; width: 177.312%;"><a style="color: #f29925;" href="https://community.isctglobal.org/viewdocument/gene-therapy-and-gene-editing-for-h" target="_blank" rel="noopener">ISCT Webinar – Gene Therapy and Gene Editing for Hemoglobinopathies</a></p> <p>The ongoing progression of gene therapies towards clinical use has led to an increased number of clinical trials in recent years and global discourse around the therapeutic potential, ethical considerations and future application of gene therapy and gene editing. As a result, there is an increased need for patient resources that provide information and insight into these novel therapies.</p> <p>Developed by the ISCT Immuno-Gene Therapy Committee as a resource for patient advocacy groups, patients and their families, this webinar will define gene therapy and outline the mechanism of action and current status of gene therapies for hemoglobinopathies, such as sickle cell disease and thalassemia. To close the session the future of gene therapy and gene editing will be discussed, and key considerations identified that can help ensure the safe and effective utilization and overall advancement of such therapeutic products.</td> </tr> <tr> <td style="text-align: left; width: 24.0069%;">ISCT Commercialization Committee Patient Advocacy Task Force</td> <td style="text-align: left; width: 177.312%;"><a style="color: #f29925;" href="https://cdn.ymaws.com/my.isctglobal.org/resource/resmgr/communityresources/Empowering_Patient_Advocates.pdf" target="_blank" rel="noopener">Empowering Patient Advocates</a></td> </tr> <tr> <td style="text-align: left; width: 24.0069%;">ISCT Australia & New Zealand Regional Committee</td> <td style="text-align: left; width: 177.312%;"><a style="color: #f29925;" href="https://my.isctglobal.org/store/ViewProduct.aspx?ID=7670721" target="_blank" rel="noopener">ISCT Webinar – Unregulated Clinics in Australia and Japan</a></td> </tr> <tr> <td style="width: 24.0069%;"></td> <td style="width: 177.312%;"></td> </tr> </tbody> </table> </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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Informational Resources – ISCT ECGT Committee