To access the ISCT Presidential Task Force’s full publication – CLICK HERE
List of Cell/Tissue/Gene Products with marketing authorization (MA) in Australia by TGA (Therapeutic Goods Administration)
| Name (MA Holder) | Product description and indication(s) | Product category | Date of MA | Current Status | Additional information |
| Chondrocytes – T – Ortho-ACI (Orthocell Pty Ltd) | Autologous cultured chondrocytes for use in treatment of cartilage lesions associated with the knee, patella and ankle | Cell Therapy Product | 26-Mar-2017 | Still in market | Click Here for Link to TGA Website |
List of Cell/Tissue/Gene Products with MA in Canada by Health Canada (March 2018)
| Name (MA Holder) | Product description and indication(s) | Product category | Date of MA | Current Status | Additional information |
| KYMRIAH (NOVARTIS PHARMACEUTICAL S CANADA INC) | CD19-directed genetically modified autologous T-cell immunotherapy indicated for the treatment of pediatric and young adult patients 3 to 25 years with B-cell acute lymphoblastic leukemia (ALL) who are refractory, have relapsed after allogeneic stem cell transplant (SCT) or are otherwise ineligible for SCT, or have experienced second or later relapse and for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. | Gene Therapy Product | 05-Sept2018 | In market | Click Here for Link to Health Canada Website |
| Prochymal (MESOBLAST INTERNATIONAL SARL) | Allogeneic ex-vivo cultured adult human mesenchymal stem cells for the management of acute Graft versus Host Disease (aGvHD) in pediatric patients | Cell Therapy Product | 02-May-2015 | The product was never marketed in Canada | Click Here for Link to Health Canada Website |
List of Cell/Tissue/Gene Products with MA in China by CSFDA (Chinese Food and Drug Administration)
| Name (MA Holder) | Product description and indication(s) | Product category | Date of MA | Current Status | Additional information |
| Gendicine (Shenzhen SiBiono GeneTech Co. Ltd.) | Recombinant adenovirus expressing p53 for treatment of head and neck squamous cell carcinoma | Gene Therapy Product | Oct-2003 | Still in market | Click Here |
List of Cell/Tissue/Gene Products with MA in European Union by European Medicines Agency (EMA)
| Name (MA Holder) | Product description and indication(s) | ATMP | Date of MA | Current Status | Additional information |
| YESCARTA
(Kite Pharma EU B.V.) |
CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory diffuse large B‑cell lymphoma (DLBCL) and primary mediastinal large B‑cell lymphoma (PMBCL), after two or more lines of systemic therapy | GTMP | 27-Aug-2018 | Details of MA conditions not displayed at EMA Website as of 31 August 2018 | Click Here for Link to EMA Website |
| KYMRIAH
(Novartis Europharm Limited) |
CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of paediatric and young adult patients up to 25 years of age with B‑cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post‑transplant or in second or later relapse, and for the treatment of adult patients with relapsed or refractory diffuse large B‑cell lymphoma (DLBCL) after two or more lines of systemic therapy | GTMP | 27-Aug-2018 | Details of MA conditions not displayed at EMA Website as of 31 August 2018 | Click Here for Link to EMA Website |
| ALOFISEL
(Takeda Pharma A/S) |
Expanded allogeneic adipose stem cells as a suspension for injection for the treatment of complex perianal fistulas in patients with Crohn’s disease | SCTMP | 27-Mar-2018 | The company will complete a study to continue to collect information on the effectiveness and safety | Click Here for Link to EMA Website |
| SPHEROX
(CO.DON AG) |
Spheroids of human autologous matrix-associated chondrocytes for knee repairing cartilage defects | TEP | 10-Jul-2017 | MA under several obligations (post-authorization long-term efficacy and safety study, a prospective process validation study and to re-validate the potency assay) | Click Here for Link to EMA Website |
| ZALMOXIS
(MolMed SpA) |
Donor’s T lymphocytes genetically modified with a suicide gene as a control mechanism for GvHD after haploidentical Bone Marrow transplant | GTMP | 18-Aug-2016 | Granted MA under conditional approval | Click Here for Link to EMA Website |
| STRIMVELIS
(GSK Trading Services Limited) |
Autologous CD34+ cells transduced with a retroviral vector that encodes for the human ADA cDNA sequence for severe combined immunodeficiency due to ADA deficiency | GTMP | 26-May-2016 | Granted MA under additional monitoring until 2037 | Click Here for Link to EMA Website |
| IMLYGIC
(Amgen Europe B.V.) |
Oncolytic immunotherapy derived from a herpex simplex virus-1 genetically engineered to infect and replicate within melanoma cells and to produce GM-CSF for unresectable melanoma | GTMP | 16-Dec-2015 | Granted MA under additional monitoring | Click Here for Link to EMA Website |
| HOLOCLAR
(Chiesi Farmaceutici S.p.A.) |
Ex vivo expanded autologous human corneal epithelial cells containing stem cells for severe limbal stem cell deficiency | SCTMP | 17-Feb-2015 | Granted MA under conditional approval | Click Here for Link to EMA Website |
ATMP: Advanced Therapy Medicinal Product // TEP: Tissue Engineered Product // GTMP: Gene Therapy Medicinal Product // SCTMP: Somatic Cell Therapy Medicinal Product // EC: European Commission
List of Cell/Tissue/Gene Products with MA Withdrawn or Suspended in European Union by European Medicines Agency (EMA)
| Name (MA Holder) | Product description and indication(s) | ATMP | Date of MA | Current Status | Additional information |
| PROVENGE (Dendreon) | Autologous peripheral-blood mononuclear cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor for metastatic prostate cancer | SCTMP | 6-Sep-2013 | Granted MA under additional monitoring. Withdrawn: Company announced Bankruptcy in 2015 | Click Here for Link to EMA Website |
| MACI (Aastrom Biosciences, Inc.) | Matrix applied characterised autologous cultured chondrocytes for repairing knee cartilage defects | TEP | 27-Jun-2013 | Granted MA under additional monitoring. MA suspended: 25-Sept-2014 | Click Here for Link to EMA Website |
| GLYBERA (uniQure biopharma BV) | Alipogene tiparvovec (human lipoprotein lipase gene variant in a adeno-associated viral vector) for adult patients with familiar lipoprotein lipase deficiency | GTMP | 25-Oct-2012 | Granted MA under additional monitoring. Withdrawn: MA expired on 25-Oct-2017. The company did not apply for renewal due to the lack of demand | Click Here for Link to EMA Website |
| CHONDROCELECT (TiGenix NV) | Characterised viable autologous cartilage cells expanded ex vivo for repairing knee cartilage defects | TEP | 5-Oct-2009 | The product was reimbursed in 3 countries. Withdrawn: 30-Nov-2016. Requested by the company for commercial reasons | Click Here for Link to EMA Website |
List of Cell/Tissue/Gene products with MA in India by Drug Controller General of India (DCGI)
| Name (MA Holder) | Product description and indication(s) | Product category | Date of MA | Current Status | Additional information |
| CARTIGROWTM (Chondron ACI) (RMS Regrow) | Autologous cultured cartilage cells for treatment of articular cartilage defects | Cell Therapy Product | Apr-2017 | Conditional approval, post market surveillance study required (50 subjects) | Click Here |
| OSSGROWTM (Ossron ABI) (RMS Regrow) | Autologous cultured osteoblasts for avascular necrosis of hip | Cell Therapy Product | Apr-2017 | Conditional approval, post market surveillance study required (50 subjects) | |
| APCEDEN (APAC Biotech) | Autologous monocyte-derived mature dendritic cells for treatment of prostate, ovarian, colorectal and non-small cell lung carcinoma | Cell Therapy Product | Mar-2017 | Conditional approval, post market surveillance study required | Click Here |
| Stempeucel® (Stempeutics Research) | Ex-vivo cultured adult allogeneic mesenchymal stromal cells for treatment of critical limb ischemia due to Thromboangiitis Obliterans (Buerger’s disease) | Cell Therapy Product | May 2016 | In market, limited release (200 patients on a cost recovery basis), post market surveillance study required | Click Here |
List of Cell/Tissue/Gene products with MA in Japan by PMDA (Pharmaceuticals and Medical Devices Agency)
| Name (MA Holder) | Product description and indication(s) | Product category | Date of MA | Current Status | Additional information (In Japanese) |
| Temcell HS (JCR Pharmaceuticals Co. Ltd.) | Allogeneic mesenchymal stromal cells for treatment of acute graft versus host disease (aGVHD) | Cell Therapy Product | September 2015 | In market | Click Here for Link to PMDA Website |
| HeartSheet (Terumo Corporation, Ltd.) | Autologous skeletal myoblast sheet product for the treatment of severe heart failure | Tissue Engineered Product | September 2015 | Conditional approval | Click Here for Link to PMDA Website |
| JACC (J-TEC) | Autologous cultured cartilage | Tissue Engineered Product | July 2012 | Still in market, previous authorization was as medical device | Click Here for Link to PMDA Website |
| JACE (J-TEC) | Autologous cultured epidermis for treatment of severe burns | Tissue Engineered Product | October 2007 | Still in market, previous authorization was as medical device | Click Here for Link to PMDA Website |
List of Cell/Tissue/Gene Products with MA in New Zealand by MEDSAFE (Medicines and Medical Devices Safety Authority)
| Name (MA Holder) | Product description and indication(s) | Product category | Date of MA | Current Status | Additional information |
| Prochymal (Osiris Therapeutics Incorporated. | Allogeneic ex-vivo cultured adult human mesenchymal stem cells indicated for the rescue of patients NLT 6 months to 17 years of age with acute graft versus host disease (aGvHD), refractory to treatment with systemic corticosteroid therapy or other immunosuppressive agents | Cell Therapy Product | 14-Jun-2012 | Approval lapsed | Click Here for Link to MEDSAFE Website |
List of Cell/Tissue/Gene Products with MA in South Korea by MFDS (Ministry of Food and Drug Safety)
| Name (MA Holder) | Product description and indication(s) | Product category | Date of MA | Current Status | Additional information |
| Rosmir® (Tego Science, Inc) | Injectable autologous fibroblasts for improvement of nasojugal groove (a.k.a. tear trough) | Cell Therapy Product | 27-Dec-2017 | Still in market | Click Here for Link to MFDS Website |
| INVOSSA®-K (Kolon Life Science, Inc.) | Non-transduced and retrovirally transduced allogeneic chondrocytes to overexpress Transforming Growth Factor-β1 (TGF-β1) in 3:1 ratio for treatment of moderate knee osteoarthritis (Kellgren & Lawrence grade 3) | Gene Therapy Product | 12-Jul-2017 | Still in market | Click Here for Link to MFDS Website |
| KeraHeal-Allo™ (Biosolution Co., Ltd.) | Composite cell product (allogeneic skin-derived keratinocytes suspended in a thermosensitive hydrogel) for deep 2nd degree burns | Cell Therapy Product | 16-Oct-2015 | Still in market | Click Here for Link to MFDS Website |
| NEURONATA-R® (Corestem, Inc.) | Autologous bone marrow mesenchymal stem cell therapy for Amyotrophic Lateral Sclerosis | Cell Therapy Product | 30-Jul-2014 | Orphan product | Click Here for Link to MFDS Website |
| Cupistem® (Anterogen) | Autologous adipose tissue-derived mesenchymal stem cell for Crohn’s fistula | Cell Therapy Product | 18-Jan-2012 | Covered by insurance as of January 2014, orphan product | Click Here for Link to MFDS Website |
| CARTISTEM® (Medipost Co., Ltd.) | Human Umbilical Cord Blood-derived Mesenchymal Stem Cells for the treatment of knee articular cartilage defects in patients with osteoarthritis (ICRS grade IV) | Cell Therapy Product | 18-Jan-2012 | Still in market | Click Here for Link to MFDS Website |
| Cellgram®-AMI (Pharmicell Co., Ltd.) | Autologous Bone Marrow-derived Mesenchymal Stem Cells for Acute Myocardial Infarction patients (improvement of LVEF(Left Ventricular Ejection Fraction) | Cell Therapy Product | 1-Jul-2011 | Name at time of approval was Hearticellgram®-AMI, still in market | Click Here for Link to MFDS Website |
| CureSkin Inj. (S.Biomedics Co., Ltd.) | Autologous dermal fibroblasts (Depressed acne scar) | Cell Therapy Product | 11-May-2010 | Still in market | Click Here for Link to MFDS Website |
| Queencell® (Anterogen) | Autologous adipose tissue-derived adipose cell by minimal manipulation for subcutaneous tissue defect | Cell Therapy Product | 26-Mar-2010 | Still in market | Click Here for Link to MFDS Website |
| Kaloderm® (Tego Science, Inc) | Allogeneic keratinocytes (cell sheet) for deep 2nd degree burn or diabetic foot ulcer | Tissue Engineered Product | 21-Mar-2005 (2nd degree burn) 24-Jun- 2010 (Diabetic foot ulcer) |
Still in market | Click Here for Link to MFDS Website |
| RMS OssronTM (Sewon Cellontech Co., Ltd.) | Cultured Autologous Osteoblasts for focal bone formation, can be used with or without fibrin glue | Cell Therapy Product | 26-Aug-2009 | Still in market | Click Here for Link to MFDS Website |
| Immuncell-LC (GC Cell Corp.) | Autologous activated T-cell for liver cancer(hepatocellular carcinoma) | Cell Therapy Product | 6-Aug-2007 | Click Here for Link to MFDS Website | |
| CreaVax-RCC® (JW CreaGene Corporation) | Autologous Dendritic Cells for Metastatic Renal Cell Carcinoma | Cell Therapy Product | 15-May-2007 | Received tentative approval in 2007 and product manufacture license as export product in 2013 from MFDS. | Click Here for Link to MFDS Website |
| KeraHeal® (Biosolution Co., Ltd.) | Autologous skin-derived keratinocytes for deep 2nd degree burns that cover more than 30% of TBSA and 3rd degree burns that cover more than 10% of TBSA | Cell Therapy Product | 3-May-2006 | Still in market | Click Here for Link to MFDS Website |
| Holoderm® (Tego Science, Inc) | Autologous keratinocytes for deep 2nd degree burns that cover more than 30% of TBSA and 3rd degree burns that cover more than 10% of TBSA | Tissue Engineered Product | 10-Dec-2002 | Still in market, reimbursed by insurance | Click Here for Link to MFDS Website |
| ChondronTM (Sewon Cellontech Co., Ltd.) | Cultured Autologous Chondrocytes for focal cartilage defect of knee, can be used with or without fibrin glue | Cell Therapy Product | 30-Jan-2001 | Still in market | Click Here for Link to MFDS Website |
List of Cell/Tissue/Gene Products with MA in the United States by US-FDA (United States Food and Drug Administration)
| Name (MA Holder) | Product description and indication(s) | Product category | Date of MA | Current Status | Additional information |
| HPC, Cord Blood (MD Anderson Cord Blood Bank) | For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment | Cell Therapy Product | 06-Jun-2018 | Still in market | Click Here for Link to FDA Website |
| LUXTURNA (voretigene neparvovec-rzyl) (Spark Therapeutics, Inc.) | Adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy | Gene Therapy Product | 19-Dec-2017 | Still in market | Click Here for Link to FDA Website |
| YESCARTA (axicabtagene ciloleucel) (Kite Pharma, Incorporated) | A CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma | Gene Therapy Product | 18-Oct-2017 | Still in market | Click Here for Link to FDA Website |
| KYMRIAH (tisagenlecleucel) (Novartis Pharmaceuticals Corporation) | CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse | Gene Therapy Product | 30-Aug-2017 | Still in market | Click Here for Link to FDA Website |
| MACI (Vericel Corporation) | Autologous Cultured Chondrocytes on a Porcine Collagen Membrane for the repair of single or multiple symptomatic, full-thickness cartilage defects of the knee with or without bone involvement in adults | Tissue Engineered Product | 13-Dec-2016 | Still in market | Click Here for Link to FDA Website |
| Clevecord (HPC, Cord Blood) (Cleveland Cord Blood Center) | For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment | Cell Therapy Product | 1-Sep-2016 | Still in market | Click Here for Link to FDA Website |
| HPC, Cord Blood (Bloodworks) | For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment | Cell Therapy Product | 28-Jan-2016 | Still in market | Click Here for Link to FDA Website |
| IMLYGIC (talimogene laherparepvec) (Amgen Inc.) | Genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery | Gene Therapy Product | 27-Oct-2015 | Still in market | Click Here for Link to FDA Website |
| HPC, Cord Blood (LifeSouth Community Blood Centers, Inc.) | For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment | Cell Therapy Product | 13-Jun-2013 | Still in market | Click Here for Link to FDA Website |
| ALLOCORD (SSM Cardinal Glennon Children’s Medical Center) | For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment | Cell Therapy Product | 30-May-2013 | Still in market | Click Here for Link to FDA Website |
| Ducord (HPC, Cord Blood) (Duke University School of Medicine) | For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment | Cell Therapy Product | 4-Oct-2012 | Still in market | Click Here for Link to FDA Website |
| HPC, Cord Blood (Clinimmune Labs, University of Colorado Cord Blood Bank) | For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment | Cell Therapy Product | 24-May-2012 | Still in market | Click Here for Link to FDA Website |
| GINTUIT (Organogenesis, Inc.) | Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen (cellular sheets) for topical (non-submerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults | Tissue Engineered Product | 9-Mar-2012 | Still in market | Click Here for Link to FDA Website |
| Hemacord (HPC, Cord Blood) (New York Blood Center, Inc.) | For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment | Cell Therapy Product | 1-Nov-2011 | Still in market | Click Here for Link to FDA Website |
| Laviv® (Azficel-T) (Fibrocell Technologies, Inc.) | Autologous fibroblasts for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults | Cell Therapy Product | 21-Jun-2011 | Still in market | Click Here for Link to FDA Website |
| PROVENGE (sipuleucel-T) (Dendreon Corporation) | Autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer | Cell Therapy Product | 29-Apr-2010 | Still in market | Click Here for Link to FDA Website |
List of Cell/Tissue/Gene Products with Regenerative Medicine Advanced Therapy (RMAT) Designation [4] in the United States by US-FDA (United States Food and Drug Administration, August 2018)
| Name (MA Holder) | Product description and indication(s) | Product category | Date of RMAT Designation | Additional designations | Additional information |
| P-BCMA-101 (Poseida Therapeutics Inc.) | Autologous CAR-T therapy targeting cells that express B cell maturation antigen, or BCMA, to treat patients with relapsed/refractory multiple myeloma | Gene Therapy Product | 5-Nov-2018 | Press Release | |
| Avance® Nerve Graft (AxoGen, Inc.) | Off-the-shelf processed human nerve allograft intended for the surgical repair of peripheral nerve discontinuities. | Cell Therapy Product | 29-Oct-2018 | Press Release | |
| AT132 (Audentes Therapeutics, Inc.) | AAV-mediated gene therapy for the treatment of X-linked Myotubular Myopathy (XLMTM), a rare monogenic disease caused by mutations in the MTM1 gene | Gene Therapy Product | 21-Aug-2018 | Rare Pediatric Disease; Fast Track; Orphan Drug | Press Release |
| Romyelocel-L (Cellerant Therapeutics, Inc.) | Off-the-shelf human myeloid progenitor cells for the prevention of serious bacterial and fungal infections in patients with de novo acute myeloid leukemia (AML) undergoing induction chemotherapy | Cell Therapy Product | 02-Jul-2018 | Press Release | |
| VY-AADC (Voyager Therapeutics, Inc.) | AAV-mediated gene therapy for the treatment of Parkinson’s disease in patients with motor fluctuations that are refractory to medical management | Gene Therapy Product | 21-Jun-2018 | Press Release | |
| CLBS14-RfA (Caladrius Biosciences, Inc.) | CD34+ cell therapy program for the treatment of refractory angina | Cell Therapy Product | 19-Jun-2018 | Press Release | |
| NSR-REP1 (Nightstar Therapeutics plc) | AAV-mediated gene therapy for the treatment of choroideremia, a rare, degenerative, genetic retinal disorder that leads to blindness | Gene Therapy Product | 14-Jun-2018 | Press Release | |
| ABO-102 (Abeona Therapeutics Inc.) | AAV-mediated gene therapy for the treatment of Sanfilippo syndrome Type A (MPS IIIA), a rare autosomal-recessive lysosomal storage disease | Gene Therapy Product | 23-Apr-2018 | Press Release | |
| AmnioFix® (MiMedx) | Allogeneic micronized dehydrated human amnion/chorion membrane for use in the treatment of Osteoarthritis (OA) of the knee | Tissue Engineered Product | 9-Mar-2018 | Press Release | |
| CAP-1002 (Capricor Therapeutics) | Allogeneic cell therapy (cardiosphere-derived cells) that is currently in clinical development for the treatment of Duchenne muscular dystrophy | Cell Therapy Product | 5-Feb-2018 | Orphan Drug; Rare Pediatric Disease | Press Release |
| EB-101 (Abeona Therapeutics Inc.) | Gene-corrected autologous cell therapy product for patients with recessive dystrophic epidermolysis bullosa (RDEB) | Gene Therapy Product | 29-Jan-2018 | Breakthrough therapy; Orphan Drug; Rare Pediatric Disease | Press Release |
| MPC therapy (Mesoblast Limited) | Mesenchymal precursor cell (MPC) therapy in the treatment of heart failure patients with left ventricular systolic dysfunction and left ventricular assist devices (LVADs) | Cell Therapy Product | 21-Dec-2017 | Press Release | |
| CEVA101 (Cellvation) | Autologous bone marrow-derived stem cells for the treatment of traumatic brain injury | Cell Therapy Product | 8-Nov-2017 | Press Release | |
| Multistem (Athersys) | Proprietary stem cell product for the treatment of ischemic stroke | Cell Therapy Product | 5-Oct-2017 | Press Release | |
| AST-OPC1 (Asterias Biotherapeutics) | Oligodendrocyte progenitor cells manufactured from pluripotent embryonic stem cell for treatment of spinal cord injury patients | Cell Therapy Product | 2-Oct-2017 | Press Release | |
| LentiGlobin® BB305 (Bluebird Bio) | Ex-vivo modified autologous hematopoietic stem cells for treatment of transfusion-dependent β-thalassemia (also known as β-thalassemia major) and severe sickle cell disease (SCD) | Gene Therapy Product | 1-Oct-2017 | Press Release | |
| ATIR101™ (Kiadis Pharma) | Adjunctive immunotherapeutic on top of allogeneic hematopoietic stem cell transplantation (HSCT) | Cell Therapy Product | 20-Sep-2017 | Press Release | |
| StrataGraft (Mallinckrodt plc) | Autologous skin cell product for the treatment of deep partial thickness burns | Tissue Engineered Product | 18-Jul-2017 | Press Release | |
| Ixmyelocel-T (Vericel) | Autologous expanded multicellular (mesenchymal cells, monocytes and alternatively activated macrophages) product for the treatment of patients with advanced heart failure due to ischemic dilated cardiomyopathy | Cell Therapy Product | 10-May-2017 | Press Release | |
| jCell (jCyte) | Adult retinal progenitor cells for the treatment of retinitis pigmentosa (RP) | Cell Therapy Product | 2-May-2017 | Press Release | |
| RVT-802 (Enzyvant) | Allogeneic thymic tissue for the treatment of primary immune deficiency resulting from complete diGeorge Syndrome (cDGS) | Cell Therapy Product | 17-Apr-2017 | Breakthrough Therapy, Rare Pediatric Disease, Orphan Drug | Press Release |
| HUMACYL® (Humacyte) | Human acellular vessel (HAV) for patients undergoing hemodialysis | Tissue Engineered Product | 20-Mar-2017 | Press Release | |
| JCAR017 (Juno Therapeutics) | Treatment of r/r aggressive large B-cell Non-Hodgkin Lymphoma | Cell Therapy Product |
To access the ISCT Presidential Task Force’s full publication – CLICK HERE