Table 2.
All approved nongenetically modified cell therapies as of June 2023
| Product name | Generic name | Originator company | Modality | Disease(s) | Year first approved | Locations approved |
|---|---|---|---|---|---|---|
| Omisirge | Omidubicel | Gamida Cell | Hematopoietic progenitor stem cells | Stem cell engraftment | 2023 | USA |
| Vyznova | Corneal endothelial cell therapy | Aurion Biotech | Corneal endothelial cells | Corneal dystrophy | 2023 | Japan |
| Tab-cel | Tabelecleucel | Atara Biotherapeutics | T cell immunotherapy | Posttransplant lymphoproliferative disorder | 2022 | EU, UK |
| Sakracy | Autologous cultured oral mucosal epithelium | Hirosaki Lifescience Innovation | Mucosal epithelium | Limbal stem cell deficiency | 2022 | Japan |
| Trinity ELITE | Cellular allograft | Orthofix | Mesenchymal stem cells, osteoprogenitor cells, and demineralized cortical bone | Musculoskeletal disease | 2021 | USA |
| Stemedyne-MSC | Mesenchymal bone marrow–derived stem cells | Stemedica | Mesenchymal stem cells | Infarction, myocardial | 2021 | Kazakhstan |
| CardioRel | Autologous mesenchymal stem cell therapy | Reliance Life Sciences | Mesenchymal stem cells | Infarction, myocardial | 2021 | India |
| Rethymic | Allogeneic processed thymus tissue-agdc | Sumitomo Dainippon Pharma | Thymus tissue-agdc | DiGeorge syndrome | 2021 | USA |
| Ocural | Autologous cultured oral mucosal epithelium | Teijin Pharma | Mucosal epithelium | Limbal stem cell deficiency | 2021 | Japan |
| Stratagraft | Allogenic skin tissue cells | Mallinckrodt | Dermal and epidermal cells | Wound healing | 2021 | USA |
| Kaloderm | Allogeneic keratinocyte therapy | Tego Science | Keratinocytes | Burns; ulcer, diabetic | 2020 | South Korea, Indonesia, Mongolia |
| Nepic | Autologous corneal epithelium cells | Teijin Pharma | Epithelial cells | Limbal stem cell deficiency | 2020 | Japan |
| StemSpine | Autologous stem cell therapy | Creative Medical Technologies | Bone marrow aspirate | Pain, musculoskeletal; regeneration, cartilage, intervertebral disc | 2019 | USA |
| FemCelz | Female sexual dysfunction stem cell therapy | Creative Medical Technologies | Stem cells, including hematopoietic and mesenchymal stem cells | Sexual dysfunction, female | 2019 | EU, UK, USA |
| CartiLife | Autologous chondrocytes | Biosolution Co. | Chondrocytes | Arthritis, osteo | 2019 | South Korea |
| Cellistem | Umbilical cord mesenchymal stem cells | Cells for Cells | Mesenchymal stem cells | Arthritis, osteo; heart failure | 2018 | Chile |
| Epicel | Cultured epidermal autograft | Vericel Innovative Cellular Therapeutics | Epidermal cells | Burns | 2018 | USA |
| Stemirac | Stemirac | Nipro | Mesenchymal stem cells | Spinal cord injury | 2018 | Japan |
| Kyslecel | Minimally manipulated autologous pancreatic islets | Orgenesis | Pancreatic islet cells | Pancreatitis | 2018 | USA |
| Alofisel | Darvadstrocel | Takeda | Adipose-derived stem cells | Anal fistula, Crohn disease | 2018 | EU, Israel, Japan, UK |
| Spherox | Spheroids of human autologous matrix-associated chondrocytes | co.don | Chondrocytes | Regeneration, cartilage, orthopediac lesion | 2017 | EU, UK |
| Keraheal-Allo | Allogeneic keratinocytes | Biosolution Co. | Keratinocytes | Burns | 2017 | South Korea |
| Keraheal | Autologous keratinocytes | Biosolution Co. | Keratinoyctes | Burns | 2017 | South Korea |
| Apceden | Autologous dendritic cells | APAC Biotech | Dendritic cell immunotherapy | Colorectal cancer, non-small cell lung cancer, ovarian cancer, prostate cancer | 2017 | India |
| Chondron | Autologous chondrocytes | Sewon Cellontech | Chondrocytes | Regeneration, cartilage, orthopediac lesion | 2017 | China, India, Malaysia, Singapore, EU, South Korea, UK |
| Chondroseal | Chondroseal | Theracell Advanced Biotechnology | Adipose-derived stem cells | Regeneration, cartilage, orthopediac lesion | 2016 | UK |
| Cartil-S | Cartil-S | Theracell Advanced Biotechnology | Adipose-derived stem cells | Arthritis, osteo | 2016 | UK |
| AlloStem | Allogeneic adipose-derived mesenchymal stem cells | AlloSource | Mesenchymal stem cells | Regeneration, bone | 2016 | USA |
| Stempeucel | Allogeneic mesenchymal stem cells | Stempeutics | Mesenchymal stem cells | Ischemia, limb | 2016 | India |
| NeuroNata-R | Lenzumestrocel | Corestem | Mesenchymal stem cells | Amyotrophic lateral sclerosis | 2015 | South Korea |
| CureSkin | CureSkin | S.Biomedics | Skin cell therapy | Wound healing | 2015 | South Korea |
| TCD-51073 | Autologous myoblast cell therapy | Precigen | Myoblasts | Heart failure | 2015 | Japan |
| Holoclar | Autologous corneal epithelial cells | Holostem Terapie Avanzate | Corneal epithelial cells | Limbal stem cell deficiency | 2015 | EU, UK |
| Novocart 3D | Autologous chondrocyte transplantation system | Aesculap Biologics | Chondrocytes | Regeneration, cartilage, orthopediac lesion | 2014 | Germany, Switzerland |
| Ortho-ATI | Autologous tenocyte implantation | Orthocell | Tenocytes | Regeneration, ligament; regeneration, tendon | 2014 | Australia, China, New Zealand |
| Ortho-ACI | Autologous chondrocyte implantation | Orthocell | Chondrocytes | Regeneration, cartilage | 2014 | Australia |
| HiQCell | HiQCell | Regeneus | Adipose tissue stem cells | Arthritis, osteo; tendinitis | 2014 | Australia |
| Cupistem | Autologous adipose-derived stem cell therapy | Bukwang Pharmaceutical | Adipose-derived stem cells | Anal fistula | 2014 | South Korea |
| Carticel | Autologous cultured chondrocytes | Sanofi | Chondrocytes | Regeneration, cartilage, orthopediac lesion | 2014 | USA |
| Carticel II | Matrix-induced autologous chondrocyte implantation | Sanofi | Chondrocytes | Regeneration, cartilage, orthopediac lesion | 2013 | USA |
| Ryoncil | Remestemcel-L | Smith & Nephew | Mesenchymal stromal cells | Graft-versus-host disease | 2012 | Japan |
| Gintuit | Allogeneic keratinocytes/fibroblasts/collagen | Organogenesis | Dermal fibroblasts/keratinocytes/collagen | Regeneration, soft tissue, gingival | 2012 | USA |
| Cartistem | Human umbilical cord blood–derived mesenchymal stem cells | Medipost | Mesenchymal stem cells | Arthritis, osteo; regeneration, cartilage, orthopediac lesion | 2012 | South Korea |
| JACC | Autologous cultured cartilage | Teijin Pharma | Chondrocytes | Regeneration, cartilage, orthopediac lesion | 2012 | Japan |
| Hearticellgram-AMI | Autologous mesenchymal stem cell therapy | Pharmicell | Mesenchymal stem cells | Infarction, myocardial | 2011 | South Korea |
| Ossron | Autologous osteoblasts | Sewon Cellontech | Osteoblasts | Osteonecrosis; regeneration, bone, cancer-related bone loss; regeneration, bone, fracture healing | 2011 | South Korea |
| Provenge | Sipuleucel-T | Dendreon | Autologous dendritic cell vaccine | Prostate cancer | 2010 | USA |
| MPCs, autologous, bone repair | MPCs, autologous, bone repair | Mesoblast | MPCs | Regeneration, bone, fracture healing | 2010 | Australia |
| CreaVax-RCC | CreaVax-RCC | CreaGene | Dendritic cell vaccine | Renal cancer | 2010 | South Korea |
| De Novo NT | De novo natural tissue graft | Zimmer Biomet | Chondrocytes | Regeneration, cartilage, orthopediac lesion | 2007 | USA |
| Immuncell-LC | Autologous CIK cells and activated cytotoxic T lymphocytes | GC Biopharma | T cell immunotherapy | Liver cancer | 2007 | South Korea |
| Holoderm | Autologous keratinocyte therapy | Tego Science | Keratinocytes | Burns | 2007 | South Korea |
| Jacemin | Autologous cultured keratinocytes | Teijin Pharma | Keratinocytes | Burns, epidermolysis bullosa, melasma, vitiligo | 2007 | Japan |
| OsteoCel | OTI-050 | Smith & Nephew | Osteocytes derived from mesenchymal stem cells | Regeneration, bone, cancer-related bone loss; regeneration, bone, craniomaxillofacial; regeneration, bone, dental; regeneration, bone, spinal fusion | 2005 | USA |
| M-Vax | Dinitrophenyl-modified autologous tumor vaccine | AVAX Technologies | Tumor cell vaccine | Melanoma | 2005 | EU |
| EpiDex | HEALIVA 001 | Integra LifeSciences | Epidermal keratinocytes | Ulcer, diabetic | 2002 | EU |
| OrCel | Bilayered cellular matrix | Forticell Bioscience | Bilayered cellular matrix | Burns, epidermolysis bullosa | 2001 | USA |
| Melacine | Melanoma vaccine | GlaxoSmithKline | Melanoma cell vaccine | Melanoma | 1999 | Canada |
| TransCyte | Dermagraft-TC | Advanced Tissue Sciences | Dermal and epidermal cells | Burns | 1997 | USA |
| Dermagraft | ABH-001 | Advanced Tissue Sciences | Dermal fibroblasts | Ulcer, diabetic | 1997 | Australia, Canada, EU, China, New Zealand, UK, USA, Israel, Singapore |
| Apligraf | Apligraf | Organogenesis | Epidermal keratinocytes and dermal fibroblasts | Ulcer, diabetic; ulcer, venostasis; wound healing | 1997 | Canada, USA, Saudi Arabia, Switzerland |
| ProChon | Autologous chondrocyte tissue implant | Ocugen | Chondrocytes | Regeneration, cartilage, orthopediac lesion | Unknown | EU, Israel |
MPCs, mesenchymal precursor cells.