Table 1.
Cell-based therapies used in the USA and EU
| Product (brand name; company/institution) | Therapeutic area | Cell type | Approval date | Status |
|---|---|---|---|---|
| HPCs, cord blood (Bloodworks) | Oncology | Allogeneic HSCs | 2012 USA | Investigational |
| HPCs, cord blood (Ducord; Duke University) | Oncology | Allogeneic HSCs | 2012 USA | Investigational |
| HPCs, cord blood (Clinimmune Labs) | Oncology | Allogeneic HSCs | 2012 USA | Investigational |
| HPCs, cord blood (Allocord; Glennon Children’s Medical Center) | Oncology | Allogeneic HSCs | 2013 USA | Investigational |
| HPCs, cord blood (Hemacord; New York Blood Center) | Oncology | Allogeneic HSCs | 2013 USA | Investigational |
| HPCs, cord blood (Life South) | Oncology | Allogeneic HSCs | 2013 USA | Investigational |
| HPCs, cord blood (Clevecord; Cleveland Cord Blood Center) | Oncology | Allogeneic HSCs | 2015 USA | Investigational |
| HPCs, cord blood (MD Anderson) | Oncology | Allogeneic HSCs | 2018 USA | Investigational |
| Sipuleucel-T (Provenge; Dendreon Pharmaceuticals) | Oncology | Autologous dendritic cells |
2010 USA 2013 EU |
Marketed USA Withdrawn EU |
| Tisagenlecleucel (Kymriah; Novartis) | Oncology | Autologous CAR-T cells |
2017 USA 2018 EU |
Marketed |
| Axicabtagene ciloleucel (Yescarta; Kite/Gilead) | Oncology | Autologous CAR-T cells |
2017 USA 2018 EU |
Marketed |
| Brexucabtagene autoleucel (Tecartus: Kite/Gilead) | Oncology | Autologous CAR-T cells | 2020 USA | Marketed USA |
| Idecabtagene vicleucel (Abecma; Bristol-Myers Squibb) | Oncology | Autologous CAR-T cells | 2021 USA | Marketed USA |
| Lisocabtagene maraleucel (Breyanzi; Bristol-Myers Squibb) | Oncology | Autologous CAR-T cells | 2021 USA | Marketed USA |
| Allogeneically derived fibroblasts (Apligraf; Organogenesis) | Skin | Allogeneic fibroblasts | 1998 USA | Marketed |
| Articular cartilage-derived cells (ChondroCelect; TiGenix) | Cartilage | Autologous chondrocytes | 2009 EU |
Marketed Withdrawn EU |
| Azficel-T (Laviv; Fibrocell Technologies, Inc.) | Dermatology | Autologous fibroblasts | 2011 USA | Marketed |
| Allogeneic cultured keratinocytes and fibroblasts in bovine collagen (Gintuit; Organogenesis) | Dental | Allogeneic fibroblasts | 2012 USA | Marketed |
| Autologous cultured chondrocytes on porcine collagen membrane (MACI; Vericel Corp.) | Cartilage | Autologous chondrocytes |
2016 US 2013 EU |
Marketed USA; withdrawn EU |
| Ex vivo expanded autologous human corneal epithelial cells containing stem cells (Holoclar; Chiesi Farmaceutici) | Eye | Autologous limbal stem cells | 2015 EU | Marketed EU |
| Patient-derived chondrocytes (Spherox; Co-Don Ag) | Cartilage | Autologous chondrocytes | 2017 EU | Marketed |
| Adipose-derived mesenchymal stem cells (Alofisel; Takeda) | Crohn’s disease | Allogeneic adipose-derived stem cells |
2018 EU 2021 Japan |
Marketed |
CAR-T, chimeric antigen receptor T cell; HPC, haematopoietic progenitor cell; HSC, haematopoietic stem cell.