Table 1.
Clinically approved cell and tissue engineered cartilage regeneration therapies.
| Product Name | Company | Cell Type * | Support Material(s) | Country of Approval—Approval Body | Year Approved |
Refs. |
|---|---|---|---|---|---|---|
| Carticel (1st gen. ACI) | Vericel | Autologous chondrocytes | Surgical application of periosteal flap | U.S.—FDA | 1997 (2017 phased out) | [62,63] |
| Chondron™ | Sewon Cellontech |
Autologous chondrocytes | Fibrin gel | Korea—MFDS | 2001 | [64] |
| ChondroCelect® | TiGenix | Autologous chondrocytes | Surgical application of periosteal flap or commercially available collagen membrane (not included) | E.U.—EMA | 2009 (2016 withdrawn) | [65,66] |
| Cartistem® | Medipost | Allogeneic umbilical cord blood-derived mesenchymal stem cells | N/A (injection into synovial space) | Korea—MFDS | 2012 | [67] |
| JACC® | J-Tec | Autologous cultured chondrocytes | Collagen gel | Japan—MHLW | 2012 | [68] |
| Novocart® 3D | Aesculap Biologics | Autologous chondrocytes | Three-dimensional collagen-chondroitin sulphate scaffolds | Germany/Switzerland | 2014 | [69] |
| MACI® | Vericel | Autologous cultured chondrocytes | Porcine type I/III collagen membrane | E.U.—EMA | 2013 (2018 withdrawn) | [70] |
| U.S.—FDA | 2016 | [71] | ||||
| Ortho-ACI® (3rd gen. MACI) | Orthocell | Autologous chondrocytes | Porcin type I/III collagen scaffold | Australia | 2017 | [72] |
| Spherox (chondrosphere®) | co.don | Autologous matrix-associated chondrocytes | N/A (self-adhering) | E.U.—EMA | 2017 | [73] |
| Invossa™ (TissueGene-C) | Kolon Life Sciences | Allogeneic chondrocytes (retrovirally transduced to be TGF-β-expressing) | N/A (injection into synovial space) | Korea—MFDS | 2017 (2019 revoked) | [74,75] |
* All cell types are human unless otherwise noted. ACI: Articular Chondrocyte Implantation. MACI: matrix-supported autologous cultured chondrocyte therapy. U.S.: United States of America. E.U.: European Union. FDA: Federal Drug Admnistration. MFDS: Ministry of Food and Drug Safety. EMA: European Medicines Agency. MHLW: Ministry of Health, Labour and Welfare. Not Applicable (N/A) refers to products that are not prepared, or indicated to be used, with any biomaterials for supporting adhesion or localization.