Table 1.
Product name | Company | Country | Approval | Indication | Remarks |
---|---|---|---|---|---|
Carticel® | Vericel | US | 1997 FDA | Cartilage defects of the femoral condyle (medial, lateral, or trochlea) | First ACI/2017 phased out |
MACI® | Vericel | US | 2016 FDA | Full-thickness cartilage defects of the knee | Second ACI |
ChondroCelect® | TiGenix | EU | 2009 EMA | Cartilage defects of the femoral condyle of the knee | First ACI/2016 withdrawn |
MACI® | Vericel | EU | 2013 EMA | Full-thickness cartilage defects of the knee | Second ACI/2014 suspended |
Spherox (chondrosphere®) | co.don | EU | Jul 2017 EMA | Articular cartilage defects of the femoral condyle and knee patella | Third ACI |
Chondron™ | Sewon Cellontech | Korea | 2001/2008 MFDS | Articular cartilage defect (knee/ankle) | Second ACI |
CARTISTEM® | Medipost | Korea | 2012 MFDS | Osteoarthritis due to degeneration or repetitive trauma | Allogeneic umbilical cord blood-derived MSC drug |
Invossa™ (TissueGene-C) | Kolon Life Sciences | Korea | Jul 2017 MFDS | Moderate knee osteoarthritis with persistent symptoms despite ≥3 months of conservative treatment | TGF-β-expressing allogeneic chondrocytes |
JACC | Japan Tissue Engineering | Japan | 2012 MHLW | Traumatic arthritis, osteochondritis dissecans of the knee | Second ACI |
The list includes marketed products announced by each national regulatory authority as of 1 August 2017. For the United States, the FDA-approved products are listed, but not 361 HCT/P products. For the European Medicines Agency (EMA), the EMA-approved products are listed, but not the hospital exemption products. For Korea, MFDS-approved products are listed. In Japan, the MHLW-approved products are listed