autologous cultured chondrocytes
autologous cultured chondrocytes is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including MACI. Available dosage form: implant.
Drug Details
- Generic Name
- autologous cultured chondrocytes
- Brand Names
- MACI
- Application Number
- BLA125603
- Sponsor
- Vericel Corporation
- NDC Codes
- 1
- Dosage Forms
- IMPLANT
- Routes
- INTRA-ARTICULAR
- Active Ingredients
- AUTOLOGOUS CULTURED CHONDROCYTES, PORK COLLAGEN
Indications and Usage
1 INDICATIONS AND USAGE MACI ® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the knee with or without bone involvement in adults. Limitations of Use Effectiveness of MACI in joints other than the knee has not been established. Safety and effectiveness of MACI in patients over the age of 55 years have not been established. MACI ® is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. ( 1 ) Limitations of Use Effectiveness of MACI in joints other than the knee has not been established. Safety and effectiveness of MACI in patients over the age of 55 years have not been established.