In short
Autologous cultured chondrocytes are a cell therapy made from a patient's own cartilage cells, used to repair full-thickness cartilage defects of the knee. One Phase 3 trial in the EU registry compares two forms of this therapy in 166 participants with knee cartilage defects. The product MACI is authorised in the United States for this indication.
Autologous cultured chondrocytes are a cell therapy prepared from a patient's own cartilage cells (chondrocytes), used to repair full-thickness cartilage defects of the knee. The product is authorised in the United States as MACI (autologous cultured chondrocytes on porcine collagen membrane) for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. In the European Union, a Phase 3 trial is comparing two forms of this therapy.
Key points
- Autologous cultured chondrocytes are grown from a patient's own cartilage cells.
- The therapy is used to repair full-thickness cartilage defects of the knee in adults.
- A Phase 3 trial in the EU registry compares two implantation forms in 166 participants.
- The trial measures the KOOS5 score at 24 months as its primary endpoint.
- One product form, MACI, is authorised in the United States for knee cartilage repair.
What is autologous cultured chondrocytes?
Autologous cultured chondrocytes are an autologous cellularized scaffold product, meaning the cells come from the same patient who receives the treatment. The product known as MACI consists of the patient's own cultured chondrocytes placed on a porcine collagen membrane. In the United States, MACI is manufactured by Vericel Corporation and has been used in over 5,000 cases. Another product form studied in the European trial is Spherox, which contains spheroids of the patient's own chondrocytes.
How does autologous cultured chondrocytes work?
The therapy works by implanting the patient's own cartilage cells into the damaged area of the knee. The cells are cultured in a laboratory to increase their number, then placed onto a scaffold or delivered as spheroids into the cartilage defect. The implanted cells are intended to form new cartilage tissue to fill the defect.
Which conditions is autologous cultured chondrocytes used or studied for?
- Full-thickness cartilage defects of the knee — the authorised indication in the United States for MACI is the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults.
- Large full-thickness cartilage defects of knee joints — the European Phase 3 trial studies the treatment of large full-thickness cartilage defects of knee joints.
How is autologous cultured chondrocytes given?
Autologous cultured chondrocytes are given by surgical implantation into the knee. In the European trial, MACI is implanted as a matrix containing 500,000 to 1,000,000 cells per square centimetre, while Spherox is implanted as a suspension of 10 to 70 spheroids per square centimetre. The therapy is delivered directly into the cartilage defect during a surgical procedure.
What do the clinical trials show?
The European Union registry contains one Phase 3 trial of autologous cultured chondrocytes, with 166 participants, currently in the status "Authorised". The trial compares two forms of the therapy: MACI (matrix-associated autologous chondrocyte implantation) and Spherox (autologous minced cartilage implantation).
The primary efficacy endpoint is the KOOS5 score, a composite Knee injury and Osteoarthritis Outcome Score, measured at 24 months after randomisation. The trial is designed to assess whether the minced cartilage procedure is non-inferior to matrix-associated autologous chondrocyte implantation.
What side effects are known?
The supplementary sources provided do not include a detailed side-effect profile. The FDA product page for MACI refers to the package insert for safety information but does not list specific side effects in the provided content.