Histogenics Corporation, a privately held regenerative medicine company, presented positive P2 data for the NeoCart Autologous Cartilage Tissue Implant (ACTI).
- The perspective, randomized, controlled study, compared NeoCart to microfracture (MF) for knee cartilage injury treatment at 2 years post-operation;
- The P2 study of NeoCart evaluated 30 subjects, with a 2:1 randomization ratio of NeoCart treatment to MF treatment. Efficacy outcome measures applied included the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the International Knee Documentation Committee (IKDC) Score.
The Bottom Line: NeoCart is a bio-engineered neo-cartilage implant containing an autologous chondrocyte population matured in a biodegradable collagen matrix. The P2 results showed that ACTI treatment using NeoCart is associated with statistically significant improvements in knee and general health outcomes scores by 6 months, at the primary endpoint of 12 months, and that are then sustained for at least 2 years, and NeoCart had a higher proportion of therapeutic responders in comparison to MF at 1 and 2 years. These P2 results demonstrate advancing this program into a P3 trial under a Special Protocol Assessment (NYSE:SPA) with the FDA to addressing a significant opportunity – pain associated with cartilage injury – in the large and fast-growing global sports medicine market. Cartilage has a poor ability to repair itself, and, as a result, these injuries can persist indefinitely and often lead to pain and compromised joint function. According to results from the study, there were no serious adverse events related to treatment with NeoCart. Both cohorts demonstrated improvements in a measure of general health status at 6, 12 and 24 months. NeoCart-treated patients demonstrated significant improvement for all outcome measures included in the study at 12 and 24 months, including knee function, pain (including maximum pain), activities of daily living, and sport and knee quality of life. The study also confirmed a favorable safety profile for NeoCart.