Promising ChondroCelect Data Shows Structural Superiority at Three Years
BY LAUREN UZDIENSKI, APRIL 28, 2008
Just over a year ago, TiGenix published 12 and 18-month results from their ChondroCelect clinical trial that showed advantages to the ACI treatment when compared to microfracture. Now the company has released further data showing that three years following treatment, ChondroCelect patients continue to improve and demonstrate superior outcomes over microfracture.
One of the more impressive outcomes of the ChondroCelect study has been the structural quality of the regenerated cartilage. Earlier results have shown that the quality of the new tissue associated with ChondroCelect is higher than tissue quality following microfracture. Additionally, the latest data show that patients gained, on average, 22 percentage points on the Knee Injury and Osteoarthritis Outcome Score scale. This reflects a 39% improvement when compared to pre-treatment levels. Microfracture patients gained 15 percentage points, or a 24% improvement from pre-treatment levels.
ChondroCelect patients also showed a lower failure rate than the microfracture group, and a sub-analysis shows that the earlier patients were treated, the better. ChondroCelect patients that were treated within 2 or 3 years after symptom onset showed superior clinical improvement compared to microfracture. Additionally, cells with a higher ChondroCelect score (a measurement of cell quality) were associated with superior clinical outcomes.
Three years after treatment, 83% of the ChondroCelect patients experienced clinically relevant improvement in clinical outcome; only 61% of the microfracture patients met the same criteria, demonstrating ChondroCelect's compelling clinical progress in the challenging field of cartilage regeneration. The study, which was initiated in 2002, will continue to follow patients through five-year follow-up, and the company is aiming for a U.S. IND application sometime this year. Currently, Genzyme's Carticel is the only ACI treatment approved in the U.S.
