Piramal Healthcare presents positive results of pivotal phase III clinical trial for BST-CarGel

Piramal Healthcare Bio-Orthopaedics, a division of Piramal Healthcare announced that positive data from their pivotal (phase III) clinical trial has been presented in three podium presentations as well as during an industry symposium at the 10th World Congress of the International Cartilage Repair Society (ICRS), which was held in Montreal, Quebec, Canada.

Dr William Stanish, Orthopaedic Surgeon, Professor of Surgery at Dalhousie University in Halifax, Nova Scotia, and Principal Investigator for the trial commented, “The significant level of evidence from the BST-CarGel clinical trial, using multiple and independent methodologies, truly supports the positive effect of BST-CarGel over the standard of care on both the quantity and quality of regenerated cartilage tissue. This represents a cost-effective, off-the-shelf surgical alternative that may dramatically improve cartilage repair over traditional methods in a minimally invasive manner.”

This international, multicentre randomised clinical trial was conducted to evaluate BST-CarGel efficacy at 12 months in repairing cartilage lesions and improving patient clinical symptoms, compared to a surgical control called microfracture, the current standard of care. The trial represents the first of its kind in cartilage repair using novel, three-dimensional quantitative MRI techniques that substantially improve comparisons of repair cartilage structure (quantity and quality) through standardised data acquisition and precise and blinded analyses.

BST-CarGel treatment met both co-primary trial endpoints by achieving statistical significance over microfracture in both the degree of filling of treated lesions and the quality of the new tissue. Overall, this trial demonstrated that cartilage repair structural outcomes resulting from BST-CarGel treatment were superior at 12 months to microfracture, the current standard of care, with a similar safety profile. This represents a critical finding as cartilage structure (quantity and quality) is believed to translate to longer durability and sustained clinical benefit.

“The 2012 ICRS World Congress is the best venue for Piramal to announce our positive clinical findings for BST-CarGel as the ICRS membership includes the most renowned international orthopaedic surgeons and researchers in this growing clinical field. Our Symposium at ICRS represents the next step in our commercialisation pathway for this exciting new medical device,” remarked Dr Swati A Piramal, Director, Piramal Healthcare.

EP News Bureau – Mumbai