Piramal Healthcare Bio-Orthopaedics, a division of Piramal Healthcare, has announced positive data from its pivotal Phase 3 clinical trial of BST-CarGel.
BST-CarGel is a chitosan-based liquid scaffold that is first mixed with autologous whole blood and then implanted into a debrided cartilage defect prepared with bone marrow stimulation for cartilage repair.
The BST-CarGel implant resists the contraction experienced by natural clots, enabling biodegradable scaffolding for cartilage regeneration by stem cells that migrate from the bone marrow.
The international, multicentre, randomised Phase 3 clinical trial evaluated the efficacy of BST-CarGel in repairing cartilage lesions and improving patients’ clinical symptoms, compared to a surgical control called microfracture, the current standard of care.
BST-CarGel treatment met both co-primary trial endpoints by achieving superiority over microfracture in both the degree of filling of treated lesions and the quality of the new tissue.
The BST-CarGel hybrid clot improves cartilage repair outcomes by stabilising the implanted active clot and by guiding the repair process, the company said.
Dalhousie University in Halifax, Canada, surgery professor and principal investigator for the trial William Stanish said the evidence from the BST-CarGel clinical trial, using multiple and independent methodologies, 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," Stanish added.
In April 2012, BST-CarGel scaffold has been approved by the European Union, and now the company plans to launch the product for commercial sale in the fourth quarter of 2012.