Phase III clinical trial of hyaluronan-based scaffold for knee cartilage defect lesions enrolls first patient
Anika Therapeutics, Inc. (MA, USA) has recruited the first patient in its HYALOFAST® FastTRACK Phase III clinical study of a hyaluronan-based scaffold with autologous bone marrow aspirate concentrate for the treatment of articular knee cartilage defect lesions.
Anika Therapeutics, Inc. (MA, USA), a global orthopedic medicine company, has recruited the first patient in its HYALOFAST® FastTRACK Phase III clinical study. The trial is a prospective, randomized, active treatment-controlled, evaluator-blinded multicenter study that will evaluate the use of their hyaluronan-based scaffold with autologous bone marrow aspirate concentrate to treat articular knee cartilage defect lesions. They aim to enrol approximately 200 participants across up to 30 sites in Europe and the USA.
“I congratulate the FastTRACK investigators for beginning enrollment in this trial,” stated Alberto Gobbi (Anika Therapeutics). “We know from prior research that the HYALOFAST® scaffold supports the adhesion, migration and proliferation of mesenchymal stem cells, and their differentiation into chondrocytes. We look forward to demonstrating the unique advantages of HYALOFAST® in a randomized clinical trial.”
HYALOFAST® is a biodegradable scaffold that enables cartilage regeneration among people with cartilage defects. European clinical data provided evidence that HYALOFAST® plus BMAC regenerates hyaline-like cartilage as a minimally invasive arthroscopic procedure.
“HYALOFAST is an exciting, emerging product in our pipeline, representing Anika’s expansion into the rapidly evolving field of regenerative medicine in the orthopedics space,” concluded Charles Sherwood (Anika Therapeutics). “We have seen very positive clinical outcomes in the treatment of knees and ankles internationally using HYALOFAST. We believe the FastTRACK study will give us the pivotal clinical data to support a marketing application for an indication for the repair of cartilage defects of the knee in the U.S.”
— Written by Daphne Boulicault