Anika Therapeutics, Inc. has announced the enrollment of the first patient in its pivotal HYALOFAST FastTRACK Phase III clinical study, a prospective, randomized trial. In this multicenter study where the evaluators are blinded, the goal is to establish the superiority of a hyaluronan-based scaffold (HYALOFAST) with autologous bone marrow aspirate concentrate (BMAC) in the treatment of articular knee cartilage defect lesions.
Anika Therapeutics Enrolls First Patient in HYALOFAST Phase III Study
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As indicated in the news release, “HYALOFAST is a biodegradable scaffold that is used to enable cartilage regeneration in patients suffering from cartilage defects European clinical data demonstrates that patients treated with HYALOFAST plus autologous BMAC in a one-step, minimally invasive arthroscopic procedure were able to successfully regenerate hyaline-like cartilage. HYALOFAST is CE Marked in Europe and is available commercially in 18 countries with more than 6, 000 uses to date.”
“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.” said Anika Therapeutics President and CEO Dr. Charles H. Sherwood. “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.”
“I congratulate the FastTRACK investigators for beginning enrollment in this trial, ” said Dr. Alberto Gobbi, Global Principal Investigator. “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.”
Dr. Sherwood told OTW, “The study will enroll approximately 200 patients at up to 30 sites in the U.S. and Europe.”
“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.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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