HYALOFAST® is a one-step procedure to help regrow cartilage. It has been in use since 2009 in Europe and is now part of a clinical research study in the US.
ONE-STEP CARTILAGE REGENERATION
Chondral and osteochondral lesions are notoriously difficult to treat due to the poor healing capacity of articular cartilage. In fact, the ultimate destiny of such lesions, if left untreated, is disabling pain and osteoarthritis. Hyalofast® is a biodegradable, hyaluronan-based (HYAFF®) scaffold for one-step surgical treatment of chondral and osteochondral defects.
Hyalofast® is intended for the repair of chondral or osteochondral lesions, acting as a support for mesenchymal stem cells (MSC) from bone marrow aspirate or as a chondroprotective coverage which favors in situ residence of mesenchymal stem cells after their mobilization due to micro-fracture and/or perforation procedures.
CLINICAL STUDY PROCESS
The study will conduct a screening period, a treatment procedure, and a post-procedure rehabilitation and a period for follow-up. The period for screening may last up to 60 days prior to randomization. Once randomized, patients are then treated with a microfracture comparator treatment or the one-step Hyalofast® procedure. Patients will participate in six follow-up clinical visits after the procedure.
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