4 results
The objective of this study is to evaluate efficacy and the safety of GelrinC® implant microfracture in the treatment of patients with symptomatic articular cartilage defect(s) of the femoral condyle.
Primary objectives: 1. To compare the efficacy of vamorolone administered orally at daily doses of 6.0 mg/kg over a 24-week treatment period vs. placebo in ambulant boys ages 4 to <7 years with DMD; and2. To evaluate the safety and…
To demonstrate the superior clinical efficacy of GelrinC on pain and function for the treatment of symptomatic focal articular cartilage defects of the femoral condyle in comparison to microfracture historical control at 24 months post-surgery.
To evaluate the efficacy of each combination arm, as measured by confirmed objective response rate (ORR)