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 objective: To evaluate the safety and tolerability of SOBI003 at different dose levels.Secondary objectives:1. To characterize the pharmacokinetic (PK) properties of SOBI003 following single and repeated administration by the use of non-…
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)