This is a phase 2B, prospective, double-blind, randomized controlled trial of the micronized DHACM injection as compared to saline placebo injection in the treatment of osteoarthritis of the knee. Approximately 30 experienced clinical centers in the United States and Denmark will participate in the study. Each subject will receive one injection and be evaluated for efficacy and safety during the 12-month observation period. Endpoints will be measured at 30 days, 60 days, 90 days, 120 days, 150 days, 180 days, 270 days and 365 days.
Key objective is to determine the safety and efficacy of the 40 mg and 100 mg doses of allogeneic micronized dehydrated human amnion/chorion membrane (micronized DHACM) injectable compared to 0.9% sodium chloride injection, placebo control for the treatment of knee osteoarthritis