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Phase 2B Micronized DHACM vs. Saline in the Treatment of Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:
A Phase 2B, Prospective, Double-Blind, Randomized Controlled Trial of the Micronized DHACM Injectable Product Compared to Saline Placebo Injection for the Treatment of Osteoarthritis of the Knee

Clinical Trial Summary

The purpose of this study 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

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05796765
Study type Interventional
Source MiMedx Group, Inc.
Contact
Status Terminated
Phase Phase 2
Start date March 24, 2023
Completion date December 15, 2023
View Details
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