NCT05796765

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: MiMedx Group, Inc. · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
BIOLOGICAL	Micronized DHACM 40 mg	Injection of 40 mg allogeneic micronized dehydrated human amnion chorion membrane (DHACM) suspended in 2.5 mL, 0.9% Sodium Chloride, USP
BIOLOGICAL	Micronized DHACM 100 mg	Injection of 100 mg allogeneic micronized dehydrated human amnion chorion membrane (DHACM) suspended in 2.5 mL, 0.9% Sodium Chloride, USP
DRUG	Saline	Injection of 2.5 ml, 0.9% Sodium Chloride, USP

Timeline

• Start date: 2023-03-24
• Primary completion: 2023-12-15
• Completion: 2023-12-15
• First posted: 2023-04-04
• Last updated: 2024-01-17

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study