Micronized DHACM Injection for Knee Osteoarthritis

Recruiting in Palo Alto (17 mi)

+27 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: MiMedx Group, Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Research Team

Eligibility Criteria

Adults aged 21-80 with primary knee osteoarthritis (OA) for at least 6 months, experiencing moderate pain despite trying two standard treatments. Participants must have a specific level of OA severity on X-rays and be willing to stop current pain medications except acetaminophen. They should not have severe knee issues like locking or infections, other major joint pains, autoimmune diseases, recent surgeries in the affected knee, or use certain drugs that could affect the trial.

Inclusion Criteria

Subject must agree not to donate sperm during the study.

Subject is age ≥ 21 and ≤ 80 years.

Subject has a diagnosis of primary OA of the target knee (as per American College of Rheumatology clinical and radiological criteria) with OA symptoms (as reported by the subject) that have been present for at least 6 months prior to Screening.

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Exclusion Criteria

Subject has a BMI greater than 40 kg/m².

Subject has documented history of gout or pseudogout.

Subject has Grade 1 or 4 OA of the target knee on the Kellgren Lawrence (KL) grading scale as evaluated by central reading of screening X-ray.

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Treatment Details

Interventions

Micronized DHACM Injectable Product (Biological)

Trial OverviewThe trial is testing two doses of micronized DHACM injectable (40 mg and 100 mg) against a saline placebo to see if they are safe and effective for treating knee OA. The goal is to find out which treatment helps reduce pain and improve function better than just getting a saltwater shot.

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Micronized DHACM 40 mgExperimental Treatment1 Intervention

Injection of 40 mg allogeneic micronized dehydrated human amnion chorion membrane (DHACM) suspended in 2.5 mL, 0.9% Sodium Chloride, USP

Group II: Micronized DHACM 100 mgExperimental Treatment1 Intervention

Injection of 100 mg allogeneic micronized dehydrated human amnion chorion membrane (DHACM) suspended in 2.5 mL, 0.9% Sodium Chloride, USP

Group III: SalinePlacebo Group1 Intervention

Injection of 2.5 ml, 0.9% Sodium Chloride, USP