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

NCT05796765 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2024-01-17

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Rho, Inc.

    collaborator INDUSTRY

  • United BioSource, LLC

    collaborator INDUSTRY

  • NBCD A/S

    collaborator INDUSTRY

  • MiMedx Group, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-24
Primary Completion
2023-12-15
Completion
2023-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05796765 on ClinicalTrials.gov