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Completed Phase 2 Interventional Results available

Micronized dHACM vs. Saline in the Treatment of Osteoarthritis of the Knee

ClinicalTrials.gov ID: NCT03485157

Public ClinicalTrials.gov record NCT03485157. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 5:38 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2B, Prospective, Double-blinded, Randomized Controlled Trial of the Micronized Dehydrated Human Amnion Chorion Membrane Injection as Compared to Saline Placebo Injection in the Treatment of Osteoarthritis of the Knee

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to determine the safety and effectiveness of micronized dehydrated human amnion chorion membrane as compared to the 0.9% Sodium Chloride Injection, USP placebo control for the treatment of knee osteoarthritis

Study identification

NCT ID
NCT03485157
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
MiMedx Group, Inc.
Industry
Enrollment
447 participants

Conditions and interventions

Interventions

Biological · Drug

Eligibility (public fields only)

Age range
21 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 26, 2018
Primary completion
Apr 18, 2022
Completion
Apr 18, 2022
Last update posted
Dec 10, 2023

2018 – 2022

United States locations

U.S. sites
17
U.S. states
14
U.S. cities
17
Facility City State ZIP Site status
Central Research Associates, Inc Birmingham Alabama 35205
Fiel Family and Sports Medicine Tempe Arizona 85283
Horizon Clinical Research La Mesa California 91942
UConn Health Farmington Connecticut 06030
Bone & Joint Inst. at Hartford Hospital Hartford Connecticut 06106
Gulfcoast Research Institute Sarasota Florida 34232
Paragon Sports Medicine Atlanta Georgia 30327
Hinsdale Orthopedics Hinsdale Illinois 60521
Arthritis Care Specialist of Maryland Columbia Maryland 21046
MedSport Ann Arbor Michigan 48106
Weill Cornell Medicine New York New York 10065
Wake Reseach Durham North Carolina 27704
Wake Research Raleigh North Carolina 27612
University Orthopedics Center Altoona Pennsylvania 16602
University Orthopedics Center State College Pennsylvania 16801
SAMMC Fort Sam Houston Texas 78234
Ortho Virginia Richmond Virginia 23294

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03485157, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 10, 2023 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03485157 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →