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Completed Phase 3 Interventional

Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee

ClinicalTrials.gov ID: NCT04636229

Public ClinicalTrials.gov record NCT04636229. 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 Oct 23, 2026, 9:09 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 3 Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy of Amniotic Suspension Allograft (ASA) in Patients With Osteoarthritis of the Knee

Brief summary

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

This study is being conducted to evaluate the efficacy and safety of ASA compared to placebo in the management of osteoarthritis (OA) symptoms of the knee.

Study identification

NCT ID
NCT04636229
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Organogenesis
Industry
Enrollment
516 participants

Conditions and interventions

Interventions

Biological · Drug

Eligibility (public fields only)

Age range
18 Years and older
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
Dec 14, 2020 (Actual)
Primary completion
Jul 30, 2023 (Actual)
Completion
Aug 19, 2025 (Actual)
Last update posted
Oct 16, 2025

2020 – 2025

United States locations

U.S. sites
38
U.S. states
17
U.S. cities
33
Facility City State ZIP Site status
Central Research Associates Birmingham Alabama 35205 —
Alabama Clinical Therapeutics Birmingham Alabama 35235 —
AMR Mobile Mobile Alabama 36608 —
Arizona Arthritis & Rheumatology Research Glendale Arizona 85306 —
Fiel Family & Sports Medicine/ CCT Research Tempe Arizona 85283 —
Arizona Arthritis & Rheumatology Research Tucson Arizona 85704 —
Tri West Research Associates El Cajon California 92020 —
Horizon Clinical Research Center La Mesa California 91942 —
Actca, A Member of the Allliance Inc. Los Angeles California 90036 —
University of California at Los Angeles Los Angeles California 90095 —
Stanford Medicine Redwood City California 94063 —
University of California at Davis Sacramento California 95186 —
AARDS Research, Inc. Aventura Florida 33180 —
Gulfcoast Research Institute Sarasota Florida 34232 —
Pinnacle Trials, Inc. Stockbridge Georgia 30281 —
Injury Care Research Boise Idaho 83713 —
Chicago Clinical Research Institute Inc Chicago Illinois 60607 —
Rush University Medical Center Chicago Illinois 60612 —
Affinity Health Oak Brook Illinois 60523 —
Sinai Hospital of Baltimore Baltimore Maryland 21215 —
Klein & Associates, MD, PA Hagerstown Maryland 21740 —
Tufts Medical Center Boston Massachusetts 02111 —
Methodist Physicians Clinic/ CCT Researc Fremont Nebraska 68025 —
Physician Research Collaboration Lincoln Nebraska 68516 —
NYU Langone Health New York New York 10016 —
Hospital for Special Surgery New York New York 10021 —
Lenox Hill Hospital (Northwell Health) New York New York 10075 —
M3 Emerging Medical Research, LLC Durham North Carolina 27704 —
Moore Orthopedics and Sports Medicine Morehead City North Carolina 28557 —
M3 Emerging Medical Research, LLC Raleigh North Carolina 27612 —
Lehigh Center for Clinical Research Allentown Pennsylvania 18104 —
University Orthopedics Center Altoona Pennsylvania 16602 —
University Orthopedic Center State College Pennsylvania 16801 —
PCPMG Clinical Research Unit, LLC Greenville South Carolina 29501 —
Coastal Carolina Research Center North Charleston South Carolina 29406 —
Affinity Health Nashville Tennessee 37203 —
Cedar Health Research, LLC Burleson Texas 76028 —
Spectrum Medical, Inc Danville Virginia 24541 —

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 NCT04636229, 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 Oct 16, 2025 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04636229 live on ClinicalTrials.gov.

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