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NCT06000410

PHASE3

A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee

Sponsor: Organogenesis

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

594

Start Date

2023-09-06

Completion Date

2025-11-30

Last Updated

2026-04-21

Healthy Volunteers

Conditions

Knee Osteoarthritis

Interventions

BIOLOGICAL

Amniotic Suspension Allograft

This investigational product is a cryopreserved product derived from human amnion and cells from the amniotic fluid.

DRUG

Placebo

Matching placebo is 0.9% normal saline: 4 mL to be injected IA.

Inclusion Criteria: * Males or females 18 years of age or older * Diagnosis of OA of the index knee by a combination of clinical and radiographic findings. * OA of the index knee with Kellgren and Lawrence radiographic classification (Grades 2-4 inclusive), * Patients who have failed to adequately respond for at least 6 months to at least two osteoarthritis therapies within the last 12 months * Overall index knee pain score above minimum required WOMAC Pain scale. * Body mass index \< 40 kg/m2 * Using birth control, sterile or post-menopausal. * Able to understand and provide written informed consent Exclusion Criteria: * Kellgren and Lawrence radiographic grade 1 OA of the knee * Use of pain medication less than 5 days before the baseline visit * Regular use of anticoagulants * Symptoms that could indicate meniscal displacement or an IA loose body. * Corticosteroid injection into the index knee within 3 months prior to screening. * Viscosupplement or any other autologous or allogeneic product into the index knee within 6 months prior to screening. * Patients with known hypersensitivity reactions to ASA or any of its constituents. * Knee surgery on the index knee within 12 months prior to screening and/or planned knee surgery during the study * Knee surgery on the contralateral knee within 6 months prior to screening and/or planned knee surgery during the study * Acute index knee trauma within 3 months prior to screening * Knee effusion requiring aspiration of the index or contralateral knee within 3 months prior to screening. * Contralateral knee pain above limits defined in the protocol * Current therapy with any immunosuppressive therapy or medical conditions likely to require systemic steroids during the study. * Any active or systemic infection including infection of the index knee joint or breakdown or disease of the index knee skin/soft tissues. * Clinically significant intercurrent illness, medical condition, non-knee pain, or medical history that would jeopardize patient safety, limit participation, or compromise interpretation of data derived from the patient * Active alcohol or substance use disorder, or any other reason that would make it unlikely that the patient will comply with study procedures * Females who are pregnant or lactating * Participation in another clinical trial within the 30 days (or 5 half-lives of the investigational compound, whichever is longer) before screening.

Locations (41)

Central Research Associates, Inc.

Birmingham, Alabama, United States

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, United States

Fiel Family & Sports Medicine

Tempe, Arizona, United States

Horizon Clinical Research

La Mesa, California, United States

Neurovations Research

Napa, California, United States

Infinity Clinical Research

Norco, California, United States

Dream Team Clinical Research

Pomona, California, United States

Stanford Medicine

Redwood City, California, United States

TriWest Research Associates

San Diego, California, United States

AppleMed Research Group, LLC.

Miami, Florida, United States

Gulfcoast Research Institute

Sarasota, Florida, United States

CenExcel/ACMR

Atlanta, Georgia, United States

Vista Clinical Research

Newnan, Georgia, United States

Chicago Clinical Research Institute Inc.

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

Advanced Quality Medical Research, Inc

Orland Park, Illinois, United States

MediSphere Medical Research Center

Evansville, Indiana, United States

Sinai Hospital

Baltimore, Maryland, United States

Klein & Associates M.D., P.A.

Hagerstown, Maryland, United States

Skylight Health Research

Burlington, Massachusetts, United States

Oakland Medical Research

Troy, Michigan, United States

Sundance Clinical Research

St Louis, Missouri, United States

Physician Research Collaboriation, LLC

Lincoln, Nebraska, United States

Quality Clinical Research

Omaha, Nebraska, United States

NYU Langone Health

New York, New York, United States

Hospital for Special Surgery

New York, New York, United States

Northwell Health

New York, New York, United States

Upstate Clinical Research Associates, LLC

Williamsville, New York, United States

West Clinical Research

Morehead City, North Carolina, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Conrad Clinical Research

Edmond, Oklahoma, United States

Tekton Research

Yukon, Oklahoma, United States

Lehigh Center for Clinical Research

Allentown, Pennsylvania, United States

Clinical Trials of South Carolina

Charleston, South Carolina, United States

Tekton Research

Austin, Texas, United States

Cedar Health Research, LLC

Burleson, Texas, United States

ClinRXResearch INC

Carrollton, Texas, United States

Zenos Clinical Research

Dallas, Texas, United States

JBR Clinical Research

Salt Lake City, Utah, United States

Spectrum Medical, Inc.

Danville, Virginia, United States

Spokane Joint Replacement Center

Spokane, Washington, United States

Clinical Research Directory

A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (41)