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

NCT06000410 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: 22 OA 003 ASA
• Study Type: interventional
• Target: 594
• Locations: 1 country
• Sites: 41

Brief 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.

Conditions

Knee Osteoarthritis

Keywords

Osteoarthritis; Knee; Arthritis; Joint Disease; Musculoskeletal Diseases; Rheumatic Diseases

Outcome Measures

Primary Outcomes (1)

• The difference in change from baseline in WOMAC Pain scale at 6 months between ASA- and placebo-treated patients

  The WOMAC is widely used in the evaluation of hip and knee OA. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain, stiffness, and physical function. The WOMAC measure has been used in clinical trials to evaluate the efficacy of surgical treatments, medicinal and biological products, devices, and physical therapies.

  Baseline to Week 26

Secondary Outcomes (3)

• The difference between changes from baseline for ASA- and placebo- treated patients in WOMAC Function at 6 months

  Baseline to Week 26

• The difference between changes from baseline for ASA- and placebo-treated patients in the OMERACT-OARSI responder rate at 6 months

  Baseline to Week 26

• The difference between changes from baseline for ASA- and placebo-treated patients in WOMAC Pain at 3 months

  Baseline to Week 12

Study Arms (2)

ASA

EXPERIMENTAL

Participants receive a single IA injection of 2 mL of ASA (plus 2 mL of normal saline)

Biological: Amniotic Suspension Allograft

Placebo

PLACEBO COMPARATOR

Participants receive a single IA injection of 4 mL of normal saline

Drug: Placebo

Interventions

Amniotic Suspension Allograft BIOLOGICAL

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

ASA

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organogenesis: lead

Study Sites (41)

Central Research Associates, Inc.

Birmingham, Alabama, 35205, United States

Location

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 35235, United States

Location

Fiel Family & Sports Medicine

Tempe, Arizona, 85283, United States

Location

Horizon Clinical Research

La Mesa, California, 91942, United States

Location

Neurovations Research

Napa, California, 94558, United States

Location

Infinity Clinical Research

Norco, California, 92860, United States

Location

Dream Team Clinical Research

Pomona, California, 91767, United States

Location

Stanford Medicine

Redwood City, California, 94063, United States

Location

TriWest Research Associates

San Diego, California, 92108, United States

Location

AppleMed Research Group, LLC.

Miami, Florida, 33126, United States

Location

Gulfcoast Research Institute

Sarasota, Florida, 34232, United States

Location

CenExcel/ACMR

Atlanta, Georgia, 30331, United States

Location

Vista Clinical Research

Newnan, Georgia, 30265, United States

Location

Chicago Clinical Research Institute Inc.

Chicago, Illinois, 60607, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Advanced Quality Medical Research, Inc

Orland Park, Illinois, 60462, United States

Location

MediSphere Medical Research Center

Evansville, Indiana, 47714, United States

Location

Sinai Hospital

Baltimore, Maryland, 21215, United States

Location

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

Hagerstown, Maryland, 21740, United States

Location

Skylight Health Research

Burlington, Massachusetts, 01803, United States

Location

Oakland Medical Research

Troy, Michigan, 48085, United States

Location

Sundance Clinical Research

St Louis, Missouri, 63141, United States

Location

Physician Research Collaboriation, LLC

Lincoln, Nebraska, 68516, United States

Location

Quality Clinical Research

Omaha, Nebraska, 68114, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Northwell Health

New York, New York, 10065, United States

Location

Upstate Clinical Research Associates, LLC

Williamsville, New York, 14221, United States

Location

West Clinical Research

Morehead City, North Carolina, 28557, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43202, United States

Location

Conrad Clinical Research

Edmond, Oklahoma, 73013, United States

Location

Tekton Research

Yukon, Oklahoma, 73099, United States

Location

Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18104, United States

Location

Clinical Trials of South Carolina

Charleston, South Carolina, 29406, United States

Location

Tekton Research

Austin, Texas, 78745, United States

Location

Cedar Health Research, LLC

Burleson, Texas, 76028, United States

Location

ClinRXResearch INC

Carrollton, Texas, 75007, United States

Location

Zenos Clinical Research

Dallas, Texas, 75230, United States

Location

JBR Clinical Research

Salt Lake City, Utah, 84107, United States

Location

Spectrum Medical, Inc.

Danville, Virginia, 24541, United States

Location

Spokane Joint Replacement Center

Spokane, Washington, 99218, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) All clinic staff who may be involved in making assessments of safety will be blinded to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, multicenter, randomized, double-blind, placebo-controlled study of ASA in patients with OA of the knee. Patients will be randomly assigned in a 1:1 ratio to receive a single IA injection of 2 mL of ASA (plus 2 mL of normal saline) or 4 mL of normal saline.

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: September 6, 2023
• Primary Completion: August 15, 2025
• Study Completion: November 30, 2025
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (41)