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

NCT04636229 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: 19 OA 001 ASA
• Study Type: interventional
• Target: 516
• Locations: 1 country
• Sites: 38

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 Diseases; 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 Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  Baseline to Week 26

Secondary Outcomes (10)

• 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

• The difference between changes from baseline for ASA- and placebo- treated patients in non-inferiority of WOMAC Function at 3 months

  Baseline to Week 12

• The difference between changes from baseline for ASA- and placebo-treated patients in the OMERACT-OARSI responder rate 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 knee by a combination of clinical and radiographic findings
• OA of the knee with Kellgren and Lawrence radiographic classification (Grade 2-4 inclusive) confirmed by posterior-anterior, weight-bearing, fixed flexion radiography with 10° caudal beam angulation. A specially designed positioning frame will be used to standardize the positioning for image acquisition.
• Patients who have failed to adequately respond for at least 6 months to at least 2 OA therapies that include conservative, non-pharmacological therapy and simple analgesics (e.g., acetaminophen); nonsteroidal anti-inflammatory drugs (NSAIDS); avoidance of activities that cause joint pain; exercise; weight loss; physical therapy; and removal of excess fluid from the knee
• Overall pain score over the previous 7 days of 11 or more on the WOMAC Pain scale.
• Body mass index (BMI) \< 40 kg/m²
• If female, must be postmenopausal (for at least 2 years), surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), sexually abstinent, or willing and able to use 2 methods of contraception from Day 1 through 12 months after treatment
• Males who are not surgically sterile (vasectomy) for at least 6 months prior to screening must confirm their willingness to use adequate methods of contraception from Day 1 through 12 months after treatment
• Willing to agree not to use illicit drugs during the study, and to have illicit drug testing at screening and at later time points, if illicit drug use is suspected during the study
• Able to comply with study requirements and complete the full sequence of protocol-related procedures and evaluations, including post-hospitalization, out-patient, and follow-up visits
• Able to understand and provide written informed consent

You may not qualify if:

• Use of pain medication (including NSAIDs and cannabidiol \[CBD\] oil) less than 15 days before treatment (acetaminophen allowed)
• Regular use of anticoagulants
• Symptoms of locking, intermittent block to range of motion, or loose body sensation that could indicate meniscal displacement or an IA loose body
• Corticosteroid injection into the index knee within 3 months prior to screening
• Viscosupplement (e.g., hyaluronic acid \[HA\]) injection, platelet-rich plasma injection, bone marrow aspirate (BMA) or bone marrow aspiration concentrate (BMAC), placental-derived tissue/cells, adipose tissue, 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 (e.g., HA, dimethyl sulfoxide \[DMSO\])
• 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 ≥ 4 on the WOMAC Pain scale on most days during the past week.
• Current therapy with any immunosuppressive therapy, including corticosteroids (\> 5 mg/day of prednisone)
• Clinically significant findings on the screening laboratory tests or physical examination that are not specific to OA of the knee and may interfere with study conduct or interpretation of data or increase patient risk
• Clinically significant intercurrent illness, medical condition, non-knee pain, or medical history (including neurological or mental illness, human immunodeficiency virus, fibromyalgia, complex regional pain syndrome, or any active infection, including hepatitis B or C) that could jeopardize the 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 for the patient to comply with study procedures

Sponsors & Collaborators

• Organogenesis: lead
• Premier Research: collaborator

Study Sites (38)

Central Research Associates

Birmingham, Alabama, 35205, United States

Location

Alabama Clinical Therapeutics

Birmingham, Alabama, 35235, United States

Location

AMR Mobile

Mobile, Alabama, 36608, United States

Location

Arizona Arthritis & Rheumatology Research

Glendale, Arizona, 85306, United States

Location

Fiel Family & Sports Medicine/ CCT Research

Tempe, Arizona, 85283, United States

Location

Arizona Arthritis & Rheumatology Research

Tucson, Arizona, 85704, United States

Location

Tri West Research Associates

El Cajon, California, 92020, United States

Location

Horizon Clinical Research Center

La Mesa, California, 91942, United States

Location

Actca, A Member of the Allliance Inc.

Los Angeles, California, 90036, United States

Location

University of California at Los Angeles

Los Angeles, California, 90095, United States

Location

Stanford Medicine

Redwood City, California, 94063, United States

Location

University of California at Davis

Sacramento, California, 95186, United States

Location

AARDS Research, Inc.

Aventura, Florida, 33180, United States

Location

Gulfcoast Research Institute

Sarasota, Florida, 34232, United States

Location

Pinnacle Trials, Inc.

Stockbridge, Georgia, 30281, United States

Location

Injury Care Research

Boise, Idaho, 83713, United States

Location

Chicago Clinical Research Institute Inc

Chicago, Illinois, 60607, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Affinity Health

Oak Brook, Illinois, 60523, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Klein & Associates, MD, PA

Hagerstown, Maryland, 21740, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Methodist Physicians Clinic/ CCT Researc

Fremont, Nebraska, 68025, United States

Location

Physician Research Collaboration

Lincoln, Nebraska, 68516, 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

Lenox Hill Hospital (Northwell Health)

New York, New York, 10075, United States

Location

M3 Emerging Medical Research, LLC

Durham, North Carolina, 27704, United States

Location

Moore Orthopedics and Sports Medicine

Morehead City, North Carolina, 28557, United States

Location

M3 Emerging Medical Research, LLC

Raleigh, North Carolina, 27612, United States

Location

Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18104, United States

Location

University Orthopedics Center

Altoona, Pennsylvania, 16602, United States

Location

University Orthopedic Center

State College, Pennsylvania, 16801, United States

Location

PCPMG Clinical Research Unit, LLC

Greenville, South Carolina, 29501, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29406, United States

Location

Affinity Health

Nashville, Tennessee, 37203, United States

Location

Cedar Health Research, LLC

Burleson, Texas, 76028, United States

Location

Spectrum Medical, Inc

Danville, Virginia, 24541, United States

Location

Related Links

• Farr J, et al. A randomized controlled single-blind study demonstrating superiority of ASA injection over hyaluronic acid and saline control for modification of knee OA symptoms. J Knee Surg. 2019; https://doi.org/10.1055/s-0039-1696672.

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: 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: November 5, 2020
• First Posted: November 19, 2020
• Study Start: December 14, 2020
• Primary Completion: July 30, 2023
• Study Completion: August 19, 2025
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (38)