Can amniotic tissue ease arthritic knees? large trial completed

NCT ID NCT04636229

Symptom relief Sponsor: Organogenesis Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether an injection made from donated human amniotic tissue and cells (called ASA) can reduce pain and improve function in people with knee osteoarthritis. Over 500 adults with moderate to severe knee OA received either ASA or a placebo (salt water) injection. The main goal was to see if ASA provided better pain relief at 6 months compared to placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: amniotic suspension allograft (a biologic made from donated human amniotic tissue and cells)
What this could lead to: If it works, this could offer a new, non-surgical option to reduce pain and improve knee function in people with osteoarthritis.
What could go wrong: This is a completed Phase 3 trial, but results are not yet published. The treatment may not prove more effective than a placebo injection, and risks include injection-site reactions or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

516 people

The number who actually took part.

Started

Dec 2020

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Males or females 18 years of age or older 2. Diagnosis of OA of the knee by a combination of clinical and radiographic findings 3. 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. 4. 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 5. Overall pain score over the previous 7 days of 11 or more on the WOMAC Pain scale. 6. Body mass index (BMI) \< 40 kg/m² 7. 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 8. 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 9. 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 10. 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 11. Able to understand and provide written informed consent Exclusion Criteria: 1. Use of pain medication (including NSAIDs and cannabidiol \[CBD\] oil) less than 15 days before treatment (acetaminophen allowed) 2. Regular use of anticoagulants 3. Symptoms of locking, intermittent block to range of motion, or loose body sensation that could indicate meniscal displacement or an IA loose body 4. Corticosteroid injection into the index knee within 3 months prior to screening 5. 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 6. Patients with known hypersensitivity reactions to ASA or any of its constituents (e.g., HA, dimethyl sulfoxide \[DMSO\]) 7. Knee surgery on the index knee within 12 months prior to screening and/or planned knee surgery during the study 8. Knee surgery on the contralateral knee within 6 months prior to screening and/or planned knee surgery during the study 9. Acute index knee trauma within 3 months prior to screening 10. Knee effusion requiring aspiration of the index or contralateral knee within 3 months prior to screening 11. Contralateral knee pain ≥ 4 on the WOMAC Pain scale on most days during the past week. 12. Current therapy with any immunosuppressive therapy, including corticosteroids (\> 5 mg/day of prednisone) 13. 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 14. 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 15. Active alcohol or substance use disorder, or any other reason that would make it unlikely for the patient to comply with study procedures 16. Females who are pregnant (positive pregnancy test at screening or prior to treatment) or lactating 17. Participation in another clinical trial within the 30 days (or 5 half-lives of the investigational compound, whichever is longer) before screening

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Conditions

The condition(s) this trial relates to.

arthritic joint disease arthropathy musculoskeletal system disorder osteoarthritis osteoarthritis, knee rheumatic disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Knee osteoarthritis

Contacts and locations

Locations

AARDS Research, Inc.

Aventura, Florida, 33180, United States
AMR Mobile

Mobile, Alabama, 36608, United States
Actca, A Member of the Allliance Inc.

Los Angeles, California, 90036, United States
Affinity Health

Oak Brook, Illinois, 60523, United States
Affinity Health

Nashville, Tennessee, 37203, United States
Alabama Clinical Therapeutics

Birmingham, Alabama, 35235, United States
Arizona Arthritis & Rheumatology Research

Glendale, Arizona, 85306, United States
Arizona Arthritis & Rheumatology Research

Tucson, Arizona, 85704, United States
Cedar Health Research, LLC

Burleson, Texas, 76028, United States
Central Research Associates

Birmingham, Alabama, 35205, United States
Chicago Clinical Research Institute Inc

Chicago, Illinois, 60607, United States
Coastal Carolina Research Center

North Charleston, South Carolina, 29406, United States
Fiel Family & Sports Medicine/ CCT Research

Tempe, Arizona, 85283, United States
Gulfcoast Research Institute

Sarasota, Florida, 34232, United States
Horizon Clinical Research Center

La Mesa, California, 91942, United States
Hospital for Special Surgery

New York, New York, 10021, United States
Injury Care Research

Boise, Idaho, 83713, United States
Klein & Associates, MD, PA

Hagerstown, Maryland, 21740, United States
Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18104, United States
Lenox Hill Hospital (Northwell Health)

New York, New York, 10075, United States
M3 Emerging Medical Research, LLC

Durham, North Carolina, 27704, United States
M3 Emerging Medical Research, LLC

Raleigh, North Carolina, 27612, United States
Methodist Physicians Clinic/ CCT Researc

Fremont, Nebraska, 68025, United States
Moore Orthopedics and Sports Medicine

Morehead City, North Carolina, 28557, United States
NYU Langone Health

New York, New York, 10016, United States
PCPMG Clinical Research Unit, LLC

Greenville, South Carolina, 29501, United States
Physician Research Collaboration

Lincoln, Nebraska, 68516, United States
Pinnacle Trials, Inc.

Stockbridge, Georgia, 30281, United States
Rush University Medical Center

Chicago, Illinois, 60612, United States
Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States
Spectrum Medical, Inc

Danville, Virginia, 24541, United States
Stanford Medicine

Redwood City, California, 94063, United States
Tri West Research Associates

El Cajon, California, 92020, United States
Tufts Medical Center

Boston, Massachusetts, 02111, United States
University Orthopedic Center

State College, Pennsylvania, 16801, United States
University Orthopedics Center

Altoona, Pennsylvania, 16602, United States
University of California at Davis

Sacramento, California, 95186, United States
University of California at Los Angeles

Los Angeles, California, 90095, United States

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