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Could a single injection from donated tissue ease knee arthritis pain?

NCT ID NCT06000410

Symptom relief Sponsor: Organogenesis Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Summary

This study tested whether a single injection of amniotic suspension allograft (ASA) can reduce pain and improve function in adults with knee osteoarthritis who haven't found relief from other treatments. About 594 participants received either ASA or a placebo, and their pain and function were measured using a standard questionnaire. The goal was to see if ASA provides meaningful symptom relief compared to placebo.

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

594 people

The number who actually took part.

Started

Sep 2023

Finished

Nov 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: * 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.

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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

  • Advanced Quality Medical Research, Inc

    Orland Park, Illinois, 60462, United States

  • Alabama Clinical Therapeutics, LLC

    Birmingham, Alabama, 35235, United States

  • AppleMed Research Group, LLC.

    Miami, Florida, 33126, United States

  • Cedar Health Research, LLC

    Burleson, Texas, 76028, United States

  • CenExcel/ACMR

    Atlanta, Georgia, 30331, United States

  • Central Research Associates, Inc.

    Birmingham, Alabama, 35205, United States

  • Chicago Clinical Research Institute Inc.

    Chicago, Illinois, 60607, United States

  • ClinRXResearch INC

    Carrollton, Texas, 75007, United States

  • Clinical Trials of South Carolina

    Charleston, South Carolina, 29406, United States

  • Conrad Clinical Research

    Edmond, Oklahoma, 73013, United States

  • Dream Team Clinical Research

    Pomona, California, 91767, United States

  • Fiel Family & Sports Medicine

    Tempe, Arizona, 85283, United States

  • Gulfcoast Research Institute

    Sarasota, Florida, 34232, United States

  • Horizon Clinical Research

    La Mesa, California, 91942, United States

  • Hospital for Special Surgery

    New York, New York, 10021, United States

  • Infinity Clinical Research

    Norco, California, 92860, United States

  • JBR Clinical Research

    Salt Lake City, Utah, 84107, United States

  • Klein & Associates M.D., P.A.

    Hagerstown, Maryland, 21740, United States

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18104, United States

  • MediSphere Medical Research Center

    Evansville, Indiana, 47714, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • Neurovations Research

    Napa, California, 94558, United States

  • Northwell Health

    New York, New York, 10065, United States

  • Oakland Medical Research

    Troy, Michigan, 48085, United States

  • Physician Research Collaboriation, LLC

    Lincoln, Nebraska, 68516, United States

  • Quality Clinical Research

    Omaha, Nebraska, 68114, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Sinai Hospital

    Baltimore, Maryland, 21215, United States

  • Skylight Health Research

    Burlington, Massachusetts, 01803, United States

  • Spectrum Medical, Inc.

    Danville, Virginia, 24541, United States

  • Spokane Joint Replacement Center

    Spokane, Washington, 99218, United States

  • Stanford Medicine

    Redwood City, California, 94063, United States

  • Sundance Clinical Research

    St Louis, Missouri, 63141, United States

  • Tekton Research

    Yukon, Oklahoma, 73099, United States

  • Tekton Research

    Austin, Texas, 78745, United States

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43202, United States

  • TriWest Research Associates

    San Diego, California, 92108, United States

  • Upstate Clinical Research Associates, LLC

    Williamsville, New York, 14221, United States

  • Vista Clinical Research

    Newnan, Georgia, 30265, United States

  • West Clinical Research

    Morehead City, North Carolina, 28557, United States

  • Zenos Clinical Research

    Dallas, Texas, 75230, United States

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