A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee
NCT ID: NCT06000410
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
594 participants
INTERVENTIONAL
2023-09-06
2025-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
They will have serial assessments of knee pain, function, and symptoms scores, as well as safety assessments for up to 52 weeks after administration of the study drug.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ASA
Participants receive a single IA injection of 2 mL of ASA (plus 2 mL of normal saline)
Amniotic Suspension Allograft
This investigational product is a cryopreserved product derived from human amnion and cells from the amniotic fluid.
Placebo
Participants receive a single IA injection of 4 mL of normal saline
Placebo
Matching placebo is 0.9% normal saline: 4 mL to be injected IA.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Amniotic Suspension Allograft
This investigational product is a cryopreserved product derived from human amnion and cells from the amniotic fluid.
Placebo
Matching placebo is 0.9% normal saline: 4 mL to be injected IA.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Organogenesis
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
22 OA 003 ASA
Identifier Type: -
Identifier Source: org_study_id