CompletedPhase 3
A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee
Key facts
- Who runs it
- Organogenesis
- Where
- Allentown, Atlanta, Austin, Baltimore, Birmingham, Burleson, Burlington, Carrollton, Charleston, Chicago, Columbus, Dallas, Danville, Edmond, Evansville, Hagerstown, La Mesa, Lincoln, Miami, Morehead City, Napa, New York, Newnan, Norco, Omaha, Orland Park, Pomona, Redwood City, Salt Lake City, San Diego, Sarasota, Spokane, St Louis, Tempe, Troy, Williamsville, and Yukon, United StatesSee the 41 sites
- Trial code
- Status
- Completed
- Phase
- Phase 3
- People taking part
- 594 people enrolled
- Started
- 6 Sept 2023
- Ended
- 30 Nov 2025
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Amniotic Suspension Allograft
- Placebo
- Record updated
- 21 April 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 26 criteriaShow less
Who can take part
- 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
Who cannot take part
- Use of pain medication less than 5 days before the baseline visit
- 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
- 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
- Patients with known hypersensitivity reactions to ASA or any of its constituents
- 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
- Kellgren and Lawrence radiographic grade 1 OA of the knee
- Regular use of anticoagulants
- Symptoms that could indicate meniscal displacement or an IA loose body
- Contralateral knee pain above limits defined in the protocol
- 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
Where in United States
- Lehigh Center for Clinical ResearchAllentown, United StatesNo longer taking part
- CenExcel/ACMRAtlanta, United StatesNo longer taking part
- Tekton ResearchAustin, United StatesNo longer taking part
- Sinai HospitalBaltimore, United StatesNo longer taking part
- Alabama Clinical Therapeutics, LLCBirmingham, United StatesNo longer taking part
- Central Research Associates, IncBirmingham, United StatesNo longer taking part
- Cedar Health Research, LLCBurleson, United StatesNo longer taking part
- Skylight Health ResearchBurlington, United StatesNo longer taking part
- ClinRXResearch INCCarrollton, United StatesNo longer taking part
- Clinical Trials of South CarolinaCharleston, United StatesNo longer taking part
- Chicago Clinical Research Institute INCChicago, United StatesNo longer taking part
- Rush University Medical CenterChicago, United StatesNo longer taking part
- The Ohio State University -Wexner Medical CenterColumbus, United StatesNo longer taking part
- Zenos Clinical ResearchDallas, United StatesNo longer taking part
- Spectrum Medical, Inc.Danville, United StatesNo longer taking part
- Conrad Clinical ResearchEdmond, United StatesNo longer taking part
- Medisphere Medical Research CenterEvansville, United StatesNo longer taking part
- Klein & Associates, M.D., P.A.Hagerstown, United StatesNo longer taking part
- Horizon Clinical ResearchLa Mesa, United StatesNo longer taking part
- Physician Research Collaboriation, LLCLincoln, United StatesNo longer taking part
- AppleMed Research Group, LLCMiami, United StatesNo longer taking part
- West Clinical ResearchMorehead City, United StatesNo longer taking part
- Neurovations ResearchNapa, United StatesNo longer taking part
- Hospital for Special SurgeryNew York, United StatesNo longer taking part
- Northwell HealthNew York, United StatesNo longer taking part
- NYU Langone HealthNew York, United StatesNo longer taking part
- Vista Clinical ResearchNewnan, United StatesNo longer taking part
- Infinity Clinical ResearchNorco, United StatesNo longer taking part
- Quality Clinical ResearchOmaha, United StatesNo longer taking part
- Advanced Quality Medical Research, IncOrland Park, United StatesNo longer taking part
- Dream Team Clinical ResearchPomona, United StatesNo longer taking part
- Stanford MedicineRedwood City, United StatesNo longer taking part
- JBR Clinical ResearchSalt Lake City, United StatesNo longer taking part
- Triwest Research AssociatesSan Diego, United StatesNo longer taking part
- Gulfcoast Research InstituteSarasota, United StatesNo longer taking part
- Spokane Joint Replacement CenterSpokane, United StatesNo longer taking part
- Sundance Clinical ResearchSt Louis, United StatesNo longer taking part
- Fiel Family & Sports MedicineTempe, United StatesNo longer taking part
- Oakland Medical ResearchTroy, United StatesNo longer taking part
- Upstate Clinical Research Associates, LLCWilliamsville, United StatesNo longer taking part
- Tekton ResearchYukon, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- ASATreatment being tested
Participants receive a single IA injection of 2 mL of ASA (plus 2 mL of normal saline)
Treatment: Amniotic Suspension Allograft
- PlaceboPlacebo, for comparison
Participants receive a single IA injection of 4 mL of normal saline
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase 3 Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy of Amniotic Suspension Allograft (ASA) in Patients With Osteoarthritis of the Knee
- Record updated
- 21 April 2026