A Phase 3 interventional study of Amniotic Suspension Allograft and Placebo in Knee Osteoarthritis, sponsored by Organogenesis. Completed at 41 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Organogenesis · Phase 3, Interventional, and Treatment
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.
This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3 study of ASA in patients with OA of the knee. Initially, 474 subjects are planned for inclusion in this study using a group sequential design with an interim analyses and a final analysis. Patients will be randomly assigned in a 1:1 ratio to receive a single intra-articular (IA) injection of 2 mL of ASA (plus 2 mL of normal saline) or 4 mL of normal saline on Day 1.
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.
Exclusion Criteria:
Participants receive a single IA injection of 2 mL of ASA (plus 2 mL of normal saline)
Biological: Amniotic Suspension Allograft
Participants receive a single IA injection of 4 mL of normal saline
Drug: Placebo
This investigational product is a cryopreserved product derived from human amnion and cells from the amniotic fluid.
Matching placebo is 0.9% normal saline: 4 mL to be injected IA.
The difference in change from baseline in WOMAC Pain scale at 6 months between ASA- and placebo-treated patients
The WOMAC is widely used in the evaluation of hip and knee OA. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain, stiffness, and physical function. The WOMAC measure has been used in clinical trials to evaluate the efficacy of surgical treatments, medicinal and biological products, devices, and physical therapies.
Time frame: Baseline to Week 26
The difference between changes from baseline for ASA- and placebo- treated patients in WOMAC Function at 6 months
The WOMAC is widely used in the evaluation of hip and knee OA. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain, stiffness, and physical function. The WOMAC measure has been used in clinical trials to evaluate the efficacy of surgical treatments, medicinal and biological products, devices, and physical therapies.
Time frame: 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
The OMERACT-OARSI core domain set for clinical trials in hip and/or knee osteoarthritis responder criteria will be used to assess whether a patient is a responder or not.
Time frame: Baseline to Week 26
The difference between changes from baseline for ASA- and placebo-treated patients in WOMAC Pain at 3 months
The WOMAC is widely used in the evaluation of hip and knee OA. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain, stiffness, and physical function. The WOMAC measure has been used in clinical trials to evaluate the efficacy of surgical treatments, medicinal and biological products, devices, and physical therapies.
Time frame: Baseline to Week 12
Plan to share: No
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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Organogenesis