Knee OsteoarthritisPhase 3NCT06000410
A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee
A Phase 3 study testing Amniotic Suspension Allograft in people with Knee Osteoarthritis, run by Organogenesis at 41 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Amniotic Suspension Allograft
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 594 participants
- Where
- 41 sitesUnited States
- Study dates
- 6 Sep 2023to 30 Nov 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
United States41 sites
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104
CenExcel/ACMR
Atlanta, Georgia, 30331
Tekton Research
Austin, Texas, 78745
Sinai Hospital
Baltimore, Maryland, 21215
Central Research Associates, Inc.
Birmingham, Alabama, 35205
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235
Cedar Health Research, LLC
Burleson, Texas, 76028
Skylight Health Research
Burlington, Massachusetts, 01803
ClinRXResearch INC
Carrollton, Texas, 75007
Clinical Trials of South Carolina
Charleston, South Carolina, 29406
Chicago Clinical Research Institute Inc.
Chicago, Illinois, 60607
Rush University Medical Center
Chicago, Illinois, 60612
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43202
Zenos Clinical Research
Dallas, Texas, 75230
Spectrum Medical, Inc.
Danville, Virginia, 24541
Conrad Clinical Research
Edmond, Oklahoma, 73013
MediSphere Medical Research Center
Evansville, Indiana, 47714
Klein & Associates M.D., P.A.
Hagerstown, Maryland, 21740
Horizon Clinical Research
La Mesa, California, 91942
Physician Research Collaboriation, LLC
Lincoln, Nebraska, 68516
AppleMed Research Group, LLC.
Miami, Florida, 33126
West Clinical Research
Morehead City, North Carolina, 28557
Neurovations Research
Napa, California, 94558
NYU Langone Health
New York, New York, 10016
Hospital for Special Surgery
New York, New York, 10021
Northwell Health
New York, New York, 10065
Vista Clinical Research
Newnan, Georgia, 30265
Infinity Clinical Research
Norco, California, 92860
Quality Clinical Research
Omaha, Nebraska, 68114
Advanced Quality Medical Research, Inc
Orland Park, Illinois, 60462
Dream Team Clinical Research
Pomona, California, 91767
Stanford Medicine
Redwood City, California, 94063
JBR Clinical Research
Salt Lake City, Utah, 84107
TriWest Research Associates
San Diego, California, 92108
Gulfcoast Research Institute
Sarasota, Florida, 34232
Spokane Joint Replacement Center
Spokane, Washington, 99218
Sundance Clinical Research
St Louis, Missouri, 63141
Fiel Family & Sports Medicine
Tempe, Arizona, 85283
Oakland Medical Research
Troy, Michigan, 48085
Upstate Clinical Research Associates, LLC
Williamsville, New York, 14221
Tekton Research
Yukon, Oklahoma, 73099
About this study
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
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.
Read the detailed description
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Amniotic Suspension Allograft, Placebo
- Keywords
- Osteoarthritis, Knee, Arthritis, Joint Disease, Musculoskeletal Diseases, Rheumatic Diseases
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amniotic Suspension AllograftBiological
This investigational product is a cryopreserved product derived from human amnion and cells from the amniotic fluid.
PlaceboDrug
Matching placebo is 0.9% normal saline: 4 mL to be injected IA.
| Study group | Role | What they receive |
|---|---|---|
| ASA | Experimental | Participants receive a single IA injection of 2 mL of ASA (plus 2 mL of normal saline) Receives: Biological: Amniotic Suspension Allograft |
| Placebo | Placebo comparator | Participants receive a single IA injection of 4 mL of normal saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 26
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start6 Sep 2023
- Primary completion15 Aug 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, multicenter, randomized, double-blind, placebo-controlled study of ASA in patients with OA of the knee. Patients will be randomly assigned in a 1:1 ratio to receive a single IA injection of 2 mL of ASA (plus 2 mL of normal saline) or 4 mL of normal saline.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 594 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organogenesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000410
- Sponsor's protocol ID
- 22 OA 003 ASA
- Status last verified
- Apr 2026
- First submitted
- 14 Aug 2023
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No