Knee OsteoarthritisPhase 3NCT04636229
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 38 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
- 516 participants
- Where
- 38 sitesUnited States
- Study dates
- 14 Dec 2020to 19 Aug 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 knee by a combination of clinical and radiographic findings
- OA of the knee with Kellgren and Lawrence radiographic classification (Grade 2-4 inclusive) confirmed by posterior-anterior, weight-bearing, fixed flexion radiography with 10° caudal beam angulation. A specially designed positioning frame will be used to standardize the positioning for image acquisition.
- Patients who have failed to adequately respond for at least 6 months to at least 2 OA therapies that include conservative, non-pharmacological therapy and simple analgesics (e.g., acetaminophen); nonsteroidal anti-inflammatory drugs (NSAIDS); avoidance of activities that cause joint pain; exercise; weight loss; physical therapy; and removal of excess fluid from the knee
- Overall pain score over the previous 7 days of 11 or more on the WOMAC Pain scale.
- Body mass index (BMI) < 40 kg/m²
Show all 11Show fewer
- If female, must be postmenopausal (for at least 2 years), surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), sexually abstinent, or willing and able to use 2 methods of contraception from Day 1 through 12 months after treatment
- Males who are not surgically sterile (vasectomy) for at least 6 months prior to screening must confirm their willingness to use adequate methods of contraception from Day 1 through 12 months after treatment
- Willing to agree not to use illicit drugs during the study, and to have illicit drug testing at screening and at later time points, if illicit drug use is suspected during the study
- Able to comply with study requirements and complete the full sequence of protocol-related procedures and evaluations, including post-hospitalization, out-patient, and follow-up visits
- Able to understand and provide written informed consent
Who cannot join
- Use of pain medication (including NSAIDs and cannabidiol [CBD] oil) less than 15 days before treatment (acetaminophen allowed)
- Regular use of anticoagulants
- Symptoms of locking, intermittent block to range of motion, or loose body sensation that could indicate meniscal displacement or an IA loose body
- Corticosteroid injection into the index knee within 3 months prior to screening
- Viscosupplement (e.g., hyaluronic acid [HA]) injection, platelet-rich plasma injection, bone marrow aspirate (BMA) or bone marrow aspiration concentrate (BMAC), placental-derived tissue/cells, adipose tissue, 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 (e.g., HA, dimethyl sulfoxide [DMSO])
Show all 17Show fewer
- 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 ≥ 4 on the WOMAC Pain scale on most days during the past week.
- Current therapy with any immunosuppressive therapy, including corticosteroids (> 5 mg/day of prednisone)
- Clinically significant findings on the screening laboratory tests or physical examination that are not specific to OA of the knee and may interfere with study conduct or interpretation of data or increase patient risk
- Clinically significant intercurrent illness, medical condition, non-knee pain, or medical history (including neurological or mental illness, human immunodeficiency virus, fibromyalgia, complex regional pain syndrome, or any active infection, including hepatitis B or C) that could jeopardize the 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 for the patient to comply with study procedures
- Females who are pregnant (positive pregnancy test at screening or prior to treatment) 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
38 sites in 1 country.
38 sites in 1 country
United States38 sites
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104
University Orthopedics Center
Altoona, Pennsylvania, 16602
AARDS Research, Inc.
Aventura, Florida, 33180
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Central Research Associates
Birmingham, Alabama, 35205
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235
Injury Care Research
Boise, Idaho, 83713
Tufts Medical Center
Boston, Massachusetts, 02111
Cedar Health Research, LLC
Burleson, Texas, 76028
Chicago Clinical Research Institute Inc
Chicago, Illinois, 60607
Rush University Medical Center
Chicago, Illinois, 60612
Spectrum Medical, Inc
Danville, Virginia, 24541
M3 Emerging Medical Research, LLC
Durham, North Carolina, 27704
Tri West Research Associates
El Cajon, California, 92020
Methodist Physicians Clinic/ CCT Researc
Fremont, Nebraska, 68025
Arizona Arthritis & Rheumatology Research
Glendale, Arizona, 85306
PCPMG Clinical Research Unit, LLC
Greenville, South Carolina, 29501
Klein & Associates, MD, PA
Hagerstown, Maryland, 21740
Horizon Clinical Research Center
La Mesa, California, 91942
Physician Research Collaboration
Lincoln, Nebraska, 68516
Actca, A Member of the Allliance Inc.
Los Angeles, California, 90036
University of California at Los Angeles
Los Angeles, California, 90095
AMR Mobile
Mobile, Alabama, 36608
Moore Orthopedics and Sports Medicine
Morehead City, North Carolina, 28557
Affinity Health
Nashville, Tennessee, 37203
NYU Langone Health
New York, New York, 10016
Hospital for Special Surgery
New York, New York, 10021
Lenox Hill Hospital (Northwell Health)
New York, New York, 10075
Coastal Carolina Research Center
North Charleston, South Carolina, 29406
Affinity Health
Oak Brook, Illinois, 60523
M3 Emerging Medical Research, LLC
Raleigh, North Carolina, 27612
Stanford Medicine
Redwood City, California, 94063
University of California at Davis
Sacramento, California, 95186
Gulfcoast Research Institute
Sarasota, Florida, 34232
University Orthopedic Center
State College, Pennsylvania, 16801
Pinnacle Trials, Inc.
Stockbridge, Georgia, 30281
Fiel Family & Sports Medicine/ CCT Research
Tempe, Arizona, 85283
Arizona Arthritis & Rheumatology Research
Tucson, Arizona, 85704
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 two interim analyses and a final analysis. Sample size re-estimation is planned at the second interim analysis. Based on conditional power, the maximum sample size may be increased to up to 700 patients. 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.
Patients will be screened after informed consent is obtained. Eligible patients will be randomized to receive a single IA injection 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.
The planned sequence and maximum duration of the study periods will be as follows:
- Screening: 2 weeks
- Treatment: 1 day
- Follow-up: 52 weeks
The maximum treatment duration for each patient is 1 day.
The maximum study duration for each patient is 54 weeks.
Efficacy will be assessed via Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) responder rates.
Safety will be assessed via monitoring of adverse events (AEs), safety laboratory testing, vital signs, physical examination, and concomitant medication use.
An independent data monitoring committee (DMC) with a defined charter will review study data and make preliminary decisions relative to interim analyses.
The assessments that are used in this study are standard, and are generally recognized as reliable, accurate, and relevant.
No pediatric patients will be included as OA of the knee is an age-related disorder and rarely occurs in patients under the age of 18 years. The sponsor plans to submit a waiver for studies in all pediatric age subgroups.
- Conditions
- Knee Osteoarthritis
- Being tested
- Amniotic Suspension Allograft, Placebo
- Keywords
- Osteoarthritis, Knee, Arthritis, Joint Diseases, 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 Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: Baseline to Week 26
Secondary outcomes (10)
The difference between changes from baseline for ASA- and placebo- treated patients in WOMAC Function at 6 months
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
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
Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International. (OMERACT-OARSI) Responders are defined as participants with high improvement in pain or function.
Measured: Baseline to Week 26
The difference between changes from baseline for ASA- and placebo-treated patients in WOMAC Pain at 3 months
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: Baseline to Week 12
The difference between changes from baseline for ASA- and placebo- treated patients in non-inferiority of WOMAC Function at 3 months
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: Baseline to Week 12
The difference between changes from baseline for ASA- and placebo-treated patients in the OMERACT-OARSI responder rate at 3 months
Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International. (OMERACT-OARSI) Responders are defined as participants with high improvement in pain or function.
Measured: Baseline to Week 12
The difference between changes from baseline for ASA- and placebo-treated patients in the WOMAC Total at 6 months
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: Baseline to Week 26
The difference between ASA- and placebo-treated patients in the WOMAC Stiffness at 6 months
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: Baseline to Week 26
The difference between changes from baseline for ASA- and placebo- treated patients in the WOMAC Total at 3 months
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: Baseline to Week 12
The difference between changes from baseline for ASA- and placebo-treated patients in the WOMAC Stiffness at 3 months
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: Baseline to Week 12
Incidence of adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study patient administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
This includes any occurrence that is new in onset or aggravated in severity or frequency from the baseline condition, or abnormal result of diagnostic procedures, including clinical laboratory test abnormalities.
Measured: Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start14 Dec 2020
- Primary completion30 Jul 2023
- Study completion19 Aug 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
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organogenesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636229
- Sponsor's protocol ID
- 19 OA 001 ASA
- Status last verified
- Oct 2025
- First submitted
- 5 Nov 2020
- Last updated
- 16 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04636229
- Acronym / sponsor ID
- 19 OA 001 ASA
- Conditions
- Knee Osteoarthritis
- Keywords
- Osteoarthritis, Knee, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- OrganogenesisIndustry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 19 Aug 2025 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 two interim analyses and a final analysis. Sample size re-estimation is planned at the second interim analysis. Based on conditional power, the maximum sample size may be increased to up to 700 patients. 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.
Patients will be screened after informed consent is obtained. Eligible patients will be randomized to receive a single IA injection 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.
The planned sequence and maximum duration of the study periods will be as follows:
- Screening: 2 weeks
- Treatment: 1 day
- Follow-up: 52 weeks
The maximum treatment duration for each patient is 1 day.
The maximum study duration for each patient is 54 weeks.
Efficacy will be assessed via Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) responder rates.
Safety will be assessed via monitoring of adverse events (AEs), safety laboratory testing, vital signs, physical examination, and concomitant medication use.
An independent data monitoring committee (DMC) with a defined charter will review study data and make preliminary decisions relative to interim analyses.
The assessments that are used in this study are standard, and are generally recognized as reliable, accurate, and relevant.
No pediatric patients will be included as OA of the knee is an age-related disorder and rarely occurs in patients under the age of 18 years. The sponsor plans to submit a waiver for studies in all pediatric age subgroups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ASA | Experimental | Biological: Amniotic Suspension AllograftParticipants receive a single IA injection of 2 mL of ASA (plus 2 mL of normal saline) |
| Placebo | Placebo comparator | Drug: PlaceboParticipants receive a single IA injection of 4 mL of normal saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Males or females 18 years of age or older
- Diagnosis of OA of the knee by a combination of clinical and radiographic findings
- OA of the knee with Kellgren and Lawrence radiographic classification (Grade 2-4 inclusive) confirmed by posterior-anterior, weight-bearing, fixed flexion radiography with 10° caudal beam angulation. A specially designed positioning frame will be used to standardize the positioning for image acquisition.
- Patients who have failed to adequately respond for at least 6 months to at least 2 OA therapies that include conservative, non-pharmacological therapy and simple analgesics (e.g., acetaminophen); nonsteroidal anti-inflammatory drugs (NSAIDS); avoidance of activities that cause joint pain; exercise; weight loss; physical therapy; and removal of excess fluid from the knee
- Overall pain score over the previous 7 days of 11 or more on the WOMAC Pain scale.
Key exclusion criteria (17 listed)
- Use of pain medication (including NSAIDs and cannabidiol [CBD] oil) less than 15 days before treatment (acetaminophen allowed)
- Regular use of anticoagulants
- Symptoms of locking, intermittent block to range of motion, or loose body sensation that could indicate meniscal displacement or an IA loose body
- Corticosteroid injection into the index knee within 3 months prior to screening
- Viscosupplement (e.g., hyaluronic acid [HA]) injection, platelet-rich plasma injection, bone marrow aspirate (BMA) or bone marrow aspiration concentrate (BMAC), placental-derived tissue/cells, adipose tissue, or any other autologous or allogeneic product into the index knee within 6 months prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amniotic Suspension AllograftThis investigational product is a cryopreserved product derived from human amnion and cells from the amniotic fluid. | Biological | ASA |
| PlaceboMatching placebo is 0.9% normal saline: 4 mL to be injected IA. | Drug | Placebo |
Primary outcome
The difference in change from baseline in WOMAC Pain scale at 6 months between ASA- and placebo-treated patients
Time frame: Baseline to Week 26
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
10 secondary outcomes
The difference between changes from baseline for ASA- and placebo- treated patients in WOMAC Function at 6 months
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
Time frame: Baseline to Week 26
The difference between changes from baseline for ASA- and placebo-treated patients in WOMAC Pain at 3 months
Time frame: Baseline to Week 12
The difference between changes from baseline for ASA- and placebo- treated patients in non-inferiority of WOMAC Function at 3 months
Time frame: Baseline to Week 12
The difference between changes from baseline for ASA- and placebo-treated patients in the OMERACT-OARSI responder rate at 3 months
Time frame: Baseline to Week 12
The difference between changes from baseline for ASA- and placebo-treated patients in the WOMAC Total at 6 months
Time frame: Baseline to Week 26
The difference between ASA- and placebo-treated patients in the WOMAC Stiffness at 6 months
Time frame: Baseline to Week 26
The difference between changes from baseline for ASA- and placebo- treated patients in the WOMAC Total at 3 months
Time frame: Baseline to Week 12
The difference between changes from baseline for ASA- and placebo-treated patients in the WOMAC Stiffness at 3 months
Time frame: Baseline to Week 12
Incidence of adverse events (AEs)
Time frame: Baseline to Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Farr J, et al. A randomized controlled single-blind study demonstrating superiority of ASA injection over hyaluronic acid and saline control for modification of knee OA symptoms. J Knee Surg. 2019; https://doi.org/10.1055/s-0039-1696672.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amniotic Suspension Allograft in people with Knee Osteoarthritis, run by Organogenesis at 38 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in change from baseline in WOMAC Pain scale at 6 months between ASA- and placebo-treated patients (time frame: Baseline to Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025.