A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

- 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06000410
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Organogenesis
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Knee Osteoarthritis

Additional Details

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.

Arms & Interventions

Arms

Experimental: ASA

Participants receive a single IA injection of 2 mL of ASA (plus 2 mL of normal saline)

Placebo Comparator: Placebo

Participants receive a single IA injection of 4 mL of normal saline

Interventions

Biological: - Amniotic Suspension Allograft

This investigational product is a cryopreserved product derived from human amnion and cells from the amniotic fluid.

Drug: - Placebo

Matching placebo is 0.9% normal saline: 4 mL to be injected IA.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Central Research Associates, Inc., Birmingham, Alabama

Status

Recruiting

Address

Central Research Associates, Inc.

Birmingham, Alabama, 35205

Site Contact

Melissa Martin

Clinical Trial Finder