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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06000410
• Other study ID #: 22 OA 003 ASA
• Status: Recruiting
• Phase: Phase 3
• Start date: September 6, 2023
• Est. completion date: March 2026

Study information

• Verified date: February 2024
• Source: Organogenesis
• Contact: Clinical Trials Office
• Phone: 857-300-1167
• Email: ClinicalTrials[@]organo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 474
• Est. completion date: March 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
United States	Lehigh Center for Clinical Research	Allentown	Pennsylvania
United States	CenExcel/ACMR	Atlanta	Georgia
United States	Tekton Research	Austin	Texas
United States	Sinai Hospital	Baltimore	Maryland
United States	Alabama Clinical Therapeutics, LLC	Birmingham	Alabama
United States	Central Research Associates, Inc.	Birmingham	Alabama
United States	Cedar Health Research, LLC	Burleson	Texas
United States	Skylight Health Research	Burlington	Massachusetts
United States	ClinRXResearch INC	Carrollton	Texas
United States	Clinical Trials of South Carolina	Charleston	South Carolina
United States	Chicago Clinical Research Institute Inc.	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Zenos Clinical Research	Dallas	Texas
United States	Spectrum Medical, Inc.	Danville	Virginia
United States	Conrad Clinical Research	Edmond	Oklahoma
United States	MediSphere Medical Research Center	Evansville	Indiana
United States	Klein & Associates M.D., P.A.	Hagerstown	Maryland
United States	Horizon Clinical Research	La Mesa	California
United States	Physician Research Collaboriation, LLC	Lincoln	Nebraska
United States	AppleMed Research Group, LLC.	Miami	Florida
United States	West Clinical Research	Morehead City	North Carolina
United States	Neurovations Research	Napa	California
United States	Hospital for Special Surgery	New York	New York
United States	Northwell Health	New York	New York
United States	NYU Langone Health	New York	New York
United States	Vista Clinical Research	Newnan	Georgia
United States	Infinity Clinical Research	Norco	California
United States	Quality Clinical Research	Omaha	Nebraska
United States	Advanced Quality Medical Research, Inc	Orland Park	Illinois
United States	Dream Team Clinical Research	Pomona	California
United States	Stanford Medicine	Redwood City	California
United States	Sundance Clinical Research	Saint Louis	Missouri
United States	JBR Clinical Research	Salt Lake City	Utah
United States	TriWest Research Associates	San Diego	California
United States	Gulfcoast Research Institute	Sarasota	Florida
United States	Spokane Joint Replacement Center	Spokane	Washington
United States	Fiel Family & Sports Medicine	Tempe	Arizona
United States	Oakland Medical Research	Troy	Michigan
United States	Upstate Clinical Research Associates, LLC	Williamsville	New York
United States	Tekton Research	Yukon	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Organogenesis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to Week 26
Secondary	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.	Baseline to Week 26
Secondary	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.	Baseline to Week 26
Secondary	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.	Baseline to Week 12