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

February 1, 2024 updated by: Organogenesis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

474

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Recruiting
        • Central Research Associates, Inc.
        • Contact:
          • Melissa Martin
      • Birmingham, Alabama, United States, 35235
        • Recruiting
        • Alabama Clinical Therapeutics, LLC
        • Contact:
          • Brittany Fry
    • Arizona
      • Tempe, Arizona, United States, 85283
        • Recruiting
        • Fiel Family & Sports Medicine
        • Contact:
          • Kathleen May
    • California
      • La Mesa, California, United States, 91942
        • Recruiting
        • Horizon Clinical Research
        • Contact:
          • Jennifer Terrell
      • Napa, California, United States, 94558
        • Recruiting
        • Neurovations Research
        • Contact:
          • Louiza Khedim
      • Norco, California, United States, 92860
        • Recruiting
        • Infinity Clinical Research
        • Contact:
          • Juliana Corcoran
      • Pomona, California, United States, 91767
        • Recruiting
        • Dream Team Clinical Research
        • Contact:
          • Shannon Mckernan
      • Redwood City, California, United States, 94063
        • Not yet recruiting
        • Stanford Medicine
        • Contact:
          • Monica Vel
      • San Diego, California, United States, 92108
        • Recruiting
        • Triwest Research Associates
        • Contact:
          • Sandra Nissan
    • Florida
      • Miami, Florida, United States, 33126
        • Recruiting
        • AppleMed Research Group, LLC.
        • Contact:
          • Lilibeth Paz
      • Sarasota, Florida, United States, 34232
        • Recruiting
        • Gulfcoast Research Institute
        • Contact:
          • Jesse D'Alessio
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Recruiting
        • CenExcel/ACMR
        • Contact:
          • Morgan Hecker
      • Newnan, Georgia, United States, 30265
        • Recruiting
        • Vista Clinical Research
        • Contact:
          • Debra Helton
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Not yet recruiting
        • Rush University Medical Center
        • Contact:
          • Kavita Ahuja
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • Chicago Clinical Research Institute Inc.
        • Contact:
          • Nursat Deen
      • Orland Park, Illinois, United States, 60462
        • Recruiting
        • Advanced Quality Medical Research, Inc
        • Contact:
          • Margarita Bahena
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Recruiting
        • Medisphere Medical Research Center
        • Contact:
          • Carissa Covert
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Recruiting
        • Sinai Hospital
        • Contact:
          • Taj Andrews
      • Hagerstown, Maryland, United States, 21740
        • Recruiting
        • Klein & Associates M.D., P.A.
        • Contact:
          • Jamie Demroy
    • Massachusetts
      • Burlington, Massachusetts, United States, 01803
        • Recruiting
        • Skylight Health Research
        • Contact:
          • Ryan Elder
    • Michigan
      • Troy, Michigan, United States, 48085
        • Recruiting
        • Oakland Medical Research
        • Contact:
          • Julie LaFave
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • Sundance Clinical Research
        • Contact:
          • Christy Schultz
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Recruiting
        • Physician Research Collaboriation, LLC
        • Contact:
          • Leah Zeleski
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Quality Clinical Research
        • Contact:
          • Jonathan Patterson
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
        • Contact:
          • Ivanka Bhambhani
      • New York, New York, United States, 10021
        • Recruiting
        • Hospital for Special Surgery
        • Contact:
          • Morgan Ritzy
      • New York, New York, United States, 10065
        • Recruiting
        • Northwell Health
        • Contact:
          • Pam Kaur
      • Williamsville, New York, United States, 14221
        • Recruiting
        • Upstate Clinical Research Associates, LLC
        • Contact:
          • Kaylie Briner
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Recruiting
        • West Clinical Research
        • Contact:
          • Jordan Lewis
    • Ohio
      • Columbus, Ohio, United States, 43202
        • Recruiting
        • The Ohio State University Wexner Medical Center
        • Contact:
          • Angela Pedroza
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Recruiting
        • Conrad Clinical Research
        • Contact:
          • Shelly Todd
      • Yukon, Oklahoma, United States, 73099
        • Recruiting
        • Tekton Research
        • Contact:
          • Montana Watson
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Recruiting
        • Lehigh Center for Clinical Research
        • Contact:
          • Sandy Martinez
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Recruiting
        • Clinical Trials of South Carolina
        • Contact:
          • Karla Guthrie
    • Texas
      • Austin, Texas, United States, 78745
        • Recruiting
        • Tekton Research
        • Contact:
          • Tiffany Okoli
      • Burleson, Texas, United States, 76028
        • Recruiting
        • Cedar Health Research, LLC
        • Contact:
          • Mariah McElheney
      • Carrollton, Texas, United States, 75007
        • Recruiting
        • ClinRXResearch INC
        • Contact:
          • Vandana Agarwal
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Zenos Clinical Research
        • Contact:
          • Mia Glasco
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Recruiting
        • JBR Clinical Research
        • Contact:
          • Jenn Knowles
    • Virginia
      • Danville, Virginia, United States, 24541
        • Recruiting
        • Spectrum Medical, Inc.
        • Contact:
          • April Marshall, RN
    • Washington
      • Spokane, Washington, United States, 99218
        • Recruiting
        • Spokane Joint Replacement Center
        • Contact:
          • Annalise Mcinelly

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ASA
Participants receive a single IA injection of 2 mL of ASA (plus 2 mL of normal saline)
Biological: Amniotic Suspension Allograft
This investigational product is a cryopreserved product derived from human amnion and cells from the amniotic fluid.
Placebo Comparator: Placebo
Participants receive a single IA injection of 4 mL of normal saline
Drug: Placebo
Matching placebo is 0.9% normal saline: 4 mL to be injected IA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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
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 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
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 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organogenesis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

August 14, 2023

First Submitted That Met QC Criteria

August 14, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

February 2, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22 OA 003 ASA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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