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

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Amniotic Suspension Allograft
Placebo
Sponsored by
Organogenesis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Osteoarthritis, Knee, Arthritis, Joint Disease, Musculoskeletal Diseases, Rheumatic Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Central Research Associates, Inc.Recruiting
  • Alabama Clinical Therapeutics, LLCRecruiting
  • Spectrum Medical, Inc.Recruiting
  • Fiel Family & Sports MedicineRecruiting
  • Horizon Clinical ResearchRecruiting
  • Gulfcoast Research InstituteRecruiting
  • Chicago Clinical Research Institute Inc.Recruiting
  • West Clinical ResearchRecruiting
  • Cedar Health Research, LLCRecruiting
  • JBR Clinical ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ASA

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
August 14, 2023
Last Updated
October 3, 2023
Sponsor
Organogenesis
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1. Study Identification

Unique Protocol Identification Number
NCT06000410
Brief Title
A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2023 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organogenesis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Osteoarthritis, Knee, Arthritis, Joint Disease, Musculoskeletal Diseases, Rheumatic Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) All clinic staff who may be involved in making assessments of safety will be blinded to treatment assignment.
Allocation
Randomized
Enrollment
474 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ASA
Arm Type
Experimental
Arm Description
Participants receive a single IA injection of 2 mL of ASA (plus 2 mL of normal saline)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive a single IA injection of 4 mL of normal saline
Intervention Type
Biological
Intervention Name(s)
Amniotic Suspension Allograft
Intervention Description
This investigational product is a cryopreserved product derived from human amnion and cells from the amniotic fluid.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo is 0.9% normal saline: 4 mL to be injected IA.
Primary Outcome Measure Information:
Title
The difference in change from baseline in WOMAC Pain scale at 6 months between ASA- and placebo-treated patients
Description
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.
Time Frame
Baseline to Week 26
Secondary Outcome Measure Information:
Title
The difference between changes from baseline for ASA- and placebo- treated patients in WOMAC Function at 6 months
Description
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.
Time Frame
Baseline to Week 26
Title
The difference between changes from baseline for ASA- and placebo-treated patients in the OMERACT-OARSI responder rate at 6 months
Description
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.
Time Frame
Baseline to Week 26
Title
The difference between changes from baseline for ASA- and placebo-treated patients in WOMAC Pain at 3 months
Description
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.
Time Frame
Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials Office
Phone
857-300-1167
Email
ClinicalTrials@organo.com
Facility Information:
Facility Name
Central Research Associates, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Martin
Facility Name
Alabama Clinical Therapeutics, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittany Fry
Facility Name
Spectrum Medical, Inc.
City
Danville
State/Province
Alabama
ZIP/Postal Code
24541
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
April Marshall, RN
Facility Name
Fiel Family & Sports Medicine
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen May
Facility Name
Horizon Clinical Research
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Terrell
Facility Name
Gulfcoast Research Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesse D'Alessio
Facility Name
Chicago Clinical Research Institute Inc.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nursat Deen
Facility Name
West Clinical Research
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordan Lewis
Facility Name
Cedar Health Research, LLC
City
Burleson
State/Province
Texas
ZIP/Postal Code
76028
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariah McElheney
Facility Name
JBR Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenn Knowles

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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