Back to resultsMicronized dHACM vs. Saline in the Treatment of Osteoarthritis of the Knee
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Micronized DHACM
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 21 and ≤ 80 years
- Subject has a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale
- Subject is willing and able provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study
- Subject must have a VAS pain scale greater than 45
Exclusion Criteria:
- Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale
- BMI greater than 40 kg/m2
- Subject has active infection at the injection site
- Symptomatic OA of the contralateral knee or of either hip that is not responsive to acetaminophen (Tylenol®) and requires other therapy.
- Subject has rheumatoid arthritis, psoriatic arthritis, or have been diagnosed with any other disorders that is the primary source of their knee pain, including but not limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor, cancer
- Subject has documented history of gout or pseudo-gout
- Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndromes (AIDS) or HIV
Subject has received any of the following to the target knee:
- Intra-articular hyaluronic acid (HA) injection within 12 weeks prior to screening
- Steroid or platelet rich plasma (PRP) injection within 12 weeks prior to screening
- Has had or is planning to have major surgery or arthroscopy in the target knee within 26 weeks of treatment
- History of a total knee arthroplasty
- Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment
- Subject has a history of immunosuppressive or chemotherapy in the last 5 years
- Subject has had prior radiation at the site
- Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)
- Subject is pregnant or plans to become pregnant within 365 days of treatment
- Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
- Subject is a worker's compensation patient
- Subject is a prisoner
Sites / Locations
- Central Research Associates, Inc
- Fiel Family and Sports Medicine
- Horizon Clinical Research
- UConn Health
- Bone & Joint Inst. at Hartford Hospital
- Gulfcoast Research Institute
- Paragon Sports Medicine
- Hinsdale Orthopedics
- Arthritis Care Specialist of Maryland
- MedSport
- Weill Cornell Medicine
- Wake Reseach
- Wake Research
- University Orthopedics Center
- University Orthopedics Center
- SAMMC
- Ortho Virginia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Micronized dHACM
Saline
Arm Description
Injection of micronized dHACM
Injection of 0.9% Sodium Chloride Injection, USP
Outcomes
Primary Outcome Measures
Primary Efficacy Endpoint: Change from baseline in Visual Analog Scale (VAS) for Pain at 90 days
VAS: 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain
Primary Efficacy Endpoint: Change from baseline in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 90 days
Western Ontario and McMaster Universities Arthritis Index (WOMAC) evaluation of Hip and Knee Osteoarthritis. Self-administered questionnaire consisting of 24 items divided into 3 subscales:
Pain (5 items)
Stiffness (2 items)
Physical Function (17 items)
The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score.
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Primary Safety Endpoint: The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events
The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events
Secondary Outcome Measures
Secondary Endpoint: Change from baseline in Visual Analog Scale (VAS) at 180 days
VAS: 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain
Secondary Endpoint:Change from baseline in WOMAC at 180 days
Western Ontario and McMaster Universities Arthritis Index (WOMAC) evaluation of Hip and Knee Osteoarthritis. Self-administered questionnaire consisting of 24 items divided into 3 subscales:
Pain (5 items)
Stiffness (2 items)
Physical Function (17 items)
The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score.
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03485157
Brief Title
Micronized dHACM vs. Saline in the Treatment of Osteoarthritis of the Knee
Official Title
A Phase 2B, Prospective, Double-blinded, Randomized Controlled Trial of the Micronized Dehydrated Human Amnion Chorion Membrane Injection as Compared to Saline Placebo Injection in the Treatment of Osteoarthritis of the Knee
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 27, 2018 (Actual)
Primary Completion Date
April 19, 2022 (Actual)
Study Completion Date
April 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MiMedx Group, Inc.
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
The purpose of this study is to determine the safety and effectiveness of micronized dehydrated human amnion chorion membrane as compared to the 0.9% Sodium Chloride Injection, USP placebo control for the treatment of knee osteoarthritis
Detailed Description
Each subject will receive 1 injection (micronized dHACM or placebo) and be evaluated for efficacy and safety during a 12-month observation period. A second injection (open-label access to micronized dHACM) will be offered to all subjects at the 180-day, 270-day, and 365-day time points, it may only be used once. Blinding for the first injection treatment allocation will be maintained until the end of the study.
Subjects who receive the open-label access treatment will continue to be followed for 180 days after this second injection, regardless of the time at which treatment was received.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
447 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Micronized dHACM
Arm Type
Experimental
Arm Description
Injection of micronized dHACM
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Injection of 0.9% Sodium Chloride Injection, USP
Intervention Type
Biological
Intervention Name(s)
Micronized DHACM
Intervention Description
Injection of 40 mg micronized dehydrated human amnion chorion membrane (dHACM) suspended in 1 mL 0.9% Sodium Chloride, USP
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Injection of 1 mL 0.9% Sodium Chloride, USP
Primary Outcome Measure Information:
Title
Primary Efficacy Endpoint: Change from baseline in Visual Analog Scale (VAS) for Pain at 90 days
Description
VAS: 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain
Time Frame
90 days
Title
Primary Efficacy Endpoint: Change from baseline in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 90 days
Description
Western Ontario and McMaster Universities Arthritis Index (WOMAC) evaluation of Hip and Knee Osteoarthritis. Self-administered questionnaire consisting of 24 items divided into 3 subscales:
Pain (5 items)
Stiffness (2 items)
Physical Function (17 items)
The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score.
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame
90 days
Title
Primary Safety Endpoint: The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events
Description
The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events
Time Frame
365 days
Secondary Outcome Measure Information:
Title
Secondary Endpoint: Change from baseline in Visual Analog Scale (VAS) at 180 days
Description
VAS: 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain
Time Frame
180 days
Title
Secondary Endpoint:Change from baseline in WOMAC at 180 days
Description
Western Ontario and McMaster Universities Arthritis Index (WOMAC) evaluation of Hip and Knee Osteoarthritis. Self-administered questionnaire consisting of 24 items divided into 3 subscales:
Pain (5 items)
Stiffness (2 items)
Physical Function (17 items)
The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score.
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame
180 days
Other Pre-specified Outcome Measures:
Title
Exploratory Endpoint: Change from baseline in the Visual Analog Scale (VAS) for pain at 270, and 365 days
Description
VAS: 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain
Time Frame
Up to 365 days
Title
Exploratory Endpoint: Change from baseline in the WOMAC scores at 270 and 365 days
Description
Western Ontario and McMaster Universities Arthritis Index (WOMAC) evaluation of Hip and Knee Osteoarthritis. Self-administered questionnaire consisting of 24 items divided into 3 subscales:
Pain (5 items)
Stiffness (2 items)
Physical Function (17 items)
The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score.
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame
Up to 365 days
Title
Exploratory Endpoint: Change from baseline in the Visual Analog Scale (VAS) for satisfaction at 90, 180, 270 and 365 days
Description
VAS: 0 to 100 mm horizontal visual analog scale with a higher score indicating greater satisfaction
Time Frame
Up to 365 days
Title
Exploratory Endpoint: Change from baseline in the KOOS scores at 90, 180, 270, and 365 days
Description
Knee Injury and Osteoarthritis Outcome Score (KOOS): 5 subscales scored on a 5 point scale where the final score is summed and transformed into a 100 point scale with a higher score representing no disability and a lower score representing extreme disability
Time Frame
Up to 365 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 21 and ≤ 80 years
Subject has a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale
Subject is willing and able provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study
Subject must have a VAS pain scale greater than 45
Exclusion Criteria:
Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale
BMI greater than 40 kg/m2
Subject has active infection at the injection site
Symptomatic OA of the contralateral knee or of either hip that is not responsive to acetaminophen (Tylenol®) and requires other therapy.
Subject has rheumatoid arthritis, psoriatic arthritis, or have been diagnosed with any other disorders that is the primary source of their knee pain, including but not limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor, cancer
Subject has documented history of gout or pseudo-gout
Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndromes (AIDS) or HIV
Subject has received any of the following to the target knee:
Intra-articular hyaluronic acid (HA) injection within 12 weeks prior to screening
Steroid or platelet rich plasma (PRP) injection within 12 weeks prior to screening
Has had or is planning to have major surgery or arthroscopy in the target knee within 26 weeks of treatment
History of a total knee arthroplasty
Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment
Subject has a history of immunosuppressive or chemotherapy in the last 5 years
Subject has had prior radiation at the site
Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)
Subject is pregnant or plans to become pregnant within 365 days of treatment
Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
Subject is a worker's compensation patient
Subject is a prisoner
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfred C Gellhorn, MD
Organizational Affiliation
Esprit R&D Associate GSK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Research Associates, Inc
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Fiel Family and Sports Medicine
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Horizon Clinical Research
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
UConn Health
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Bone & Joint Inst. at Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Gulfcoast Research Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Paragon Sports Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Facility Name
Hinsdale Orthopedics
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Arthritis Care Specialist of Maryland
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21046
Country
United States
Facility Name
MedSport
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Wake Reseach
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Wake Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
University Orthopedics Center
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
University Orthopedics Center
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
SAMMC
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Ortho Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Micronized dHACM vs. Saline in the Treatment of Osteoarthritis of the Knee
We'll reach out to this number within 24 hrs