Micronized dHACM vs. Saline in the Treatment of Osteoarthritis of the Knee
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
1 other identifier
interventional
447
1 country
17
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 knee-osteoarthritis
Started Mar 2018
Longer than P75 for phase_2 knee-osteoarthritis
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2018
CompletedStudy Start
First participant enrolled
March 27, 2018
CompletedFirst Posted
Study publicly available on registry
April 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 19, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2022
CompletedResults Posted
Study results publicly available
December 11, 2023
CompletedDecember 11, 2023
December 1, 2023
4.1 years
March 20, 2018
May 31, 2023
December 7, 2023
Conditions
Outcome Measures
Primary Outcomes (5)
Primary Efficacy Endpoint: Change From Baseline in Visual Analog Scale (VAS) for Pain at 90 Days
Visual Analog Scale (VAS): 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain
90 days
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 questions divided into 3 subscales: * Pain (5 questions) * Stiffness (2 questions) * Physical Function (17 questions) 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, with a possible total score range of 0-96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
90 days
Primary Safety Endpoint: Number of Participants With Adverse Events (AEs)
Number of Participants with At Least 1 Treatment Emergent Adverse Event (TEAE) Reported
365 days
Primary Safety Endpoint: Number of Participants With Serious Adverse Events (SAEs)
Number of Participants with At Least 1 Serious Treatment Emergent Adverse Event (TEAE) Reported
365 days
Primary Safety Endpoint: Number of Participants With Unanticipated Adverse Events
Number of Participants with At Least 1 Unanticipated Treatment Emergent Adverse Event (TEAE) Reported
365 days
Secondary Outcomes (2)
Secondary Endpoint: Change From Baseline in Visual Analog Scale (VAS) at 180 Days
180 days
Secondary Endpoint:Change From Baseline in WOMAC at 180 Days
180 days
Other Outcomes (4)
Exploratory Endpoint: Change From Baseline in the Visual Analog Scale (VAS) for Pain at 270, and 365 Days
Up to 365 days
Exploratory Endpoint: Change From Baseline in the WOMAC Scores at 270 and 365 Days
Up to 365 days
Exploratory Endpoint: Change From Baseline in the Visual Analog Scale (VAS) for Satisfaction at 90, 180, 270 and 365 Days
Up to 365 days
- +1 more other outcomes
Study Arms (2)
Micronized dHACM
EXPERIMENTALInjection of micronized dHACM
Saline
PLACEBO COMPARATORInjection of 0.9% Sodium Chloride Injection, USP
Interventions
Injection of 40 mg micronized dehydrated human amnion chorion membrane (dHACM) suspended in 1 mL 0.9% Sodium Chloride, USP
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale
- BMI greater than 40 kg/m\^2
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Central Research Associates, Inc
Birmingham, Alabama, 35205, United States
Fiel Family and Sports Medicine
Tempe, Arizona, 85283, United States
Horizon Clinical Research
La Mesa, California, 91942, United States
UConn Health
Farmington, Connecticut, 06030, United States
Bone & Joint Inst. at Hartford Hospital
Hartford, Connecticut, 06106, United States
Gulfcoast Research Institute
Sarasota, Florida, 34232, United States
Paragon Sports Medicine
Atlanta, Georgia, 30327, United States
Hinsdale Orthopedics
Hinsdale, Illinois, 60521, United States
Arthritis Care Specialist of Maryland
Columbia, Maryland, 21046, United States
MedSport
Ann Arbor, Michigan, 48106, United States
Weill Cornell Medicine
New York, New York, 10065, United States
Wake Reseach
Durham, North Carolina, 27704, United States
Wake Research
Raleigh, North Carolina, 27612, United States
University Orthopedics Center
Altoona, Pennsylvania, 16602, United States
University Orthopedics Center
State College, Pennsylvania, 16801, United States
SAMMC
Fort Sam Houston, Texas, 78234, United States
Ortho Virginia
Richmond, Virginia, 23294, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- MIMEDX
Study Officials
- PRINCIPAL INVESTIGATOR
Alfred C Gellhorn, MD
Esprit R&D Associate GSK
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2018
First Posted
April 2, 2018
Study Start
March 27, 2018
Primary Completion
April 19, 2022
Study Completion
April 19, 2022
Last Updated
December 11, 2023
Results First Posted
December 11, 2023
Record last verified: 2023-12