Micronized dHACM vs. Saline in the Treatment of Osteoarthritis of the Knee
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Micronized dHACM Injection of micronized dHACM |
Biological: Micronized DHACM
Injection of 40 mg micronized dehydrated human amnion chorion membrane (dHACM) suspended in 1 mL 0.9% Sodium Chloride, USP
|
| Placebo Comparator: Saline Injection of 0.9% Sodium Chloride Injection, USP |
Drug: Saline
Injection of 1 mL 0.9% Sodium Chloride, USP
|
Outcome Measures
Primary Outcome Measures
- Primary Efficacy Endpoint: Change from baseline in Visual Analog Scale (VAS) for Pain at 90 days [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 [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 [365 days]
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 [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 [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.
Other Outcome Measures
- Exploratory Endpoint: Change from baseline in the Visual Analog Scale (VAS) for pain at 270, and 365 days [Up to 365 days]
VAS: 0 to 100 mm horizontal visual analog scale with a higher score indicating greater pain
- Exploratory Endpoint: Change from baseline in the WOMAC scores at 270 and 365 days [Up to 365 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.
- Exploratory Endpoint: Change from baseline in the Visual Analog Scale (VAS) for satisfaction at 90, 180, 270 and 365 days [Up to 365 days]
VAS: 0 to 100 mm horizontal visual analog scale with a higher score indicating greater satisfaction
- Exploratory Endpoint: Change from baseline in the KOOS scores at 90, 180, 270, and 365 days [Up to 365 days]
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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Central Research Associates, Inc | Birmingham | Alabama | United States | 35205 |
| 2 | Fiel Family and Sports Medicine | Tempe | Arizona | United States | 85283 |
| 3 | Horizon Clinical Research | La Mesa | California | United States | 91942 |
| 4 | UConn Health | Farmington | Connecticut | United States | 06030 |
| 5 | Bone & Joint Inst. at Hartford Hospital | Hartford | Connecticut | United States | 06102 |
| 6 | Gulfcoast Research Institute | Sarasota | Florida | United States | 34232 |
| 7 | Paragon Sports Medicine | Atlanta | Georgia | United States | 30327 |
| 8 | Hinsdale Orthopedics | Hinsdale | Illinois | United States | 60521 |
| 9 | Arthritis Care Specialist of Maryland | Columbia | Maryland | United States | 21046 |
| 10 | MedSport | Ann Arbor | Michigan | United States | 48106 |
| 11 | Weill Cornell Medicine | New York | New York | United States | 10065 |
| 12 | Wake Reseach | Durham | North Carolina | United States | 27704 |
| 13 | Wake Research | Raleigh | North Carolina | United States | 27612 |
| 14 | University Orthopedics Center | Altoona | Pennsylvania | United States | 16602 |
| 15 | University Orthopedics Center | State College | Pennsylvania | United States | 16801 |
| 16 | SAMMC | Fort Sam Houston | Texas | United States | 78234 |
| 17 | Ortho Virginia | Richmond | Virginia | United States | 23294 |
Sponsors and Collaborators
- MiMedx Group, Inc.
Investigators
- Principal Investigator: Alfred C Gellhorn, MD, Esprit R&D Associate GSK
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AIOA001