Clinical trial NCT03485157: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Knee Osteoarthritis
Lead sponsor: MiMedx Group, Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-02
Enrollment: 447
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 21 and ≤ 80 years
2. Subject has a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale
3. Subject is willing and able provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study
4. Subject must have a VAS pain scale greater than 45

Exclusion Criteria:

1. Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale
2. BMI greater than 40 kg/m\^2
3. Subject has active infection at the injection site
4. Symptomatic OA of the contralateral knee or of either hip that is not responsive to acetaminophen (Tylenol®) and requires other therapy.
5. 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
6. Subject has documented history of gout or pseudo-gout
7. Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndromes (AIDS) or HIV
8. Subject has received any of the following to the target knee:

   1. Intra-articular hyaluronic acid (HA) injection within 12 weeks prior to screening
   2. Steroid or platelet rich plasma (PRP) injection within 12 weeks prior to screening
   3. Has had or is planning to have major surgery or arthroscopy in the target knee within 26 weeks of treatment
   4. History of a total knee arthroplasty
9. Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment
10. Subject has a history of immunosuppressive or chemotherapy in the last 5 years
11. Subject has had prior radiation at the site
12. Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)
13. Subject is pregnant or plans to become pregnant within 365 days of treatment
14. Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
15. Subject is a worker's compensation patient
16. Subject is a prisoner

Primary outcomes:
measure: Primary Efficacy Endpoint: Change From Baseline in Visual Analog Scale (VAS) for Pain at 90 Days
timeFrame: 90 days
measure: Primary Efficacy Endpoint: Change From Baseline in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 90 Days
timeFrame: 90 days
measure: Primary Safety Endpoint: Number of Participants With Adverse Events (AEs)
timeFrame: 365 days
measure: Primary Safety Endpoint: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: 365 days
measure: Primary Safety Endpoint: Number of Participants With Unanticipated Adverse Events
timeFrame: 365 days
Secondary outcomes:
measure: Secondary Endpoint: Change From Baseline in Visual Analog Scale (VAS) at 180 Days
timeFrame: 180 days
measure: Secondary Endpoint:Change From Baseline in WOMAC at 180 Days
timeFrame: 180 days
Other outcomes:
measure: Exploratory Endpoint: Change From Baseline in the Visual Analog Scale (VAS) for Pain at 270, and 365 Days
timeFrame: Up to 365 days
measure: Exploratory Endpoint: Change From Baseline in the WOMAC Scores at 270 and 365 Days
timeFrame: Up to 365 days
measure: Exploratory Endpoint: Change From Baseline in the Visual Analog Scale (VAS) for Satisfaction at 90, 180, 270 and 365 Days
timeFrame: Up to 365 days
measure: Exploratory Endpoint: Change From Baseline in the KOOS Scores at 90, 180, 270, and 365 Days
timeFrame: Up to 365 days
Locations:
city: Birmingham
country: United States
facility: Central Research Associates, Inc
state: Alabama
city: Tempe
country: United States
facility: Fiel Family and Sports Medicine
state: Arizona
city: La Mesa
country: United States
facility: Horizon Clinical Research
state: California
city: Farmington
country: United States
facility: UConn Health
state: Connecticut
city: Hartford
country: United States
facility: Bone & Joint Inst. at Hartford Hospital
state: Connecticut
city: Sarasota
country: United States
facility: Gulfcoast Research Institute
state: Florida
city: Atlanta
country: United States
facility: Paragon Sports Medicine
state: Georgia
city: Hinsdale
country: United States
facility: Hinsdale Orthopedics
state: Illinois
city: Columbia
country: United States
facility: Arthritis Care Specialist of Maryland
state: Maryland
city: Ann Arbor
country: United States
facility: MedSport
state: Michigan
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Durham
country: United States
facility: Wake Reseach
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research
state: North Carolina
city: Altoona
country: United States
facility: University Orthopedics Center
state: Pennsylvania
city: State College
country: United States
facility: University Orthopedics Center
state: Pennsylvania
city: Fort Sam Houston
country: United States
facility: SAMMC
state: Texas
city: Richmond
country: United States
facility: Ortho Virginia
state: Virginia
Study officials:
affiliation: Esprit R&D Associate GSK
name: Alfred C Gellhorn, MD
role: PRINCIPAL_INVESTIGATOR
References: