Status and phase
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About
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
Full 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.
Enrollment
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Volunteers
Inclusion criteria
Exclusion criteria
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:
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
Primary purpose
Allocation
Interventional model
Masking
447 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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