Micronized dHACM vs. Saline in the Treatment of Osteoarthritis of the Knee
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Micronized dHACM; Saline
Intervention description: Injection of 40 mg micronized dehydrated human amnion chorion membrane (dHACM) suspended in 1 mL 0.9% Sodium Chloride, USP; Injection of 1 mL 0.9% Sodium Chloride, USP
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 447.0
Sex: All
Minimum age: 21 Years
Maximum age: 80 Years
Healthy volunteers: No

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
    

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