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

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

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.

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