A Phase 1/2a to Evaluate the Safety and Efficacy of Adipose Tissue Allograft (BRC-OA) in Patients With Osteoarthritis of the Knee

Exclusion Criteria

• •1. BMI greater than 40 kg/m2
• •2. Previous IA injections (e.g., corticosteroid, hyaluronic acid (HA), platelet rich plasma (PRP), etc.) into the index knee within 3 months prior to screening
• •3. Prior Partial Joint Replacement (PJR) or Total Joint Replacement (TJR) of one or both knees
• •4. Knee surgery in the previous 6 months prior to enrollment and/or planned knee surgery during the study
• •5. Symptomatic OA of the hips, spine, or ankle that would interfere with the evaluation of the treated knee
• •6. Rapidly progressing osteoarthritis (RPOA)
• •7. Prior cartilage transplants in the index knee
• •8. Subjects who are actively treated with oral anticoagulants or heparin therapy (treatment such as low dose Aspirin and Plavix are allowed)
• •9. Current therapy with any immunosuppressive therapy, including corticosteroids (\> 5mg/day of prednisone)
• •10. Any method of medical marijuana use containing THC or CBD, including smoke or vaporized spray inhalation, pills or liquids, edible foods, topical applications, etc.
• •11. Clinically significant intercurrent illness, medical condition, non-knee pain, or medical history that could jeopardize the patient safety, limit participation, or compromise interpretation of data derived from the patient; this includes neurological or mental illness, human immunodeficiency virus, fibromyalgia, complex regional pain syndrome, or any active infection - including hepatitis B or C
• •12. Active alcohol or substance use disorder, or any other reason that would make it unlikely for the patient to comply with study procedures
• •13. Females who are lactating or pregnant (positive pregnancy test for females of childbearing potential at screening Females of childbearing potential must be willing to use an acceptable method of contraception from screening up until 90 days after study drug injection administration Acceptable methods of contraception include abstinence, female subject/partner's use of hormonal contraceptive (oral, patch, injectable, depot, or vaginal) in conjunction with a barrier method (e.g., diaphragm, cervical cap, condom, spermicide, or sponge), or female subject/partner's use of an implantable device (implantable rod or intrauterine device)
• •14. Subject has known allergy to any components of BRC-OA
• •15. Subject has received an investigational product within 3 months before screening
• •16. Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome of the patient