Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee

Inclusion Criteria:

1. Males or females 18 years of age or older

2. Diagnosis of OA of the knee by a combination of clinical and radiographic findings

3. OA of the knee with Kellgren and Lawrence radiographic classification (Grade 2-4inclusive) confirmed by posterior-anterior, weight-bearing, fixed flexionradiography with 10° caudal beam angulation. A specially designed positioning framewill be used to standardize the positioning for image acquisition.

4. Patients who have failed to adequately respond for at least 6 months to at least 2OA therapies that include conservative, non-pharmacological therapy and simpleanalgesics (e.g., acetaminophen); nonsteroidal anti-inflammatory drugs (NSAIDS);avoidance of activities that cause joint pain; exercise; weight loss; physicaltherapy; and removal of excess fluid from the knee

5. Overall pain score over the previous 7 days of 11 or more on the WOMAC Pain scale.

6. Body mass index (BMI) < 40 kg/m²

7. If female, must be postmenopausal (for at least 2 years), surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), sexuallyabstinent, or willing and able to use 2 methods of contraception from Day 1 through 12 months after treatment

8. Males who are not surgically sterile (vasectomy) for at least 6 months prior toscreening must confirm their willingness to use adequate methods of contraceptionfrom Day 1 through 12 months after treatment

9. Willing to agree not to use illicit drugs during the study, and to have illicit drugtesting at screening and at later time points, if illicit drug use is suspectedduring the study

10. Able to comply with study requirements and complete the full sequence ofprotocol-related procedures and evaluations, including post-hospitalization,out-patient, and follow-up visits

11. Able to understand and provide written informed consent

Exclusion Criteria:

1. Use of pain medication (including NSAIDs and cannabidiol [CBD] oil) less than 15days before treatment (acetaminophen allowed)

2. Regular use of anticoagulants

3. Symptoms of locking, intermittent block to range of motion, or loose body sensationthat could indicate meniscal displacement or an IA loose body

4. Corticosteroid injection into the index knee within 3 months prior to screening

5. Viscosupplement (e.g., hyaluronic acid [HA]) injection, platelet-rich plasmainjection, bone marrow aspirate (BMA) or bone marrow aspiration concentrate (BMAC),placental-derived tissue/cells, adipose tissue, or any other autologous orallogeneic product into the index knee within 6 months prior to screening

6. Patients with known hypersensitivity reactions to ASA or any of its constituents (e.g., HA, dimethyl sulfoxide [DMSO])

7. Knee surgery on the index knee within 12 months prior to screening and/or plannedknee surgery during the study

8. Knee surgery on the contralateral knee within 6 months prior to screening and/orplanned knee surgery during the study

9. Acute index knee trauma within 3 months prior to screening

10. Knee effusion requiring aspiration of the index or contralateral knee within 3months prior to screening

11. Contralateral knee pain ≥ 4 on the WOMAC Pain scale on most days during the pastweek.

12. Current therapy with any immunosuppressive therapy, including corticosteroids (> 5mg/day of prednisone)

13. Clinically significant findings on the screening laboratory tests or physicalexamination that are not specific to OA of the knee and may interfere with studyconduct or interpretation of data or increase patient risk

14. Clinically significant intercurrent illness, medical condition, non-knee pain, ormedical history (including neurological or mental illness, human immunodeficiencyvirus, fibromyalgia, complex regional pain syndrome, or any active infection,including hepatitis B or C) that could jeopardize the patient safety, limitparticipation, or compromise interpretation of data derived from the patient

15. Active alcohol or substance use disorder, or any other reason that would make itunlikely for the patient to comply with study procedures

16. Females who are pregnant (positive pregnancy test at screening or prior totreatment) or lactating

17. Participation in another clinical trial within the 30 days (or 5 half-lives of theinvestigational compound, whichever is longer) before screening