Clinical trial: Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee (NCT04636229)

Eligibility criteria:
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 2-4
             inclusive) confirmed by posterior-anterior, weight-bearing, fixed flexion radiography
             with 10° caudal beam angulation. A specially designed positioning frame will 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 2 OA
             therapies that include conservative, non-pharmacological therapy and simple analgesics
             (e.g., acetaminophen); nonsteroidal anti-inflammatory drugs (NSAIDS); avoidance of
             activities that cause joint pain; exercise; weight loss; physical therapy; 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), sexually
             abstinent, 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 to
             screening must confirm their willingness to use adequate methods of contraception from
             Day 1 through 12 months after treatment

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

         10. Able to comply with study requirements and complete the full sequence of
             protocol-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 15 days
             before treatment (acetaminophen allowed)

          2. Regular use of anticoagulants

          3. Symptoms of locking, intermittent block to range of motion, or loose body sensation
             that 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 plasma
             injection, bone marrow aspirate (BMA) or bone marrow aspiration concentrate (BMAC),
             placental-derived tissue/cells, adipose tissue, or any other autologous or allogeneic
             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 planned knee
             surgery during the study

          8. Knee surgery on the contralateral knee within 6 months prior to screening and/or
             planned 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 3 months
             prior to screening

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

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

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

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

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

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

         17. Participation in another clinical trial within the 30 days (or 5 half-lives of the
             investigational compound, whichever is longer) before screening
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment