Clinical trial: Safety and Tolerability of StroMel™ in Subjects With Moderate to Severe Osteoarthritis of the Knee Joint (NCT04750252)

Eligibility criteria:
Inclusion Criteria:

          1. Adults between the ages of 25-65 years

          2. Body Mass Index (BMI) less than 40 kg/m2

          3. Ambulatory and in good general health as described by vital signs (blood pressure
             90/60 mm Hg to 120/80 mm Hg, pulse rate 60-100 beats per minute, temperature 97.2-99.1
             °F) and normal blood chemistry.

          4. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score of ≥
             11 (worst possible = 20) over the previous 7 days

          5. OA of the knee with Kellgren and Lawrence radiographic classification (Grade 2-4
             inclusive) within the last 6 months

          6. Minimum score of 40 out of possible 100 on the VAS (Visual Analog Scale) for pain.

          7. 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.

          8. Have suitable knee joint anatomy for intra-articular injection.

          9. For adults of reproductive potential: use of effective contraception for at least 1
             month prior to screening and agreement to use such a method during study
             participation.

        Exclusion Criteria:

          1. Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis,
             or arthritis associated with inflammatory bowel disease.

          2. Subject with an infection that requires parenteral antibiotic administration.

          3. Active infection or crystal disease in the index joint within 1 month of screening

          4. History of fracture in the index limb, joint instability, or history of acute
             dislocation within 12 months of screening, or fracture with sequelae at any time

          5. Intra-articular treatment of any joint with any of the following agents within 6
             months of screening: Any corticosteroid preparation (investigational or marketed),
             sodium hyaluronate, any biologic agent (e.g., platelet rich plasma (PRP) injection,
             stem cells, prolotherapy, amniotic fluid injection); investigational six months prior
             to enrollment.

          6. Presence of surgical hardware or other foreign body in the index joint

          7. Subjects who were administered with immunosuppressants such as cyclosporin A or
             azathioprine within 6 weeks before screening.

          8. Planned or anticipated surgery of the joint during the study period

          9. Allergies to anesthesia

         10. Subjects who tested positive for HIV, HCV, WNV, CMV, HBV, HTLV, ZIKA, syphilis, flu or
             COVID-19. Note: CMV is not a relevant communicable disease agent. A subject who tests
             positive or reactive for CMV is not necessarily ineligible. Physicians will determine
             donor eligibility for subjects with positive CMV test results.

         11. History of lipid disorders: lipedema, lipomatosis, or lipodystrophies.

         12. Active cancer, chemotherapy, or other malignancies in the last 6 months.

         13. Recent history of DVT or pulmonary embolism requiring anticoagulants or other
             medicines per the hematologist.

         14. Subject who participated in another clinical trial within 3 months before the
             screening visit

         15. Any illness which, in the Investigator's judgment, will interfere with the subject's
             ability to comply with the protocol, compromise patient safety, or interfere with the
             interpretation of the study results.

         16. Subjects who are breastfeeding

         17. Subjects with uncontrolled arrhythmias

         18. Subjects with hemophilia; factor II, V, VII, X, or XII deficiencies; or Von
             Willebrand's disease.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
Subject must be at most 65 Years

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