Clinical trial: Clinical Study of Intra Articular Injection of Catholic MASTER Cell (Bone Marrow Derived Mesenchymal Stem Cell) in Knee Osteoarthritis (NCT04240873)

Eligibility criteria:
Inclusion Criteria:

          1. Age 20-80

          2. diagnosed with knee osteoarthritis (OA) according to ACR classfication criteia for
             knee OA

          3. symptomatic OA that lastede for at least 3 months before screening

          4. Baseline Pain VAS ≥50 mm

          5. treated with medication such as acetaminophen, tramadol, NSAID for at least 1month due
             to OA pain

          6. X-ray Kellgren-Lawrence grade 1~4

          7. volauntarily enrolled with informed consent

          8. no improvement with medical treatment for at least 3 months

        Exclusion Criteria:

          1. disease in spine or lower extremities that can affect the outcome of index knee

          2. surgery on lower extremities within 6month before injection or planned

          3. joint symptoms that can affect the interpretation of the trial data or prevent the
             subject from enrollement including but not limited to symptomatic fracture,
             fibromyalgia, rheumatoid arthritis, reactive arthritis

          4. steroid injection to the index knee within preivious 3months

          5. hyaluronic acid injection to the index knee within preivious 6months

          6. underwent cell therapy or gene therapy in the past

          7. more than 3 times upper normal limit in one or more of the followings: serum
             creatinine, bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase
             (AST) or more than 3 times upper normal limit in two or more of the followings:
             bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST)

          8. participation in a different clinical trial other than this within 4 weeks after
             initiation of the current study

          9. use (reccuent use or addiction) of substances that can affect pain sensation such as
             narcotics

         10. females of childbearing age who do not consent to effective contraceptive methods
             during the study period

         11. pregnant or lactating woman

         12. malignancy

         13. considered to be inappropriate for the trial by investigators
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 80 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