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 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? 1