Clinical trial: Investigator Initiated Trial to Evaluate the Efficacy and Safety of Intra-articular Injection of ADMSC Comared to Negative Control After High Tibial Osteotomy in the Osteoarthritis Patients. (NCT03000712)

Eligibility criteria:
Inclusion Criteria:

          1. Patients must consent in writing to participate in the study by signing and dating an
             informed consent document

          2. Patients who can communicate (exclusion of anyone who cannot understand the
             questionnaire)

          3. between 20 years and 80 years of age

          4. BMI≤30

          5. Diagnosis of osteoarthritis by radiographic criteria of Kellgren and Lawrence grade
             2-4

          6. Diagnosis of osteoarthritis by ACR(American College of Rheumatology Criteria) Global
             functional criteria : There is the pain of the knee and radiographic osteophyte and at
             least one of the following (1) age >50 years (2) Less than 30 minutes of morning
             stiffness (3) The friction When moving weighted the knee

          7. Patients who agree with contraception

          8. Patients who agree to stop the existing osteoarthritis treatment and to get enough
             washout periods until medication time

          9. Patients scheduled for High tibial osteotomy due to medial gonarthrosis

        Exclusion Criteria:

          1. patients with osteoporosis

          2. Preparing for Pregnancy or Pregnant women or lactating mothers.

          3. Patients with positive human immunodeficiency (HIV), hepatitis B (HBV), hepatitis C
             (HCV), venereal disease research laboratory(VDRL)

          4. Patients with hypersensitivity to investigator product or investigational product
             component or those with a history

          5. Patients who had participated in other clinical trials within 12 weeks prior to this
             study

          6. Patients who received any drug by intra-articular injection for treatment within 2
             months prior to this enrollment.

          7. Patients who experienced as the knee joint cartilage and stem cell therapy or failure
             to treat

          8. Patents who started or changed the physical therapy program established within 2 weeks
             before the start of the study or during the study(An established physical therapy
             program may continue for the duration of the trial, provided that it does not change
             in frequency and intensity)

          9. Patents included in the following specific risk groups that may influence safety and
             efficacy assessments at the discretion of the investigator:: septic arthtritis,
             rheumatic disease, gout, recurrent pseudogout, paget disease, joint fracture,
             alcaptonuria, acromegaly, hemochromatosis, wilson's disease, primary osteochondrosis,
             hereditary disorder(ex: hyperkinesia), collagen gene abnormality ,etc

         10. Patients who have clinically significant severe medical illnesses judged the principal
             investigator

         11. Patients who have been diagnosed with malignancy within 5 years before screening
             (except for patients who were completely remissioned three years before screening
             criteria)

         12. Patients who the principal investigator consider inappropriate for the clinical trial
             due to any other reasons

         13. Patients who received concomitant contraindications and who have not passed the
             prescribed wash-out period before participating in the clinical trial
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? Entailment