Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis

Inclusion Criteria:

1. Subjects who understand and voluntarily sign the consent form before this study；

2. According to the diagnostic criteria (American Rheumatology Association, clinical +radiology criteria), patients with knee osteoarthritis are definitelydiagnosed；Course of knee osteoarthritis was more than 6 months;

3. Age: 40-75, males and females；

4. The subjects' WOMAC score was 24-72

5. The Kellgren Lawrence grade (X-ray axial position of knee joint) of subjects wasgrade II / III;

6. Subjects are generally in good condition and can walk autonomously, except for thosewho use wheelchairs, walking aids or crutches.

Exclusion Criteria:

1. The subject may be allergic to the main cell preparation components (B vitamins,amino acids and so on).

2. The subject received systemic and / or local treatment with autologous and / orallogeneic mesenchymal progenitor cells.

3. The subject considered obese.

4. Laboratory test (any item meets): neutrophil absolute number < 1.0 × 10^9 / L,platelet count < 50 × 10^9 / L, serum albumin < 30g / L, serum creatinine > upperlimit of 1.2 times normal value range, total bilirubin、alanineaminotransferase、aspartate aminotransferase > upper limit of 2 times of normal valuerange.

5. The subject has diseases or symptoms may affect VAS, WOMAC and so on.

6. The subject has serious and poorly controlled concomitant diseases, such as (but notlimited to) nervous system, cardiovascular, liver, kidney, gastrointestinal andendocrine diseases, which may prevent the subjects from participating in the studyaccording to the judgment of the researchers.

7. The subject has an history malignant tumour.

8. The subject has connective tissue disease or rheumatoidarthritis、chondropathy、Chondrocalcinosis articularis、 Hemochromatosis、inflammatoryarthropathy、avascular necrosis of femoral head、Paget's disease、hemophilicarthropathy、infectional arthritis、Charcot' s disease、villonodular synovitis orsynovial chondromatosis.

9. The subject has severe generalized infectious diseases or local knee infection (including skin and intra-articular infection) in the 3 months prior to this trial.

10. According to the researchers, the subject has disease of lower limbs which may beinterfered knee evaluation, for example fibromyalgia, osphyalgia, lumbar discprotrusion and so on.

11. The subject had any other coagulation dysfunction caused by acute or chronicdiseases, according to the judgment of the researchers, this coagulation dysfunctionmay endanger the safety of patients and / or affect the judgment of knee jointevaluation indicators.

12. The subject has received arthroscopic surgery or other open surgery related to kneejoint operation in the 6 months prior to this trial.

13. The subject has received other intra-articular injections, including but not limitedto hyaluronic acid, hormone, PRP, BMP (bone morphogenetic protein) , hypertonicglucose and so on for KOA in the 3 months preceding the trial.

14. The subject has received aminoglucose or chondroitin sulfate within 1 month beforethe treatment.

15. The subject has used dexamethasone, prednisone, hydrocortisone and other hormonesorally / intravenously within 1 month before the treatment.

16. The subject has attenuated or live attenuated vaccine injection with 1 month beforethe treatment.

17. The subject has undergone knee prosthesis or a plan of knee prosthesis within thetrial.

18. The subject has contraindication of MRI, included but not only: the subjectinstalled heart pacemaker, defibrillator, heart bracket, heart valve prosthesis,metal clip after aneurysm surgery, drug infusion device implanted in vivo, anyelectronic device implanted in the body (nerve stimulator, bone growth stimulator)endovascular coil, strainer, ECG monitor, metal suture, shrapnel or sand of body,plate fixation and steel nail after fracture surgery, artificial cochlea, middle earshift plant, metallic intraocular foreign body etc; the subject is a claustrophobia,critical ill patient and so on.

19. The subject tests positive for: HIV, HBV, HCV and treponema pallidum.

20. The subject has history of alcoholism, drug abuse, or mental illness in the 3 yearsprior to this trial.

21. The subject has participated in any other clinical trial in the 3 months prior tothis trial.

22. The subject (including male subjects) has fertility, sperm donation or egg donationplans during the trial period; the female subject is pregnant, lactating or having apositive pregnancy test.

23. The subject is legally disabled by reference to the law of the people's Republic ofChina on the protection of disabled persons (April 2008).

24. The subject has any other unsuitable condition (such as factors reducing thefollow-up compliance) to be determined by the investigator.

25. The Kellgren Lawrence grade (X-ray axial position of knee joint) of any knee jointof the subjects was grade IV.