The Safety and Effects of Mesenchymal Stem Cell (MSCs) in the Treatment of Rheumatoid Arthritis

Inclusion Criteria:

1. Fulfill 2010 ACR/ the European League Against Rheumatism (EULAR) classificationcriteria or the 1987 ACR classification criteria.

2. Age limits:18 to 70 years old.

3. Freely given informed consent.

4. Disease Activity Score (DAS) 28≥3.2或 Simple Disease Activity Index (SDAI)>11.0或Clinical Disease Activity Index (CDAI) >10.0.

5. Hemoglobin < 90 g/L and/or interstitial lung disease shown in high resolution CT.

6. Poor response to current treatment. The current treatment refers to receive themedicines (including Leflunomide, Methotrexate, Sulphasalazine, Hydroxychloroquine,Cyclosporine A,and Tacrolimus, alone or in combination ) for 3 months, and maintainthe stable-dose of drugs for at least 1 month.

7. More than 3 months and a stable dose for at least 1 month are required ifglucocorticoid is used. The dose of glucocorticoid is less than or equal to10mg/ dayof prednisone.

Exclusion Criteria:

1. Participants who received glucocorticoid therapy by intra-articular injection within 1week.

2. Glucocorticoid that participants received is more than 10 mg/day of prednisone within 1 months.

3. Complication with other connective tissue disease (except for Sjogren syndrome) .

4. Participants with chronic and acute infection (bacteria, virus and parasite,etc.).

5. Participants with acute and chronic tuberculosis infection.

6. Malignant tumors or participants with a family history of malignant tumors.

7. Participants have a family history of allergic conditions.

8. Participants infected by Hepatitis B Virus(HBV), Hepatitis C Virus (HCV) and HumanImmunodeficiency Virus （HIV）.

9. Participants suffer from central nervous system demyelinating disease or multiplesclerosis (MS) currently or in the past.

10. Participants received live vaccines with 3 months.

11. Drug abuse and alcoholism.

12. Participants with severe mental or neurological disorders that affect informed consentand/or the presentation or observer of adverse events.

13. Participants with pregnant or in breast-feeding, and patients who has a pregnancy planwithin 1 year.

14. Participants received stem cell therapy in the past.

15. Participants received any biological agents within 3 months.

16. Anemia (such as anemia with dysplasia) and interstitial lung disease for otherreasons.

17. Participants with cardiovascular and cerebrovascular damage, such as thrombosis.

18. Participants taking drugs that affect the test for blood and lung.

19. Participants taking any traditional Chinese medicine.

20. Participants taking immune modulators such as Transfer Factor, Thymosin andIntravenous Immunoglobulin (IVIG), and so on.

21. Other cases that participants are considered by investigator that they did not meetthe requirements for enrollment.