Rheumatoid arthritis
Conditions
Interventions
intervention group:Intravenous injection of dead mesenchymal stem cells
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) those who signed the informed consent form and were able to complete the trial according to the plan; (2) 18-65 years old, male or female; (3) weight = 30kg; (4) according to the 2010 ACR/EULAR classification diagnostic criteria, diagnosed as rheumatoid arthritis, the course of disease = 6 months. (5) for those with swollen joint count = 6 (based on 66 joint count) and tenderness joint count = 6 (based on 68 joint count) during the screening period, if the same joint has both swelling and tenderness, then both swollen joint and tenderness joint count are included (except artificial joints); (6) C-reactive protein (CRP) = 5mg/L or erythrocyte sedimentation rate (ESR) > 28mm/hr during the screening period. (7) at the time of screening, if the subjects were taking prednisone or equivalent doses of glucocorticoids, they were treated with a stable dose of prednisone (prednisone = 10mg/ days) for at least 4 weeks. (8) the blood pregnancy test of women of childbearing age is negative, and during the trial period, the subjects or their spouses use appropriate and effective contraceptive measures, such as abstinence, oral contraceptive, intrauterine device or double barrier method (such as condom plus contraceptive diaphragm), and must be non-pregnant or non-lactating women. (9) have received at least one traditional abiotic agent treatment, which allows the use of basic drugs such as methotrexate, leflunomide, hydroxychloroquine, sulfasalazine, Tripterygium wilfordii, alamod, etc. if the patient uses a stable dose for a long time, there is no need to stop the drug. (10) DAS28 score 3.2 or above. (11) if biological agents such as TNF- a inhibitor, IL-6 inhibitor, JAK inhibitor and CD20 monoclonal antibody fail, they need to wait for 5 drug half-lives to enter the group, whichever is longer. (12) if the patient's condition fluctuates slightly during screening and elution, acetaminophen can be used for symptomatic treatment.
Exclusion criteria
Exclusion criteria: (1) those who have been treated with mesenchymal stem cell preparations in the past and are allergic to any of them; (2) those whose ACR function is classified as IV or long-term bedridden / sedentary wheelchair; (3) those with past or present history of inflammatory joint diseases other than rheumatoid arthritis (e.g. gout, reactive arthritis, psoriatic arthritis, spinal arthritis, Lyme disease, etc.). Or other systemic autoimmune diseases (such as systemic lupus erythematosus, scleroderma, inflammatory myopathy, mixed connective tissue disease or other overlapping syndrome, except in patients with rheumatoid arthritis secondary to Schergren syndrome). (4) there are serious poorly controlled concomitant diseases that researchers consider clinically significant, such as, but not limited to, nervous system, cardiovascular, kidney, liver, endocrine or gastrointestinal diseases. (5) patients with any congenital or acquired neurological, vascular or systemic diseases (such as Parkinson's disease, cerebral palsy, diabetic neuropathy) that may affect the evaluation of the efficacy of this trial (especially joint pain and swelling); or with neuropathy or other pain disorders that may interfere with pain assessment. (6) the examination conducted before the screening visit or during the screening period showed malignant tumor and pulmonary infection; those with positive TB screening results and judged by the researchers to be active tuberculosis were diagnosed as latent tuberculosis, those who did not receive prophylactic treatment or treatment less than 4 weeks before the first administration of the trial; (7) those who had received intra-articular corticosteroids within 4 weeks before random administration. (8) participated in clinical studies of other drugs within one month before screening or within 5 half-lives of the original experimental drugs, whichever is longer; (9) screening tests met any of the following conditions: serum creatinine > 1.5 times the upper limit of normal value; ALT or AST > 1.5 times the upper limit of normal value; PLT 1.5x 109L. Fibrinogen exceeds the lower limit of the normal value (with reference to each central value); (10) other conditions identified by the researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Both hands X-ray positive;DAS28 score;HAQ score;VAS score;Joint swelling and joint tenderness were counted;ESR;CRP;routine blood test;biochemical indexes;Urination and defecation routine; | — |
Countries
China
Contacts
Public ContactXuelei Ma
West China Hospital, Sichuan University
Outcome results
None listed