Systemic Lupus Erythematosus
Conditions
Interventions
Experimental group:T cell vaccination
Control group:Routine treatment
Sponsors
Shenzhen Ruipuxun Academy for Stem Cell & Regenerative Medicine
Eligibility
Sex/Gender
All
Age
16 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of systemic lupus erythematosus comply with the 1997 SLE classification diagnostic criteria of the American Society of Rheumatology; 2. Aged 16 to 70 years old, Both men and women; 3. Prednisone=10mg/d, CTX cumulative use of 6-8g is invalid, other immunosuppressants(Cyclosporin A, Azathioprine,Mycophenolate mofetil,et al ) treat for 3 monthes are invalid; 4. The patients have clinical manifestation of different degrees fever, fatigue, alopecia, joint pain, facial redness, reynolds phenomenon, proteinuria respectively; 5. The function of important organs is good; 6. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Systemic lupus erythematosus is associated with serious complications of important organ failure; 2. Unable to produce T cell vaccine; 3. Peripheral blood leukocyte and(or)platelet are below the lower limit value of normal reference value; 4. Malignant tumor; 5. The history of organ transplantation; 6. Acquired and congenital immunodeficiency disease; 7. A history of allergies; 8. Women of pregnancy or lactation; 9. Participating in other clinical trials of drugs in the latest month; 10. There are serious diseases that endanger patients' safety or affect patients' completion of this study; 11. Patients who have not signed the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SLEDAI score;Leucocyte count;PLT Count;ALB;Cr;U- Pro;ANA;hs- CRP;Treg;IFN-?;dsDNA antibody;Sm antibody;ENA;AHA;ANCA;aCL;Mixed lymphocyte reaction; | — |
Secondary
| Measure | Time frame |
|---|---|
| C3;C4;IL-10; | — |
Countries
China
Contacts
Public ContactZhao Zhenlin
Shenzhen Ruipuxun Academy for Stem Cell & Regenerative Medicine
Outcome results
None listed