Refractory Lupus Nephritis
Conditions
Interventions
Sponsors
Shanghai Children's Medical Center, Affiliated to Shanghai Jiaotong University, School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with SLE with onset less than 18 years of age, refer to the diagnostic classification criteria for SLE in children based on the Expert Consensus on Clinical Diagnosis and Treatment of Systemic Lupus Erythematosus (2022 Edition), have good clinical treatment compliance, receive standardized treatment, and meet one of the following conditions: 1. Lupus nephritis, standard glucocorticoids combined with immunosuppressants, including biologics, have not reached partial remission after 6 months of treatment; 3. Lupus nephritis, standard glucocorticoid combined with immunosuppressant therapy, including biologics, has not met the DORIS criteria for lupus remission for 24 months; 4. The results of renal pathology had been obtained before enrollment; 5. The guardians of all enrolled children need to sign the informed consent form (if the child is over 8 years old, in addition to the guardian signing the informed consent form, the patient himself should also sign the children's version of the informed consent form), and enroll in the group for treatment in accordance with the ethical requirements.
Exclusion criteria
Exclusion criteria: 1. Children with SLE with one or more of the following lupus crises, manifested as rapidly progressive lupus nephritis, diffuse alveolar hemorrhage, thrombotic microangiopathy, neuropsychiatric lupus, diffuse alveolar hemorrhage, cardiac tamponade, lupus mesenteric vasculitis, catastrophic antiphospholipid antibody syndrome; 2. Estimated survival 220umol/L; ALT/AST > 5 times normal; bilirubin >34umol/L; 4. There is no suitable vein for peripheral blood lymphocyte collection or the number of collected is insufficient; 5. There is an active infection that cannot be controlled, such as hepatitis B, hepatitis C in the active stage, HIV, fungal, tuberculosis, EBV, CMV infection, etc.; 6. The in vitro expansion effect of lymphocytes after isolation is not good, and the dose cannot be used in clinical practice; 7. Early post-treatment loss to follow-up (< 3 months), unable to evaluate short-term and long-term prognosis; 8. Presence of other systemic diseases that interfere with this study; 9. Monogenic lupus; 10. Other indicators that the investigator believes can be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cytokines;SLE serological testing;Liver and kidney function; | — |
Countries
China
Contacts
Public ContactBenshang Li, Lei Yin
Shanghai Children's Medical Center affiliated to school of medicine, Shanghai Jiaotong University
Outcome results
None listed