High-dose Immunosuppression And Autologous Peripheral Blood Cd34 ~ + Cell Transplantation For The Treatment Of Severe / Refractory Autoimmune Disease Clinical Research

ObjectivesTo assess the feasibility, safety, and efficacy of intensive immunosuppression and autologous hemopoietic stem cell transplantation in severe systemic lupus erythematosus and refractory rheumatoid arthritis.MethodsTen patients with severe and persistent SLE despite use of prednisone and immunosupression agents and one patient with active, destructive, refractory RA entered the study. The eligible patients were with no severe non-reversible organ function impairment, no history of severe allergy to drugs. All patients provided written informed consent.1. Treatment protocols of HDIT+HSCT:1.1. Mobilization and leukapheresis of peripheral stem cell and selection of CD34⁺ cells: The mobilization regimen was CY 2 4 g/m² and G-CSF 5 μg·Kg^-1·d^-1. Peripheral mononuclear cells fraction in which stem cells were enriched was collected by use of the cytocentrifuge. Then a ClinMACS was used to select CD34⁺ cells.1.2.Conditioning regimen: We applied regimens of CY+ATG or CY+TBI. Total dose is CY 200 mg/kg , ATG 90 mg/kg and TBI 4 Gy.1.3. Infusion of CD34⁺ cells: CD34⁺ cells were reinfused intravenously within 10 to 30 minutes after defrostment.2. Monitoring of hematopoietic and immune reconstitution: ANC > 1.0 × 10⁹/L for consecutive 3 days, the first day of these 3 days is defined to the neutrophil recovering time. Platelet count > 20× 10⁹/L for consecutive 3 days, the third day of those 3 days is defined to the platelet recovering time. Detect the phenotype of the lymphocyte in the peripheral blood every three months after transplantation to monitor the immune reconstitution process. The difference of lymphocyte...