Autologous Stem Cell Transplantation for Refractory Systemic Lupus Erythematosus (ASSIST)

Inclusion Criteria

• •1. Diagnosis of SLE according to American College of Rheumatology (ACR) classification criteria
• •2. Age between 18 and 60 years, inclusive
• •3. Provision of informed consent
• •4. Active disease, refractory to standard immunosuppressive therapy defined as:
• •* BILAG level A and a SLEDAI-score of at least 10, despite treatment with high-dose corticosteroids and pulse intravenous CYC at doses of 500-1000mg/m2 for at least 6 months or mycophenolate mofetil (MMF) at doses of at least 2g -
• •* Lupus nephritis with renal biopsy performed within one year prior to screening showing glomerulonephritis WHO class III or IV
• •* Parenchymal disease of heart or lung
• •* Neuropsychiatric lupus
• •* Autoimmune cytopenia OR
• •* recurrence of disease activity (defined as BILAG level A and a SLEDAI of at least 10) within one year after successful induction therapy with cyclophosphamide or MMF in the presence of an adequate maintenance therapy with either cyclophosphamide (at least 500mg/m2 monthly), mycophenolate mofetil (at least 2g daily), azathioprine (at least 1.5mg/kg/d), methotrexate (at least 15mg weekly), cyclosporine (at least 3mg/kg/d) in patients with persistent anti-dsDNA antibodies