Conditions: Systemic Lupus Erythematosus Systemic Sclerosis
Keywords: Autoimmune Disease Reduced Intensity Transplant
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if a reduced intensity (RI) (non-myeloablative) chemoimmunotherapy followed by Allogeneic Stem Cell Transplantation AlloSCT (matched family donors and matched unrelated cord blood donors) will be well tolerated.

Detailed description:
This is to test whether a reduced intensity will result in a high degree of mixed or complete donor chimerism and stabilization of autoimmune disease in a select group of patients with medically refractory SLE or SSc.

Arms:
arm 1: RI regimen of fludarabine/busulfan and Alemtuzumab (FBA) followed by AlloSCT in selected patients with medically refractory Systemic Lupus Erythematosus (SLE). arm 2: RI regimen of fludarabine/busulfan and Alemtuzumab (FBA) followed by AlloSCT in selected patients with Systemic Sclerosis (SSc).

Interventions: intervention 1: Reduced Intensity Allogeneic Transplant intervention 2: Fludarabine intervention 3: Busulfan intervention 4: Campath
Intervention descriptions: intervention 1: Eeduced intensity allogeneic stem cell transplantation with a fludarabine/busulfan/alemtuzumab conditioning regimen is anticipated to result in mixed and/or complete donor chimerism and potentially alter the natural history and outcome of patients with medically refractory Systemic Lupus Erythematosus (SLE) or Systemic Sclerosis (SSc). intervention 2: Fludarabine 30 mg/m2 Day -7, -6, -5, -4, -3, -2 intervention 3: Busulfan 3.2 mg/kg Days \_8, -7, -6, -5 intervention 4: Campath: 2 mg/m2 Day -5; 6 mg/m2 Day -4, -3; 20 mg/m2 Day -2

Protocol document: