Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic Sclerosis

"HSCT comprises the following consecutive steps:~1. Mobilisation~ * Infusions of CYC 2g/m2 on 1 day.~ * Hyperhydration, alkalinisation of urine and mesna to prevent haemorrhagic cystitis.~ * Filgrastim (G-CSF) 5-10 μg/kg/day subcutaneously for 5 days (or more when necessary).~2. Leukapheresis Prompt start of leukapheresis is required at a CD34+ cell count of ≥10-20/μL. Goal: at least 2 x 10\^6 CD34+ cells per kilogram body weight.~3. Conditioning~ * CYC 50 mg/kg/day intravenously for 4 consecutive days (total 200 mg/kg)~ * Rabbit Antithymocyte Globulin (rbATG), a total dose of 7.5 mg/kg i.v., from Genzyme.~ Hyperhydration, alkalinisation of the urine and mesna will be given to prevent haemorrhagic cystitis.~ I.v. methylprednisolone 2 mg/kg will be administered on the days ATG, to improve tolerability of the ATG.~4. Peripheral stem cell infusion The number of CD34+ cells to be reinfused should be ≥ 2.0 x 10\^6/kg."