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Autologous stem cell therapy has been shown to be effective in patients with systemic sclerosis. Nevertheless treatment is associated with treatment related mortality and patients die during follow up despite successful transplantation.
Intention of this trial is to improve overall survival by modifying the existing protocol used for the ASTIS trial.
To reduce treatment toxicity we reduce the dose of Cyclophosphamide (CYC) for mobilisation to 2x1g.
Especially in patients with cardiac manifestations we also modify the conditioning regimen by adding thiotepa and reducing CYC; as CYC has known cardiotoxic side effects.
Enrollment
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Inclusion criteria
Diagnosis of progressive systemic sclerosis <7 years
Progressive course despite cyclophosphamide pretreatment
Cyclophosphamide i.v.: at least 3 x with 500-1000 mg/m² every 3-4 weeks or
Cyclophosphamide p.o. with at least 100mg/day for at least 2 months or
Contraindication to treatment with cyclophosphamide
Progress defined as at least one of the following criteria:
Limited or diffuse cutaneous progressive form of Ssc with organ manifestation in the lungs/heart or kidneys
Exclusion criteria
Primary purpose
Allocation
Interventional model
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44 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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