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Cardiac Involvement clinical trials

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NCT ID: NCT01895244 Active, not recruiting - Scleroderma Clinical Trials

Autologous Stem Cell Transplantation for Progressive Systemic Sclerosis

AST-MOMA
Start date: September 2012
Phase: Phase 2
Study type: Interventional

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.