Severe Systemic Sclerosis - Combination Therapy Study
A Randomized, Open-Label, Phase II/III Multicenter Study of High-Dose Immunosuppressive Therapy Using Total Body Irradiation, Cyclophosphamide, ATGAM, and Autologous Transplantation with Auto-CD34+HPC versus Intravenous Pulse Cyclophosphamide for the Treatment of Severe Systemic Sclerosis
Protocol ID
Protocol Description
The main purpose of this study is to determine the safety and effectiveness of high-dose immunosuppressive therapy followed by reinfusion (transplantation) of ones own autologous (self) peripheral blood stem cells (PBSCs) compared to treatment with monthly (for 12 months) intravenous doses of Cytoxan therapy for the treatment of severe systemic sclerosis (SSc). These treatments are being given in order to determine if they will slow down or stop SSc from becoming more severe, and if they can reverse the effects of the disease. We are evaluating the effects of the two treatments on serious organ damage and survival related to SSc, while also looking at the side effects of the two treatments. We do not know how effective each treatment is or which causes more side effects.
Eligibility Criteria
Patients with severe systemic sclerosis (SSc)
Primary Investigator(s)
- Avram Goldberg, MD