Autologous Stem Cell Transplantation for Refractory Systemic Lupus Erythematosus (ASSIST) — ASSIST  

Systemic Lupus Erythematosus Clinical Trial

Official title: An Open-Label, Phase II Multicenter Cohort Study of Immunoablation With Cyclophosphamide and Antithymocyte-Globulin and Transplantation of Autologous Cd34-Enriched Hemapoietic Stem Cells Versus Currently Available Immunosuppressive/Immunomodulatory Therapy for Treatment of Refractory Systemic Lupus Erythematosus

Status Recruiting

Clinical Trial Summary

While glucocorticoids and immunosuppressants ameliorate manifestations of SLE in many patients, current therapies are insufficient to control the disease in a subset of patients, and their clinical prognosis remains poor due to the development of vital organ failure, cumulative drug toxicity and to the increased risk of cardiovascular disease and malignancy. Immunoablative chemotherapy followed by autologous hematopoietic stem cell transplantation (ASCT) has recently emerged as a promising experimental therapy for severely affected patients, providing them the potential to achieve treatment-free, long-term remission. The investigators postulate that immunoablative therapy eliminates or effectively reduces the level of autoreactive T and B lymphocytes and then regeneration of de novo immunity resets the autoreactive immune system into a self-tolerant, protective immune system resulting in prolonged and treatment-free remission.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

• NCT number: NCT00750971
• Study type: Interventional
• Source: Charite University, Berlin, Germany
• Contact: Falk Hiepe, Prof.
• Phone: +49 30 450 513026
• Email: falk.hiepe@charite.de
• Status: Recruiting
• Phase: Phase 2
• Start date: August 2008
• Completion date: August 2020