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Sponsored by: |
Charite University, Berlin, Germany |
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Information provided by: | Charite University, Berlin, Germany |
ClinicalTrials.gov Identifier: | NCT00742300 |
While glucocorticoids and immunosuppressants ameliorate manifestations of autoimmune diseases 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 rationale for applying ASCT to autoimmune diseases has been the hope that immunoablation could eliminate inflammation-driving pathogenic cells from the immune system, and that regeneration of the patients' immune system from hematopoietic precursors could re-establish immunological tolerance.
Condition | Intervention | Phase |
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Autoimmune Diseases |
Procedure: Autologous hematopoietic stem cell transplantation |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Open-Label Monocentric Clinical Trial for Induction of Tolerance With CD34-Enriched Autologous Hematopoietic Stem Cell Transplantation After High-Dose Chemotherapy With Cyclophosphamide and Rabbit-Antithymocyte Globulin for Refractory Autoimmune Diseases |
Study Start Date: | January 1998 |
Arms | Assigned Interventions |
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A: Experimental
Treatment Group
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Procedure: Autologous hematopoietic stem cell transplantation
Transplantation of CD34-selected autologous hematopoietic stem cells after high-dose chemotherapy with cyclophosphamide (200mg/kg) and rabbit-antithymocyteglobulin (90mg/kg)
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Charité Universitätsmedizin Berlin | |
Berlin, Germany, 10117 |
Principal Investigator: | Renate Arnold, Prof. Dr. med. | Charité Universitätsmedizin Berlin |
Study Chair: | Falk Hiepe, Prof. Dr. med. | Charité Universitätsmedizin Berlin |
Responsible Party: | Charité Universitätsmedizin Berlin ( Christoph Krukenkamp ) |
Study ID Numbers: | CT-0198 |
Study First Received: | August 26, 2008 |
Last Updated: | November 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00742300 |
Health Authority: | Germany: Paul-Ehrlich-Institut |
ASCT Tolerance induction SLE Transplantation Autoimmune diseases |
Antilymphocyte Serum Autoimmune Diseases Cyclophosphamide |
Molecular Mechanisms of Pharmacological Action Immunologic Factors Immune System Diseases Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Immunosuppressive Agents Pharmacologic Actions |