Ignite Creation Date:
2024-05-05 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00742300
Status:
UNKNOWN
Last Update Posted:
2008-11-24
First Post:
2008-08-26
Brief Title:
Autologous Hematopoietic Stem Cell Transplantation for Refractory Autoimmune Diseases
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
Phase III 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
Status:
UNKNOWN
Status Verified Date:
2008-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASTRAD
Brief Summary:
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None