Ignite Creation Date:
2024-05-05 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00750971
Status:
UNKNOWN
Last Update Posted:
2017-03-20
First Post:
2008-09-10
Brief Title:
Autologous Stem Cell Transplantation for Refractory Systemic Lupus Erythematosus ASSIST
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
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 ImmunosuppressiveImmunomodulatory Therapy for Treatment of Refractory Systemic Lupus Erythematosus
Status:
UNKNOWN
Status Verified Date:
2017-03
Last Known Status:
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:
ASSIST
Brief 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
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