750971
Last Update Posted: 2017-03-20
Recruiting status is unknown
All Genders accepted | 18 Years-60 Years |
30 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Autologous Stem Cell Transplantation for Refractory Systemic Lupus Erythematosus (ASSIST)
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.
Eligibility
Relevant conditions:
Systemic Lupus Erythematosus
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
Inclusion criteria
Exclusion criteria
locations
Contact Information
Overall Contact
Falk Hiepe, Prof.
falk.hiepe@charite.de
+49 30 450 513026
Renate Arnold, Prof.
renate.arnold@charite.de
+49 30 450-553-302
Data sourced from ClinicalTrials.gov