Autologous Stem Cell Transplantation for Refractory Systemic Lupus Erythematosus (ASSIST)
Germany30 participantsStarted 2008-08
Plain-language 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.
Who can participate
Age range18 Years ā 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Diagnosis of SLE according to American College of Rheumatology (ACR) classification criteria
ā. Age between 18 and 60 years, inclusive
ā. Provision of informed consent
ā. Active disease, refractory to standard immunosuppressive therapy defined as:
Exclusion criteria
ā. Severe concomitant disease or organ damage
ā. Ongoing cancer or history of malignancy within 5 years of screening
ā. Women who are pregnant or breastfeeding or use non-reliable methods of contraception
ā. Subjects with active systemic infection
ā. Subjects with history of active viral infection within 6 months prior to screening, known HIV-infection or chronic Hepatitis B or Hepatitis C
ā. History of allergic reaction to cyclophosphamide, G-CSF or ATG