Status:
UNKNOWN
Autologous Hematopoietic Stem Cell Transplantation for Refractory Autoimmune Diseases
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Autoimmune Diseases
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
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 t...
Eligibility Criteria
Inclusion
- Autoimmune disease
- Active disease with inadequate response to standard protocols (glucocorticoids and at least two different regimens of immunosuppressive drugs, such as intravenous cyclophosphamide 800-1000mg/application)
- Provision of informed consent by subject
Exclusion
- Active or chronic infections
- Uncontrolled arrhythmia or congestive heart failure (ejection fraction below 50% determined by echocardiogram)
- Lung fibrosis (transfer factor for carbon monoxide \[TLCO\] \<45%)
- renal insufficiency (glomerular filtration rate below 40 ml/min)
- Pulmonary arterial hypertension (\>40mmHg)
- History of malignancy
- Women who are pregnant or breastfeeding
- Use non-reliable methods of contraception
Key Trial Info
Start Date :
January 1 1998
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00742300
Start Date
January 1 1998
Last Update
November 24 2008
Active Locations (1)
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1
Charité Universitätsmedizin Berlin
Berlin, Germany, 10117