Status:
TERMINATED
Reduced Intensity Transplant in Medically Refractory Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc)
Lead Sponsor:
New York Medical College
Conditions:
Systemic Lupus Erythematosus
Systemic Sclerosis
Eligibility:
All Genders
7-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine if a reduced intensity (RI) (non-myeloablative) chemoimmunotherapy followed by Allogeneic Stem Cell Transplantation AlloSCT (matched family donors and matched...
Detailed Description
This is to test whether a reduced intensity will result in a high degree of mixed or complete donor chimerism and stabilization of autoimmune disease in a select group of patients with medically refra...
Eligibility Criteria
Inclusion
- Diffuse Systemic Sclerosis and variants as per ACR criteria
- Medically refractory disease
- Adequate Organ Function - Pulmonary function
- Renal function, Cardiac function defined as:
- SGOT (AST) or SGPT (ALT) \<5 x upper limit of normal
- Diagnosis of SLE - Medically refractory disease
Exclusion
- Karnofsky/Lansky \<60%
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00684255
Start Date
August 1 2007
End Date
July 1 2008
Last Update
April 1 2014
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032