Status:
COMPLETED
Stem Cell Transplantation With Identical Donors for Patients With Sickle Cell Disease
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE2
Brief Summary
This protocol studied the effect of administration of a myeloablative pretransplant preparative regimen followed by an infusion of donor stem cells in children with severe sickle cell disease. The don...
Detailed Description
The secondary objectives of this protocol evaluated the effect of this transplant procedure on the subsequent clinical course of patients with severe SCD. Specifically, to determine whether pre-transp...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Diagnosis of severe' disease is denoted by one of the following:
- Previous central nervous system vaso-occlusive episode with or without residual neurologic findings or
- Frequent painful vaso-occlusive episodes with significant interference with normal life activities and which necessitates chronic transfusion therapy or
- Recurrent SCD chest syndrome events which necessitate chronic transfusion therapy.
- Exclusion criteria:
- Patient with SCD chronic lung disease greater than or equal to stage 3
- Patient with severe renal dysfunction defined as creatinine clearance \< 40 ml/min/1.73m2.
- Patient with severe cardiac dysfunction defined as echocardiogram shortening fraction \< 25%.
- Patient with HIV infection.
- Pregnant or lactating.
- Patient with unspecified chronic toxicity that in the opinion of the Principal Investigator is serious enough to detrimentally affect the patient's capacity to tolerate SCT.
- Patient or patient's guardian(s) unable to understand the nature and risks inherent in the BMT process
Exclusion
Key Trial Info
Start Date :
December 1 1992
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00186810
Start Date
December 1 1992
End Date
October 1 2007
Last Update
May 29 2009
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105