Status:
COMPLETED
Purified CD34+ Hematopoietic Stem Cell Transplantation From Alternate Donors for Patients With Severe Aplastic Anemia
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Aplastic Anemia
Eligibility:
All Genders
Up to 21 years
Phase:
NA
Brief Summary
This study is for patients with Severe Aplastic Anemia (SAA). A stem cell transplant from a genetically matched sibling donor can help or cure this disease in 85 to 100 percent of patients. Stem cells...
Eligibility Criteria
Inclusion
- Age \< 21 years
- Diagnosis of severe aplastic anemia. (As defined by at least 2 of the following: ANC \< 500/μl, platelet count \< 20,000/μl, and a reticulocyte count \< 1% after correction for the hematocrit. In addition, the diagnostic bone marrow biopsy must contain less than 25% of the normal cellularity).
- Patient must have failed one or more courses of immunosuppressive therapy that included ATG. As immunosuppression may take up to 6 months to demonstrate a response, patients must have been observed to have failed immunosuppression for a minimum of six months.
- Absence of suitable HLA-matched sibling donor.
- Negative serum pregnancy test for females with child bearing potential.
- Patient/parent/guardian is able to provide informed consent.
Exclusion
- Patients with a life expectancy \< 6 weeks.
- Patients with severe renal disease (creatinine clearance \< 40cc/min/1.73m2)
- Patients with pre-existing severe restrictive pulmonary disease (FVC \<40% of predicted)
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00186797
Start Date
December 1 2002
End Date
May 1 2007
Last Update
April 9 2010
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105