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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00152100 |
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Date of registration:
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07/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Transplantation of Hematopoietic Cells in Children With Severe Combined Immunodeficiency Syndrome
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Scientific title:
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Transplantation of Highly Purified Haploidentical CD133 Hematopoietic Cells in Children With Severe Combined Immunodeficiency Syndrome |
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Date of first enrolment:
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February 2004 |
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Target sample size:
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4 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00152100 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Kimberly Kasow, DO |
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Address:
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Telephone:
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Email:
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Affiliation:
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St. Jude Children's Research Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient with confirmed severe combined immunodeficiency
- Two years of age or younger
- A suitable matched sibling donor is not available
Exclusion Criteria:
- An available matched sibling donor or a confirmed matched unrelated donor
- Patients with DiGeorge syndrome, Zap70, MHC Class II deficiency, or cartilage-hair
hypoplasia
- Patients with a Lansky performance score of less than 10, evidence of HIV or a
congenital rubella infection or a documented neoplasm
- Patients in whom it is not possible to perform a peripheral blood cell harvest on a
haploidentical family member
Age minimum:
N/A
Age maximum:
2 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Severe Combined Immunodeficiency
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Intervention(s)
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Device: Miltenyi CliniMACS
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Drug: Filgrastim, Alemtuzumab
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Procedure: Stem cell transplant
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Primary Outcome(s)
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To investigate safety issues related to use of haploidentical highly purified CD133+ hematopoietic cells in patients with SCID
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To study the effects (good and bad) of this procedure
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To learn if this procedure will result in normal immune function in children with SCID
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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