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NCT00152100 · ClinicalTrials.gov registry record · Phase 1
Transplantation of Hematopoietic Cells in Children With Severe Combined Immunodeficiency Syndrome
A Phase 1 study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT00152100 is a Phase 1 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 4 participants.
The verdict
NCT00152100, a Phase 1 study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
Treatment for severe combined immunodeficiency (SCID) is a medical emergency. A stem cell transplant (immature blood cells that can make other blood cells) from a (MSD) matched sibling donor (brother or sister who is a "match" for your child's immune (HLA) type), usually results in complete correction of immune function. However, most patients lack a matched sibling donor, requiring the use of an alternate donor source. Transplantation of cells from haploidentical family donors (typically parents) has resulted in immune system correction in the majority of SCID individuals. However, only 65-80% of patients survive greater than one year after this procedure. Failure results from life-threatening infections, graft versus host disease (GvHD) or post-transplant treatment-related effects. Also, for patients that survive beyond one year, B-cell (type of blood cell that fights infection) and natural killer cell function (cell that attacks infections and cancer cells) frequently fail to work, resulting in the need for long-term treatment with intravenous gamma-globulin (IVIg). In this study, in an effort to restore the overall cell function in patients with SCID, researchers will use a highly purified CD133+ hematopoietic cell graft (stem cell transplant without many mature donor white cells, called T-cells) obtained via use of the Miltenyi CliniMACS device, a device not FDA approved.
Interventions
- PROCEDURE Stem cell transplant
- DRUG Filgrastim, Alemtuzumab
- DEVICE Miltenyi CliniMACS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2004-02 |
| Est. Completion | 2007-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00152100
The ClinicalTrials.gov registry entry for NCT00152100 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Stem cell transplant is the first listed.
NCT00152100 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00152100 about?
NCT00152100 is a clinical study titled "Transplantation of Hematopoietic Cells in Children With Severe Combined Immunodeficiency Syndrome". Treatment for severe combined immunodeficiency (SCID) is a medical emergency. A stem cell transplant (immature blood cells that can make other blood cells) from a (MSD) matched sibling donor (brother or sister who is a "match" for your child's immune (HLA) type), usually results in complete correcti...
What is the current status of trial NCT00152100?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2004-02. Estimated completion is 2007-08.
What interventions are being tested in trial NCT00152100?
The interventions under investigation include: Stem cell transplant (PROCEDURE), Filgrastim, Alemtuzumab (DRUG), Miltenyi CliniMACS (DEVICE).
Who is sponsoring clinical trial NCT00152100?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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