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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: Completed Phase 1 study, sponsored by St. Jude Children's Research Hospital.
NCT00152100 is a Phase 1 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00152100 record still lists
NCT00152100 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 3 interventions - of which Stem cell transplant is the first listed.
NCT00152100 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00152100's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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