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NCT07585136 · ClinicalTrials.gov registry record · Phase 1
Stem Cell Mobilization and Apheresis for Life-threatening Blood Disorders
A Phase 1 study, sponsored by St. Jude Children's Research Hospital.
- Not yet
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT07585136: Clinical Trial Phase 1 study, sponsored by St. Jude Children's Research Hospital.
NCT07585136 is a Phase 1 study that has not yet begun recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07585136, a Phase 1 study, has not yet begun recruiting, sponsored by St. Jude Children's Research Hospital.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate mobilization and collection of HSPCs in patients with bone marrow failure syndromes (BMFS) using granulocyte-colony stimulating factor (otherwise known as Filgrastim) with plerixafor to demonstrate safety and feasibility of collecting HSPCs to advance gene therapy. Primary objective: \- To characterize the safety of Filgrastim plus plerixafor in participants with bone marrow failure syndromes as determined by the incidence of adverse events (AEs). Secondary Objectives: * To characterize the feasibility of HSPC mobilization using Filgrastim plus plerixafor as determined by peripheral blood CD34+ counts. * To measure the mobilization effects of Filgrastim plus plerixafor in the peripheral blood in participants as determined by peak peripheral blood CD34+ counts. * To estimate efficacy of Filgrastim plus plerixafor for HSPC mobilization and apheresis collection in participants as determined by the yield of CD34+ cells (CD34+ cells/kg).
Primary Outcome
Safety will be assessed by the incidence, type, and severity of adverse events occurring after administration of filgrastim plus plerixafor in participants with bone marrow failure syndromes.
Interventions
- DRUG Plerixafor
- PROCEDURE Leukapheresis
- DRUG Filgrastim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2026-06 |
| Est. Completion | 2029-07-01 |
| Phase | Phase 1 |
What is known before NCT07585136 opens enrollment
NCT07585136 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 3 interventions - of which Plerixafor is the first listed.
NCT07585136 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07585136 about?
NCT07585136 is a clinical study titled "Stem Cell Mobilization and Apheresis for Life-threatening Blood Disorders". The purpose of this study is to investigate mobilization and collection of HSPCs in patients with bone marrow failure syndromes (BMFS) using granulocyte-colony stimulating factor (otherwise known as Filgrastim) with plerixafor to demonstrate safety and feasibility of collecting HSPCs to advance gene...
What is the current status of trial NCT07585136?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2026-06. Estimated completion is 2029-07-01.
What interventions are being tested in trial NCT07585136?
The interventions under investigation include: Plerixafor (DRUG), Leukapheresis (PROCEDURE), Filgrastim (DRUG).
Who is sponsoring clinical trial NCT07585136?
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 NCT07585136's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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