Stem Cell Mobilization and Apheresis for Life-threatening Blood Disorders

StatusRecruiting
PhasePhase 1
Started

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Record History

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  1. Recruitment opened Show 4 more changesShow less
    • Lead sponsor: St. Jude Children's Research Hospital to St. Jude Children's Research Hospital
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: details revised at 3 of 4 entries
    • Site details revised
  2. Start date: Jun 2026 to Nov 2026v3
  3. Re-verified, no change to tracked fieldsv2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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 life threatening blood disorders as determined by the incidence of adverse events (AEs). Secondary Objectives: * To measure the mobilization effects of Filgrastim plus plerixafor in the peripheral blood in participants as determined by peak peripheral blood CD34+ counts. * To characterize the feasibility of HSPC mobilization using Filgrastim plus plerixafor as determined by 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).
Trial Details
NCT Number NCT07585136
Lead Sponsor St. Jude Children's Research Hospital
Conditions
(from sponsor)		 Bone Marrow Failure Syndrome
Related terms Bone Marrow Failure Disorders
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov