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NCT01123499 · ClinicalTrials.gov registry record
Collection of Peripheral Blood Stem Cells Using G-CSF and Plerixafor in Normal Volunteers
A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- 5
- Enrollment target
NCT01123499: Clinical Trial study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01123499 is a clinical trial that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 5 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01123499 was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- 5 participants
- Enrollment target
Study Summary
Background: * Many treatments for immune system disorders involve the use of stem cells that have been collected from blood marrow. To obtain these stem cells without surgery, individuals receive granulocyte colony-stimulating factor (G-CSF) to encourage the production of stem cells that can be collected through blood donations. However, not all patients or normal donors respond to G-CSF alone. * Plerixafor, recently approved by the Food and Drug Administration, is different from G-CSF but also allows stem cells to be collected from donated blood. However, more research is needed on the quality and viability of the stem cells collected after using both G-CSF and plerixafor. Objectives: \- To collect and study the blood cells produced after treatment with G-CSF and plerixafor in healthy volunteers. Eligibility: \- Healthy volunteers between 18 and 65 years of age who are eligible to donate blood. Design: * Participants will be screened with a medical history, physical examination, and initial blood tests. * At the start of the study cycle, participants will receive daily morning injections of G-CSF for 5 days. These may be given at the clinical center or by the participant after teaching, depending on the participant s preference. * On the morning of Day 4, participants will visit the clinical center to provide a blood sample after the injection. On the evening of Day 4, participants will receive an injection of plerixafor. * Participants will have the final injection of G-CSF on the morning of Day 5, and will provide another blood sample. * On Day 5, participants will have apheresis to separate the stem cells from the rest of the blood. The apheresis may take up to 5 hours to complete. * The study will end after a follow-up phone call 7 to 14 days after the apheresis procedure.
Primary Outcome
To collect cells from normal volunteers using both G-CSF and plerixafor, to be able to use these in various research applications.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2016-10-06 |
| Est. Completion | 2022-04-28 |
Why NCT01123499 stopped before completion
NCT01123499 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 5 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01123499 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01123499 about?
NCT01123499 is a clinical study titled "Collection of Peripheral Blood Stem Cells Using G-CSF and Plerixafor in Normal Volunteers". Background: * Many treatments for immune system disorders involve the use of stem cells that have been collected from blood marrow. To obtain these stem cells without surgery, individuals receive granulocyte colony-stimulating factor (G-CSF) to encourage the production of stem cells that can be col...
What is the current status of trial NCT01123499?
This trial is currently terminated. The enrollment target is 5 participants. The study started on 2016-10-06. Estimated completion is 2022-04-28.
Who is sponsoring clinical trial NCT01123499?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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