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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 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.
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2016-10-06 |
| Est. Completion | 2022-04-28 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01123499
The ClinicalTrials.gov registry entry for NCT01123499 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01123499 reports 0 study locations.
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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