Collection of Peripheral Blood Stem Cells Using G-CSF and Plerixafor in Normal Volunteers
Public ClinicalTrials.gov record NCT01123499. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Collection of Peripheral Blood Stem Cells Using G-CSF and Plerixafor in Healthy Volunteers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01123499
- Recruitment status
- Terminated
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 5 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 5, 2016
- Primary completion
- Jan 26, 2017
- Completion
- Apr 27, 2022
- Last update posted
- May 5, 2022
2016 – 2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01123499, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 5, 2022 · Synced Sep 14, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01123499 live on ClinicalTrials.gov.