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NCT00082329 · ClinicalTrials.gov registry record · Phase 2
G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers
A Phase 2 study of Healthy, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT00082329 is a Phase 2 study of Healthy that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 9 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00082329, a Phase 2 study of Healthy, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
This 12-day study will test whether the combination of G-CSF (granulocyte-colony stimulating factor) and AMD3100 (Mozobil) is more efficient in mobilizing stem cells for collection than the use of G-CSF alone. Traditionally, the growth factor G-CSF has been given to stem cell donors to mobilize, or push, stem cells out of the bone marrow and into the blood circulation for collection for transplantation. Although a sufficient quantity of cells usually can be collected with G-CSF treatment, some donors do not respond well and may require multiple apheresis procedures (see below) to collect enough cells. Studies indicate that G-CSF used together with a drug called AMD3100 may be more effective in mobilizing stem cells for collection than G-CSF alone. The Food and Drug Administration has approved G-CSF for stem cell mobilization. AMD3100 is a new drug that also mobilizes stem cells in large numbers within a few hours. Normal healthy volunteers between 18 and 60 years of age may be eligible for this study.
Conditions Studied
Interventions
- DRUG AMD 3100 (Mozobil plerixafor)
- DRUG Granulocyte colony-stimulating factor (G-CSF)
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2004-06-18 |
| Est. Completion | 2012-10-25 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00082329
The ClinicalTrials.gov registry entry for NCT00082329 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (99% lower). The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which AMD 3100 (Mozobil plerixafor) is the first listed.
NCT00082329 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00082329 about?
NCT00082329 is a clinical study titled "G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers". This 12-day study will test whether the combination of G-CSF (granulocyte-colony stimulating factor) and AMD3100 (Mozobil) is more efficient in mobilizing stem cells for collection than the use of G-CSF alone. Traditionally, the growth factor G-CSF has been given to stem cell donors to mobilize, or ...
What is the current status of trial NCT00082329?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2004-06-18. Estimated completion is 2012-10-25.
What conditions does trial NCT00082329 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT00082329?
The interventions under investigation include: AMD 3100 (Mozobil plerixafor) (DRUG), Granulocyte colony-stimulating factor (G-CSF) (DRUG).
Who is sponsoring clinical trial NCT00082329?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00082329 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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