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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: Completed Phase 2 study of Healthy, sponsored by National Heart, Lung, and Blood Institute (NHLBI).

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis. We propose that the combination of single dose AMD 3100 and G-CSF as combined mobilizing agents will improve the peripheral blood progenitor cells mobilization. Successful treatment responders is defined by completing study treatment with cell mobilization and cell co

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

FieldValue
Enrollment Target 9 participants
Start Date 2004-06-18
Est. Completion 2012-10-25
Phase Phase 2

What the finished NCT00082329 record still lists

NCT00082329 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (99% lower).

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 a single indexed study location in 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.

Similar trials for Healthy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00082329's enrollment target sits among peer trials

9 1057th of 1090 higher than 31 of 1,090 other Healthy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00082329, the US trial registry maintained by the National Library of Medicine. NCT00082329 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.