G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers

Completed · Phase 2

Conditions studied: Healthy

In brief

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.

Key facts

Study ID
NCT00082329
Run by
National Heart, Lung, and Blood Institute (NHLBI)
People needed
9
Starts
2004-06-18
Expected to finish
2012-10-25
Last updated by the study team
2021-07-22

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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