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
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.