G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers
Status:
Completed
Trial end date:
2012-10-25
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI) Richard Childs, M.D.