AMD 3100 (Mozobil Plerixafor) to Mobilize Stem Cells for Donation
Status:
Completed
Trial end date:
2012-08-01
Target enrollment:
Participant gender:
Summary
Peripheral blood progenitor cells (PBPC) have become the preferred source of hematopoetic
stem cells for allogeneic transplantation because of technical ease of collection and shorter
time required for engraftment. Traditionally, granulocyte-colony stimulating factor (G-CSF)
has been used to procure the peripheral blood stem cell graft. Although regimens using G-CSF
usually succeed in collecting adequate numbers of PBPC from healthy donors, 5%-10% will
mobilize stem cells poorly and may require multiple large volume apheresis or bone marrow
harvesting. Although G-CSF is generally well tolerated in healthy donors, it may be
associated with bone pain, headache, myalgia and rarely life threatening side effects like
stroke, myocardial infarction and splenic rupture.
AMD3100, is a bicyclam compound that inhibits the binding of stromal cell derived factor-1
(SDF-1) to its cognate receptor CXC- chemokine receptor 4 (CXCR4). CXCR4 is present on
cluster of differentiation 34 (CD34)+ hematopoetic progenitor cells and its interaction with
stromal cell derived factor 1 (SDF-1) plays a pivotal role in the homing of CD34+ cells in
the bone marrow. Inhibition of the CXCR4-SDF1 axis by AMD3100 releases CD34+ cells into the
circulation, which can then be collected easily by apheresis.
Recently, a published report demonstrated that large numbers of CD34+ cells were rapidly
mobilized in healthy volunteers following a single subcutaneous injection of AMD3100.
Remarkably, the number of CD34+ cells collected by apheresis following a single injection of
AMD3100 was comparable to the number of CD34+ cells collected from historical controls
receiving 5 days of G-CSF prior to stem cell mobilization.
In this study we will collect PBPCs following a single subcutaneous injection of AMD3100 from
healthy donors who have previously had PBPC collected using standard G-CSF mobilization. The
AMD3100 mobilized cells, G-CSF mobilized cells, and circulating cells prior to both AMD3100
and G-CSF mobilization will be analyzed in terms of cellular content and function of
lymphocytes, natural killer (NK) cells, and antigen presenting cells. AMD3100 mobilized PBPC
will be collected for the purpose of research studies and will not be used for therapeutic
purposes.