Stem Cells Clinical Trial
Official title:
Peripheral Blood Collection of Adult Stem Cells
This study is designed for the collection of stem cells from the bloodstream for use in
research studies. These cells will be studied to determine if they have unique features
particular to the donor that may or may not affect their use for developing new treatments.
Volunteers with or without a blood disease may be eligible to donate stem cells for this
study. Women who are pregnant or breastfeeding may not enroll.
Donors are evaluated with a medical history and physical examination, blood tests and an
ultrasound examination of the spleen. They then undergo stem cell mobilization and apheresis
as follows:
Donors are given injections of a hormone called G-CSF every day for 5 days to stimulate
release of stem cells from the bone marrow into the bloodstream for collection. On the day of
the last injection, donors undergo apheresis to obtain white cells and stem cells. For this
procedure, blood is withdrawn through a catheter (plastic tube) placed in a vein and directed
into a machine where the white cells and stem cells are separated from the rest of the blood
by a spinning process. These cells are extracted and collected in a bag inside the machine,
and the rest of the blood is returned to the donor through a second catheter in a vein in the
other arm. The procedure takes 4 to 5 hours.
Recent advances in the area of stem cell research suggest that redirected differentiation of
stem cells may prove useful for the treatment of a variety of diseases including diabetes and
other systemic diseases. In the hematopoietic system, recent studies have also demonstrated
the ability of adult erythroid stem cells to undergo differentiation toward a fetal-like
phenotype. This fetal-like phenotype is crucial in eliminating the clinical sequelae of
sickle syndromes and beta hemoglobinopathies. However, additional studies are needed to
determine if these results can be applied to patients with diseases involving hematopoietic
stem cells or other blood cells. In addition, it is clear that the stem cells from separate
donors do not possess identical properties of growth and differentiation.
The immediate aim of this protocol is to obtain hematopoietic stem cells from many human
donors for examination of the biological properties of those cells. The study is also
designed to determine if the donor-specific factors can influence the properties of their
hematopoietic stem cells. Each volunteer will undergo stem cell mobilization after
administration of granulocyte-colony stimulating factor (G-CSF) for five consecutive days
followed by a large volume apheresis on the 5th day after G-CSF injection. The harvested
product will be purified for the primitive hematopoietic progenitor cells and viably
preserved in multiple aliquots. The cells will then be studied in-depth for a better
understanding of their biological properties, growth and differentiation. Donor-specific
information will be correlated with these research studies to identify factors that may
assist with the understanding of adult stem cell biology.
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