Mobilization and Handling of Stem Cells for Transplant From Healthy Volunteers With Sickle Cell Trait
Status:
Completed
Trial end date:
2002-07-01
Target enrollment:
Participant gender:
Summary
This study will examine the effects of granulocyte colony-stimulating factor (G-CSF) on bone
marrow stem cells in healthy volunteers with sickle cell trait and determine if cells
collected for transplantation from donors with sickle cell trait require special handling.
Stem cells, which the bone marrow produces, are responsible for making all the different
kinds of blood cells. They are the cells used in bone marrow, or stem cell, transplantation.
The drug G-CSF, which is a naturally occurring hormone, causes stem cells to mobilize-that
is, to be released from the bone marrow and enter the blood stream. This drug is given to
stem cell donors to increase the amount of cells that can be collected. Stem cell donors for
patients with sickle cell disease are often healthy siblings of the patient who have a
matching bone marrow type. Some siblings carry the sickle cell trait, however, and, even
though they do not have sickle cell disease and their blood and bone marrow are normal, it is
not known how their cells will react to G-CSF stimulation. Nor is it known if their stem
cells require special methods of removal, processing or storing.
Healthy volunteers 18 years or older with sickle cell trait who have no history of sickle
cell disease and no known medical problems may be eligible for this study. Participants will
have a medical history and physical examination, including blood tests and urinalysis. They
will receive injections of G-CSF under the skin once a day for 5 days. On the fifth day, stem
cells will be collected through leukapheresis. In this procedure, whole blood is drawn from
an arm vein, similar to donating whole blood. The blood then circulates through a cell
separator machine, the stem cells are removed, and the rest of the blood is transfused back
to the donor through a vein in the other arm.
The information gained from this study will be used to ensure the safety of stem cell donors
with sickle cell trait and to better prepare stem cells for transplantation in sickle cell
patients.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)