Mobilization and Handling of Stem Cells for Transplant From Healthy Volunteers With Sickle Cell Trait
NCT ID: NCT00005782
Last Updated: 2008-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
12 participants
INTERVENTIONAL
2000-01-31
2002-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Granulocyte colony-stimulating factor
Leukapheresis
Eligibility Criteria
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Inclusion Criteria
No history of sickle cell crises.
Children less than 18 years of age are excluded as is per routine for normal volunteer protocols.
No active systemic viral, bacterial, fungal, or parasitic infection.
No female volunteers with positive pregnancy test or who are lactating.
No history of autoimmune disease, such as rheumatoid arthritis and systemic lupus erythematosus.
No history of cancer excluding squamous or basal cell carcinoma of the skin.
No history of any malignant hematologic disorders.
No history of cardiovascular disease or related symptoms such as chest pain and shortness of breath..
No allergy to G-CSF or bacterial E. coli products.
No history of G-CSF administration or leukapheresis.
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Locations
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Bethesda, Maryland, United States
Countries
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Other Identifiers
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00-DK-0060
Identifier Type: -
Identifier Source: secondary_id
000060
Identifier Type: -
Identifier Source: org_study_id
NCT00001980
Identifier Type: -
Identifier Source: nct_alias
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