- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00033774
Stem Cell Collection for Adult Volunteers
Peripheral Blood Stem Cell Collection From Adult Volunteers
This study will examine the development of stem cells (very immature cells produced by the bone marrow) and their potential to change into cells of other organ types. These cells will be studied for their potential use in creating replacement tissue for diseases ranging from diabetes to Parkinson s.
Healthy volunteers 18 years of age or older may be eligible for this study. Candidates will be screened with a medical history, physical examination, and blood tests.
Participants will undergo a process called 'stem cell mobilization and apheresis' to collect bone marrow stem cells. For five days before the collection they will receive injections of a hormone called G-CSF, which stimulates release of stem cells from the bone marrow into the bloodstream. On the fifth day of the injections, stem cells will be collected through apheresis. For this procedure, blood is collected through a catheter (plastic tube) placed in an arm vein and directed into a cell separator machine. There, the white cells and stem cells are separated from the other blood components through a spinning process and collected in a bag inside the machine. The rest of the blood is returned to the donor through a catheter in the other arm.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
- INCLUSION CRITERIA:
Age 18 or greater.
Normal renal function: creatinine less than1.5 mg/dL, proteinuria less than1+.
Normal liver function: bilirubin less than 2.5 mg/dL, ALT less than 2.5 times the upper limit of normal, all other transminases less than 2.5 times the upper limit of normal.
Normal blood counts: WBC 3,000-10,000/mm3, granulocytes greater than 1,500/mm3, platelets greater than 150,000/mm3, hemoglobin greater than 12.5g/dL, MCV within normal limits.
Female volunteers of childbearing age should have a negative serum pregnancy test within one week of beginning G-CSF administration.
Meets NIH Department of Transfusion Medicine (DTM) eligibility criteria for blood component donation for in vitro research use (negative serologic tests for syphilis, hepatitis B and C, HIV, and HTLV-1).
Ability to give informed consent to participate in the protocol.
EXCLUSION CRITERIA:
Any underlying hematologic disorder including sickle cell disease.
Active viral, bacterial, fungal, or parasitic infection.
History of autoimmune disease, such as rheumatoid arthritis or systemic lupus erythematosus.
History of cancer excluding squamous carcinoma of the skin and cervical carcinoma in situ.
History of cardiovascular disease or related symptoms such as chest pain or shortness of breath.
Any positive serum screening test as listed below.
Allergy to G-CSF or bacterial E. coli products.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
Eligible healthy volunteers 18 and older
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Collection of peripheral blood stem cells via standard leukapheresis
Time Frame: 5 days
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To explore the control of normal differentiation of adult hematopoietic stem cells collected from the peripheral blood after G-CSF mobilization.
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5 days
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Collaborators and Investigators
Publications and helpful links
General Publications
- Wei G, Schubiger G, Harder F, Muller AM. Stem cell plasticity in mammals and transdetermination in Drosophila: common themes? Stem Cells. 2000;18(6):409-14. doi: 10.1634/stemcells.18-6-409.
- Orkin SH. Diversification of haematopoietic stem cells to specific lineages. Nat Rev Genet. 2000 Oct;1(1):57-64. doi: 10.1038/35049577.
- Lemischka I. Stem cell dogmas in the genomics era. Rev Clin Exp Hematol. 2001 Mar;5(1):15-25. doi: 10.1046/j.1468-0734.2001.00030.x.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 020160
- 02-H-0160
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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