View Clinical Trial (Medical Research Study)
Peripheral Blood Stem Cell Collection From Adult Volunteers
| City: |
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Bethesda |
| State: |
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Maryland |
| Zip Code: |
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20892 |
| Conditions: |
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Healthy |
| Purpose: |
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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.
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| Study Summary: |
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The concept that renewal of various tissues and organs at steady state or following damage
relies upon a small population of locally residing tissue specific "stem cells" has remained
unchallenged for decades; however, recent work by several groups has demonstrated a
remarkable capacity of cells from one tissue to participate in the repair or repopulation of
disparate organs, a process termed transdifferentiation. Stem cells from adult bone marrow
represent an ideal stem cell source based on their ease of collection. In order to begin to
explore the potential of adult bone marrow, we propose in vitro and in vivo mouse studies to
examine the regulation of both normal differentiation and transdifferentiation of
hematopoietic stem cells collected from adult volunteers. In order to obtain adult
hematopoietic stem cells in large numbers for in vitro and in vivo studies, volunteers will
undergo mobilization with G-CSF for 5 consecutive days followed by large volume apheresis on
the 5th day of G-CSF injection. The harvested product will be immunomagnetically purified
for the primitive progenitor population and viably cryopreserved in multiple aliquots.
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| Criteria: |
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- 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.
Splenic enlargement at baseline on ultrasound.
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| NCT ID: |
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NCT00033774 |
| Primary Contact: |
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Principal Investigator
John F Tisdale, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
John F Tisdale, M.D.
Phone: (301) 402-6497
Email: johntis@mail.nih.gov
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| Backup Contact: |
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N/A |
| Location Contact: |
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Bethesda, Maryland 20892
United States
For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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