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Stem Cell Collection for Adult Volunteers

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ClinicalTrials.gov Identifier: NCT00033774
Recruitment Status : Recruiting
First Posted : April 10, 2002
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Brief Summary:

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.


Condition or disease
Sickle Cell

Detailed Description:
The renewal of various tissues and organs at steady state or following damage relies upon a small population of locally residing tissue specific "stem cells" 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 for the correction of genetic diseases that affect the blood such as sickle cell disease, we propose in vitro and in vivo mouse studies to examine the regulation of normal differentiation 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.

Study Type : Observational
Estimated Enrollment : 99999 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Peripheral Blood Stem Cell Collection From Adult Volunteers
Actual Study Start Date : April 29, 2002

Group/Cohort
1
Intervention(medication):Volunteers will undergo mobilization with G-CSF for 5 consecutive days followed by large volume apheresis on the 5th day of G-CSF injection.



Primary Outcome Measures :
  1. To explore the control of normal differentiation of adult hematopoietic stem cells collected from the peripheral blood after G-CSF mobilization. [ Time Frame: ongoing ]
    Collection and storage of hematopoietic stem cells will allow in vitro studies to explore the control of normal hematopoiesis stem cell differentiation. In some cases, steady state (without G-CSF mobilization) peripheral blood mononuclear cells will be collected to serve as controls. The hematopoietic stem cells will be cultured under a variety of conditions designed to mimic normal hematopoietic stem cell terminal differentiation. The hematopoietic stem cells will also be transplanted into immunodeficient mice, a surrogate stem cell assay, to further study in vivo differentiation potential. Populations of cultured cells will be analyzed for genes involved in the process ofnormal differentiation. Following collection and processing, identifiers will be stripped from the samples prior to their distribution to the investigators with retention of only the gender of the donor for purposes of cell tracking.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Recruitment will occur from a pool of normal volunteers. Volunteers who are not undergoing pretreatment with G-CSF will receive two hundred and fifty (250) dollars for the leukapheresis. Volunteers who undergo pretreatment with G-CSF will receive a payment of five hundred (500) dollars upon completion of 5 days of G-CSF, blood draws, and the leukapheresis. In the event of early withdrawal from the study before the leukapheresis, the volunteer will receive fifty (50) dollars for each visit to the hospital which includes blood draws and G-CSF administration.
Criteria
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00033774


Contacts
Contact: John F Tisdale, M.D. (301) 402-6497 johntis@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: John F Tisdale, M.D. National Heart, Lung, and Blood Institute (NHLBI)

Additional Information:
Publications:
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00033774     History of Changes
Other Study ID Numbers: 020160
02-H-0160
First Posted: April 10, 2002    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 11, 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Leukapheresis
G-CSF
Mobilization
Stem Cells
Adult
Healthy Volunteer
HV
Normal Control