Clinical Trials Directory

Trials / Terminated

TerminatedNCT00033774

Stem Cell Collection for Adult Volunteers

Peripheral Blood Stem Cell Collection From Adult Volunteers

Status
Terminated
Phase
Study type
Observational
Enrollment
136 (actual)
Sponsor
National Heart, Lung, and Blood Institute (NHLBI) · NIH
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Accepted

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.

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.

Conditions

Timeline

Start date
2002-04-29
Primary completion
2022-06-27
Completion
2022-08-19
First posted
2002-04-10
Last updated
2022-08-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00033774. Inclusion in this directory is not an endorsement.