Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033774
Status:
TERMINATED
Last Update Posted:
2022-08-25
First Post:
2002-04-09
Brief Title:
Stem Cell Collection for Adult Volunteers
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Peripheral Blood Stem Cell Collection From Adult Volunteers
Status:
TERMINATED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
There is another active NHLBI protocol for the collection of stem cells for research from healthy volunteers and no need for this separate Protocol
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-H-0160 | None | None | None |