Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039650
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2002-06-06
Brief Title:
Pilot Study Effects of G-CSF on T Cell Function
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pilot Study of the Effects of G-CSF on T Cell Function
Status:
COMPLETED
Status Verified Date:
2004-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate changes in T cells-infection-fighting white blood cells of the immune system-in people given a drug called G-CSF before donating stem cells immature bone marrow cells for transplantation Originally bone marrow cells were obtained using a needle inserted into the hipbone of the donor However when it was discovered that immature bone marrow cells also circulate in the blood scientists began to develop techniques to collect quantities of these cells from the blood instead of the bone G-CSF is a blood cell growth factor that pushes stem cells from the bone marrow into the bloodstream Stem cell donors are given this drug 5 to 6 days before donation to make more cells available in the circulating blood for collection
Stem cell transplantation requires careful regulation of immune cell function to allow the donated stem cells to grow in the transplant recipient to prevent the transplanted cells from damaging the recipient and to allow the recipients new immune system to develop normally so it can fight infections Studies comparing the outcome of patients transplanted with bone marrow cells with those transplanted with stem cells suggest that the G-CSF given to stem cell donors affects the function of T cells in transplant recipients This study will collect white cells containing T cells before and after G-CSF administration to determine the effects of the drug on both T cells and stem cells
Healthy normal volunteers 18 years of age and older who meet the health criteria for donating blood may participate in this study Pregnant and breastfeeding women are not eligible
Participants will undergo the following procedures
Blood sample collection 15 milliliters or 3 teaspoons to measure blood cell counts
Electrocardiogram to assess heart function
Apheresis to donate white blood cells Participants will undergo two apheresis procedures-once before receiving G-CSF and a second time immediately after finishing the 5-day course of the drug For this procedure whole blood is removed using a needle placed in an arm vein The blood is circulated through a cell separator machine where the white cells are removed and collected in a plastic bag The rest of the blood including the red cells platelets and plasma are returned to the donor through a needle in the other arm The procedure takes 2 to 3 hours during which time the donor lies quietly
Stem cell transplantation requires careful regulation of immune cell function to allow the donated stem cells to grow in the transplant recipient to prevent the transplanted cells from damaging the recipient and to allow the recipients new immune system to develop normally so it can fight infections Studies comparing the outcome of patients transplanted with bone marrow cells with those transplanted with stem cells suggest that the G-CSF given to stem cell donors affects the function of T cells in transplant recipients This study will collect white cells containing T cells before and after G-CSF administration to determine the effects of the drug on both T cells and stem cells
Healthy normal volunteers 18 years of age and older who meet the health criteria for donating blood may participate in this study Pregnant and breastfeeding women are not eligible
Participants will undergo the following procedures
Blood sample collection 15 milliliters or 3 teaspoons to measure blood cell counts
Electrocardiogram to assess heart function
Apheresis to donate white blood cells Participants will undergo two apheresis procedures-once before receiving G-CSF and a second time immediately after finishing the 5-day course of the drug For this procedure whole blood is removed using a needle placed in an arm vein The blood is circulated through a cell separator machine where the white cells are removed and collected in a plastic bag The rest of the blood including the red cells platelets and plasma are returned to the donor through a needle in the other arm The procedure takes 2 to 3 hours during which time the donor lies quietly
Detailed Description:
T cells play a critical role in hematopoietic stem cell transplantation Many transplant protocols involving HLA matched sibling donors make use of T cell mediated graft-versus-leukemia or graft-versus-cancer effects to clear andor prevent the recurrent growth of malignant cells Donor T cells are also responsible for reconstituting cellular immune function following transplantation but often cause graft-versus-host disease GVHD Over the past several years the major source of hematopoietic stem cells for transplantation has changed from marrow to granulocyte-colony stimulating factor G-CSF-mobilized peripheral blood stem cells PBSCs Despite the fact that patients transplanted with allogeneic G-CSF-mobilized PBSCs receive approximately 10-fold more T-cells than those transplanted with marrow the incidence and severity of acute GVHD is similar among the two groups although chronic GVHD is higher in PBSC recipients Using cellular function assays some investigators have shown that G-CSF affects T cell function When healthy subjects are given G-CSF a decrease is seen in the concentration of circulating type 1 helper T cells Th1 with subsequent falls in the cytokine levels produced by these cells In contrast an increase occurs in the concentration of type 2 helper T cells TH2 and the level of cytokines produced The purpose of this study is to assess G-CSF-induced changes in T cells cDNA microarrays will be used to compare genes expressed in CD4 and CD8 cells before and after G-CSF is given Up to fifteen healthy subjects will be given a typical PBSC mobilization regimen for allogeneic transplants 10 microgramskgday of G-CSF for 5 days Peripheral blood mononuclear cells will be collected by apheresis before the mobilization regimen is given and the day after the mobilization is complete CD4 CD8 and CD34 cells will be isolated from the peripheral blood mononuclear cells and gene expression will be assessed using cDNA microarrays containing over 8000 genes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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-CC-0201 | None | None | None |