Ignite Creation Date:
2024-05-05 @ 10:06 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01026987
Status:
COMPLETED
Last Update Posted:
2017-01-25
First Post:
2009-12-01
Brief Title:
Granulocyte Colony-stimulating Factor G-CSF Plus or Minus AMD3100 for Engraftment Post Allogeneic Transplant
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
A Pilot Study of G-CSF - Plerixafor AMD3100 Mobilized Donor CD34 Enriched Peripheral Blood Mononuclear Cells for the Treatment of Allogeneic Stem Cell Transplant Recipients With Limited Donor Engraftment
Status:
COMPLETED
Status Verified Date:
2017-01
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:
Patients who have not had adequate blood count recovery post related or unrelated stem cell transplant will be given a boost of T-cell depleted enriched stem cells to hopefully improve their blood counts
Detailed Description:
Patients who have not had adequate blood count recovery post related or unrelated stem cell transplant will be given a boost of T-cell depleted enriched stem cells to hopefully improve their blood counts
The unrelated donors will receive G-CSF prior to pheresis collection of the stem cells to boost the number of CD34 cells The related donors will receive G-CSF and AMD3100 prior to pheresis to boost the number of CD34 cells Once the CD34 cells are collected they will be T-cell depleted using a cell separation device called the CliniMACS systems The CliniMACS system will select the CD34 cell and remove the T-cells By removing the T-cells we can minimize the risk of Graft Versus Host Disease GVHD The enriched CD34 cells will be given to them to hopefully give them a boost of cells that can permanently produce new blood cells to improve their risk of infection and bleeding
The unrelated donors will receive G-CSF prior to pheresis collection of the stem cells to boost the number of CD34 cells The related donors will receive G-CSF and AMD3100 prior to pheresis to boost the number of CD34 cells Once the CD34 cells are collected they will be T-cell depleted using a cell separation device called the CliniMACS systems The CliniMACS system will select the CD34 cell and remove the T-cells By removing the T-cells we can minimize the risk of Graft Versus Host Disease GVHD The enriched CD34 cells will be given to them to hopefully give them a boost of cells that can permanently produce new blood cells to improve their risk of infection and bleeding
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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