Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-01-05 @ 9:58 PM
Study NCT ID:
NCT02158767
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2025-03-12
First Post:
2014-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Access Protocol. Infusion of CD34+ Enriched, T Cell Depleted Hematopoietic Stem Cell Grafts.
Sponsor:
Leland Metheny
Organization:
Study Overview
Official Title:
Access Protocol. Infusion of CD34+ Enriched, T Cell Depleted Hematopoietic Stem Cell Grafts.
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2025-03
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 clinical trial studies the use of a second infusion of donor hematopoietic cells that have had removal of T cells for the treatment of engraftment failure after a first hematopoietic stem cell transplant.
Hematopoietic cell transplants from donors can be complicated by complete or incomplete failure of recovery of blood counts. This results in frequent needs for transfusions and other methods to maintain blood counts at acceptable levels. One way of improving the blood counts in the recipient is to give a "booster" dose of cells from the donor, but this is associated with increased risk of an immune reaction from the donor cells against the recipient cells. To decrease this risk, it is possible to decrease the amount of T cells, responsible for this type of immune reaction. These cells are removed by a special handling of the graft, which allows to remove the cells directly or indirectly (by selecting other cells to "stay" in the graft").
Hematopoietic cell transplants from donors can be complicated by complete or incomplete failure of recovery of blood counts. This results in frequent needs for transfusions and other methods to maintain blood counts at acceptable levels. One way of improving the blood counts in the recipient is to give a "booster" dose of cells from the donor, but this is associated with increased risk of an immune reaction from the donor cells against the recipient cells. To decrease this risk, it is possible to decrease the amount of T cells, responsible for this type of immune reaction. These cells are removed by a special handling of the graft, which allows to remove the cells directly or indirectly (by selecting other cells to "stay" in the graft").
Detailed Description:
PRIMARY OBJECTIVES:
I. To provide patients with suboptimal engraftment after allogeneic stem cell transplantation access to donor - derived, cluster of differentiation (CD34)+ enriched or T-cell depleted peripheral blood stem cells isolated by the CliniMACS System.
OUTLINE:
Patients undergo CD34+ enriched or T-cell depleted peripheral blood stem cell infusion (PBSCT) over 1-3 hours.
After completion of study treatment, patients are followed up for 100 days.
I. To provide patients with suboptimal engraftment after allogeneic stem cell transplantation access to donor - derived, cluster of differentiation (CD34)+ enriched or T-cell depleted peripheral blood stem cells isolated by the CliniMACS System.
OUTLINE:
Patients undergo CD34+ enriched or T-cell depleted peripheral blood stem cell infusion (PBSCT) over 1-3 hours.
After completion of study treatment, patients are followed up for 100 days.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: