NCT02158767

Access Protocol. Infusion of CD34+ Enriched, T Cell Depleted Hematopoietic Stem Cell Grafts.

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Leland Metheny · Academic / Other
• Sex: All
• Age: 80 Years
• Healthy volunteers: Not accepted

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").

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.

Conditions

• Hematopoietic/Lymphoid Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Allogenic T cell-depleted hematopoietic stem cell transplantation	Undergo CD34+ enriched T-cell depleted allogeneic peripheral blood stem cell transplant. T-cells will be removed using the experimental CliniMACS(r) Reagent System used in vitro to select and enrich CD34+ cells

Timeline

• First posted: 2014-06-09
• Last updated: 2025-03-12

Locations

1 site across 1 country: United States