Access Protocol. Infusion of CD34+ Enriched, T Cell Depleted Hematopoietic Stem Cell Grafts.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02158767|
Expanded Access Status : Available
First Posted : June 9, 2014
Last Update Posted : August 19, 2019
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").
|Condition or disease||Intervention/treatment|
|Hematopoietic/Lymphoid Cancer||Biological: Allogenic T cell-depleted hematopoietic stem cell transplantation|
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.
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 Type :||Expanded Access|
|Official Title:||Access Protocol. Infusion of CD34+ Enriched, T Cell Depleted Hematopoietic Stem Cell Grafts.|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02158767
|Contact: Paolo Caimi, MDemail@example.com|
|United States, Ohio|
|University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Contact: Paolo F. Caimi 216-844-8220 firstname.lastname@example.org|
|Principal Investigator: Paolo F. Caimi|
|Principal Investigator:||Paolo Caimi||Case Comprehensive Cancer Center|