Stem Cell Transplant with CliniMACS® Device

Use of Miltenyi Biotec’s CliniMACS CD34 Reagent System as a Humanitarian Use Device for Isolation of Hematopoietic Stem Cells or T-cell Depletion in Multiple Settings

Protocol Description

This program enables the use of the CliniMACS CD34 Reagent System in humanitarian use cases for individuals whose bone marrow is failing due to some form of anemia, whose previous cell graft is not working well and may need a boost, or who have a malignant or nonmalignant disease. The CliniMACS system can identify and collect certain immune cells called CD34 cells from donor blood or marrow, while at the same time removing other cells that are responsible for causing graft versus host disease (GVHD). GVHD is a risk of stem cell transplant and occurs when donor cells attack the recipient. Although cell transplant is standard treatment for the conditions named, the collection of the CD34 cells using the CliniMACS system is currently not considered to be standard.

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling participants of both genders and of any age, who require a blood or marrow transplant for a CD34 infusion in which doctors believe treatment with the CliniMACS device may provide a benefit.
Males and Females: All ages

Requirements

Blood or bone marrow identified for the participant’s transplant will be processed using the CliniMACS CD34 Reagent System to select stem cells and leave behind other cells to be discarded. The selected stem cells will be collected and used for the child’s transplant. All other tests and procedures will be the same as with any other routinely performed stem cell transplant.
Visits: None beyond normal clinical care for this condition
Duration: Not applicable

Primary Investigator

Jessie Barnum, MD

Contact Information

For more information about the study or enrollment, please contact:
Shawna McIntyre, Clinical Research Supervisor
412-692-5552