NA - this is a humanitarian use device
Your donor?s hematopoietic stem cells will be processed using the CliniMACS device. The cells will be infused fresh without prior freezing. By processing the collected donor cells with the CliniMACS device it is anticipated that the device will be able to purify the donor cells.
The blood cells collected from your donor as part of the donation process will have large numbers of T cells, along with other cells, including your blood stem cells. The process of removing these T cells is called T-cell depletion. They are being removed through a process called negative selection. The device used to do this is called CliniMACS and is produced by Miltenyi Biotec. The procedure involves labeling the stem cells, also called CD34+ cells, with an antibody attached to a magnetic substance. The CliniMACS tubing set has columns that will bind only the CD34+ cells allowing all the other cells, including the T cells, to pass through. After the selection is done, the stem cell product will have mainly CD34+ cells, or stem cells, and will be depleted of T cells. The CliniMACS device has been extensively used in transplantation and has been proven to be safe. These enriched cells will be infused back into you through the central venous Trifusion catheter in order to promote donor blood cell recovery.