Clinical information
Clinical utility
Graft-versus-host disease (GVHD) is a serious complication of allogeneic hematopoietic progenitor cell transplantation (HPCT). Decreasing the number of T lymphocytes from progenitor cell donation has been shown to reduce the risk of GVHD.
There are different approaches to reduce the number of T lymphocytes in a hematopoietic progenitor cell (HPC) donation, such as a combination of immunomagnetic techniques and monoclonal antibodies specific for a cell subset.
Method
The device used is the CliniMACS System (Milteny Biotec). The maximum processing capacity of the instrument is 6E10 total nucleated cells.
Using a CD34 monoclonal antibody (coupled to magnetic particles), CD34-positive cells are bound by the antibody and pass through a column with a strong magnetic field. In this way, the cells bound with the antibody are retained by the magnetic force and the rest of the cells are rejected.
When the magnetic field is removed, the retained cells are released and recovered.
The volume of the final product is less than the initial volume. Therefore, in the case of freezing, less dimethyl sulfoxide (DMSO) will be added.
Reference values
The purity of the selected product is > 90% CD34, with CD34 recoveries with respect to the initial product higher than 55-60%.
Specimen information
Product: CD34 selected peripheral blood HPCs.
Tube: quality control (0.5 ml).
Volume: 40-45 ml.
Shelf life: *72 hours?*
Transport instructions: 2-8 °C.
Storage instructions: 2-8 °C.
Administrative information
BST code:BT501, PRG034.
Test description: selection of CD34 positive cells from an apheresis HPC donation.
Synonyms: HPC-PS CD34-selected.
Section: Cell Therapy Service. Cell Therapy Laboratory.
Service: CD34 positive selection using Miltenyi technology is the method validated by the BST to achieve this purpose.
References
Areman, E. M.; Loper, K., editors. Cellular therapy: Principles, methods, and regulations. 2nd ed. Bethesda (MD): AABB Press, 2016.
Quality
The BST has ISO 9001, ISO 14001, OSHAS 18001 and European Seal of Excellence 500+ quality certifications. The BST is accredited by CAT, JACIE-FACT, FACT-NETCORD and EFI. It complies with the guidelines of good manufacturing and good distribution practices.
