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CliniMACS CD34 Reagent System

Development stage: Unknown
Lead developer: Miltenyi Biotec
Administration: Ex Vivo Processing (cells Are Processed Outside The Body; Final Product Is Infused Intravenously)

Overview

The CliniMACS CD34 Reagent System is a medical device and reagent system designed for the immunomagnetic selection and enrichment of human hematopoietic progenitor cells (HPCs) expressing the CD34 antigen from apheresis products. The system uses a murine IgG1 monoclonal antibody directed against the Class II epitope of human CD34, conjugated to dextran beads with an iron oxide/hydroxide core. These labeled cells are separated using magnetic-activated cell sorting (MACS) technology in combination with the CliniMACS Plus Instrument and proprietary tubing sets. The primary indication is to obtain a population enriched for CD34+ cells from allogeneic, HLA-identical sibling donors for hematopoietic reconstitution following myeloablative conditioning in patients with acute myeloid leukemia (AML) in first morphologic complete remission, without additional graft versus host disease (GVHD) prophylaxis. The mechanism of action involves positive selection of stem/progenitor cells while depleting T lymphocytes that can cause GVHD[2][5][7][8].

Brand names: CliniMACS CD34 Reagent System
Other names: CliniMACS CD34+Reagent SystemCliniMACS CD34 Reagent CR/GMP

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