The CliniMACS® CD34 Reagent System is an FDA-approved method for selecting hematopoietic stem cells from donor apheresis, while passively depleting T cells that can cause graft-versus-host disease (GVHD). Ex vivo T cell depletion can be a viable option to reduce GVHD incidences in patients with AML undergoing allogeneic stem cell transplantation.
If you have questions regarding the CliniMACS CD34 Reagent System, please visit the contact page for healthcare professionals or patients.
Authorized by U.S. Federal Law for use in the treatment of patients with acute myeloid leukemia (AML) in first complete remission. The effectiveness of the device for this use has not been demonstrated.
Indications for Use
The CliniMACS® CD34 Reagent System is indicated for processing hematopoietic progenitor cells collected by apheresis (HPC, Apheresis) from an allogeneic, HLA-identical, sibling donor to obtain a CD34+ cell-enriched population for hematopoietic reconstitution following a myeloablative preparative regimen without the need for additional graft versus host disease (GVHD) prophylaxis in patients with acute myeloid leukemia (AML) in first morphologic complete remission.
Do not use CD34+ cells prepared with CliniMACS CD34 Reagent System in patients with known hypersensitivity to murine (mouse) proteins or iron dextran.