Do not infuse the CliniMACS® CD34 Reagent or the CliniMACS® PBS/EDTA Buffer into patients directly.
Hypersensitivity reactions, including anaphylaxis, have been observed during infusion of CD34+ cells from the CliniMACS® CD34 Reagent System. Monitor the patient for hypersensitivity reactions, including anaphylaxis, during infusion of CD34+ cells from the CliniMACS® CD34 Reagent System.
Failure to infuse an adequate number of functioning CD34+ cells can result in engraftment failure. Collect sufficient HPC, Apheresis to yield at least 2.4 x 106 CD34+ cells per kg of patient body weight after system processing. The clinical trial using the CliniMACS® CD34 Reagent System to process HPC, Apheresis did not test allografts with less than 2.4 x 106 CD34+ cells per kg of recipient body weight. Monitor patients for laboratory evidence of hematopoietic recovery after transplantation
GVHD can occur in patients who receive HPC, Apheresis processed using the CliniMACS® CD34 Reagent System. Use pharmacologic prophylaxis if more than 1 x 105 CD3+ cells per kilogram of recipient body weight are infused.
Removal of T cells from the HPC, Apheresis can delay immune reconstitution after transplantation. Patients who receive the CD34+ cell-enriched population prepared using the CliniMACS® CD34 Reagent System are at risk for serious opportunistic viral infections, including post-transplant lymphoproliferative disorder caused by Epstein-Barr virus (EBV) and cytomegalovirus (CMV). Monitor for EBV and CMV in the peripheral blood of patients after transplantation and initiate appropriate treatment promptly.
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.