Warnings and precautions

Do not infuse the CliniMACS® CD34 Reagent or the CliniMACS® PBS/EDTA Buffer into patients directly.

Hypersensitivity Reactions

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.

Engraftment failure

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

Acute and chronic graft versus host disease (GVHD)

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.

Delayed immune reconstitution after transplantation

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.

• Safety and probable benefit in children under the age of 17 years have not been established
• Drugs may be incompatible with the CliniMACS® PBS/EDTA Buffer. Do not add drugs to the buffer other than Human Serum Albumin as specified in the CliniMACS® User Manual for the CD34 Reagent System.
  
• Do not use cryopreserved and thawed HPC, Apheresis because cryopreservation promotes cell clumping, which may lead to device performance issues. Process HPC, Apheresis as soon as available, but not longer than 24 hours after collection.
  
• Use only HPC, Apheresis from an allogeneic, HLA-identical sibling donor with the CliniMACS® CD34 Reagent System.
  
• Collect HPC, Apheresis according to standard hospital or institutional leukapheresis procedures in standard leukapheresis collection bags. Do not include additional anticoagulants or blood additives, such as heparin, other than those normally used during leukapheresis. Keep the HPC, Apheresis at controlled room temperature (+19 °C to +25°C (67° to 77° F)) if it has to be stored, e.g., overnight, before processing. Do not allow the concentration of leukocytes to exceed 0.2 x 10⁹ cells per mL.
  
• Only trained operators should use the CliniMACS® CD34 Reagent System to prepare CD34+ cells for infusion. Operator training is provided by Miltenyi Biotec authorized personnel.