The FDA-approved System

The CliniMACS® CD34 Reagent System is approved by the U.S. Food and Drug Administration (FDA) as a Humanitarian Use Device (HUD) for use in specific patients with Acute Myeloid Leukemia (AML), an aggressive blood cancer with poor survival rates, and an incidence of 3 per 100,000 population.

The approved label indication is as follows:

Humanitarian Device
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.

Contraindications
Do not use CD34+ cells prepared with CliniMACS CD34 Reagent System in patients with known hypersensitivity to murine (mouse) proteins or iron dextran.


Rx only