CliniMACS CD34 Reagent System

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.


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Background information

Technology

The CD34 antigen is expressed on early hematopoietic progenitor cells.
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What is a HUD?

A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the US per year.
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Reimbursement information

This Reimbursement Resource Web site is a tool to help understand the U.S. health care insurance environment for cell processing and ex vivo T cell depletion in allogeneic transplantation.
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Warnings and precautions

See the U.S. edition of the CliniMACS® User Manual for a complete list of precautions.
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Miltenyi Biotec Inc.
phone: +1 800 FOR MACS
fax: +1 530 745 2806
macs@miltenyibiotec.com