Description
Applications
The CliniMACS CD56 Product Line was developed for the enrichment of NK and NKT cells from human heterogeneous hematologic cell populations in combination with the CliniMACS® System.
In order to enrich CD56+CD3– NK cells, the CliniMACS CD56 Reagent is used in combination with the CliniMACS CD3 Reagent. In this approach, the cellular product is first depleted of CD3+ cells and subsequently enriched for CD56.1,2
Referenced literature
NK cells and NKT cells may be a perfect tool to exert GvT effects in the transplant as well as in the non-transplant setting, since they have not been observed to induce GvHD. NK cell donor lymphocyte infusions (DLIs) have been infused in non-transplant and in haploidentical and unrelated donor PBSC transplantation settings in order to explore GvT effects.
Furthermore, the capacity to reduce risk for GvHD and early relapse of hematological malignant diseases (e.g. AML, CML) and the potential to emend an unstable donor chimerism after stem cell transplantation (SCT) are under clinical investigation.3–19
Disclaimer
The CliniMACS® System components, including Reagents, Tubing Sets, Instruments, and PBS/EDTA Buffer, are designed, manufactured and tested under a quality system certified to ISO 13485.
In the EU, the CliniMACS System components are available as CE-marked medical devices for their respective intended use, unless otherwise stated. The CliniMACS Reagents and Biotin Conjugates are intended for in vitro use only and are not designated for therapeutic use or direct infusion into patients. The CliniMACS Reagents in combination with the CliniMACS System are intended to separate human cells. Miltenyi Biotec as the manufacturer of the CliniMACS System does not give any recommendations regarding the use of separated cells for therapeutic purposes and does not make any claims regarding a clinical benefit. For the manufacturing and use of target cells in humans the national legislation and regulations - e.g., for the EU the Directive 2004/23/EC ("human tissues and cells"), or the Directive 2002/98/EC ("human blood and blood components") - must be followed. Thus, any clinical application of the target cells is exclusively within the responsibility of the user of a CliniMACS System.
In the US, the CliniMACS CD34 Reagent System, including the CliniMACS Plus Instrument, CliniMACS CD34 Reagent, CliniMACS Tubing Sets TS and LS, and the CliniMACS PBS/EDTA Buffer, is FDA approved as a Humanitarian Use Device (HUD), 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 indication has not been demonstrated. Other products of the CliniMACS Product Line are available for use only under an approved Investigational New Drug (IND) application, Investigational Device Exemption (IDE) or FDA approval.
CR/GMP products are for ex vivo cell processing only, and are not intended for human in vivo applications. CR/GMP products are designed, manufactured and tested under an ISO 13485 quality management system and are in compliance with relevant GMP guidelines. They are designed following the recommendations of USP <1043> on ancillary materials. The manufacturing and testing of CR/GMP products of biological origin are in compliance with EP chapter 5.2.12 for “Raw materials of biological origin for the production of cell-based and gene therapy medicinal products”.
Overview
CD56 is an isoform of the neural cell adhesion molecule (NCAM). Among human hematopoietic cell populations it is expressed on natural killer (NK) cells, natural killer T (NKT) cells, and on subpopulations of T cells, monocytes, and dendritic cells.
The CliniMACS® CD56 Product Line consists of murine anti-CD56 monoclonal antibodies conjugated to superparamagnetic iron dextran particles.
One vial contains 7.5 mL sterile, non-pyrogenic solution.
The performance of the CliniMACS CD56 Product Line depends on the individual separation strategy. For information on respective capacities, refer to the CliniMACS User Manual or contact your local representative.
Please inquire about required CliniMACS System components and accessories.
