Description
Applications
The CliniMACS CD8 Product Line was developed for enrichment or depletion of CD8+ T cells from human heterogeneous hematologic cell populations in combination with the CliniMACS System.
Referenced literature
In the allogeneic transplantation setting CD8+ T cells may be removed from a graft or DLI with the goal of preventing GvHD while maintaining GvL effects. 1-6 In addition, this treatment option may also be applied in order to emend an unstable donor chimerism after SCT. 7
The combined depletion of CD4+ and CD8+ T cells results in a cellular product enriched for cells of the innate immune system, such as TCRγ/δ T cells and subpopulations of NK cells. 8,9 The use of such donor innate lymphocyte infusions (DILI) is aiming at improving engraftment and anti-tumor effects, while at the same time reducing the risk of GvHD.
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”.
In Canada, any clinical application of the output product must be performed in accordance with applicable Canadian legislation and regulations that pertain to cellular therapies (e.g. for advanced cellular therapies, the applicable sections of the Food and Drugs Act and the Food and Drug Regulations).
Overview
The CD8 antigen, a coreceptor for MHC class I molecules, is expressed strongly on cytotoxic T cells and dimly on a subset of NK cells.
The CliniMACS® CD8 Product Line consists of murine anti-CD8 monoclonal antibodies conjugated to superparamagnetic iron dextran particles.
One vial contains 7.5 mL sterile, non- pyrogenic solution.
The performance of the CliniMACS CD8 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.
