Description
Applications
The CliniMACS CD137 Product Line was developed for the biotin-labeling of CD137 positive cells. To be used in combination with suitable products including but not limited to Instruments, tubing sets, buffers.
Referenced literature
CD137 has been described to be a suitable marker for antigen-specific activation of human CD4+ and CD8+ T cells, regardless of profile of cytokine secretion or knowledge of epitope specificity1 and for the enrichment of activated CD4+ and CD8+ T cells specific for multiple virus epitopes2. CD137 is not expressed on resting CD8+ T cells and its expression is reliably induced after 24 hours of stimulation.1
After immunosuppressive therapies infections with viruses, fungi and bacteria can cause life-threatening complications. Adoptively transferred antigen-specific T cells have been shown to effectively restore immunity and control established infection after hematopoietic stem cell or solid organ transplantation.3-5
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
CD137 (4-1BB) is expressed on activated CD4+ and CD8+ T cells, activated B cells, and natural killer cells, and can also be found on resting monocytes and dendritic cells. As a costimulatory molecule it is involved in the activation and survival of CD4+ and CD8+ T cells, and NK cells. CD137 has been described to be a suitable marker for antigen-specific activation of human CD8+ T cells, as CD137 is not expressed on resting CD8+ T cells and its expression is reliably induced after 24 hours of stimulation.1
The CliniMACS CD137 Product Line consists of murine anti-CD137 monoclonal antibodies conjugated to biotin.
One vial contains 7.5 mL sterile, non-pyrogenic solution.
The performance of the CliniMACS CD137 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 components and accessories.
