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

Data and images for
CliniMACS
®
CD8 Product Line

Figures

Figure 1

Flow cytometric analysis of CD8–depleted cells using the CliniMACS CD8 System.
Before depletion
After depletion
View details

Figure 1

Flow cytometric analysis of CD8–depleted cells using the CliniMACS CD8 System.
View details

Figure 1

Flow cytometric analysis of CD8–depleted cells using the CliniMACS CD8 System.

Specifications for
CliniMACS
®
CD8 Product Line

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.

Detailed product information

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.
CliniMACS GMP MicroBeads are for research use and ex vivo cell processing only.
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).

References for
CliniMACS
®
CD8 Product Line

Publications

  1. Nimer, S. D. et al. (1994)
    Selective depletion of CD8
    +
    cells for prevention of graft-versus-host disease after bone marrow transplantation. A randomized controlled trial.
    Transplantation 57: 82-87
  2. Baron, F. et al. (2003) Low incidence of acute graft-versus-host disease after non-myeloablative stem cell transplantation with CD8-depleted peripheral blood stem cells: an update. Haematologica 88: 835-837
  3. Meyer et al. (2004) Blood 104: 5069
  4. Meyer, R. G. et al. (2007) Prophylactic transfer of CD8-depleted donor lymphocytes after T-cell-depleted reduced-intensity transplantation. Blood 109: 374-382
  5. Orti, G. et al. (2009) Phase I study of high-stringency CD8 depletion of donor leukocyte infusions after allogeneic hematopoietic stem cell transplantation. Transplantation 88: 1312-8
  6. Dodero A. et al. (2009) Haploidentical stem cell transplantation after a reduced-intensity conditioning regimen for the treatment of advanced hematologic malignancies: posttransplantation CD8-depleted donor lymphocyte infusions contribute to improve T-cell recovery. Blood 113: 4771-4779
  7. Meyer et al. (2010) Donor CD4 T cells convert mixed to full donor T-cell chimerism and replenish the CD52-positive T-cell pool after alemtuzumab-based T-cell-depleted allo-transplantation. Bone Marrow Transplant. 45: 668-674
  8. Smetak et al. (2008) Clinical-scale single-step CD4(+) and CD8(+) cell depletion for donor innate lymphocyte infusion (DILI). Bone Marrow Transplant. 41: 643-650
  9. Lamb et al. (2001)
    Human gammadelta
    +
    T lymphocytes have
    in vitro
    graft vs leukemia activity in the absence of an allogeneic response.
    Bone Marrow Transplant. 27: 601-606

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®
CD8 Product Line

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