YILIMART - CliniMACS CD4 Reagent, CE（276-01）

CD4 is an accessory molecule involved in the recognition of foreign antigens in association with MHC class II antigens by T cells. T helper cells and to a lower degree monocytes and dendritic cells express CD4.

The CliniMACS® CD4 Product Line consists of murine anti-CD4 monoclonal antibodies conjugated to superparamagnetic iron dextran particles.

One vial contains 7.5 mL sterile, non-pyrogenic solution.

The performance of the CliniMACS CD4 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.

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.

CliniMACS MicroBeads are for research use only and not for human therapeutic or diagnostic use.

Applications

The CliniMACS CD4 Product Line was developed for the depletion or enrichment of CD4

⁺

cells from human heterogeneous hematologic cell populations in combination with the CliniMACS System.

Referenced literature

CD4

⁺

T cells have been used as the basis for various gene therapy approaches, for example, in the human immunodeficiency virus (HIV) setting.

^1-4

In the allogeneic transplantation setting, CD4

⁺

T cells in donor lymphocyte infusions (DLI) may be capable of mounting GvT responses, concomitantly reducing the risk of GvHD

^5,6

and reconstituting the recipient’s immune system.

⁷

Additionally, Th2 cells have been successfully used to support stem cell grafts.

⁸

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.

^9,10

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.

Figure 1

Flow cytometric analysis of CD4–enriched cells using CliniMACS CD4 System.

Before enrichment

After enrichment
Figure 2

Flow cytometric analysis of CD4–depleted cells using the CliniMACS CD4 System.

Before depletion

After depletion

Selected references
1. Bernstein et al. (2004)
  
  Immune reconstitution following autologous transfers of CD3/CD28 stimulated CD4
  ⁺
  T cells to HIV-infected persons.
  
  Clin. Immunol. 111: 262-274
2. Levine, B. L. et al. (2002)
  
  Adoptive transfer of costimulated CD4
  ⁺
  T cells induces expansion of peripheral T cells and decreased CCR5 expression in HIV infection.
  
  Nat. Med. 8: 47-53
3. Davis, B. M. et al. (2004)
  In vivo
  selection for human and murine hematopoietic cells transduced with a therapeutic MGMT lentiviral vector that inhibits HIV replication.
  
  Mol. Ther. 9: 160-172
4. Levine, B. L. et al. (2006) Gene transfer in humans using a conditionally replicating lentiviral vector. Proc. Natl. Acad. Sci. U.S.A. 103: 17372-17377
5. Alyea et al. (1998)
  
  Toxicity and efficacy of defined doses of CD4
  ⁺
  donor lymphocytes for treatment of relapse after allogeneic bone marrow transplant.
  
  Blood 91: 3671-3680
6. Klyuchnikov et al. (2010) Bone Marrow Transplant. 45(suppl. 2): P956
7. Bellucci et al. (2002) Blood 15: 4610-4617
8. Fowler, D. H. et al. (2004) Immunoablative reduced-intensity stem cell transplantation: potential role of donor Tʜ2 and Tc2 cells. Semin. Oncol. 31: 56-67
9. 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
10. 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
Brochures and posters

CliniMACS Prodigy T Cell Transduction

CAR T cells

CliniMACS Prodigy TCT Transduction Application Sheet
Scientific posters

Automated manufacturing of gene-engineeredT cells under serum-free conditions

Automated clinical-scale retroviral transduction of T cells in a functionally closed system

Chimeric antigen receptor T cells

Polyclonal T cell activation and expansion tool for clinical-scale manufacturing - ICIC 2017
Certificates

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CliniMACS CD4 Reagent, CE（276-01）

CE

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Disclaimer

Applications

Referenced literature

Figure 1

Figure 2

Selected references

Brochures and posters

Scientific posters

Certificates

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Before enrichment	After enrichment

Before depletion	After depletion