CliniMACS
^®
CD25 Product Line

Name: CliniMACS® CD25 Product Line
Availability: InStock

CliniMACS
^®
CD25 Product Line

The CD25 antigen, the low affinity interleukin-2 receptor alpha chain (IL-2Rα) is highly expressed on naturally occuring CD25

^hi

CD4

⁺

regulatory T cells (Treg cells).

¹

In addition, CD25 is expressed on activated T and B cells.

The CliniMACS® CD25 Product Line consists of murine anti-CD25 monoclonal antibodies conjugated to superparamagnetic iron dextran particles.

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

The performance of the CliniMACS CD25 Product Line depends on the individual separation strategy. For information on respective capacities, refer to the CliniMACS User Manual or

Product data and images for CliniMACS
^®
CD25 Product Line

Figures

Figure 1

Flow cytometric analysis of CD25–enriched cells using the CliniMACS CD25 System. Analysis of the content of CD25

^hi

CD4

⁺

regulatory T cells before and after enrichment (A and B). Analysis of CD25

^hi

CD127

^–

regulatory T cells among CD4

⁺

T cells after enrichment (C).

A:	B:
Before enrichment	After enrichment
View details CliniMACS ^® CD25 Product Line Figure 1 Flow cytometric analysis of CD25–enriched cells using the CliniMACS CD25 System. Analysis of the content of CD25 ^hi CD4 ⁺ regulatory T cells before and after enrichment (A and B). Analysis of CD25 ^hi CD127 ^– regulatory T cells among CD4 ⁺ T cells after enrichment (C).	View details CliniMACS ^® CD25 Product Line Figure 1 Flow cytometric analysis of CD25–enriched cells using the CliniMACS CD25 System. Analysis of the content of CD25 ^hi CD4 ⁺ regulatory T cells before and after enrichment (A and B). Analysis of CD25 ^hi CD127 ^– regulatory T cells among CD4 ⁺ T cells after enrichment (C).
C:
After enrichment
View details CliniMACS ^® CD25 Product Line Figure 1 Flow cytometric analysis of CD25–enriched cells using the CliniMACS CD25 System. Analysis of the content of CD25 ^hi CD4 ⁺ regulatory T cells before and after enrichment (A and B). Analysis of CD25 ^hi CD127 ^– regulatory T cells among CD4 ⁺ T cells after enrichment (C).

Figure 2

Flow cytometric analysis of CD25–depleted cells using the CliniMACS CD25 System.

Before depletion	After depletion
View details CliniMACS ^® CD25 Product Line Figure 2 Flow cytometric analysis of CD25–depleted cells using the CliniMACS CD25 System.	View details CliniMACS ^® CD25 Product Line Figure 2 Flow cytometric analysis of CD25–depleted cells using the CliniMACS CD25 System.

Specifications for CliniMACS
^®
CD25 Product Line

Overview

The CD25 antigen, the low affinity interleukin-2 receptor alpha chain (IL-2Rα) is highly expressed on naturally occuring CD25

^hi

CD4

⁺

regulatory T cells (Treg cells).

¹

In addition, CD25 is expressed on activated T and B cells.

The CliniMACS® CD25 Product Line consists of murine anti-CD25 monoclonal antibodies conjugated to superparamagnetic iron dextran particles.

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

The performance of the CliniMACS CD25 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 CD25 Product Line was developed for the enrichment or depletion of CD25

⁺

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

Referenced literature

In allogeneic stem cell transplantation graft- versus-host disease (GvHD) is one of the most frequent and severe complications.

Data generated from studies in mice have demonstrated that adoptively transferred Treg cells preserve graft-versus-tumor (GvT/L) activity while inhibiting GvHD.

²

By adding CD25

^hi

CD4

⁺

Treg cells, either to the graft or as DLI GvHD alloresponses might be downregulated and though allow at the same time the transfer of more immune effector cells.

^2,3,4

In pre-clinical animal models the adoptive transfer of CD4

⁺

CD25

⁺

Treg cells has been shown to prevent and even cure certain autoimmune disease as well as prevent pathogenic alloreactive responses after solid organ transplantation.

⁵

To favour anti-tumor responses CD25

^hi

CD4

⁺

Treg cells may be depleted from patient’s leukapheresis samples.

^6,7

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.

Resources for CliniMACS
^®
CD25 Product Line

Documents and Protocols

References

CliniMACS® CD25 System - selected references

Certificates

Please follow this

link

to search for Certificates of Analysis (CoA) by lot number.

References for CliniMACS
^®
CD25 Product Line

Publications

Hannon, M. et al. (2014) Infusion of clinical‑grade enriched regulatory T cells delays experimental xenogeneic graft‑versus‑host disease. Transfusion 54(2): 353-363
Martelli, M. F. et al. (2014) HLA‑haploidentical transplantation with regulatory and conventional T‑cell adoptive immunotherapy prevents acute leukemia relapse. Blood 124(4): 638-644
Martelli, M. F. et al. (2015) Next generation HLA-haploidentical HSCT. Bone Marrow Transplant. 50: 63-66
Theil, A. et al. (2015) Adoptive transfer of allogeneic regulatory T cells into patients with chronic graft‑versus‑host disease. Cytotherapy 17(4): 473-486
Zhang, W. et al. (2015) An innovative method to generate a Good Manufacturing Practice‑ready regulatory T‑cell product from non‑mobilized leukapheresis donors. Cytotherapy 7(9): 1268-1279
Safina, N. et al. (2016) Successful expansion of functional and stable regulatory T cells for immunotherapy in liver transplantation. Oncotarget. 7(7): 7563-7577

Data and images