Clinical applications - CliniMACS System - CliniMACS Reagents - CliniMACS® CD3 Product Line

CliniMACS® CD3 Product Line

Overview

CD3 is expressed on all T cells and is associated with the T cell receptor. Approximately 70– 80% of human peripheral blood lymphocytes and 65–85% of thymocytes are CD3+.
The CliniMACS CD3 Product Line consists of murine anti-CD3 monoclonal antibodies conjugated to superparamagnetic iron dextran particles.
One vial contains 7.5 mL sterile, non-pyrogenic solution.
The performance of the CliniMACS CD3 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; all other products of the CliniMACS Product Line are available for use only under an approved Investigational New Drug (IND) application or Investigational Device Exemption (IDE).
CliniMACS MicroBeads are for research use only and not for human therapeutic or diagnostic use. Unless otherwise specifically indicated, Miltenyi Biotec products and services are for research only and not for therapeutic or diagnostic use.

Details

Applications

The CliniMACS CD3 Product Line was developed for the depletion of unwanted T cells from human heterogeneous hematologic cell populations in combination with the CliniMACS System. This approach maintains the stem cells and immune effector cells, such as NK cells, in the cellular product.1,2 The CliniMACS CD3 Reagent can also be used in combination with the CliniMACS CD19 Reagent to additionally remove the CD19+ B cells from the graft.3,4
In order to generate highly purified CD56+CD3NK cells, the CliniMACS CD3 Reagent is used in combination with the CliniMACS CD56 Reagent. In this approach, the cellular product is first depleted of CD3+cells and then further enriched for CD56.5–7

Gallery

Figure 1

Flow cytometric analysis of CD3–depleted cells from a leukapheresis product using the CliniMACS CD3 System.
Before depletion
After depletion

Related Items

Library

Selected references

  1. Gordon et al. (2002) A large-scale method for T cell depletion: towards graft engineering of mobilized peripheral blood stem cells. Bone Marrow Transplant. 30: 69–74.
  2. Dykes, J. H. et al. (2007) Rapid and effective CD3 T-cell depletion with a magnetic cell sorting program to produce peripheral blood progenitor cell products for haploidentical transplantation in children and adults. Transfusion 47: 2134–2142.
  3. Lang, P. et al. (2006) Haploidentical stem cell transplantation in patients with pediatric solid tumors: preliminary results of a pilot study and analysis of graft versus tumor effects. Klin. Padiatr. 218: 321–326.
  4. Bethge et al. (2008) Haploidentical allogeneic hematopoietic cell transplantation in adults using CD3/CD19 depletion and reduced intensity conditioning: an update. Blood Cells Mol. Dis. 40: 13–19.
  5. McKenna, D. H. Jr. et al. (2007) Good manufacturing practices production of natural killer cells for immunotherapy: a six-year single-institution experience. Transfusion 47(3): 520–528.
  6. Rubnitz. J. E. et al. (2010) NKAML: a pilot study to determine the safety and feasibility of haploidentical natural killer cell transplantation in childhood acute myeloid leukemia. J. Clin. Oncol. 28(6): 955–959.
  7. Verneris, M.R. and Grupp, S. A. (2010) Natural killer cell consolidation for acute myelogenous leukemia: a cell therapy ready for prime time? J. Clin. Oncol. 28(6): 909–910.

Certificates

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Customer reports and application notes

Product Order no. Price

CliniMACS CD3 Reagent

Availability: Europe (1), USA (2), other (3)
Content: 7.5 mL

Availability

(1)In the EU, the CliniMACS System components are available as CE-marked medical devices for their respective intended use, unless otherwise stated.
(2)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. All other products of the CliniMACS Product Line are available for use only under an approved Investigational New Drug (IND) application or Investigational Device Exemption (IDE).
(3)For availability in your country please contact your local representative.
 
273-01 price on request here

CliniMACS CD3 MicroBeads

Regulatory status: For research use only, not for use in humans
Availability: worldwide (3)
Content: 7.5 mL

Availability

(3)For availability in your country please contact your local representative.
 
130-017-601 $3,450.00

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Miltenyi Biotec Inc.
Phone: +1 800 FOR MACS
Fax:+1 877 591 1060
macs@miltenyibiotec.com
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