Monitoring of CMV-specific T-cells following tolerance induction protocols: A safety approach

Principal Investigator

Florian Kern | Institut für Medizinische Immunologie | Berlin, Germany

Locations

Berlin, Germany

Study Code

ITN506AS

Study Status

Completed

Abstract

A manipulation of the immune system of a transplant recipient in such a way that foreign tissue is not rejected is bound to affect important defense mechanisms, including protection against viruses, bacteria and fungi. Based on previous experience with conventional immunosuppressive drugs, viral defenses seem most crippled in the immunosuppressed patient. The loss of anti-viral defense mechanisms could potentially be very dangerous and result in severe pathology.

This study employs a rapid laboratory test that would enable the transplant physicians to look at the patient's immune response to a model virus – human Cytomegalovirus (CMV). Chosen for its prevalence in transplant patients, CMV may cause severe clinical complications and even death. This protocol has been modified from the Central European original to allow U.S. study participants, including the numerous American ethnicities who may not recognize the virus in the same way as Caucasians. The protocol also includes an approach to testing the efficiency of tolerization protocols and the development of a new laboratory test that could be useful in identifying the nature of an immune response to the virus, and answer more precisely if the immune system would be able to destroy virally infected cells.

The approach suggested in this study is unique in that is blood-saving, cost-saving, simple to perform and rapid. Successful use of this test within the ITN may result in the development of a laboratory test that can predict the necessity of specific anti-viral chemotherapy before the onset of symptoms.

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