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Methods of monitoring immunosuppressive therapies in transplant recipient

A technology of immunosuppression and therapy, applied in biochemical equipment and methods, microbiological determination/testing, computer-aided medical procedures, etc., can solve irreplaceable problems

Active Publication Date: 2017-03-22
凯尔迪克斯公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, identification of these clinical risk factors does not replace the need for individualized treatment and routine monitoring of transplant recipients

Method used

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  • Methods of monitoring immunosuppressive therapies in transplant recipient
  • Methods of monitoring immunosuppressive therapies in transplant recipient
  • Methods of monitoring immunosuppressive therapies in transplant recipient

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0090] Example 1 - Analysis of Cell Free DNA to Determine Graft Organ Status in Transplant Recipients and Determine the Need for Modulating Immunosuppressive Therapy

[0091] This example demonstrates the analysis of a sample comprising cell-free DNA from a transplant recipient to determine the level of donor-derived cell-free DNA in the sample. Changes or differences in levels of donor-derived cell-free DNA over time are used to diagnose the status of the transplanted organ in the transplant recipient, as well as to indicate the need for adjustment or maintenance of immunosuppressive therapy administered to the graft recipient.

[0092] object selection

[0093] Human patients who were candidates for kidney transplantation 12 months before the assay described in this example were selected. The patient was being treated with immunosuppressive therapy to prevent allograft rejection. Beginning at the 12th month (one year anniversary) after the transplant event, separate plasma...

Embodiment 2

[0112] Example 2 - Additional Analysis of Cell Free DNA to Determine Graft Organ Status in Transplant Recipients and Determine Need for Modulating Immunosuppressive Therapy

[0113] This example demonstrates that, in addition to the analysis described in Example 1, additional analyzes were performed on a sample comprising cell-free DNA from a transplant recipient to determine the level of donor-derived cell-free DNA in the sample. Changes or differences in levels of donor-derived cell-free DNA over time are used to diagnose the status of the transplanted organ in the transplant recipient, as well as to indicate the need for adjustment or maintenance of immunosuppressive therapy administered to the graft recipient.

[0114] object selection

[0115] Human patients who were candidates for kidney transplantation 12 months before the assay described in this example were selected. The patient was being treated with immunosuppressive therapy to prevent allograft rejection. Beginni...

Embodiment 3

[0135] Example 3 - Analysis of Cell Free DNA to Determine Cardiac Transplant Organ Status in Transplant Recipients and Predict Need for Regulatory Immunosuppressive Therapy

[0136] This example demonstrates the analysis of samples comprising cell-free DNA from 18 transplant recipients to determine the level of donor-derived cell-free DNA in the samples. Levels of donor-derived cell-free DNA over time are used to diagnose the status of a transplanted organ in a transplant recipient and to predict the future status of that transplanted organ, as well as to indicate the need for regulation or maintenance of immunosuppression administered to a graft recipient The need for therapy.

[0137] object selection

[0138] Human patients who were subjects of heart transplantation prior to the assays described in this example were selected. The patient is being treated with immunosuppressive therapy to prevent allograft rejection. During five consecutive months, separate plasma samples...

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Abstract

The present disclosure relates to methods of monitoring the status of an allograft in a transplant recipient, as well as to methods of monitoring and adjusting immunosuppressive therapies being administered to the transplant recipient.

Description

[0001] Cross References to Related Applications [0002] This application claims US Provisional Application No. 61 / 953582, filed March 14, 2014, which is hereby incorporated by reference in its entirety. technical field [0003] The present invention relates to methods of monitoring the status of allografts in transplant recipients, as well as methods of monitoring and modulating immunosuppressive therapy administered to transplant recipients. Background technique [0004] The immune system plays a defensive role in a subject, such as a human individual, but can also cause disease, disorders, and other undesirable conditions. In the case of transplantation of non-self (allogeneic) cells, tissues or organs into an individual for medical purposes, the recipient's immune system recognizes the allograft as foreign to the body and activates various mechanisms to reject the allograft. Allografts. Therefore, medical suppression of transplant rejection by the normal immune system ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/68C07H21/04
CPCC12Q1/6883C12Q2600/118C12Q2600/156C12Q2600/158G16H50/30Y02A90/10C12Q1/6876
Inventor 罗伯特·伍德沃德马里卡·格尔斯科维克吉姆·伊米奇·内勒斯大卫·赫勒
Owner 凯尔迪克斯公司