	US 11,998,331 B2
	Use of micro-ribonucleic acid (miRNA) to diagnose transplant rejection and tolerance of immunosuppression therapy
Abraham Shaked, Wynnewood, PA (US); Bao-Li Chang, Paoli, PA (US); Brendan Keating, Philadelphia, PA (US); and Toumy Guettouche, Miami, FL (US)
Assigned to The Trustees of the University of Pennsylvania, Philadelphia, PA (US)
Filed by THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, Philadelphia, PA (US)
Filed on Mar. 26, 2019, as Appl. No. 16/365,194.
Application 16/365,194 is a continuation of application No. 15/302,815, abandoned, previously published as PCT/US2015/025382, filed on Apr. 10, 2015.
Claims priority of provisional application 61/977,980, filed on Apr. 10, 2014.
Prior Publication US 2019/0313957 A1, Oct. 17, 2019
Int. Cl. C12Q 1/6883 (2018.01); A61B 5/15 (2006.01); A61B 10/00 (2006.01); C12N 15/113 (2010.01); G16B 25/00 (2019.01); G16B 25/10 (2019.01); G16B 25/20 (2019.01); G16H 50/50 (2018.01)

CPC A61B 5/15 (2013.01) [A61B 10/0038 (2013.01); A61B 10/007 (2013.01); C12N 15/113 (2013.01); C12Q 1/6883 (2013.01); G16B 25/00 (2019.02); G16B 25/10 (2019.02); G16B 25/20 (2019.02); G16H 50/50 (2018.01); A61B 2010/0061 (2013.01); C12Q 2600/158 (2013.01); C12Q 2600/178 (2013.01)]

7 Claims

1. A method for detecting or predicting transplant rejection of a transplanted liver in a subject being administered a dose of an immunosuppressant, the method comprising:

i) determining a level of expression of hsa-miR-483-5p (SEQ ID NO: 3), hsa-miR-885-5p (SEQ ID NO: 4) and hsa-miR-122-5p (SEQ ID NO: 5) in a sample from the subject wherein the sample is selected from the group consisting of blood, plasma and serum;

ii) comparing the level of expression of hsa-miR-483-5p (SEQ ID NO: 3), hsa-miR-885-5p (SEQ ID NO: 4) and hsa-miR-122-5p (SEQ ID NO: 5) in the sample from the subject relative to a baseline level in a control wherein an increase in the level of expression in the sample from the level of the at least one miRNA in the control is indicative of an acute transplant rejection;

iii) wherein when acute transplant rejection is indicated, the rejection is treated by increasing the dose of the immunosuppressant; and

iv) wherein when acute transplant rejection is not indicated in step ii., decreasing or minimizing the dose of the immunosuppressant.