Correlation of Donor-specific Anti-endothelial Cells

Completed

Conditions studied: Living-Donor Kidney Transplants

In brief

Antibody Mediated Rejection (AMR) is a major complication of solid organ transplantation. The main reason for AMR is pre-formed, or de-novo, donor specific antibodies against the donor human leukocyte antigens (HLA). Additional potential targets are antibodies against MIC-A antigens or antibodies against targets expressed on the donor endothelial cells. Until recently, no specific means were available to test for the presence of donor-specific endothelial cell antibodies. The newly introduced XM-One AbSorber® assay allows isolating precursor endothelial cells from donor peripheral blood, and thus assessing the presence of donor-specific endothelial cell antibodies. XM-One AbSorber® is an in-vitro assay that allows for the specific enrichment of precursor endothelial cells which in turn promotes endothelial cells specific cross match testing. This assay is currently being used in an on-going Northwestern University (NU) research study (STU#00029988). The preliminary results of this study indicate that indeed some of the patients test positive against their respective donors. One potential explanation for this observation, that was not previously entertained, is that the antibodies causing the positive cross match response are actually of autoimmune nature. In order to rule-out such a potential explanation the investigators would like to further test these patients by performing an autologous XM-One AbSorber® assay in which the recipient sera will be incubated with the patients' own cells (as opposed to the respective donor cells in the parental study). This information is crucial for proper analysis of the data obtained in the NU STU#00029988 study.

Key facts

Study ID
NCT01545713
Run by
Northwestern University
People needed
16
Starts
2011-06-01
Expected to finish
2017-12-01
Last updated by the study team
2018-08-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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