Paired Marrow Aspirations to Assess Assays in Sensitized Renal Allograft Recipients

Transplantation, Kidney Clinical Trial

Official title: Paired Bone Marrow Aspirations to Assess the Variability of Allo-ELISPOT and Allo-Specificities Assays in Sensitized Renal Allograft Recipients

Status Recruiting

Clinical Trial Summary

The aim of this study is to determine the validity of two tests on bone marrow of sensitized kidney transplant recipients in order to better understand why these patients with antibodies against their donors are at a greater risk of rejection of their transplanted organs.

Clinical Trial Description

The aim of this risk protocol is to determine the variability of the AlloElispot and Allospecificities assay. Our group has developed two novel assays to determine: 1) the number of donor-specific alloantibody (DSA) secreting bone marrow derived plasma cells (AlloELISPOT assay); and 2) the function of DSA-secreting Plasma cells (Allospecificities assay). These assays were developed over the past 3 years and already have provided an important means of testing new therapeutic protocols aimed at controlling DSA production. It is important to note that repeated attempts to isolate PCs from peripheral blood have been unsuccessful (PCs are extremely rare in peripheral blood) and the bone marrow is the only accessible source of PCs. It is now clear to that we have reached a point that we must validate these assays (coefficient of variation, etc), in order to appropriately evaluate data derived from these assays. Inter-assay variability can be assessed by performing two paired assays in the same patient. This could be done in two ways-paired bone marrow aspirations separated by time or two bone marrow aspirations performed at the same time. We have decided to pursue the latter approach. We will do both marrows either at the time of transplantation when the subjects are under general anesthesia or in the Clinical Research Unit (CRU) using conscious sedation.. We believe that this is safe and will be well-tolerated and will provide the data that we need to validate the assays. ;

Related Conditions & MeSH terms

• Living Donors
• Transplantation, Kidney

• NCT number: NCT01150487
• Study type: Interventional
• Source: Mayo Clinic
• Contact: Nong Yowe Braaten
• Phone: 507-538-9617
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2010
• Completion date: April 2030