Paired Marrow Aspirations to Assess Assays in Sensitized Renal Allograft Recipients

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

The aim of this study is to determine a comprehensive immune profile of transplant donors and recipients through assessment of immune cell compositions in bone marrow, and lymph nodes.

Study Overview

• Status: Completed
• Conditions: Transplantation, Kidney; Kidney Transplant Recipients; Living Donors
• Intervention / Treatment: Procedure: bone marrow aspirations; Procedure: lymph node collection

Detailed Description

The aim of this risk protocol is to determine the variability of the AlloElispot and Allospecificities assay.

Our group has developed a number of assays to assess the immune cell population in our transplant population. This has included: 1) the number of donor-specific alloantibody (DSA) secreting bone marrow derived plasma cells (AlloELISPOT assay), 2) the function of DSA-secreting Plasma cells (Allospecificities assay), 3)Culture of plasma cells in human stromal cells to produce specific HLA antibodies and tetanus antibodies, 4) Understand the critical pathways for the survival and function of plasma cells, 5)Characterize the different phenotypes and genotypes of the plasma cell, 6)Phenotype analyses of the immune cell population using flow cytometry and/or mass spectrometry (ie. cytometry by time of flight/CyTOF), 7)Functional assessments of T and B-cells, and 8)T-cell receptor diversity.

These assays were developed over the 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 or while they are undergoing a surgical procedure. Lymph node retrieval will also be performed at the time for abstraction of immune cells for additional analysis. We believe that this is safe and will be well-tolerated and will provide the data that we need to validate the assays.

• Study Type: Interventional
• Enrollment (Actual): 288
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria.

• Pre or post renal transplant recipients.
• Renal transplant donors.
• Those who give voluntary written informed consent before performance of any study-related procedures, which are not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Exclusion criteria.

• Any patient currently receiving systemic anticoagulation therapy with heparin or coumadin.
• Patient has a platelet count of <30 x 10(9)/L within 14 days before enrollment.
• Patient has an absolute neutrophil count of ANC<1.0 x 10(9)/L within 14 days before enrollment.
• Patient has received other investigational drugs within14 days before enrollment.
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
• Diagnosed or treated for malignancy within 5 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
• Contraindication to kidney transplantation or donation-active infection, comorbid medical conditions, etc

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kidney recipients or kidney donors; Patients who have had a Kidney transplant or are undergoing a kidney transplant. Kidney donors.	Procedure: bone marrow aspirations; A bone marrow aspiration from each hip bone of the patients.; Procedure: lymph node collection; An Iliac lymph node collection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine a comprehensive immune profile of transplant donors and recipients through assessment of immune cell compositions in bone marrow, and lymph nodes.	1 week Post bone marrow and lymph node collection.

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Mark Stegall, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2010
• Primary Completion (Actual): December 15, 2025
• Study Completion (Actual): December 15, 2025

Study Registration Dates

• First Submitted: June 23, 2010
• First Submitted That Met QC Criteria: June 23, 2010
• First Posted (Estimated): June 25, 2010

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: kidney transplant
• Other Study ID Numbers: 10-002572; R21AI125719 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No