Paired Bone Marrow Aspirations to Assess the Variability of Allo-ELISPOT and Allo-Specificities Assays in Sensitized Renal Allograft Recipients
Trial status: Open for Enrollment
Why is this study being done?
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.
Who is eligible to participate?
- Pre or post renal transplant recipients who are "sensitized", having allo antibodies as evidenced by single antigen bead analysis (mean fluorescence index, MFI >1000).
- 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of any study-related procedures, which are not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
- Any patient currently receiving systemic anticoagulation therapy with heparin or Coumadin.
- Patient has a platelet count of <30x 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 within 14 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—active infection, comorbid medical conditions, etc.