An In-vitro Standardization of B Cell Elispot Assays

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2012-10-31

Brief Summary

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This study is being done because the study doctor is trying to develop a new test which will help transplant doctors monitor patients with high panel reactive antibodies (PRA). The test would be used to monitor patients' PRA when doctors are trying to lower it through a process known as desensitization. Desensitization lowers high PRA levels and allows patients to receive transplants. This is a single center study to evaluate and optimize the use of a new laboratory test to detect and measure the immune system's functioning.

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Detailed Description

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Sensitization to HLA antigens is the main barrier to solid organ transplantation. Currently, HLA sensitization is monitored by testing patients' serum against a panel of HLA antigens (whether those will be presented on cell surface or on solid phase matrixes) and calculating the % of positive responses. Such result give indication of the relative breadth of sensitization but not on it "depth" - the relative strength of specific antibodies, nor does it provide any information regarding the memory B cells / plasma cells that can manufacture a specific HLA directed antibody.

This is a single center study to evaluate and optimize the use of in-vitro assay to enumerate B cells producing human leukocyte antigens (HLA)-specific antibodies. The proposed assay is based on principles used for enumeration of specific cytokine producing memory T cells - an ELISPOT assay. The investigators are currently using the T cell ELISPOT assay in our laboratory.

The investigators believe that the proposed assay will provide biologically relevant immune measures that are crucial for the long term outcome of transplantation in highly sensitized patients.

Highly sensitized patients encompass a high risk patient group among transplant recipients. The proposed assay is designed to predict the fate of DSA producing (or capable of producing) memory and plasma cells. Thus, it should allow prediction and early detection of activation of the humoral arm of the immune system, specifically against the donor. This, in turn, may prompt early intervention and preservation of the allograft. Three tubes of blood will be drawn twice, 8-12 weeks apart, during clinic or standard of care dialysis visits following optimization. Subjects undergoing desensitization will have three tubes of blood drawn seven times over the course of two years for the analysis.

Conditions

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Transplant Sensitization Panel Reactive Antibody Sensitization to HLA Antigens

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Blood: Undergoing Desensitization

Transplant subjects give blood at specified time points. Sensitization to HLA antigens is a barrier to transplant. Several U.S. institutions have protocols for desensitization where patients are treated with IV immunoglobulins (IVIg) and plasmapheresis (PP) to reduce circulating HLA-directed antibody levels. Labs provide doctors information on circulating donor-specific antibody (DSA) levels. These results are the main indicator whether to proceed with transplant. However, no information is given on the fate of the B cells that produce the DSA.

Blood Draw

Intervention Type PROCEDURE

Three tubes of blood will be drawn (three 10ml-green top), 7 times (total of 210 ml for study) at the indicated time points: 1) enrollment, 2) anticipated midpoint of desensitization, 3) prior to transplant, 4) three months post-transplant, 5) six months post-transplant, 6) 12 months post-transplant, and 7) 24 months post-transplant.

Blood: NOT Undergoing Desensitization

Transplant subjects give blood at specified time points. Sensitization to HLA antigens is a barrier to transplant. Several U.S. institutions have protocols for desensitization where patients are treated with IV immunoglobulins (IVIg) and plasmapheresis (PP) to reduce circulating HLA-directed antibody levels. Labs provide doctors information on circulating donor-specific antibody (DSA) levels. These results are the main indicator whether to proceed with transplant. However, no information is given on the fate of the B cells that produce the DSA.

Blood Draw

Intervention Type PROCEDURE

Three tubes of blood will be drawn (three 10ml-green top) twice (60 ml total for study), 8-12 weeks apart. Can be drawn during clinic visit or separate standard of care dialysis visit.

Interventions

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Blood Draw

Three tubes of blood will be drawn (three 10ml-green top), 7 times (total of 210 ml for study) at the indicated time points: 1) enrollment, 2) anticipated midpoint of desensitization, 3) prior to transplant, 4) three months post-transplant, 5) six months post-transplant, 6) 12 months post-transplant, and 7) 24 months post-transplant.

Intervention Type PROCEDURE

Blood Draw

Three tubes of blood will be drawn (three 10ml-green top) twice (60 ml total for study), 8-12 weeks apart. Can be drawn during clinic visit or separate standard of care dialysis visit.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Subjects should be listed for solid organ transplant at NU/NMH
* Subjects should be \> or = to 18 years of age, either gender
* Subjects should have history of prior sensitization of HLA antigens
* Subjects should have documented antibody specificity previously tested at the transplant immunology lab at NU
* Subjects should be capable of understanding the study, consents, HIPAA process and be able to give informed consent.