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Effects of Thymoglobulin on Human B Cells

NCT02137876 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2018-03-29

No results posted yet for this study

Summary

This study is being done to better understand how immunosuppressive medications (anti-rejection medications that may or may not be approved by the Food and Drug Administration (FDA)) affect the alloimmune response (how a person's immune system reacts against another person's immune system). This will be determined by the blood tests run on the patients donated blood cells.

Specifically, the investigators will test different immunosuppression medications using in-vitro assays (in the laboratory, in test tubes) alone and/or in combination to test how they can affect B-cell proliferation and differentiation, leading to an altered distribution among defined B-cell subsets and to study if exposure of B cells to thymoglobulin can have effects on subsequent interaction between B and T cell in vitro.

To enable the investigators to understand how immunosuppressant medications affect immune systems in transplant patients, the investigators need to understand how they affect immune systems in healthy people. To do this, the investigators will need to study blood collected from healthy volunteers.

Conditions

  • Acute Humoral Rejections
  • Chronic Humoral Rejections
  • Transplant

Interventions

PROCEDURE

Blood Draws

Patients will be asked to provide blood for immune tests.Patients will not take any study medications, all the research will be performed on blood donated for the study.Patients will donate about 20mls of blood (2 tbls)to be used to determine the subject's blood group and tissue typing (genetic).Results and the patient's contact information will be maintained in a database that is accessible only by the investigators and study personnel conducting the study.For the duration of this study, the investigator will contact patients by phone to request additional samples when needed. Study staff may ask patients donate more blood on short notice (1 day). This will consist of 60-120 ml (6-12 tbls) of blood.The frequency of blood collection will not exceed more than 2 times per week.The total amount of blood collected from subjects will not exceed 360 ml (1.5 cups) within any eight week period throughout the two year timespan patients may be asked to participate in this study.

Sponsors & Collaborators

Principal Investigators

  • Lorenzo Gallon, MD · Northwestern University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02137876 on ClinicalTrials.gov