Nanoparticle for DSA Removal

N/AActive Not RecruitingNCT04277377

University of Zurich100 enrolled

Overview

Magnetic nanoparticles, coated with human leukocyte antigens (HLA) to capture anti-HLA antibodies with donor specificity (donor-specific antibodies, DSA), will be tested ex-vivo.

This project aims at developing a new method using human leukocyte antigens (HLA)-coated magnetic nanoparticles to remove donor-specific antibodies (DSA) from the patients' blood ex vivo, while trying to keep the blood unaffected after exposure to the particles. Nanoparticles will be engineered and tested ex vivo. While nanoparticles were successfully coated with macromolecules such as antibodies in the past, this is a new approach, which will be performed by the research group. The goal of this project is to capture DSA in patient blood ex vivo and to remove them by magnetic separation. Efficacy and safety of this procedure will be assessed, especially the interaction of these novel particles with other blood components such as coagulation factors or effector cells, which could produce inflammatory mediators. According analyses are initiated and carried out.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Kidney Failure Presence of Donor Specific Antibodies

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * DSA in the blood as detected by Luminex® * Adults (\>18 years old) * Informed written consent Exclusion Criteria: * Inability to follow the procedures of the study, due to language problems, psychological disorders, social conditions or dementia * Pregnancy and/or breast feeding * Unwillingness to participate in this study

Locations (1)

University Hospital Zurich, Division of Anaesthesiology

Zurich, Canton of Zurich, Switzerland

Outcomes

Primary Outcomes

Percentage of DSA removed in a blood sample using HLA-coated magnetic nanoparticles

Quantification of DSA removal using HLA-coated magnetic nanoparticles in comparison with blood treated with control nanoparticles (without HLA coating).

Time frame: 1 day

Secondary Outcomes

Blood coagulation (rotational thromboelastometry ROTEM, plasma clotting time) before and after treatment with HLA-coated magnetic nanoparticles

Coagulation parameters as described will be evaluated in blood samples. The same analyses will be repeated after exposure to HLA-coated magnetic nanoparticles.

Time frame: 1 day

Inflammatory blood mediators (IL-6, MCP-1) before and after treatment with HLA-coated magnetic nanoparticles

Inflammatory parameters as described will be evaluated in blood samples. The same analyses will be repeated after exposure to HLA-coated magnetic nanoparticles.

Time frame: 1 day

Data from ClinicalTrials.gov

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