Clinical Investigation of the Safety of the MediSieve Magnetic Haemofiltration System in Healthy Volunteers

NCT ID: NCT05713188

Last Updated: 2023-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-13
• Study Completion Date: 2022-11-30

Brief Summary

This is a single-centre, non-randomised, prospective study to assess the safety of the MediSieve blood filtration system in healthy volunteers

Detailed Description

The MediSieve Magnetic Haemofiltration System (MMHS) is a system to filter selected moieties from blood in an extracorporeal circuit by magnetic means. Initially, it is developed for the treatment of severe malaria to capture malaria-infected erythrocytes (who are weakly magnetic) to reduce the parasitaemia. However, the use of MMHS can be extended, with the use of antibodies coupled to magnetic beads, to other diseases, such as sepsis.

The MMHS has to be used first in healthy volunteers to determine its clinical safety.

To this end, 6 healthy male and female volunteers (ratio 1:1) will undergo blood filtration using the MediSieve Magnetic Haemofiltration System (without magnetic beads) for five consecutive hours. Vital signs will be continuously monitored and blood samples will be obtained serially to determine laboratory safety and immunological parameters. Furthermore, volunteers will have two follow up visits at 24 hours and 7 days post filtration.

Conditions

Haemofiltration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

All volunteers will receive the same treatment

Group Type: EXPERIMENTAL

MediSieve Magnetic Haemofiltration System

Intervention Type: DEVICE

The MediSieve Magnetic Haemofiltration System is a medical device intended for use in extracorporeal clinical procedures to remove magnetic targets (e.g. malaria infected red blood cells) from a patient's bloodstream. Healthy volunteers will undergo filtration for 5 hours.

Interventions

MediSieve Magnetic Haemofiltration System

The MediSieve Magnetic Haemofiltration System is a medical device intended for use in extracorporeal clinical procedures to remove magnetic targets (e.g. malaria infected red blood cells) from a patient's bloodstream. Healthy volunteers will undergo filtration for 5 hours.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male or female, ≥18 and ≤50 years of age
• Able to comprehend and sign the Information letter and Informed Consent (IC) prior to enrolment in the study.

Exclusion Criteria

• BMI <18.5 or >30 kg/m2
• Chronic medication use (except contraception)
• Pregnant or lactating females
• Known anaphylaxis or hypersensitivity to any (non-)investigational products or their excipients
• History or signs of severe atopic syndrome (asthma, rhinitis with medication and/or eczema)
• History or signs of haematological disease
• History or signs of thromboembolic disorders
• History of (intracranial) aneurysmal or haemorrhagic diseases
• History of any disease associated with immune deficiency
• History of cancer in the last 5 years (excluding localised skin cancer or CIS)
• History of heparin-induced thrombocytopenia (HIT)
• History of peptic / gastric ulcer disease
• Family history of haemorrhagic or thromboembolic disorders (<50 years of age)
• Thrombocytopenia (<150*109/ml) or anaemia (males: haemoglobin < 8.0 mmol/L, females: haemoglobin < 7.4 mmol/L)
• History, signs or symptoms of cardiovascular disease, in particular:

• Prone to vagal collapse
• History of atrial or ventricular arrhythmia
• Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrio-ventricular block or a complete left bundle branch block
• Hypertension (defined as RR systolic > 160 or RR diastolic > 90 mmHg)
• Hypotension (defined as RR systolic < 100 or RR diastolic < 50 mmHg)
• Renal impairment (defined as plasma creatinine >120 μmol/L)
• Liver enzyme abnormalities (above 2x the upper limit of normal)
• Signs of infection (CRP > 20 mg/L, White Blood Count > 12x109/L or < 4x109/L)
• Clinically significant acute illness, including infections or trauma, within 1 month of the experiment day
• Participation in an experimental intervention or drug trial or donation of blood within 3 months prior to the experiment day
• Recent hospital admission or surgery with general anaesthesia within 3 months prior to experiment day
• Use of recreational drugs within 2 weeks of the experiment day
• Inability to personally provide written informed consent (e.g. for linguistic or mental reasons) and/or take part in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: collaborator

MediSieve Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthijs Kox, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

MediSieve FMS study

Identifier Type: -

Identifier Source: org_study_id