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

MediSieve

Status and phase

Completed

Phase 1

Conditions

Haemofiltration

Treatments

Device: MediSieve Magnetic Haemofiltration System

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05713188

MediSieve FMS study

Details and patient eligibility

About

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

Full 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.

Enrollment

6 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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