A new clinical trial testing the MEX-CD1 hemodialysis medical device in patients with Wilson disease is now recruiting participants.
The aim of the trial is to assess whether the device works as expected by removing the excess of free copper from the blood, and whether it is safe when used according to the instructions for use.
Read more about the symptoms of Wilson disease
The trial sponsored by Mexbrain aims to recruit 17 participants with the disease in France and Spain weighing at least 30 kg and who are 10 to 80 years of age.
Depending on symptom severity, participants will receive 5 or 10 treatments on consecutive days with the device.
The primary outcome measure of the study is the performance of MEX-CD1. Secondary outcome measures are pulse, temperature, arterial blood, and weight measurements for safety purposes, adverse event recording, the number of participants with abnormal laboratory test results, the responder rate, copper kinetics, changes in copper concentration between screening visit and last visit, and the evolution of hepatic function, neurologic and psychiatric status, and Wilson disease.
The trial will also assess the nonceruloplasmin-bound copper elimination and restoration during and between treatments.
The trial opened on July 1, 2023 and is expected to be completed on April 1, 2025.
Wilson disease is a rare genetic disease affecting copper metabolism. The disease is characterized by excessive copper deposition throughout the body but especially in the liver, brain, and eyes leading to hepatic and neurological dysfunction. It is thought to affect around 1 in every 30,000 people worldwide.
There is currently no cure for Wilson disease and treatment includes medical treatment with chelating agents and/or zinc salts. These treatments must be taken daily for life.
The MEX-CD1 hemodialysis device combines dialysis to a hyper-chelating colloidal dialysate, such as MEX-CD1, to specifically extract copper from the blood.
Reference
Performance and safety of MEX-CD1 low-volume continuous veno-venous haemodialysis medical device for copper-extraction in patients with Wilson’s disease (MEXWILS). US National Library of Medicine. Updated June 28, 2023. Accessed July 7, 2023.
