New Blood-Cleansing device could help those who Can't take iron pills

NCT ID NCT06781099

Disease control Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This small study tests a device called MEX-CD1 that removes excess iron from the blood during a special type of dialysis. It is for people with myelodysplastic syndrome or myelofibrosis who have iron overload from blood transfusions but cannot take standard chelation therapy. Each participant will receive three short dialysis sessions over one week and be followed for 90 days to see if the device is safe and works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: MEX-CD1 device for extracorporeal iron chelation
What this could lead to: If it works, this could offer a new way to manage iron overload in people who cannot tolerate standard chelation pills or injections.
What could go wrong: This is a very small early feasibility study (13 people) with no control group. The device is experimental, and it is unknown if it will be safe or effective enough for routine use.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 13 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient followed for myelodysplastic syndrome or myelofibrosis. * Patient with platelet count ≥50 giga/L at inclusion. * Patients with severe anemia and hemoglobin \<70 g/L at baseline. * Patient with intolerance or contraindication to oral or subcutaneous chelation therapy. * Ferritinemia \>1000 µg/L or hepatic iron concentration ≥7 mg/g or cardiac T2\* \<20 ms at inclusion. * Patient able to understand (French-speaking) and comply with protocol, having signed informed consent. Exclusion Criteria: * Patients with primary hemochromatosis (transferrin saturation coefficient CS-Tf \> 45%). * Patients with a contraindication to the use of MEX-CD1: weight \< 30 kg, iron deficiency. * Patients with a known allergy or contraindication to heparin or citrate. * Patients undergoing azacitidine or other chemotherapy (or considered as such) for myelodysplastic syndrome or myelofibrosis. * Patient who received treatment with luspatercept or erythropoietin (EPO) during the month prior to inclusion. * Patients with indications for allogeneic bone marrow transplantation. * Patients with a known allergy to shellfish (MEX-CD1 contains chitosan of animal origin) or to one of the other components of MEX-CD1. * Patients with a peripheral vascular access that is difficult to access or that needs to be preserved. * Patients participating in other interventional research that could interfere with the results of the study. * Patients under legal protection or unable to express their consent. * Patients under psychiatric care. * Patient deprived of liberty by judicial or administrative decision. * Pregnant or breast-feeding women.

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Conditions

The condition(s) this trial relates to.

myelodysplastic syndrome Myelodysplastic Syndromes myelofibrosis primary myelofibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myelodysplastic syndrome Myelofibrosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

2 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

New Blood-Cleansing device could help those who Can't take iron pills

What the study statuses mean