Protocol for the MEXIRON study: a first-in-disease phase I–II investigation into the safety, tolerability and mechanistic proof-of-concept of extracorporeal iron depletion using the MEX-CD1 device in patients with transfusional iron overload
9 affiliations
- 1Intensive Care, Lyon Sud Hospital, Hospices Civils de Lyon, Lyon, France
- 2VetAgro Sup, Campus Vétérinaire de Lyon, Marcy L’Etoile, France
- 3Department of Hematology, Centre Hospitalier Lyon Sud, Lyon, France
- 4Service Recherche & Épidémiologie Cliniques, Pôle Santé Publique, Hospices Civils de Lyon, Lyon, France
- 5CICLY, Université Claude Bernard Lyon 1, Lyon, France
- 6Service Recherche & Épidémiologie Cliniques, Hospices Civils de Lyon, Lyon, France
- 7Service de biostatistiques, Pôle Santé Publique, Hospices Civils de Lyon, Lyon, Auvergne-Rhône-Alpes, France
- 8Université Lyon 1, CNRS, ILM, UMR 5306, Villeurbanne, France, Lyon, France
- 9Department of Anesthesia and Intensive Care, Lyon Sud Teaching Hospital, Lyon, France
Abstract
Introduction: Secondary iron overload is a frequent and debilitating complication in patients who depend on chronic red blood cell transfusion support, including those with myelodysplastic syndromes (MDS), myelofibrosis and other haematological malignancies. As transferrin becomes saturated, iron appears in plasma in non-transferrin-bound forms whose redox-active fraction mediates organ toxicity. Oral and subcutaneous iron chelators are available, but a substantial subset of patients remains intolerant of or refractory to these therapies. This protocol presents a pilot clinical trial designed to evaluate the mechanistic feasibility and the safety of a novel approach: extracorporeal iron depletion using the MEX-CD1 medical device.
Methods and analysis: The MEXIRON study is a prospective, open-label, single-arm, non-comparative, monocentric Phase I–II study sponsored by the Hospices Civils de Lyon. It aims to include 10 evaluable patients who are dependent on red blood cell transfusion in the context of a haematological malignancy or another condition of immuno-haematological origin, who have documented transfusional iron overload and who have a contraindication to or intolerance of conventional chelation. Participants will undergo a cycle of three extracorporeal iron depletion sessions over 1 week. The intervention uses the MEX-CD1 device, a functionalised biopolymer combining chitosan and DOTA-GA, coupled with a haemodialysis platform to selectively sequester plasma iron. The primary outcome is a mechanistic feasibility criterion: the mass of iron recovered in the dialysis effluent at the end of each session, quantified by inductively coupled plasma mass spectrometry. Secondary outcomes are safety and tolerance, the kinetics of iron removal, changes in serum ferritin and transferrin saturation, procedural feasibility, subsequent transfusion requirements and quality of life.
Ethics and dissemination: The protocol has received approval from the Committee for the Protection of Persons (CPP Ouest III) and authorisation from the French National Agency for the Safety of Medicines (ANSM). Results will be disseminated through peer-reviewed publications.
Trial registration number: ClinicalTrials.gov NCT06781099; ID-RCB 2024-A02473-44.
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BibTeX
@article{dargent2026protocol,
title = {{Protocol for the MEXIRON study: a first-in-disease phase I–II investigation into the safety, tolerability and mechanistic proof-of-concept of extracorporeal iron depletion using the MEX-CD1 device in patients with transfusional iron overload}},
author = {Auguste Dargent and Mael Heiblig and Laurent Villeneuve and Marine Alves Ferreira and Maxime Bonjour and Francois Lux and Olivier Tillement and Bernard Allaouchiche},
journal = {BMJ Open},
year = {2026},
month = oct,
doi = {10.1136/bmjopen-2026-121216},
url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-121216},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Protocol for the MEXIRON study: a first-in-disease phase I–II investigation into the safety, tolerability and mechanistic proof-of-concept of extracorporeal iron depletion using the MEX-CD1 device in patients with transfusional iron overload
AU - Auguste Dargent
AU - Mael Heiblig
AU - Laurent Villeneuve
AU - Marine Alves Ferreira
AU - Maxime Bonjour
AU - Francois Lux
AU - Olivier Tillement
AU - Bernard Allaouchiche
PY - 2026
DA - 2026/10/27
JO - BMJ Open
DO - 10.1136/bmjopen-2026-121216
UR - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-121216
AB - Introduction: Secondary iron overload is a frequent and debilitating complication in patients who depend on chronic red blood cell transfusion support, including those with myelodysplastic syndromes (MDS), myelofibrosis and other haematological malignancies. As transferrin becomes saturated, iron appears in plasma in non-transferrin-bound forms whose redox-active fraction mediates organ toxicity. Oral and subcutaneous iron chelators are available, but a substantial subset of patients remains intolerant of or refractory to these therapies. This protocol presents a pilot clinical trial designed to evaluate the mechanistic feasibility and the safety of a novel approach: extracorporeal iron depletion using the MEX-CD1 medical device. Methods and analysis: The MEXIRON study is a prospective, open-label, single-arm, non-comparative, monocentric Phase I–II study sponsored by the Hospices Civils de Lyon. It aims to include 10 evaluable patients who are dependent on red blood cell transfusion in the context of a haematological malignancy or another condition of immuno-haematological origin, who have documented transfusional iron overload and who have a contraindication to or intolerance of conventional chelation. Participants will undergo a cycle of three extracorporeal iron depletion sessions over 1 week. The intervention uses the MEX-CD1 device, a functionalised biopolymer combining chitosan and DOTA-GA, coupled with a haemodialysis platform to selectively sequester plasma iron. The primary outcome is a mechanistic feasibility criterion: the mass of iron recovered in the dialysis effluent at the end of each session, quantified by inductively coupled plasma mass spectrometry. Secondary outcomes are safety and tolerance, the kinetics of iron removal, changes in serum ferritin and transferrin saturation, procedural feasibility, subsequent transfusion requirements and quality of life. Ethics and dissemination: The protocol has received approval from the Committee for the Protection of Persons (CPP Ouest III) and authorisation from the French National Agency for the Safety of Medicines (ANSM). Results will be disseminated through peer-reviewed publications. Trial registration number: ClinicalTrials.gov NCT06781099; ID-RCB 2024-A02473-44.
SN - 2044-6055
SN - 2044-6055
ER -