{ "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.\n\nMethods 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.\n\nEthics 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.\n\nTrial registration number: ClinicalTrials.gov NCT06781099; ID-RCB 2024-A02473-44.", "abstract_shown": true, "affiliations": [ "Intensive Care, Lyon Sud Hospital, Hospices Civils de Lyon, Lyon, France", "VetAgro Sup, Campus Vétérinaire de Lyon, Marcy L’Etoile, France", "Department of Hematology, Centre Hospitalier Lyon Sud, Lyon, France", "Service Recherche & Épidémiologie Cliniques, Pôle Santé Publique, Hospices Civils de Lyon, Lyon, France", "CICLY, Université Claude Bernard Lyon 1, Lyon, France", "Service Recherche & Épidémiologie Cliniques, Hospices Civils de Lyon, Lyon, France", "Service de biostatistiques, Pôle Santé Publique, Hospices Civils de Lyon, Lyon, Auvergne-Rhône-Alpes, France", "Université Lyon 1, CNRS, ILM, UMR 5306, Villeurbanne, France, Lyon, France", "Department of Anesthesia and Intensive Care, Lyon Sud Teaching Hospital, Lyon, France" ], "article_type": "research article", "arxiv": null, "author_total": 8, "authors": [ { "affs": [ 0, 1 ], "name": "Auguste Dargent", "orcid": "0000-0003-1784-1212" }, { "affs": [ 2 ], "name": "Mael Heiblig" }, { "affs": [ 3, 4 ], "name": "Laurent Villeneuve", "orcid": "0000-0002-8713-7821" }, { "affs": [ 5 ], "name": "Marine Alves Ferreira" }, { "affs": [ 6 ], "name": "Maxime Bonjour" }, { "affs": [ 7 ], "name": "Francois Lux" }, { "affs": [ 7 ], "name": "Olivier Tillement" }, { "affs": [ 1, 8 ], "name": "Bernard Allaouchiche" } ], "bibtex": "https://research.draconitic.com/paper/12e2qjzy7px5e.bib", "cited_by": 0, "doi": "10.1136/bmjopen-2026-121216", "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13723837/", "id": "12e2qjzy7px5e", "issns": [ "2044-6055", "2044-6055" ], "landing_url": "https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-121216", "language": "en", "licence": "CC-BY-4.0", "licence_label": "CC BY 4.0", "licence_source": "article", "licence_url": "https://creativecommons.org/licenses/by/4.0/", "metadata_licence": null, "native_subjects": [ [ "hal", "0.chim" ], [ "heading", "1506" ], [ "heading", "1700" ], [ "heading", "Haematology (Incl Blood Transfusion)" ], [ "heading", "Protocol" ], [ "openalex", "2720|Iron Metabolism and Disorders" ] ], "openalex": "W7223901684", "pdf_url": null, "pmcid": "PMC13723837", "pmid": "42946365", "published": "2026-10-27", "publisher": "BMJ", "ris": "https://research.draconitic.com/paper/12e2qjzy7px5e.ris", "sources": [ { "first_seen": "2026-10-30T12:19:44Z", "native_id": "10.1136/bmjopen-2026-121216", "source": "crossref", "url": "https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-121216" }, { "first_seen": "2026-11-04T12:22:24Z", "native_id": "PMC13723837", "source": "pmc", "url": "https://doi.org/10.1136/bmjopen-2026-121216" }, { "first_seen": "2026-11-05T12:20:13Z", "native_id": "hal-05852610", "source": "hal", "url": "https://hal.science/hal-05852610v1" } ], "subjects": [ { "field": "chemistry", "origin": "hal:0.chim", "subfield": "general" } ], "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", "title_text": "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", "type": "peer-reviewed", "updated_at": "2026-11-06T12:20:44Z", "url": "https://research.draconitic.com/paper/12e2qjzy7px5e", "venue": "BMJ Open", "versions": [] }