Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06781099
NA

Feasibility Trial of Extracorporeal Iron Purification in Patients With Myelodysplastic Syndrome or Myelofibrosis

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

Summary

In transfusion-dependent myelodysplastic syndromes patients, regular blood transfusions lead to iron overload, which can cause organ damage, hormonal imbalances, and increased infection risk, ultimately impacting patient survival. Standard oral iron chelation therapies can be intolerable for some patients due to adverse effects. The MEX-CD1 device (class III) could potentially offer an alternative for these patients by reducing serum iron levels through a novel, extracorporeal approach. MEXIRON clinical investigation focuses on the use of MEX-CD1, a medical device designed for extracorporeal chelation therapy to reduce iron overload in patients suffering from transfusion-dependent myelodysplastic syndromes (MDS) and myelofibrosis. MEXIRON aims to evaluate the device's use feasibility, safety, and effectiveness in reducing iron levels. Transfusions needs, patient experience and quality of life are also assessed. Each enrolled patients will undergo three low-volume continuous veno-venous haemodialysis cycles within one week. Following the three- haemodialysis cycles, patients will be monitored through on-site follow-up visits at 7 days, 28 days, and 90 days post-treatment to assess long-term effects.

Official title: Feasibility, Tolerability and Efficacy of Extracorporeal Iron Purification in Patients With Myelodysplastic Syndrome or Myelofibrosis Intolerant of or Contraindicated to Oral or Subcutaneous Chelation Treatment.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

13

Start Date

2026-01-06

Completion Date

2027-05-06

Last Updated

2026-03-06

Healthy Volunteers

No

Interventions

DEVICE

Low-volume continuous veno-venous haemodialysis with MEX-CD1 use

MEX-CD1 is a hyper-chelating colloidal solution that can be added to the dialysate to be used in low-volume continuous veno-venous hemodialysis. Intervention includes 3 low-volume continuous veno-venous hemodialysis for a duration of 3h20 each. For non-hospitalized patients, the treatment is performed on an outpatient basis.

Locations (2)

Hôpital Lyon Sud

Oullins-Pierre-Bénite, France

Hôpital Lyon Sud

Oullins-Pierre-Bénite, France