Study of Extracorporeal Iron Removal Using MEX-CD1 Device in Adults with Myelodysplastic Syndrome or Myelofibrosis Who Cannot Use Oral or Injectable Iron Chelation

What this Trial Is About

Researchers are evaluating the MEX-CD1 device, a new extracorporeal chelation therapy, for patients with transfusion-dependent myelodysplastic syndromes or myelofibrosis who experience iron overload due to regular blood transfusions. Iron overload can cause organ damage, hormonal problems, and infections, affecting patient survival. This study aims to assess the feasibility, safety, and effectiveness of MEX-CD1 in reducing iron levels in these patients. Participants will receive three sessions of low-volume continuous veno-venous haemodialysis using the MEX-CD1 device within one week. Each session lasts approximately 3 hours and 20 minutes. Treatments can be done on an outpatient basis for those not hospitalized. After these sessions, patients will have follow-up visits on days 7, 28, and 90 to monitor long-term effects and assess transfusion needs, patient experience, and quality of life. During the study, researchers will measure how well MEX-CD1 reduces total iron during treatment sessions and its impact on iron profiles. They will also monitor patient safety, treatment tolerability, and quality of life up to 16 weeks after treatment. The total participation duration includes the treatment week and follow-up visits to capture both immediate and longer-term outcomes.

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