NCT01666132

METHOD - Bone Marrow Derived Mononuclear Cells in Chronic Ischemic Disease

METHOD - Phase I/II Study of Intramyocardial Injection of Bone Marrow Derived Mononuclear Cells in Chronic Ischemic Disease

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Cardiocentro Ticino · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Intramyocardial, NOGA guided injection of bone marrow derived mononuclear cells in patients with chronic ischemic heart disease and LVEF \< 40%. The primary objective is to determine whether the administration of the cells improves recovery of the left ventricular function. Secondary objective is the finding of clinical or paraclinical parameters to predict potential benefits of the treatment (basing on MRI characteristics such as size, transmurality of the myocardial infarction and peri-lesional ischemia). In the first part of the study 10 patients are treated without control group. This phase serves as feasibility and safety part of the study.

Conditions

• Chronic Ischemic Heart Disease

Interventions

Type	Name	Description
OTHER	intramyocardial injection of BM cells	only intramyocardial, NOGA guided injection on BM cells.
OTHER	intramyocardial / intracoronary injection of BM cells	combination of intramyocardial, NOGA guided injection of BM cells and intracoronary injection of those cells
OTHER	Best medical therapy	initially no intervention; crossover to therapy 6 months after enrollment

Timeline

• Start date: 2011-01-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2012-08-16
• Last updated: 2015-08-20

Locations

1 site across 1 country: Switzerland