Phase 1Not yet recruiting
Safety and Efficacy of Epicardial Implantation of Collagen Membranes With Allogeneic Adipose Derived Stem Cells (CARDIOMESH II)
First in Human Open Label Multicentre Clinical Trial to Evaluate the Safety and Efficacy of Epicardial Implantation of Collagen Membranes With Allogeneic Adipose Derived Stem Cells in Patients With Ischaemic Left Ventricular Dysfunction Scheduled to Undergo Coronary Revascularisation Surgery
- Sponsor
- Viscofan (Industry)
- Enrollment
- 10 planned
- Conditions
- CABG-patients; Heart Failure; Myocardial Infarction (MI)
- Interventions
- VB-C01 cellularised patch
- Ages
- adults, older adults
- Registry
- NCT06956807, CTIS2024-517738-16-00, EUCTR2022-002180-29
Full record on ClinicalTrials.gov
From the registry
* The Cardiomesh II clinical trial is a phase I open label study intended to enrol 10 patients to evaluate the safety and efficacy of surgical epicardial implantation of a membrane seeded with allogeneic adipose tissue derived stem cells in patients scheduled to undergo coronary revascularisation surgery and at high risk of developing heart failure. * The primary objective of the study is to evaluate the safety of surgical implantation of this membrane in patients with large ischaemic myocardial scars scheduled to undergo coronary revascularisation surgery. The secondary objective is to investigate the efficacy of the above treatment in terms of reduction of scar size and ventricular function parameters.
Primary outcomes
- combination of MACCEs at all follow up visits during the first year after treatment
History
Study completion expected
Primary completion expected
Started
Registered