Safety and Efficacy of Epicardial Implantation of Collagen Membranes With Allogeneic Adipose Derived Stem Cells

* 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.

NCT Number	NCT06956807
Lead Sponsor	Viscofan Collaborators: KCRI Sp. z o.o., Medical University of Silesia, Clinica Universidad de Navarra, Universidad de Navarra, Hospital General Universitario Gregorio Marañon
Conditions	CABG-patients, Heart Failure, Myocardial Infarction (MI)
Enrollment	10 participants
Start Date	2025-09-01
Primary Completion	2026-12-31 (estimated)
Study Completion	2027-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-05-04