NCT06956807

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Viscofan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

* 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.

Detailed description

* The clinical trial CARDIOMESH II aims to attenuate adverse remodelling of the left ventricle, which is the main cause of death in ischaemic heart disease, through the development of a new regenerative therapy consisting of the combination of allogeneic adipose derived stem cells with bovine derived collagen membranes to promote repair of damaged myocardium. This is predicted to achieve a 10% reduction in mortality related to ischaemic heart failure. * Specifically, the working hypotheses of the project are: * Surgical implantation of a membrane containing allogeneic adipose derived stem cells in patients with large myocardial scars scheduled to undergo coronary revascularisation surgery is technically feasible. * Surgical implantation of a membrane containing allogeneic adipose derived stem cells in patients with large myocardial scars scheduled to undergo coronary revascularisation surgery is safe in terms of the primary objective consisting of major adverse cardiac and cerebrovascular events (MACCEs). * Surgical implantation of the aforementioned bioengineering product is safe in terms of cardiac effects and immunological analysis. * Surgical implantation of this cellularised membrane shows beneficial effects in terms of efficacy measured by surrogate cardiac imaging parameters. * Designed as an international phase I clinical trial to be conducted at two sites in two European countries, the purpose of the study is to establish the basic safety parameters and to obtain preliminary efficacy data on clearly established surrogate variables to undertake future larger scale trials focused on clinical efficacy.

Conditions

• CABG-patients
• Heart Failure
• Myocardial Infarction (MI)

Interventions

Type	Name	Description
COMBINATION_PRODUCT	VB-C01 cellularised patch	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

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-12-31
• Completion: 2027-06-30
• First posted: 2025-05-04
• Last updated: 2025-05-04

Locations

1 site across 1 country: Poland