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NOT YET RECRUITING
NCT06956807
PHASE1

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

Sponsor: Viscofan

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-09-01

Completion Date

2027-06-30

Last Updated

2025-05-04

Healthy Volunteers

No

Interventions

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

Locations (1)

Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach

Katowice - Ochojec, Poland