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

NCT06956807 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-05-04

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • KCRI Sp. z o.o.

    collaborator UNKNOWN

  • Medical University of Silesia

    collaborator OTHER

  • Clinica Universidad de Navarra, Universidad de Navarra

    collaborator OTHER

  • Hospital General Universitario Gregorio Marañon

    collaborator OTHER

  • Viscofan

    lead INDUSTRY

Principal Investigators

  • Radoslaw Gocol, MD · Medical University of Silesia

  • Javier Bermejo, MD · Hospital General Universitario Gregorio Marañón

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • Poland

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06956807 on ClinicalTrials.gov