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

NCT06956807 | Not Yet Recruiting Phase 1 DMC

• 3 other identifiers: CARDIOMESH II2024-517738-16-002022-002180-29
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

heart failure; coronary revascularisation surgery; adipose-derived stem cells; myocardial infarction

Outcome Measures

Primary Outcomes (1)

• combination of MACCEs at all follow up visits during the first year after treatment

  combination of MACCEs at all follow up visits during the first year after treatment (after surgery, at 1, 3, 6, 9 and 12 months). MACCEs are defined as all cause death, myocardial infarction requiring target vessel revascularisation, hospitalisation for heart failure, cardiac tamponade or pericardial constriction, sustained ventricular tachycardia, ventricular fibrillation, and stroke.

  12 months

Secondary Outcomes (17)

• Safety - Composite MACCE

  12 months

• Safety - Hematology parameters

  12 months

• Safety - Adverse Events

  12 months

• Safety - Biochemical blood parameters

  12 months

• Safety - New York Heart Association (NYHA) functional class

  12 months

Study Arms (1)

Treatment with VB-C01

EXPERIMENTAL

Treatment arm in which patients will be treated with a VB-C01 cellularised patch.

Combination Product: VB-C01 cellularised patch

Interventions

VB-C01 cellularised patch COMBINATION_PRODUCT

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

Treatment with VB-C01

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients planning to undergo coronary revascularisation surgery within one month of study entry.
• LVEF ≤45% by CMRI.
• Scar covering at least 15% of the total left ventricular myocardial mass defined by late enhancement on CMRI.

You may not qualify if:

• Prior treatment with cell or gene therapy.
• Be a candidate for heart transplant at the time of study entry.
• Need for urgent revascularisation surgery.
• Strict contraindication for the use of CMRI (pacemaker or implantable automatic defibrillator carriers, previous reactions to gadolinium contrast, claustrophobia, cochlear implants, etc.).
• Presence of uncontrolled ventricular arrhythmias (ventricular tachycardia or ventricular fibrillation) at the time of implant surgery.
• Active systemic infection.
• Women who are pregnant or breastfeeding.
• Mental disease or psychological condition that impedes the subject from understanding the nature of the protocol and granting his/her consent
• Advanced dementia according to the Barthel index.
• History of autoimmune disease.
• Respiratory compromise or need for home oxygen therapy.
• Life expectancy of less than 1 year for any reason

Sponsors & Collaborators

• Viscofan: lead
• KCRI Sp. z o.o.: collaborator
• Medical University of Silesia: collaborator
• Clinica Universidad de Navarra, Universidad de Navarra: collaborator
• Hospital General Universitario Gregorio Marañon: collaborator

Study Sites (1)

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

Katowice - Ochojec, 40-635, Poland

Location

MeSH Terms

Conditions

Heart Failure; Myocardial Infarction

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Radoslaw Gocol, MD

  Medical University of Silesia

  STUDY CHAIR

• Javier Bermejo, MD

  Hospital General Universitario Gregorio Marañón

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lluis Quintana, PhD, MBA

CONTACT

+49 6201 86-236; quintana@bio.viscofan.com

Jesus Izco, PhD

CONTACT

+34948198444; IzcoJ@viscofan.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: May 4, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 4, 2025

Record last verified: 2025-04

Locations

PL (1)