Tests stem-cell patch on heart scar during bypass surgery
Tests a stem-cell patch placed on the heart in adults with heart damage.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy of Epicardial Implantation of Collagen Membranes With Allogeneic Adipose Derived Stem Cells
Key facts
- Where
- Katowice, PolandSee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who will have coronary bypass-type surgery and have a large scar on the heart muscle from an old heart attack with weak heart pumping.
- Age
- 18 years and older
- Sex
- All sexes can join.
- Disease stage
- Heart attack at least 3 months before joining; scar covering at least 15% of the left ventricular heart muscle on cardiac MRI; LVEF ≤45% by cardiac MRI; coronary revascularisation surgery planned within one month.
- Earlier treatment
- Cannot have had cell or gene therapy before.
- Biomarker or test result
- LVEF ≤45% and scar covering at least 15% of the left ventricular heart muscle, both measured by cardiac MRI (CMRI).
Main reasons for not taking part
- Pregnant or breastfeeding women
- Cannot have an MRI scan (for example pacemaker, implantable defibrillator, claustrophobia)
- Active infection, or a weak immune system or immunosuppressive treatment
- History of autoimmune disease, or cancer other than as the record allows
- Stroke within 12 months, or life expectancy under 1 year
Read by machine on 12 November 2026.
Where in Poland
- Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W KatowicachKatowice, PolandNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Viscofan
- Trial code
- NCT06956807EU 2024-517738-16-00
- Record updated
- 4 May 2025
- Original description
* 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.Read full original descriptionShow less
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
* 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.
Inclusion: Patients planning to undergo coronary revascularisation surgery within one month of study entry; LVEF ≤45% by CMRI; History of myocardial infarction at least 3 months prior to inclusion; Scar covering at least 15% of the total left ventricular myocardial mass defined by late enhancement on CMRI.
Exclusion: Participation in another clinical trial within 30 days prior to inclusion; Prior treatment with cell or gene therapy; Diagnosis of acute myocardial infarction with 3 months prior to inclusion; 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.); History of primary or acquired immunodeficiency or on immunosuppressive therapy (within 3 months prior to inclusion or if the need for immunotherapy is foreseeable at any time during the study follow up); Tumour disease, except that eradicated at least 5 years prior to inclusion in the study and without receiving chest radiotherapy. Completely eradicated non melanoma skin tumours (at any time) not requiring chest chemotherapy or radiotherapy are permitted; Stroke within 12 months prior to inclusion; Respiratory compromise or need for home oxygen therapy; Be a candidate for heart transplant at the time of study entry; Presence of uncontrolled ventricular arrhythmias (ventricular tachycardia or ventricular fibrillation) at the time of implant surgery; Active systemic infection; 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; Women who are pregnant or breastfeeding; Life expectancy of less than 1 year for any reason.