Safety and Efficacy of Epicardial Implantation of Collagen Membranes With Allogeneic Adipose Deri… (NCT06956807) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Safety and Efficacy of Epicardial Implantation of Collagen Membranes With Allogeneic Adipose Derived Stem Cells
Poland10 participantsStarted 2025-09-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. Participation in another clinical trial within 30 days prior to inclusion.
✕. Prior treatment with cell or gene therapy.
✕. Be a candidate for heart transplant at the time of study entry.
✕. 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.).
What they're measuring
1
combination of MACCEs at all follow up visits during the first year after treatment