Status:
NOT_YET_RECRUITING
Safety and Efficacy of Epicardial Implantation of Collagen Membranes With Allogeneic Adipose Derived Stem Cells
Lead Sponsor:
Viscofan
Collaborating Sponsors:
KCRI Sp. z o.o.
Medical University of Silesia
Conditions:
CABG-patients
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 allogen...
Detailed Description
* The clinical trial CARDIOMESH II aims to attenuate adverse remodelling of the left ventricle, which is the main cause of death in ischaemic heart disease, through the development of a new regenerati...
Eligibility Criteria
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.
- 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.).
- 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 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.
- History of autoimmune disease.
- Stroke within 12 months prior to inclusion.
- Respiratory compromise or need for home oxygen therapy.
- Life expectancy of less than 1 year for any reason
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06956807
Start Date
September 1 2025
End Date
June 30 2027
Last Update
May 4 2025
Active Locations (1)
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1
Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
Katowice - Ochojec, Poland, 40-635