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

Prior treatment

• 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.

Other illness

• 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.

Other

• Women who are pregnant or breastfeeding.
• Life expectancy of less than 1 year for any reason

• 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.