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

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.

Composite MACCE (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) at all follow up visits during the first year after treatment (after surgery, 1, 3, 6, 9 and 12 months),

Erythrocytes, Haemoglobin, Haematocrit, Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Platelets, Prothrombin time, APTT, INR.

Measurement of the values and evaluation of their clinical significance in case they are outside of the normal range.

Any cause adverse event at all follow up visits during the first year after treatment (after surgery, 1, 3, 6, 9 and 12 months)

Measurement of biochemistry paramenters in blood including Glucose, Creatinine, Urea, GOT, GPT, GGT, Total bilirubin, Alkaline phosphatase, Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglycerides, Total proteins, Sodium, Potassium, Calcium, Chloride.

Evaluation of clinical significance in case values are out of normal range.

Assessment of the New York Heart Association (NYHA) functional class before surgery (the first assessment will be done during the screening process and repeated before the procedure), at 6 and 12 months after surgery.

Minnesota Living with Heart Failure (MLHFQ) questionnaire, before surgery (the first assessment will be done during the screening process, at least one day before surgery), at 6 and 12 months after surgery.

The 6 minute walk test will be performed before surgery (the first assessment will be done during the screening process, at least one day before surgery), at 6 and 12 months after surgery.

Brain natriuretic peptide curve (Nt proBNP or BNP, depending on the availability at each site using the same parameter throughout the follow up of each patient). Levels will be measured during the screening process (the first assessment will be done, at least one day before surgery), on the second day after surgery and at 6 and 12 months after product administration.

C reactive protein (CRP) levels will be assessed prior to surgery (the first assessment will be done during the screening process, repeated prior to surgery), at hospital discharge, and 1 month after product administration.

Incidence of subacute pericardial inflammation or constrictive physiology as assessed by echocardiography and cardiac magnetic resonance imaging (CMRI) at months 1, 6 and 12 after treatment. The first assessment will be done during the screening process.

The following immunological analysis will be performed: B Lymphocytes, NK Lymphocytes (CD16+), T Lymphocytes (CD3+), Th Lymphocytes (CD4+), Activated Th Lymphocytes (CD4+DR+), Treg Lymphocytes (CD4+CD25+), Treg Lymphocytes (CD4+CD25+), Activated Treg Lymphocytes (CD4+CD25+DR+), Cytotoxic T Lymphocytes (CD8+), Activated Cytotoxic T Lymphocytes (CD8+DR+), Cytotoxic Treg Lymphocytes (CD8+CD25+), Activated Cytotoxic Treg Lymphocytes (CD8+CD25+DR+), Albumin, Alpha globulin, Beta globulin, Gamma globulin, IgG, IgM and anti-HLA antibodies (the first assessment will be done during the screening process) at discharge (at discharge excluding Serum Cytokines and anti-HLA antibodies) and 1 month after product administration.

Absolute change in scar size expressed as percentage of left ventricular mass (i.e. scar mass corrected for total left ventricular mass), absolute change in percentage of viable left ventricular mass (i.e. viable mass corrected for total left ventricular mass), absolute change in total scar size (expressed in grams), and absolute change in viable mass (expressed in grams).

Biomechanical parameters of the left ventricle: end systolic volume, end diastolic volume, ejection fraction, segmental contractility, and segmental wall thickness. All values will be obtained by CMRI analysis.

Biomechanical parameters of the left ventricle: end systolic volume, end diastolic volume, ejection fraction, segmental contractility, and segmental wall thickness. All values will be obtained by CMRI analysis.

Biomechanical parameters of the left ventricle: end systolic volume, end diastolic volume, ejection fraction, segmental contractility, and segmental wall thickness. All values will be obtained by CMRI analysis.

Biomechanical parameters of the left ventricle: end systolic volume, end diastolic volume, ejection fraction, segmental contractility, and segmental wall thickness. All values will be obtained by CMRI analysis.

Biomechanical parameters of the left ventricle: end systolic volume, end diastolic volume, ejection fraction, segmental contractility, and segmental wall thickness. All values will be obtained by CMRI analysis.