Pericardial Matrix With Mesenchymal Stem Cells for the Treatment of Patients With Infarcted Myocardial Tissue (PERISCOPE)
Myocardial Infarction
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring Cardiac repair, Wharton jelly mesenchymal stem cells, Chronic myocardial infarction, Tissue engineering, Cell therapy, Clinical trial
Eligibility Criteria
Inclusion Criteria:
- Myocardial infarction of ≥50% of transmurally due to MR
- Candidate for coronary by-pass through that or another territory
- Age ≥18 years
- Signature of informed consent
- Wave Q present in the ECG
- Followed by the cardiology service of Germans Trial i Pujol hospital
Exclusion Criteria:
- Severe valvular disease with indication of surgical repair
- Candidate for ventricular remodeling
- Contraindication for MR (creatinine clearance less than 30 ml / min / 1.73m2, metallic implant carriers, claustrophobia)
- Extracardiac disease with estimated life expectancy less than 1 year
- Neoplastic disease detected in the last five years or without complete remission
- Severe renal or hepatic insufficiency
- Abnormal laboratory values, not explainable at the time of inclusion, and that at the discretion of the investigator contraindicate the patient's participation in the study
- Patients with a previous cardiac intervention
- Women who are pregnant or breast-feeding.
- Women of childbearing age who are heterosexually active and who do not use an effective contraceptive method from 14 days before the inclusion in the study and at least up to 12 weeks after the end of the study.
- Simultaneous participation in another clinical trial or treatment with another product in investigational phase in the 30 days prior to inclusion in the study.
- Negation of the patient to be followed by a period that exceeds the clinical trial itself (long-term follow-up in the second and third year).
Sites / Locations
- Hospital Universitari Germans Trias i Pujol
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Experimental group
Control group
The patient will undergo surgery by sternotomy to perform the surgical revascularization of the arteries candidates for revascularization. In addition, the matrix-cell (PeriCord) construct will be placed on the ischemic area of the non-candidate revascularization area and will be fixed using surgical glue. PeriCord: Expanded and cryopreserved allogeneic umbilical cord Wharton´s jelly-derived adult mesenchymal stem cells colonized on human pericardial matrix .
The patient will undergo surgery by sternotomy to perform the surgical revascularization of the arteries candidates for revascularization. No additional procedure will be performed.