Randomized Study of Coronary Revascularization Surgery With Injection of WJ-MSCs and Placement of an Epicardial Extracellular Matrix

Launched by HOSPITAL SAN VICENTE FUNDACIÓN · Jul 4, 2019

Keywords

ClinConnect Summary

A randomized clinical trial will be conducted as a proof of concept in 40 patients with previous myocardial infarction and a viable myocardial zone with indications for coronary artery bypass grafts. Twenty patients will be included in each treatment arm over 36 months. One group will undergo revascularization surgery, extracellular matrix patch placement and injection of cell culture medium; the other group will undergo revascularization surgery, extracellular matrix patch placement on the epicardial surface with cultured WJ-MSCs and injection of WJ-MSCs around the infarcted zone.

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Eligibility criteria

• Inclusion Criteria:
• • Patients with a diagnosis of coronary disease, performed by coronary angiography, requiring conventional coronary revascularization surgery
• • History of myocardial infarction; evidence of akinesia or regional dyskinesia more than 1 week old
• • Ejection fraction less than 40%
• • Age between 30 and 75 years
• • Negative serology for HIV, hepatitis B virus (HBV), and hepatitis C virus HCV
• • Negative pregnancy test for women of childbearing age
• • Patients who sign the informed consent complying with all of the provisions of current regulations in Colombia
• Exclusion Criteria:
• • History of myocardial infarction with ST-segment elevation within 2 weeks prior to surgery
• • History of myocardial infarction without ST-segment elevation within the previous week (the decision to include these patients within the first week after suffering a non-ST elevation infarction is at the discretion of the research team)
• • Previous history of tachycardia or ventricular fibrillation
• • History of active neoplasia or previous chemotherapy treatment
• • Severe or uncontrolled concomitant disease (i.e., poorly controlled chronic kidney or liver failure)
• • Patients who, due to their place of residence, mental health or social situation, have difficulty meeting the conditions of the protocol
• • Women who are pregnant or breast-feeding
• • Patients or legal representatives withdrawing informed consent at any time during the study.
• • Previous history of heart transplant
• • Patients with functional organ impairment: liver function: total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase greater than 2 times the upper reference limit; kidney function: serum creatinine \> 1.5 mg/dl or creatinine clearance \< 60 ml/min.