scorem-cellsRevascularization Surgery with Wharton's Jelly-derived Mesenchymal Cells and Epicardial Extracellular Matrix Patch for Ischemic Cardiomyopathy
This study aims to evaluate the safety and effectiveness of Revascularization Surgery using Wharton's Jelly-derived Mesenchymal Cells and an Epicardial Extracellular Matrix Patch in improving heart function for individuals with Ischemic Cardiomyopathy, focusing on improvements in diastolic and systolic volumes, left ventricular ejection fraction, and reduction in ventricular arrhythmias.
Wharton's jelly-derived mesenchymal cells
Arterial Occlusive Diseases+7
+ Arteriosclerosis
+ Cardiovascular Diseases
Treatment Study
Summary
Study start date: July 2, 2019
Actual date on which the first participant was enrolled.This clinical trial is a treatment study for individuals who have previously experienced a heart attack and have a viable area of heart muscle that requires bypass surgery. The study aims to test the effectiveness of coronary revascularization surgery combined with two different treatment approaches. One approach involves the placement of an extracellular matrix patch and injection of a cell culture medium. The other approach involves the placement of an extracellular matrix patch seeded with Wharton's Jelly-derived Mesenchymal Cells (WJ-MSCs) and injection of WJ-MSCs around the area of the heart attack. The goal is to see if these treatments can improve heart function and reduce complications associated with heart disease. The study will include 40 participants, with 20 in each treatment group over a period of 36 months. Participants will be randomly assigned to one of the two treatment groups. The treatment allocation will be determined by a random number generator and will only be known by the tissue bank providing the treatment materials. The study will measure the improvement in final diastolic and systolic volumes, left ventricular ejection fraction (LVEF), left ventricular viability, and the incidence of ventricular arrhythmias. These measurements will be taken using transthoracic echocardiography and cardiac MRI.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 30 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location