Coronary Artery Disease Clinical Trial
Official title:
Randomized Study as Proof of Concept of Coronary Revascularization Surgery With Injection of Wharton's Jelly-derived Mesenchymal Cells and Placement of an Epicardial Extracellular Matrix Patch Seeded With WJ-MSCs in Patients With Ischemic Cardiomyopathy
Ischemic heart disease is one of the most important causes of mortality and morbidity in the
Western world and is a public health problem. Among ischemic heart diseases, myocardial
infarction has specific significance because the cardiac muscle does not have sufficient and
adequate capacity to regenerate; therefore, necrosis of a region leads to the formation of a
fibrous scar. Infarction can lead to a progressive and irreversible decrease in cardiac
function, resulting in heart failure (HF) syndrome, depending on the area affected by this
scar, via a ventricular remodeling mechanism.
In recent years, HF has been revealed as a major public health problem due to its incidence
and its social, economic and especially human impact, as it represents a serious limitation
of the quality of life of individuals. The prevalence of HF in the general population of the
United States and the United Kingdom is approximately 1%, and in those older than 75 years,
the prevalence varies between 5 and 10%. Regarding its prognosis, recent data from the
Framingham Study indicate that at 5 years, the mortality rate of HF is 75% in men and 62% in
women; the mean mortality rate of all cancers is 50%.
The molecular basis of congestive HF is the absence of cardiac cells capable of regenerating
the heart muscle. Despite the publication of recent studies suggesting the existence of stem
cells capable of regenerating cardiomyocytes destroyed because of myocardial infarction, in
humans, the capacity of these cells is insufficient to replace the cells destroyed due to
necrosis secondary to ischemia.
In recent years, the accumulation of results derived from preclinical studies has allowed the
development of the first clinical trials of the feasibility and safety of cardiac
regeneration using cellular therapy. Several studies have shown that t cells exist in adult
bone marrow, such as mesenchymal stem cells, hematopoietic stem cells and, more recently,
multipotent stem cells (MAPC), with the ability to differentiate into endothelial tissue and
cardiac muscle, which can contribute to the regeneration of damaged myocardial tissue and
improve cardiac function in animal infarction models. However, cell therapy research has
moved rapidly toward the use of more undifferentiated cells rather than hematopoietic
lineages, such as mesenchymal cells. These cells can be obtained from different sources, with
a tendency toward the use of characterized allogeneic cells, which are immediately available
in the potential recipient. Given that this type of therapy has not been rigorously
investigated in Latin America, we aim to determine the effect of therapy using Wharton's
jelly-derived mesenchymal cells (WJ-MSCs) from the human umbilical cord on neomyogenesis in
patients with previous myocardial infarction who are undergoing open revascularization. Our
hospital has some experience with regenerative therapy, both in patients with acute
myocardial infarction and chronic infarction, with encouraging results that support this new
phase of inter-institutional research.
Objective: To evaluate the safety and estimate the effect of coronary revascularization
accompanied by intramyocardial injection of WJ-MSCs and the placement of an extracellular
matrix patch seeded with WJ-MSCs compared to coronary revascularization accompanied by
injection of culture medium without the presence of WJ-MSC and placement of an extracellular
matrix patch without seeding with WJ-MSC on global and regional cardiac function, myocardial
viability and the incidence of adverse effects determined as ventricular arrhythmias.
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.
The allocation of treatments will be defined by block sizes of 2, 4 and 6, randomly
determined by a random number generator (ralloc, Stata Co. 8,2). This assignment will only be
known by the tissue bank that will deliver the syringes with the solution to be administered
and the epicardium patches to the study participants.
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