Ischemic Cardiomyopathy Clinical Trial
Official title:
Randomised, Double-blind, Placebo-controlled, Intracoronary or Intravenous Infusion Human Wharton' Jelly-derived Mesenchymal Stem Cells in Patients With Ischemic Cardiomyopathy
The purpose of this study is to investigate the safety and efficacy of intracoronary or intravenous infusion human umbilical Wharton's jelly-derived Mesenchymal Stem Cell (WJMSC) in patients with ischemic cardiomyopathy secondary to myocardial infarction.
Ischemic heart failure (IHF) secondary to myocardial infarction is a common, lethal,
disabling, and expensive condition. Despite advances over the last 30 years, the prognosis of
patients with IHF remains poor. At present, there has been increasing interest in attempting
to repair the failing heart with the use of stem cells, since this approach has the potential
to regenerate dead myocardium and thus alleviate the underlying cause of IHF.
A very primitive population of mesenchymal stem cells (MSCs) has been isolated from a
continuum from the sub-amnion to perivascular region of umbilical cord, referred to as
Wharton's jelly-derived MSCs (WJMSCs). WJMSCs retain a combination of most of their embryonic
stem cell (ESC) and MSC markers in primary culture and early passages, thus retaining their
multipotent stem cell characteristics. Preclinical studies have demonstrated that WJMSCs can
be induced to differentiate into cardiomyocytes and endothelial cells and to integrate into
the vasculature and ischemic cardiac tissue, as well as to improve heart function
significantly. Therefore, the investigators performed a double-blind, placebo-controlled
trial, randomly assigning 160 patients with ischemic heart failure secondary to myocardial
infarction to receive an intracoronary or intravenous infusion of WJMSCs or placebo, to
investigate the therapeutic safety and efficacy of WJMSCs in patients with ischemic
cardiomyopathy.
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