Biomedical Engineering Reference
In-Depth Information
Figure 3.1
The black and brown lines represent the number of clinical
trials of acute ischemia/AMI and chronic ischemia/congestive
heart failure. Clinical trials in humans from the period 2002-
2010 (source: clinicaltrials.gov).
SkMs have been used in heart failure patients with transepicardial
injection during coronary bypass surgery. Although there were no
changes in regional contractility, LV end-diastolic and end-systolic
volumes were decreased in the high-dose group [51]. Similar results
were reported by Dib et al. [52] by the evaluation of the LVEF and
viability at six months after SkM transendocardial injection. Most
of clinical studies focused on acute cardiomyopaties employed as a
cell source mainly BM-derived cells and those focused on chronic
cardiomyopaties mainly SkMs. Recently other cell types started
to be used, for example, adipose-derived MSCs and CPCs. The first
cell type has been used in two clinical studies (the PRECISE trial
[NCT00426868], which is a randomized, controlled clinical trial
using non-cultured adipose stromal vascular fraction cells, tested the
effect of intramyocardial delivery in patients with chronic ischemic
cardiomyopathy, and the APOLLO trial [NCT00442806], which
is a double-blind, placebo-controlled trial evaluating the safety
(defined as major adverse cardiac and cerebral events at 6 months)
of intracoronary infusion of autologous adipose-derived stem and
regenerative cells (ADRCs) in acute MI patients after successful
revascularization), both started in 2007 and currently ongoing.
The first study focuses on the use of ADSCs in patients who have
areas of myocardium not revascularizable and have demonstrated
reversible ischemia, and the second is targeted for patients who
have suffered an ST-elevation AMI. Currently CPCs are employed
in three clinical trials started in 2007 (SCIPIO trial [SCIPIO: Stem
