Table 2.

Clinical trials on dilated and ischemic cardiomyopathy.

Condition	Population	Study Design	Outcomes	Major Adverse Events	Ref
DCM	55 pts (>18 yrs old), DCM, LVEF < 30%, NYHA Class ≥ III for 3 mo before referral, on OMT for at least 6 mo.	Phase II, open-label, RCT. Intracoronary infusion of autologous CD34+ cells (average 123 ± 23 × 106) vs no infusion.	Significant improvement in LVEF and 6 MWT distance in treated pts vs ctrl group at 3 and 12 mo. Significant reduction in cardiac mortality/heart transplantation in treated pts vs ctrl group at 12 mo.	No major procedure-related complications. No effects of transplanted stem cells on QTc interval and QT interval variability.	[148]
	110 pts (18–65 yrs old), DCM, LVEF < 30%, NYHA Class III for 3 mo before referral, on OMT for at least 6 mo.	Phase II, open-label, RCT. Intracoronary infusion of autologous CD34+ cells (average 113 ± 26 × 106) vs no infusion.	Significant improvement in LVEF and 6 MWT distance in treated patients vs control group at 60 months. Significant reduction in total mortality in treated patients vs control group at 60 months (14% vs 35%).	No major procedure-related complications.	[149]
ICM	33 pts (>18 yrs old), ICM, no amenable to revascularization, LVEF < 40%, NYHA Class III for 3 mo before referral.	Phase II crossover study. In phase I, patients were treated for 6 mo with OMT. Thereafter, they crossed over to phase II where they received intramyocardial injection of autologous CD34+ cells (average 90.6 ± 7.5 × 106).	No significant improvement in LVEF and 6MWT distance after OMT, significant improvement 6 mo after cell injection.	2 deaths during phase I	[150]

Abbreviations: 6MWT= 6-Minute Walking Test; DCM = dilated cardiomyopathy; ICM = ischemic cardiomyopathy; LVEF = left ventricular ejection fraction; NYHA = New York Heart Association; OMT = optimal medical therapy; RCT = randomized controlled trial.