Phases I–III Clinical Trials Using Adult Stem Cells

Table 1

Randomized clinical trials with stem cells in patients with acute myocardial infarction (intracoronary delivery).

Trial (year)	$n$	Cell type	Cell count	Days after AMI	Primary endpoint (followup)	Comments
Chen [2] (2004)	69	MSC	9 $\times$ 10^9	18	Improved LVEF at 6 m	LVEF by echocardiography
BOOST [3] (2004)	60	BMMC	2 $\times$ 10^9	6 $\pm$ 1	Improved LVEF at 6 m	Effect diminished after 18/61 m
REPAIR-AMI [4] (2006)	187	BMMC	2 $\times$ 10^8	3–6	Improved LVEF at 4 m	LVEF by ventriculography
Janssens [5] (2006)	66	BMMC	2 $\times$ 10^8	1	No change LVEF at 4 m	Improved regional contractility and reduction in infarct size
ASTAMI [6] (2006)	97	BMMC	7 $\times$ 10^7	6 $\pm$ 1	No change LVEF at 6 m	LVEF $\uparrow$8% by SPECT, $\uparrow$1% by MRI
TCT-STAMI [7] (2006)	20	BMMC	4 $\times$ 10^7	1	Improved LVEF at 6 m	LVEF by echocardiography
FINCELL [8] (2008)	77	BMMC	4 $\times$ 10^8	3	Improved LVEF at 6 m	LVEF by ventriculography
Meluzin [9] (2006)	66	BMMC	1 $\times$ 10^7 (low d)1 $\times$ 10^8 (high d)	7	Improved LVEF at 3 m in high dose group	LVEF by SPECT
Penicka [10] (2007)	27	BMMC	3 $\times$ 10^9	9	No change LVEF at 4 m	LVEF by echocardiography
HEBE [11] (2008)	189	BMMC versus PBC	—	3–8	No changes in global or regional LV function	Final results pending
REGENT [12] (2009)	117	BMMC (unselected, CD34^+/CXCR4^+)	2 $\times$ 10^8 (unsel), 2 $\times$ 10^6 (CD34^+)	3–12	Improved LVEF with both cell types	LVEF by MRI (in 117/200 patients)

MSC: mesenchymal stem cells (bone marrow origin); BMMC: bone marrow mononuclear cells; PBC: peripheral blood cells; LVEF: left ventricular ejection fraction; LV: left ventricle; SPECT: single-photon emission computed tomography; MRI: magnetic resonance imaging.