Stem cell therapy for cardiac dysfunction

Matar, Amer A; Chong, James JH

doi:10.1186/2193-1801-3-440

SpringerPlus

Table 1 Recent and ongoing clinical trials involving extra-cardiac stem cells in patients with ischemic cardiomyopathy

From: Stem cell therapy for cardiac dysfunction

Trial name/Investigator	Study identifier	Comparators	Endpoint	Patients	Delivery route	Type classification
SKMs
MARVEL	NCT00526253	Low dose vs high dose vs placebo	Safety + QOL	170	Intramyocardial	Safety + efficacy, Phase 1/2
BMCs
REPAIR-AMI*	NCT00279175	BMC vs placebo	LVEF	204	Intracoronary	Efficacy, Phase 3
REGEN-IHD	NCT00747708	Intracoronary BMC + G-CSF vs intramyocardial BMC + G-CSF vs G-CSF vs placebo	LVEF	148	Intracoronary/Intramyocardial	Safety + efficacy, Phase 2/3
BAMI	NCT01569178	BMC vs no intervention	All-cause mortality	3000	Intramyocardial	Safety + efficacy, Phase 3
REPEAT	NCT01693042	Single vs repeated (2 times) BMC infusions	Mortality + morbidity	676	Intracoronary	Safety + efficacy, Phase 2/3
FOCUS*	NCT00824005	BMMNC vs placebo	LVESV	92	Intramyocardial	Safety + efficacy, Phase 2
ASSURANCE	NCT00869024	BMMNCs infusion	Mortality + morbidity	24	Intramyocardial	Safety, Phase 1/2
REVITALIZE	NCT00874354	BMMNCs infusion	LVEF	30	Intracoronary	Safety + efficacy, Phase 1
EPCs/CD133+ Cells
PERFECT*	NCT00950274	CD133+ vs placebo	LVEF	142	Intramyocardial	Efficacy, Phase 3
Cardio133*	NCT00462774	CD133+ vs placebo	LVEF	60	Intramyocardial	Efficacy, Phase 2/3
IMPACT-CABG	NCT01033617	CD133+ vs placebo	SAE	20	Intramyocardial	Safety + efficacy, Phase 2
AlsterMACS	NCT01337011	Intracoronary vs intramyocardial CD133+ infusions	LVEF	64	Intracoronary/Intramyocardial	Efficacy, Phase 1/2
SELECT-AMI	NCT00529932	CD133+ vs placebo	LV wall thickness	60	Intracoronary	Safety + efficacy
EPCs/CD133+ Cells vs BMCs
Baharvand et al.	NCT01167751	BMMNC vs CD133+ vs placebo infusions	LVEF	105	Intracoronary	Safety + efficacy, Phase 3
Ghassemi et al.	NCT01187654	BMMNC vs CD133+ vs placebo infusions	LVEF	80	Intracoronary	Safety + efficacy, Phase 2/3
MSCs
Adipose Tissue MSCs
ATHENA	NCT01556022	MSCs vs placebo	SAE + LVEF	45	Intramyocardial	Safety + efficacy, Phase 2
ADVANCE	NCT01216995	MSCs vs placebo	SAE + Infarct size	216	Intracoronary	Safety + efficacy, Phase 2
Parcero et al.	NCT01502514	MSCs infusion	QOL	10	Intramyocardial	Safety + efficacy, Phase 1/2
Umbilical Cord MSCs
Yan et al.	NCT01946048	MSCs vs placebo	LVEF	10	Intramyocardial	Safety + efficacy, Phase 1
Bone Marrow MSCs
ESTIMATION	NCT01394432	MSCs vs placebo	LVESV	50	Intramyocardial	Efficacy, Phase 3
SEED-MSC	NCT01392105	MSCs vs no intervention	LVEF	80	Intracoronary	Safety + efficacy, Phase 2/3
Anastasiadis et al.	NCT01753440	Allogeneic MSCs	LVEF	30	Intramyocardial	Safety + efficacy, Phase 2/3
Anastasiadis et al.	NCT01759212	Allogeneic MSCs	LVF	10	Intramyocardial	Safety + efficacy, Phase 2/3
Perin et al.	NCT00555828	25 vs 75 vs 150 million allogeneic MSCs vs placebo	Safety + LVF	25	Intramyocardial	Safety + efficacy, Phase 1/2
PROMETHEUS*	NCT00587990	Low vs high dose MSCs vs placebo	SAE	45	Intramyocardial	Safety + efficacy, Phase 1/2
MESAMI	NCT01076920	MSCs infusion	Safety + LVF	10	Intramyocardial	Safety, Phase 1/2
MSC-HF	NCT00644410	MSCs vs placebo	LVF	60	Intramyocardial	Safety + efficacy, Phase 1/2
Allogeneic vs Autologous MSCs
POSEIDON-Pilot*	NCT01087996	Auto-MSCs (20, 100 or 200 million) vs Allo-MSCs (20, 100 or 200 million)	SAE + LVF	30	Intramyocardial	Safety + efficacy, Phase 1/2
BMCs vs MSCs
TAC-HFT*	NCT00768066	MSCs (100 or 200 million) vs BMCs (100 or 200 million) vs placebo	SAE + LVF	67	Intramyocardial	Safety + efficacy, Phase 1/2

All trials use autologous infusions unless otherwise stated. BMC-Bone Marrow Stem Cell, BMMNC-Bone Marrow Mononuclear Cell, EPC-Endothelial Progenitor Cell, G-CSF-Granulocyte-Colony Stimulating Factor, LVEF-Left Ventricular Ejection Fraction, LVESV-Left Ventricular End Systolic Volume, LVF-Left Ventricular Function, MSC-Mesenchymal Stem Cell, QOL-Quality of Life, SAE-Serious Adverse Events, SKM-Skeletal Myoblast.
*Denotes trials with published results (including preliminary results).

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