Table 1.

Gene Therapy Clinical Trials in Cardiac Surgery

Therapeutic Target	Transgene	Route	Vector	Number of Patients	Phase	Procedure	Status	Results	End Points	Follow-Up	Reference/Identifier
Angiogenesis	VEGF 121	intramyocardial	adenovirus	31	1	CABG + minithoracotomy	completed	positive	angina class, survival, safety	11.8 years	[10, 11]
Angiogenesis	VEGF 165	intramyocardial	plasmid	22	1	CABG + minithoracotomy	completed	positive	EF, myocardial perfusion, angiogram	short term	[12]
Angiogenesis	HIF-1	intramyocardial	adenovirus	13	1	CABG	completed	positive in selected patients	SPECT perfusion, ECHO,MRI, PET	1 year	[13]
Angiogenesis	VEGF 165+arginine	intramyocardial	plasmid	19	1	CABG	completed	positive	PET perfusion, ECHO	3 mo	[14] NCT00134433
Angiogenesis	HGF (VM 202RY)	intramyocardial	plasmid	9	1	CABG	completed	positive	Myocardial perfusion, ECHO, MRI	6 mo	[15] NCT01422772
Angiogenesis	HIF-1	intramyocardial	adenovirus	N/A	1	CABG	withdrawn	N/A	N/A	N/A	US-0374
Angiogenesis	VEGF 121	intramyocardial	adenovirus		1, 2	off-pump CABG	closed	N/A	N/A	N/A	US-0442
Vein graft failure	Edifoligide	preimplantation	ODN	200	2	CABG	completed	positive in selected patients	vein graft failure	1 year	[16]
Vein graft failure	Edifoligide	preimplantation	ODN	2400	3	CABG	completed	no effect	vein graft failure	18 mo	[17] NCT00042081
Vein graft failure	AV1–5126	preimplantation	ODN	n/a	1, 2	CABG	terminated	N/A	vein graft failure	1 year	NCT00451256

AAV = adeno-associated virus; CABG = coronary artery bypass grafting; ECHO = echocardiography; EF = ejection fraction; HGF = hepatocyte growth factor; HIF-1 = hypoxia inducible factor; MRI = magnetic resonance imaging; N/A = not available; NCT = clinicaltrials.gov identifier; ODN = oligodeoxynucleotides; PET = positron emission tomography; SPECT = single-photon emission computed tomography; US-0374,0442 =http://www.wiley.com//legacy/wileychi/genmed/clinical/identifier; VEGF = vascular endothelial growth factor.