Safety Study of Gene Therapy for Ischemic Heart Disease in Korea

NCTID	NCT01422772 (View at clinicaltrials.gov)
Description	The purpose of this study is to evaluate the safety of VM202 (Engensis) direct injection into the cardiac muscles of the coronary artery territory where complete revascularization could not be done even through Coronary Artery Bypass Graft (CABG). (Show More)
Development Status	Active
Indication	Ischemic Heart Disease
Disease Ontology Term	DOID:3393
Compound Name	ENGENSIS
Compound Alias	donaperminogene seltoplasmid, VM202
Compound Description	pCK-HGF-X7, HGF 728, HGF723 isoforms
Sponsor	Helixmith Co., Ltd.
Funder Type	Industry
Recruitment Status	Completed
Enrollment Count	9 (ACTUAL)
Results Posted	View Results

Target Gene/Variant	HGF
Therapy Type	Gene transfer
Therapy Route	In-vivo
Mechanism of Action	Overexpression of protective allele/gene
Route of Administration	Intramyocardial
Drug Product Type	Plasmid
Target Tissue/Cell
Delivery System	None (naked plasmid)
Vector Type	none
Editor Type	none
Dose 1	0.5mg/1ml (4 sites)
Dose 2	1mg/2ml (8 sites)
Dose 3	2mg/4ml (8 sites)
Dose 4
Dose 5

No.of Trial Sites	1
Locations	South Korea