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
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)

No.of Trial Sites	1
Locations	South Korea