Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia

NCTID	NCT01064440 (View at clinicaltrials.gov)
Description	The purpose of this study is to evaluate whether intramuscular injections of VM202 into the calf is safe and effective in the treatment of critical limb ischemia. (Show More)
Development Status	Active
Indication	Critical Limb Ischemia
Disease Ontology Term	DOID:0050852
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	52
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	Intramuscular (gastrocnemius)
Drug Product Type	Plasmid
Target Tissue/Cell
Delivery System	None (naked plasmid)
Vector Type
Editor Type
Dose 1	2,4,8,16 mg total dose
Dose 2	Total dose: 8mg, 16mg
Dose 3	Total dose: 4mg/8ml, 8mg/16ml, 12mg/24ml, 16mg/32ml; concentration: 0.25/0.5ml, injections/day x 2 days: 8, 16, 24, 32
Dose 4
Dose 5

No.of Trial Sites	16
Locations	United States,Korea, Republic of