Contact SCGE
Your email
Message
Send
SCGE Consortium Home
About SCGE TCDC
Contact Us
License
Home
Gene Therapy Trial Browser
Clinical Trial Report
Gene Therapy Trial Report
Summary
Safety and Efficacy Study of Engensis (VM202) in the Treatment of Chronic Non-Healing Foot Ulcers
NCTID
NCT02563522
(View at clinicaltrials.gov)
Description
This study will assess the safety and efficacy of using gene therapy via intramuscular injections of the calf for patients with chronic non-healing foot ulcers.
(Show More)
Development Status
Active
Indication
Diabetic Foot Ulcer
Disease Ontology Term
DOID:8529
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
Terminated
Enrollment Count
44
Results Posted
View Results
Therapy Information
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
4mg (dose/day) * 4 treatment days
Dose 2
Dose 3
Dose 4
Dose 5
Study Record Dates
Current Stage
Phase3
Submit Date
2015-09-28
Completion Date
2019-09-24
Last Update
2025-03-28
Participation Criteria
Eligible Age
18 Years - 80 Years
Standard Ages
Adult, Older adult
Sexes Eligible for Study
ALL
Locations
No.of Trial Sites
22
Locations
United States
Regulatory Information
Has US IND
True
FDA Designations
Recent Updates
Same product as NL003
Resources/Links
Clinical Publications
Gene therapy for diabetic foot ulcers: Interim analysis of a randomised, placebo-controlled phase 3 study of VM202 (ENGENSIS), a plasmid DNA expressing two isoforms of human hepatocyte growth factor