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Gene Therapy Trial Browser
Clinical Trial Report
Gene Therapy Trial Report
Summary
Hepatocyte Growth Factor to Improve Functioning in PAD
NCTID
NCT03363165
(View at clinicaltrials.gov)
Description
HI-PAD is a placebo controlled double-blind randomized pilot clinical trial to determine whether VM202 may improve walking ability in people with lower extremity peripheral artery disease (PAD).
(Show More)
Development Status
Active
Indication
Peripheral Artery Disease
Disease Ontology Term
DOID:0050830
Compound Name
ENGENSIS
Compound Alias
donaperminogene seltoplasmid, VM202
Compound Description
pCK-HGF-X7 (HGF 728, HGF723 isoforms)
Sponsor
Northwestern University
Funder Type
Other
Recruitment Status
Completed
Enrollment Count
39
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/leg/day) * 4 treatment days
Dose 2
Dose 3
Dose 4
Dose 5
Study Record Dates
Current Stage
Phase2
Submit Date
2017-11-30
Completion Date
2023-09-05
Last Update
2024-05-30
Participation Criteria
Eligible Age
>=55 Years
Standard Ages
Adult, Older adult
Sexes Eligible for Study
ALL
Locations
No.of Trial Sites
1
Locations
United States
Regulatory Information
Has US IND
True
FDA Designations
Recent Updates
Same product as NL003
Resources/Links
Clinical Publications
Hepatocyte growth factor for walking performance in peripheral artery disease
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
Protocol
Clinical Trial Protocol and Statistical Analysis Plan