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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
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