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Clinical Trial Report

Gene Therapy Trial Report

Summary

Hepatocyte Growth Factor to Improve Functioning in PAD


NCTID NCT03363165 (View at clinicaltrials.gov)
Description
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