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Clinical Trial Report

Gene Therapy Trial Report

Summary

Angiogenesis and Blood Perfusion Effect of HGF Gene Therapy in PAD Patients

NCTID NCT05968118 (View at clinicaltrials.gov)
Description
Development Status Active
Indication Peripheral Artery Disease
Disease Ontology Term DOID:0050830
Compound Name NL003
Compound Description pCK-HGF-X7
Sponsor Beijing Northland Biotech. Co., Ltd.
Funder Type Industry
Recruitment Status
Recruiting
Enrollment Count 36
Results Posted Not Available

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
Drug Product Type Plasmid
Target Tissue/Cell
Delivery System None (naked plasmid)
Vector Type
Editor Type
Dose 1 Concentration: 0.5mg/1ml (32 sites x 0.5ml), Total 8mg
Dose 2
Dose 3
Dose 4
Dose 5

Study Record Dates

Current Stage Phase3
Submit Date 2023-01-04
Completion Date 2023-10-31
Last Update 2023-08-01

Participation Criteria

Eligible Age 18 Years - 80 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL

Locations

No.of Trial Sites 1
Locations China

Regulatory Information

Has US IND False
FDA Designations
Recent Updates Same product as VM202

Resources/Links

Clinical Publications