Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-1)

NCTID	NCT04275323 (View at clinicaltrials.gov)
Description	To evaluate the safety and efficacy of recombinant human hepatocyte growth factor (HGF) bare plasmid injection for local intramuscular injection in the treatment of patients with severe lower limb hemorrhagic disease (Rutherford grade 4) (Show More)
Development Status	Active
Indication	Critical Limb Ischemia
Disease Ontology Term	DOID:0050852
Compound Name	NL003
Compound Description	pCK-HGF-X7
Sponsor	Beijing Northland Biotech. Co., Ltd.
Funder Type	Industry
Recruitment Status	Completed
Enrollment Count	302
Results Posted	Not Available

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	Total dose: 12mg
Dose 3	Total dose: 18mg
Dose 4	Total dose: 24mg
Dose 5

No.of Trial Sites	13
Locations	China