Study to Assess Safety and Efficacy of Engensis in Painful Diabetic Peripheral Neuropathy

NCTID	NCT04469270 (View at clinicaltrials.gov)
Description	The purpose of this study is to evaluate the efficacy and safety of intramuscular administration of Engensis on pain in participants with painful diabetic peripheral neuropathy in the feet and lower legs, as compared to Placebo, as a second Phase 3, well controlled study, sufficient in supporting the efficacy and safety of Engensis. (Show More)
Development Status	Active
Indication	Diabetic Neuropathy
Disease Ontology Term	DOID:9743
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	Completed
Enrollment Count	162
Results Posted	View Results

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	Total dose: 4mg or 8mg or 16mg (injections divided on day 0 and day 14)
Dose 2	Total dose: 16mg/32 x 0.5ml injections/gastrocnemius
Dose 3	Total dose: 32mg/32 x 0.5ml injections/gastrocnemius
Dose 4	Total dose: 32mg, concentration: 0.25mg/0.5ml, 16injections/day, 4 days: 0, 14 ,90, 104, bilateral gastroc.
Dose 5

No.of Trial Sites	16
Locations	United States

Has US IND	True
FDA Designations	Regenerative Medicine Advanced Therapy
Recent Updates	Same product as NL003