Ignite Creation Date:
2024-05-06 @ 2:18 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04275323
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2020-01-18
Brief Title:
Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia NL003-CLI-III-1
Sponsor:
Beijing Northland Biotech Co Ltd
Organization:
Beijing Northland Biotech Co Ltd
Study Overview
Official Title:
A Phase III Double-Blind Randomized Placebo-Controlled Multicenter Study to Assess the Safety and Efficacy of NL003 in Subject With Critical Limb IschemiaRutherford 4
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Management of CLI process consumes a significant amount of healthcare resourcesand the new therapeutic approaches are required
Hepatocyte growth factor HGF has been shown to be a potent angiogenic growth factor stimulating the growth of endothelial cells and migration of vascular smooth muscle cells Because of its pluripotent capabilities increasing the availability of HGF in ischemic tissues to achieve therapeutic angiogenesis has been a growing area of research
This study will use NL003 which is a DNA plasmid that contains novel genomic cDNA hybrid human HGF coding sequence HGF-X7 expressing two isoforms of HGF HGF 728 and HGF 723 As there are currently no approved drugs that can reverse CLI and as most patients have exhausted surgical and endovascular intervention options inducing angiogenesis in the affected limb with NL003 may result in an increase in tissue perfusion which in turn improve wound healing reduce pain and improve limb salvage rates
Hepatocyte growth factor HGF has been shown to be a potent angiogenic growth factor stimulating the growth of endothelial cells and migration of vascular smooth muscle cells Because of its pluripotent capabilities increasing the availability of HGF in ischemic tissues to achieve therapeutic angiogenesis has been a growing area of research
This study will use NL003 which is a DNA plasmid that contains novel genomic cDNA hybrid human HGF coding sequence HGF-X7 expressing two isoforms of HGF HGF 728 and HGF 723 As there are currently no approved drugs that can reverse CLI and as most patients have exhausted surgical and endovascular intervention options inducing angiogenesis in the affected limb with NL003 may result in an increase in tissue perfusion which in turn improve wound healing reduce pain and improve limb salvage rates
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None