Ignite Creation Date:
2024-05-06 @ 12:20 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01548378
Status:
COMPLETED
Last Update Posted:
2020-01-22
First Post:
2012-03-05
Brief Title:
Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia
Sponsor:
Beijing Northland Biotech Co Ltd
Organization:
Beijing Northland Biotech Co Ltd
Study Overview
Official Title:
A Phase II Double-Blind Randomized Placebo-Controlled Multicenter Study to Assess the Safety and Efficacy of NL003 in Subject With Critical Limb Ischemia
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
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:
NL003CLI-II
Brief Summary:
The purpose of this study is to evaluate whether intramuscular injections of NL003 into the calf is safe and effective in the treatment of critical limb ischemia
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?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None