Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05968118
Status:
RECRUITING
Last Update Posted:
2023-08-01
First Post:
2023-01-04
Brief Title:
Angiogenesis and Blood Perfusion Effect of HGF Gene Therapy in PAD Patients
Sponsor:
Beijing Northland Biotech Co Ltd
Organization:
Beijing Northland Biotech Co Ltd
Study Overview
Official Title:
A Double-Blind Randomized Placebo-Controlled Single Center Study to Assess the Angiogenesis and Blood Perfusion Effect of NL003 in Patients With Critical Limb Ischemia by PETCT-RGD and MIBI
Status:
RECRUITING
Status Verified Date:
2023-07
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:
None
Brief Summary:
The purpose of this study is to evaluate whether PETCT-RGD or MIBI can be used for the angiogenesis assessment of NL003 in PAD patients
Detailed Description:
Hepatocyte growth factor HGF gene therapy has been shown to be a potential choice for CLI patients without surgical option 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 Animal studies showed that NL003 inducing angiogenesis in the affected limb and result in an increase in tissue perfusion Our previous phase II clinical trial has suggested the successful limb-salvaging capacity of NL003 in treatment of patients with CLTI
In this study we will use 68Ga RGD PETCT and 99mTc MIBI SPECT imaging methods to evaluate the effect of NL003 on angiogenesis and lower limb blood flow perfusion during the treatment of chronic lower limb ischemia and evaluated the effectiveness and safety of the drug The subjects will be randomly divided into the investigational drug group and the placebo group in a 11 ratio NL003 or placebo will be injected into the muscle of the affected limb on D0 D14 and D28 05mg05mLsite total 8mg 32 sites PETCT will be measured on D14 D42 before drug administration MIBI SPECT imaging will be collected on D60
In this study we will use 68Ga RGD PETCT and 99mTc MIBI SPECT imaging methods to evaluate the effect of NL003 on angiogenesis and lower limb blood flow perfusion during the treatment of chronic lower limb ischemia and evaluated the effectiveness and safety of the drug The subjects will be randomly divided into the investigational drug group and the placebo group in a 11 ratio NL003 or placebo will be injected into the muscle of the affected limb on D0 D14 and D28 05mg05mLsite total 8mg 32 sites PETCT will be measured on D14 D42 before drug administration MIBI SPECT imaging will be collected on D60
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