Angiogenesis and Blood Perfusion Effect of HGF Gene Therapy in PAD Patients

NCT05968118 | Unknown Phase 3

• 1 other identifier: NL003-PAD-III-3
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate whether PET/CT-RGD or MIBI can be used for the angiogenesis assessment of NL003 in PAD patients.

Conditions

Peripheral Artery Disease

Keywords

Peripheral Artery Disease; Hepatocyte Growth Factor; NL003; Gene therapy; PET/CT-RGD; MIBI

Outcome Measures

Primary Outcomes (2)

• Changes of the new blood vessels number

  changes in the number of new blood vessels measured by PETCT-RGD on D14 and D42, compare with that of the baseline.

  Day 14、Day 42

• Changes of local blood perfusion

  the changes of local blood perfusion measured by MIBI on D60, compare with that of baseline.

  Day 60

Secondary Outcomes (5)

• Changes to the ABI from the baseline

  Day 60

• Laser Speckle Imaging changes in blood flow from the baseline

  Day 60

• Changes of pain score from the baseline

  Day 14、Day 28、Day 42、Day 60、Day 90

• Gangrene /Ulcer changes from the baseline

  Day 14、Day 28、Day 42、Day 60、Day 90

• Changes in quality of life scores from baseline

  Day 60

Study Arms (2)

investigational product

EXPERIMENTAL

Patients in this treatment group will receive 8mg NL003 respective in D0、14、28

Drug: NL003

Placebo

PLACEBO COMPARATOR

Patients in this group will receive normal saline respective in D0、14、28

Drug: Placebo

Interventions

NL003 DRUG

Day 0: 8mg of NL003 (32 injections of 0.5ml of NL003) Day 14: 8mg of NL003 (32 injections of 0.5ml of NL003) Day 28: 8mg of NL003 (32 injections of 0.5ml of NL003)

Also known as: HGF plasmid, pCK-HGF-X7

investigational product

Placebo DRUG

Day 0: 16ml of Normal Saline (32 injections ) Day 14: 16ml of Normal Saline (32 injections ) Day 28: 16ml of Normal Saline (32 injections ) Other Name: Placebo

Also known as: Normal Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years, diagnosed with chronic lower limb ischemia;
• According to DSA or CTA，severe stenosis (≥70%) or occlusion of one or more branches of superficial femoral artery, popliteal artery, anterior tibial artery, posterior tibial artery, and peroneal artery.
• Patients with obvious symptoms of lower limb ischemia, including severe claudication, resting pain, ulcers, or gangrene.
• Agree to use appropriate contraceptive methods during the trial; Female subjects of reproductive age, blood pregnancy test negative.
• Signing the informed consent.
• Can complete PETCT-RGD check and MIBI check;

You may not qualify if:

• The foot or lower limb infection cannot be controlled, and amputation may be accepted within 3 months.
• Those with cerebral infarction, cerebral hemorrhage, heart failure, unstable angina, acute myocardial infarction, and serious arrhythmia within 3 months;
• Tumor patients diagnosed with malignant tumor or suspected of having malignant tumor after tumor screening;
• Main iliac artery stenosis ≥ 70%;
• Refractory hypertension (taking three or more antihypertensive drugs, systolic blood pressure ≥ 180mmHg or diastolic blood pressure ≥ 110mmHg);
• Anti HIV antibody positive person, anti hepatitis C antibody positive person and RNA positive person, hepatitis B surface antigen positive person (if the subject is HBsAg positive, and judging by peripheral blood HBV DNA, the researcher believes that the subject is in a stable period of chronic hepatitis B, which will not increase the risk of the subject, the subject can be selected)
• Patients with poor blood glucose control after treatment (HbA1c\>10%);
• Persons allergic to contrast medium
• The investigator believes that the patient's complications affect the evaluation of safety and effectiveness, or the expected survival period is less than 12 months;
• Those who regularly drink more than 14 units of alcohol (1 unit=360 mL beer or 45 mL liquor or 150 mL wine with 40% alcohol) or drug abusers within 12 months before signing the informed consent form;
• Acute lower limb ischemia or acute aggravation of chronic lower limb ischemia;
• Those who received vascular reconstruction of the affected limb within 4 weeks before the informed consent form and whose blood supply improved after the operation
• Serious liver or kidney disease or severe anemia judged by the investigator;
• Those who cannot correctly describe symptoms and emotions;
• Those who participated in other clinical trials within 3 months before signing the informed consent form.

Sponsors & Collaborators

• Beijing Northland Biotech. Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Deafness, Autosomal Recessive 39

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Yue Liu, MM

CONTACT

86-10-82890893; liuyue@northland-bio.com

Yinjian Sun, MS

CONTACT

+86-10-82890893; sunyinjian@northland-bio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: August 1, 2023
• Study Start: July 29, 2022
• Primary Completion: July 31, 2023
• Study Completion: October 31, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)