Status:
UNKNOWN
Angiogenesis and Blood Perfusion Effect of HGF Gene Therapy in PAD Patients
Lead Sponsor:
Beijing Northland Biotech. Co., Ltd.
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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.
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 huma...
Eligibility Criteria
Inclusion
- 18-80 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;
Exclusion
- 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.
Key Trial Info
Start Date :
July 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2023
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05968118
Start Date
July 29 2022
End Date
October 31 2023
Last Update
August 1 2023
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100032