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Gene Therapy Trial Report

Summary

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


NCTID NCT05968118 (View at clinicaltrials.gov)
Description
Development Status Active
Indication Peripheral Artery Disease
Disease Ontology Term DOID:0050830
Compound Name NL003
Compound Description pCK-HGF-X7
Sponsor Beijing Northland Biotech. Co., Ltd.
Funder Type Industry
Recruitment Status
Unknown
Enrollment Count 36 (ESTIMATED)
Results Posted Not Available

Therapy Information


Target Gene/Variant HGF
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Overexpression of protective allele/gene
Route of Administration Intramuscular
Drug Product Type Plasmid
Delivery System None (naked plasmid)
Dose 1 Concentration: 0.5mg/1ml (32 sites x 0.5ml), Total 8mg

Study Record Dates


Current Stage Phase3
Submit Date 2023-01-04
Completion Date 2023-10-31
Last Update 2023-08-01

Participation Criteria


Eligible Age 18 Years - 80 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL
Eligibility Criteria
Inclusion Criteria: 1. 18-80 years, diagnosed with chronic lower limb ischemia; 2. 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. 3. Patients with obvious symptoms of lower limb ischemia, including severe claudication, resting pain, ulcers, or gangrene. 4. Agree to use appropriate contraceptive methods during the trial; Female subjects of reproductive age, blood pregnancy test negative. 5. Signing the informed consent. 6. Can complete PETCT-RGD check and MIBI check; Exclusion Criteria: 1. The foot or lower limb infection cannot be controlled, and amputation may be accepted within 3 months. 2. Those with cerebral infarction, cerebral hemorrhage, heart failure, unstable angina, acute myocardial infarction, and serious arrhythmia within 3 months; 3. Tumor patients diagnosed with malignant tumor or suspected of having malignant tumor after tumor screening; 4. Main iliac artery stenosis ≥ 70%; 5. Refractory hypertension (taking three or more antihypertensive drugs, systolic blood pressure ≥ 180mmHg or diastolic blood pressure ≥ 110mmHg); 6. 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) 7. Patients with poor blood glucose control after treatment (HbA1c\>10%); 8. Persons allergic to contrast medium 9. 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; 10. 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; 11. Acute lower limb ischemia or acute aggravation of chronic lower limb ischemia; 12. 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 13. Serious liver or kidney disease or severe anemia judged by the investigator; 14. Those who cannot correctly describe symptoms and emotions; 15. Those who participated in other clinical trials within 3 months before signing the informed consent form.
View Inclusion and Exclusion Criteria at ClinicalTrials.gov

Locations


No.of Trial Sites 1
Locations China

Regulatory Information


Has US IND False
FDA Designations
Recent Updates

Resources/Links