Research Overview

　　“Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection” is a novel therapeutic biological product developed by Beijing Northland Biotechnology Co., Ltd. This product has not yet been approved for marketing in China.

Legality

　　This product has received clinical research approval from the National Medical Products Administration, with approval number 2017L04713. A Phase III clinical study is currently underway nationwide.

Research-related expenses

　　After screening and meeting the inclusion criteria, you will receive free access to standard medications for treating lower-limb arterial ischemic disease (cilostazol or beraprost sodium) as well as investigational drugs. You’ll also receive free DSA or CTA examinations and a series of related medical tests, along with transportation and nutritional allowances and professional guidance from physicians.

Visit Plan

　　Subjects received a single intramuscular injection on Days 0, 14, and 28 of the study. They also underwent a total of nine follow-up visits and medical examinations at the screening period, Days 0, 14, 28, 60, 90, 120, 150, and 180, with the entire trial lasting 180 days.

Target Participants

　　Patients with lower-limb arterial ischemic disease who meet the following criteria (please consult the study physician for specific standards) may participate in this study:

　　1. Age ≥ 20 years and ≤ 80 years (at the time of signing the informed consent), gender unrestricted;

　　2. Diagnosed with lower limb arterial ischemic disease based on DSA or CTA, in conjunction with medical history and clinical manifestations, and... Rutherford Grade 4 (rest pain) or Rutherford Grade 5 (with ulcers) Patients must simultaneously meet the following criteria. (If a subject has lower-limb arterial ischemic disease in both limbs, the investigator will decide which limb to select for the study.)

　　• Resting ankle systolic blood pressure on the affected limb (dorsalis pedis artery or posterior tibial artery) ≤70 mmHg, or ABI ≤0.5, or TcPO2 <30 mmHg;

　　• Within 3 months prior to randomization, patients must have had severe stenosis (≥70%) or occlusion of the superficial femoral artery, popliteal artery, or below-knee arteries confirmed by DSA or CTA.

　　3. Chronic lower limb arterial ischemia accompanied by rest pain and simultaneously meeting the following requirements:

　　• Resting pain lasting more than 2 weeks at the time of signing the informed consent form;

　　• Within 7 days prior to randomization, the subject must have completed at least 5 days of pain assessments using the Numerical Rating Scale (NRS), with an average daily pain score of ≥4 points (on a scale of 0 to 10).

　　• Or patients with chronic lower limb arterial ischemia who have ulcers and simultaneously meet the following requirements:

　　• The arterial ischemic ulcer must have persisted for at least 2 weeks at the time of signing the informed consent form.

　　• When signing the informed consent form, the area of a single ulcer ≤ 10 cm²;

　　• If multiple ulcers are present in the affected limb at the time of signing the informed consent form, the total number of ulcers shall not exceed 3.

　　• During the trial, basic ulcer care (following standard ulcer care protocols) must be maintained to prevent worsening of the infection.

　　• The ulcer does not expose the bone or joint capsule;

　　• If gangrene is present simultaneously, it is limited to localized toe gangrene.

　　4. During the trial, participants agree to use the background therapy medications as required and to complete and accurately record their diaries on time. During the screening period, adherence to the background therapy medications and diary completion must be ≥70%.

　　5. During the trial, participants agree to use appropriate contraceptive measures; female subjects of childbearing age must have a negative blood pregnancy test.

　　6. Those who sign the informed consent form.

Contact Information