About this trial
Critical limb ischemia (CLI) is the most severe ischemic stage in peripheral arterial disease (PAD) of the lower limbs, characterized by decreased walking ability, resting pain (lasting for more than 2 weeks), ulcers, and gangrene, which seriously affect the quality of life of patients. Some patients may even face amputation or death. Thrombosis is an important pathological feature of CLI. TP03HN106 can promote thrombolysis, thus having a therapeutic effect on CLI.
Eligibility criteria
Qualifiers
When signing the informed consent form, the age should be ≥ 18 years old, regardless of gender;
Clinically diagnosed as a patient with Critical limb ischemia, with a Rutherford score of 4-6.
Patients who are unable to undergo interventional surgical treatment, or whose previous interventional surgical treatment is ineffective, or who are unwilling to undergo any intervention or surgical treatment, and can only receive conventional antiplatelet and vasodilator drugs (before baseline, antiplatelet and vasodilator drugs must be used for at least 1 week);
During the screening period, lower limb artery color ultrasound or lower limb computed tomography angiography (CTA) showed severe stenosis or occlusion of one or more of the common iliac artery, external iliac artery, common femoral artery, superficial femoral artery, popliteal artery, anterior tibial artery, posterior tibial artery, and fibular artery;
Disqualifiers
Subjects who are known to be allergic to the investigational drug, its excipients, or other human blood products;
Patients with limb gangrene greater than 4 cm2;
Patients currently suffering from malignant tumor diseases (including those who have previously had malignant tumors but have not been cured);
Patients who require hemodialysis;
Trial design
Treatments tested in this trial
- TP03HN106
Treatment groups
Sponsors and collaborators
Talengen Institute of Life Sciences, Shenzhen, P.R. China.
Lead sponsor
The First Affiliated Hospital of Soochow University
Collaborator