Peripheral Vascular Diseases
Conditions
Interventions
Autologous mitochondrial transplantation group:Autologous mitochondrial transplantation
Sponsors
Zhongshan Hospital,Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: ? Age 18-80 years, male or female; ? Within one month prior to enrollment, confirmation by digital subtraction angiography (DSA), computed tomography angiography (CTA), or magnetic resonance angiography (MRA) of one or more stenoses =75% or occlusions in the superficial femoral artery (i.e., the femoral artery below the profunda femoris artery bifurcation), popliteal artery, and arteries below; ? Diagnosis of severe limb ischemia with Rutherford classification 4-5 for lower extremity arterial disease, manifesting as ischemic rest pain, small tissue defects, non-healing ulcers, etc. If both lower limbs of the subject are affected by lower extremity arterial ischemic disease, the researcher will determine and select one affected limb for the study, based on one of the following conditions: resting ankle systolic pressure (dorsalis pedis artery or posterior tibial artery) in the affected limb <60 mmHg, or toe artery systolic pressure <40 mmHg, or ABI <0.50 (if measurement is not possible due to ulceration, record as 0); ? Patients whose vascular condition is unsuitable for open surgery or endovascular therapy, or those who have undergone previous open surgery or endovascular therapy but did not improve; ? Patients with resting limb pain caused by lower limb ischemia, with a duration of at least 2 weeks, and a Numerical Rating Scale (NRS) score =4 and =7; ? If ulcers are present, patients who can maintain ulcer wound care and treatment; ? Good compliance, acceptance of dietary control and medication, and signed informed consent by the patient or their legal representative.
Exclusion criteria
Exclusion criteria: ? Patients who have received cell transplantation therapy, vascular reconstruction, or sympathectomy within the last 4 weeks (except for patients with failed vascular reconstruction within the last 4 weeks); ? Patients with acute progression of limb arterial ischemic disease; ? Patients who are likely to receive amputation surgery within the last 4 weeks, or have =75% stenosis or occlusion in the aorto-iliac artery; ? Patients with severe infection (such as cellulitis, osteomyelitis, etc.) in the limb to be observed, with distal fascial or bone exposure; or patients with life-threatening complications; ? Patients who have experienced severe adverse events such as unstable angina, myocardial infarction, cerebral infarction, cerebral hemorrhage, pulmonary embolism, severe liver dysfunction, etc., within three months before treatment; ? Patients with proliferative retinopathy and unable to undergo retinopathy examination, or who have undergone ophthalmic surgery within the last 3 months; ? Patients with a history of malignant tumors within the last 5 years or suspected of having malignant tumors based on preoperative examinations; ? Patients with comorbidities that may interfere with the evaluation of safety and effectiveness; ? Patients with an expected survival of less than 6 months due to any reason; ? Patients who are unable to comply with the study protocol, or whom the investigator believes have potential risks or any other factors that may interfere with the study participants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event rate;putationAm Free Survival ;Pain Relief Rate;Wound Healing Status ;Pain-free Walking Distance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ankle Brachial Index (ABI);Toe Brachial Index (TBI);Transcutaneous Oxygen Pressure (TcPO2) ;Pathological Angiogenesis in the Retina; | — |
Countries
China
Contacts
Public ContactSun aijun
Zhongshan Hospital,Fudan University
Outcome results
None listed