Critical Limb Ischemia
Conditions
Keywords
Leg Pain, Ulcer, iscemia, Peripheral Vascular Diseases
Brief summary
The purpose of this study is to determine if allogeneic Endothelial Progenitor Cells (EPCs) intravenous infusion to a subject with leg ulcer and/or gangrene due to poor blood flow will be safe and if it will relieve leg pain, increase blood flow, and/or cure the leg wound.
Detailed description
Critical limb ischemia (CLI) is a progressive disease, which arises as a result of atherosclerosis or vasculitis in leg arteries. Prognosis of CLI is poor, and no effective treatments have been established in patients who are not eligible for the traditional revascularization therapies such as angioplasty and bypass procedures due to the inappropriate anatomy of the leg arteries or frequent reocclusion following revascularization. Therefore, it is necessary to establish novel revascularization treatment to improve prognosis of the no-option patients. The investigators will study the safety and clinical efficiency of vascular regeneration by means of transplantation of allogeneic Endothelial Progenitor Cells in patients with CLI who are not eligible for traditional revascularization treatments. The primary endpoint is the safety and tolerance identified by adverse events related with investigated drug；while the secondary endpoints are evaluation of the preliminary efficacy of EPCs.
Interventions
DRUGEPCs
IV
BEHAVIORALClinical standard treatment (CST)
Clinical standard treatment
Sponsors
First Affiliated Hospital Xi'an Jiaotong University
Allife Medical Science and Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* CLI patients fulfilling all the following criteria are considered suitable for inclusion in the study. 1. Age is between 18 and 80. 2. Diagnosis of critical limb ischemia, no surgery or interventional therapy, or poor results one month after interventional therapy (no relief of symptoms), Rutherford grade 3, grade 4 or grade 5, while meeting one of the following criteria: 1) severe intermittent claudication; 2) resting pain; 3) ABI≤ 0.60; 3. Within the last month, Digital Subtraction Angiography (DSA), Computed Tomography Arteriography (CTA), Magnetic Resonance Angiography (MRA)，or vascular ultrasound has confirmed that one or more of the arteries (superficial femoral artery, i.e., the femoral artery below the deep femoral artery branch, the popliteal artery, and its following arteries) have a stenosis of ≥70% or occlusion; 4. The degree of skin ulcer is determined according to Wagner, grade less than or equal to 4; 5. Resting pain lasted for more than 2 weeks when signing the informed consent form 6. Eligible patients of childbearing potential (both men and women) if sexually active must agree to use a reliable method of contraception with their partners 7. The subject or agent can understand the basic requirements of the study, provide written informed consent, and follow up according to the trial requirements.
Exclusion criteria
* Any one of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adverse events | baseline to 1 year | Incidence and severity of adverse events assessed by CTCAE V5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Painless walking and intermittent claudication distance | month 6 | Changes from the baseline of painless walking and intermittent claudication distance by visit |
| Blood flow of the affected limb | month 6 | Changes from the baseline of Blood flow of the affected limb by visit |
| Rutherford grade | month 6 | Changes from the baseline of Rutherford grade by visit. The range of Rutherford grade is from 0 (normal) to 6 (worse). |
| The area of skin ulcer | month 6 | Changes from the baseline of the area of skin ulcer by visit |
| Vascular Quality of Life Questionnaire-6 score | month 6 | Changes from the baseline of Vascular Quality of Life Questionnaire-6 score by visit. The range of scores is from 6 (normal) to 24. |
Countries
China
Contacts
Primary ContactShaoying Lu, Dr
Backup ContactFanggang Li
Outcome results
None listed