Gangrene, Ischemia, Leg Pain, Peripheral Vascular Diseases, Ulcer
Conditions
Keywords
Ulcer/ gangrene, Leg diseases, Pain, Vascular diseases, Chronic limb ischemia, Peripheral artery disease
Brief summary
The purpose of this study is to determine if stem cell therapy with one's own cells (autologous cells) delivered intramuscularly to one's leg with 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
Chronic critical limb ischemia (CLI) is a progressive disease, which arises as a result of atherosclerosis or vasculitis in leg arteries. Prognosis of chronic 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. We will study the safety and clinical efficiency of vascular regeneration by means of transplantation of autologous peripheral blood endothelial progenitor cells (CD34 positive cells) in patients with chronic CLI who are not eligible for traditional revascularization treatments. The primary endpoint is the primary efficacy score identified by toe brachial blood pressure index (TBPI), absolute claudication distance (ACD) and Wong Baker's pain rating scale, while the secondary endpoints are evaluation of safety, ankle brachial blood pressure index (ABPI), percutaneous tissue oxygen pressure (TcPO2), etc.
Interventions
Sponsors
Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan
Kobe City General Hospital
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Chronic severe CLI patients fulfilling all the following criteria are considered suitable for inclusion in the study. 1. At least 6 months since the onset of CLI (Chronic peripheral artery disease or Buerger disease) 2. Patients with luminal stenosis \> 50% by leg angiography 3. Age is between 20 and 80. 4. Patients whose Rutherford's class is II-4, III-5, or III-6（Patients with rest pain or ischemic ulcer/necrosis) 5. Patients for whom angioplasty and bypass surgery are not indicated because of anatomical or procedural reasons or frequent reocclusion/ restenosis following the traditional revascularization (No option patients) 6. Patients who can give informed consent themselves in writing.
Exclusion criteria
* Any one of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major amputation | — |
Secondary
| Measure | Time frame |
|---|---|
| Limb ischemia | — |
Countries
Japan
Outcome results
None listed