Chronic clitical limb ischemia
Conditions
Interventions
Bone marrow cells collected from the patient are cultured outside the body for 14 days.Mainly consists of amplified autologous erythroblasts, and bone marrow-derived mesenchymal cells are suspended in
Sponsors
Minamino Tohru
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with peripheral artery disease (ASO/Burger disease/vasculitis with collagen disease) 1. Fontaine grade 3-4 (rest pian or ischemic ulcer/necrosis). 2. markedly impaired QOL who are not indicated for revascularization and who are expected to undergo amputation in the future, or who have poor blood flow even after revascularization (skin perfusion pressure less than 40mmHg), and cannot recovery from severe limb ischemia.
Exclusion criteria
Exclusion criteria: 1. Patients who have a life expectancy of less than one year due to complications. 2. Patients with a history of alcohol or drug dependence within the past 3 months. 3. Patients with a malignant neoplasm or have had a history within 5 years, or patients who have been determined to have a malignant tumor by other prescribed tests. 4. Patients with proliferative diabetic retinopathy (untreated proliferative retinopathy, intermediate / late proliferative retinopathy). 5. Polycythemic patients with hematocrit values of 55% or more in men and 50% or more in women. 6. Patients who cannot obtain informed consent. 7. Patients with active and moderate infection, HIV / HBV / HCV positive, and active Treponema pallidum infection. 8. Patients suffering from acute myocardial infarction, unstable angina, myocarditis, cerebral infarction within 1 month of consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in skin perfusion pressure (SPP) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. avoidance rate of lower limb amputation 2. cardiovascular event (cardiac death, non-fatal myocardial infarction, revascularization, stroke) 3. Perioperative complications 4. Symptom improvement(VAS) 5. change of lower limbs ulcer size | — |
Countries
Japan
Contacts
Public ContactTakao Yanagawa
Niigata University Medical and Dental General Hospital
Outcome results
None listed