Peripheral arterial occlusive disease
Conditions
Interventions
Implantation of PBMNCs collected from peripheral blood and cultured under hypoxia for 24 h.
Sponsors
Yamaguchi University Graduate School of Medicine Department of Surgery and Clinical Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with age 20 to 85 years. 2. Patients with Fontaine class III-IV symptoms. 3. Patients with not expected further improvement with recomended therapy. 4. Patients not adequate for conventional operative therapy. 5. Patients can provide written informed consent for study participation.
Exclusion criteria
Exclusion criteria: 1. Patients suffering from bacterial infections such as treponema palladium, chlamydia, gonorrhea and tuberculosis. 2. Patients suffering from infections such as hepatitis B and C viruses, human immunodeficiency virus, human T lymphotropic virus type 1 and parvovirus B19. 3. Patients with sepsis or suspected with. 4. Patients with malignant neoplasm or history of malignant neoplasm treatmented within five years. 5. Patients with serious endocrine disorders such as uncontrolled thyroid disfunction. 6. Patients with blood disorders except for chronic kidney disease. 7. Patients with liver disease with Child-Pugh classification B or more. 8. Patients with transmissible spongiform encephalopathy or suspected with. 9. Patients with dementia with a a revised version Hasegawa dementia scale score smaller than 4. 10. Patient determined to be ineligible for this clinical study by research attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and severity of the adverse events | — |
Countries
Japan
Contacts
Public ContactMakoto Samura
Yamaguchi University Graduate School of Medicine Department of Surgery and Clinical Science
Outcome results
None listed