venous skin ulcer
Conditions
Interventions
Self-serum was created from 200 ml blood collection for cell culture. 5 mm x 3 mm x 2mm oral tissue was surgically collected under local anesthesia to isolate fibroblasts. PBMNCs were isolated from 10
Sponsors
Hamano Kimikazu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 20 to 85. 2. Patients not adequate for conventional therapy. 3. Patients with wound area of cutaneous ulcers which is covered with cell sheets enough. 4. Patients diagnosed with C6 by ceap classification. 5. Patients can provide written informed consent for study participation. 6. Patients with venous reflux detected by air plethysmography or ultrasound.
Exclusion criteria
Exclusion criteria: 1. Patients suffering from critical limb ischemia. 2. Patients suffering from malignant neoplasm. 3. Patients suffering from bacterial infections such as treponema palladium, chlamydia, gonorrhea and tuberculosis. 4. Patients suffering from infections such as hepatitis B and C viruses, human immunodeficiency virus, human T lymphotropic virus type 1 and parvovirus B19. 5. Patients with allergy of local anesthesia. 6. Hemoglobin: < 8.0 g/dL, Plt: < 50,000 /uL, Prothrombin time: < 40% 7. Patients with sepsis or suspected with. 8. Patients with congenital coagulopathy, antiplatelet drug use, or anticoagulant use. 9. Patients who have experienced other cell or gene therapy 10. Patients who join other clinical trials or joined them within 6 months. 11. Patients with hemodialysis. 12. Patients who developed unstable angina, myocardial ischemia, or cerebral infarction within 3 months. 13. Pregnant woman and women who may possibly be pregnant, women in nursing. 14. Patients with allergy of aminoglycoside antibiotics. 15. Patient determined to be ineligible for this clinical study by research attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence or absence, frequency, and severity of all adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Presence or absence of ulcer healing at one, three and six months after transplantaion. 2. Wound healing rate at one, three and six months after transplantaion. 3. Pain scales at 7 days and one, three and six months after transplantaion. | — |
Countries
Japan
Contacts
Public ContactTakahiro Mizoguchi
Yamaguchi University
Outcome results
None listed