Clinical trial related with transplantation therapy with human autologous cell mixed sheets for refractory cutaneous ulcer
- Conditions
- refractory cutaneous ulcer
- Registration Number
- JPRN-UMIN000031645
- Lead Sponsor
- Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 6
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Presence or absence, frequency, and severity of all adverse events
- Secondary Outcome Measures
Name Time Method