Vascular regeneration therapy using autologous peripheral blood mononuclear cells for refractory skin ulcer associated with connective tissue diseases and vasculitis
- Conditions
- Patients with refractory skin ulcers resistant to normal treatment, mainly caused by connective tissue diseases and vasculitis
- Registration Number
- JPRN-UMIN000024255
- Lead Sponsor
- Kumamoto University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Not provided
1) Patients whose have severe hypersensitivity or history of side effects to aphaeresis 2) Patients whose have malignant tumor or history of malignancy within the past 5 year 3) Patients whose have suffering acute myocardial infarction, unstable angina pectoris, myocarditis or cerebral infarction within 3 months 4) Patients whose circulatory dynamics are remarkably unstable due to severe heart failure, arrhythmia and the like (in the case where it is judged that it is desirable for cardiovascular medical specialists to avoid this treatment) 5) Patients with active infection 6) Patients whose are pregnant or might be pregnant 7) Patients with proliferative diabetic retinopathy (untreated, medium-term and late proliferative retinopathy) the end of treatment example is excluded 8) Patients with less than serum albumin 2 mg/dL 9) Patients whose are judged inappropriate for this trial by their attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of skin perfusion pressure at 6 weeks after initial administration
- Secondary Outcome Measures
Name Time Method 1. reduction effect of skin ulcer area (long diameter times short diameter, mm) 6 weeks after the first dose 2. improvement degree of pain evaluation (Visual Analogue Scale for pain) 6 weeks after the first dose 3. SPP, 4. transition of ulcer area, 5. change of pain evaluation at each observation point (2, 6, 12, 24, 52 weeks) 6. period until completion of epithelialization 7. questionnaire of QO