Patients with refractory skin ulcers resistant to normal treatment, mainly caused by connective tissue diseases and vasculitis
Conditions
Interventions
The concentrated solution of the patients'
mononuclear cells administered to the affected limb with ulcer lesions by intramuscular injection. Repeat again the same treatment after two weeks.
Sponsors
Kumamoto University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with intractable cutaneous ulcers that mainly caused connective tissue diseases and vasculitis 2) Patients who sustained ulcer 3 months or more, or has significantly been QOL failure, or expected amputation 3) over 20 years old 4) patient who can take a informed consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of skin perfusion pressure at 6 weeks after initial administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 QOL | — |
Countries
Japan
Contacts
Public ContactIkko Kajihara
Kumamoto University Department of Dermatology and Plastic Surgery, Faculty of Life Sciences
Outcome results
None listed