Critical limb ischemia due to peri pheral artery disease (critical limb ischemia) and Buerger's dise
Conditions
Interventions
The concentrated solution of the patients' mononuclear cells administered to the affect limb with ulcer lesions by intramuscular injection. Repeat again the same treatment after two weeks.
Sponsors
Kenichi Tsujita
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with critical limb ischemia caused by peripheral artery disease or Burger's disease. 2) over 20 years old 3) patient who can take a informed consent.
Exclusion criteria
Exclusion criteria: 1)Patients who have severe hypersensitivity or history of side effects to aphaeresis. 2)Patients who have malignant tumor or history of malignancy with in the past 3 years. 3)Patients who have experienced acute myocardial infarction, unstable angina pectoris, myocarditis or cerebral infarction within 3 months. 4)Patients with active infection. 5)Patients who are pregnant or might be pregnant. 6)Patients with proliferative diabetic retinopathy (untreated, medium-term and late proliferative retinopathy) the end of treatment example is excluded. 7)Patients with platelets less than 70,000 platelets in blood test just before apheresis. 8)Patients with less than serum albumin 2 mg/dL. 9)Patients who are judged inappropriate for this trial by their attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of skin perfusion pr essure at 6 weeks after initial adm inistration of peripheral blood mo nonuclear cell transplantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| secondary endpoints:1)Improvement of ulcer size at 6 weeks after initial administration of peripheral blood mononuclear cell transplantation. 2)Improvement of pain at 6 weeks after initial administration of peripheral blood mononuclear cell transplantation.3)Improvement of skin perfusion pressure at each visiting point (day 0, week 2, 6, 12, 24, and 52).4)The change of ulcer size during observation duration. 5)The change of pain during observation duration.6)The time of epithelialization from peripheral blood mononuclear cell transplantation.7)Improvement of QOL assessed by questionnaire.8)Event free rate of leg amputation. | — |
Countries
Japan
Contacts
Public ContactFujisue Koichiro
Kumamoto University Hospital
Outcome results
None listed