Critical limb ischemia due to peripheral artery disease (critical limb ischemia) and Buerger'
Conditions
Interventions
The concentrated solution of the patien ts'
mononuclear cells administered to th e affected limb with ulcer lesions by int ramuscular injection. Repeat again the same treatment after two weeks.
Sponsors
Kumamoto University
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 con sent
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 within 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 apheresies. 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 pressure at 6 weeks after initial administration of peripheral blood mononuclear cell transplantation. | — |
Countries
Japan
Contacts
Public ContactKoichiro Fujisue
Kumamoto University Hospital Department of Cardiovascular Medicine
Outcome results
None listed