non-healing wound
Conditions
Interventions
Ex vivo expanded autologous peripheral mononuclear cells, 2 x 10^7 cells,within 20sites surround 20cm around the wound. subcutaneous or intramuscular injection
Sponsors
Juntendo University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Patients with severe wound more than Grade 1 of Wagner classification and our ulcer classification of Grade 3, who are resistant to the conventional therapy for more than a month and cannot expect improvement. 2 Patients who not improved wound with medical treatment for a month. 3 Patients are at the age of 20 to 75 at the time of informed consent
Exclusion criteria
Exclusion criteria: 1 Patients showed more than 60% of wound recover by conventional therapy. 2 Patients with HbA1C more than 8.0% with the medication for diabetes. 3 Patients with total occlution of all major artery in hindlimb. 4 Patients with high cardiac hypofunction with ultrasonic cardiogram with left ventricle ejection fraction less than 25%. 5 Patients with the high coronary lesion which needs treatment. 6 Patients with malignant tumor and proliferative diabetic retinopathy .and other compliated malignat ischemic disease 7 Patients who cannot expect the remaining days more than one year for some kind of causes except the ischemia disease. 8 Patients with myocardial infarction or cerebral infarction onset within six months. 9 Patients with hematologic disorders such as leukemia, myeloproliferative disease, marrow dysplasia syndrome. 10 Patients with anemia (hemoglobin concentration less than 10.0 g/dL). 11 Patients with the severe respiratory functional disorder or impairment of liver function. 12 Pregnant women, lactating women, female patients who may be pregnant, and who plan the pregnancy by the end of the observation period. 13 Patients without informed consent. 14 Patients infected with HIV, HCV, HBV, HTLV or parvovirus B19. 15 Patients who are judged to be inappropriate to participate based on medical proof by a responsibile doctor or contributed doctors of this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| wound heling | — |
Countries
Japan
Contacts
Public ContactRica Tanaka
Juntendo University School of Medicine Plastic and Reconstructive Surgery
Outcome results
None listed