Regenerative cell therapy of ex vivo expanded autologous peripheral mononuclear cells for patients with non-healing wound -phase I study
- Conditions
- non-healing wound
- Registration Number
- JPRN-UMIN000016665
- Lead Sponsor
- Juntendo 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 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety
- Secondary Outcome Measures
Name Time Method wound heling