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Ex Vivo Expanded Erythroblast-Transplantation for patient with critical limb ischemia

Not Applicable
Conditions
Peripheral Arterial Disease (PAD) , Buerger disease, and arteritis associated with collagen diseases (Fontaines stage: III and IV)
Registration Number
JPRN-UMIN000021374
Lead Sponsor
EVEETA Study Group
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
11
Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients with the expected rest of their life less than 1 year 2. Patients with drug dependence during the past 3 months 3. Patients with malignant evidence of malignant disorder during the past 5 years 4. Patients with poorly controlled diabetes mellitus accompanied with proliferative retinopathy 5. Patients with polycythemia; Hematcrit >55%(male), >50%(female) 6. Patients without informed consent 7. Pregnant or possibly pregnant females 8. Patients with acute myocardial infarction, unstable angina, myocarditis, or cerebral infarction during the past 1 month 9. Patients with active infection including Treponema pallidum, or positive test for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) 10. Patients with history of allergy for antibiotics 11. Patients with anemia or thrombocytopenia 12. Patients judged inappropriate for this study by phisician 13. Patients without agreement for including in this study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
improvement of skin perfusion pressure level at ischemic leg 1 month after EVEETA
Secondary Outcome Measures
NameTimeMethod
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