ASO, Buerger'
Conditions
Interventions
The process is started with the harvest of a 300 mg of adipose tissue by standard manual liposuction under local anesthesia using a syringe and cannula. ADRCs are separated by the fully automated isol
Sponsors
Nagoya University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male and female, their age are more than 25 years old and less than 80 years old. 2.Symptoms include rest pain, with or without established ischemic ulcers. (Fontaine class III-IV) A minimum of 4 weeks of conservative therapy without evidence of significant healing. 3.Patients accepted an informed consent.
Exclusion criteria
Exclusion criteria: 1.Patient with insufficient amount of adipose tissue. 2.Patients does not accept an informed consent. 3.Any concomitant diseases with a life expectancy of <1 year. 4.Previous (within 5 years) or current history of neoplasm. Clinically significant abnormality in laboratory tests, including tumor markers. 5.Ischemic heart desease without revascularization. 6.Untreateed diabetic retinopathy. 7.Severe infection. 8.Severe Liver and/or renal dysfunction (except for patients under hemodialysis) 9.Severe hematopoietic disease 10.Pregnant 11.Patient whom physicians consider as inadequate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The safety of ADRCs transplantation. 2. Rescue rate of amputation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Improvement rate of ischemic gangrene. 2.Improvement of QOL using Numerical Rating Scale (NRS) 3.ABI 4.SPP 5.Evaluation of angiogenesis by imaging 6.Walking distance in 6 minutes | — |
Countries
Japan
Contacts
Public ContactYuuki Shimizu
Nagoya University School of Medicine Cardiology
Outcome results
None listed