peripheral arterial disease (critical limb ischemia)
Conditions
Interventions
intra-muscular injection of G-CSF mobilized autologous peripheral blood derived CD34+ cell.
Sponsors
Shonan Kamakura General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) angiographically proven occlusion or stenosis more than 70% in SFA, or below knee arteries 2) under maintenance hemodialysis 3) Rutherford grou 3 or 4 4) no indication of endovascular therapy or bypass 5) aged 20-80 6) written informed consent from patient himself
Exclusion criteria
Exclusion criteria: 1) patient with Rutherford group 6 2) patient with Buerger disease 3) patient on peritoneal dialysis 4) low cardiac function (EF < 25%) 5) malignancy or history of malignancy within 5 years 6) advanced diabetic nephropathy 7) interstitial peumonia 8) white blood cell below 3000/uL or above 15000/uL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety evaluation of the therapy for 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) improvement in Fontaine classification 2) improvement in Rutherford classification 3) visual analogue scale 4) ulcer size 5) physiological tests (ABI/TBI/SPP/TCPo2) 6) major/minor amputation 7) mortality rate 8) cardiovascular event rate 9) amputation-free survival rate | — |
Countries
Japan
Contacts
Public ContactTakayasu Ohtake
Shonan Kamakura General Hospital Nephrology
Outcome results
None listed