G-CSF mobilized CD34+ cell transplantation for hemodialysis patients with critical limb ischemia.
Phase 1
- Conditions
- peripheral arterial disease (critical limb ischemia)
- Registration Number
- JPRN-UMIN000015266
- Lead Sponsor
- Shonan Kamakura General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Not provided
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/u
Study & Design
- Study Type
- Interventional,observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety evaluation of the therapy for 52 weeks
- Secondary Outcome Measures
Name Time Method 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