Status:
COMPLETED
Treatment of Chronic Critical Limb Ischemia With G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells
Lead Sponsor:
Mahidol University
Conditions:
Critical Limb Ischemia
Atherosclerosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the safety and efficacy of G-CSF-mobilized autologous peripheral blood mononuclear cell injection to ischemic limbs of patients with critical limb ischemia.
Eligibility Criteria
Inclusion
- Patients with critical limb ischemia confirmed by toe pressure, ABI, TCOM
- Levels of arterial occlusion are femoropopliteal or tibioperoneal occlusion
- Poor distal artery runoff
- Age 18-70 year
Exclusion
- Planned for major amputation within 4 weeks
- Receive blood component within 4 weeks
- Acute myocardial infarction
- severe valvular heart disease
- renal failure
- liver failure
- Cancer
- Hypercoagulable state
- Severe infection
- Pregnancy
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01833585
Start Date
April 1 2013
End Date
December 1 2017
Last Update
August 17 2018
Active Locations (1)
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1
Vascular Surgery, Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, Thailand, 10700