Treatment of Chronic Critical Limb Ischemia With G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells

Phase 3

Completed

• Conditions: Atherosclerosis; Gangrene; Ischemic Ulcer; Critical Limb Ischemia

• Registration Number: NCT01833585
• Lead Sponsor: Mahidol University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-09
• Study First Submitted QC: 2013-04-14
• Study First Posted: 2013-04-17
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-15
• Last Update Posted: 2018-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of patients without major amputation after mononuclear cell injection	3 month

Trial Locations

Locations (1)

Vascular Surgery, Siriraj Hospital, Mahidol University; 🇹🇭 Bangkoknoi, Bangkok, Thailand