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
• Interventions: Biological: Peripheral blood mononuclear cell

• 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

Arm && Interventions

Group	Intervention	Description
peripheral blood mononuclear cells	Peripheral blood mononuclear cell	peripheral blood mononuclear cells will be injected to calf muscle of critical limb ischemia

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