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

Mahidol University8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Critical Limb Ischemia Atherosclerosis Ischemic Ulcer Gangrene

Interventions

Peripheral blood mononuclear cellBIOLOGICAL

Peripheral blood mononuclear cell solution 59 cc will be injected to the gastrocnemius muscle of ischemic limb of patients with critical limb ischemia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Vascular Surgery, Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, Thailand

Outcomes

Primary Outcomes

Number of patients without major amputation after mononuclear cell injection

Time frame: 3 month

Data from ClinicalTrials.gov

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