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

Mahidol University

Status and phase: Completed; Phase 3

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

Treatments: Biological: Peripheral blood mononuclear cell

Study type: Interventional

Funder types: Other

Identifiers

NCT01833585

SIRIRAJR015533013

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

peripheral blood mononuclear cells

Experimental group

Description:

peripheral blood mononuclear cells will be injected to calf muscle of critical limb ischemia

Treatment:

Biological: Peripheral blood mononuclear cell