Treatment of Intermittent Claudication by G-CSF-mobilized PB-MNC

Study Overview
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Brief Summary
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This study will investigate the efficacy of G-CSF mobilized mononuclear cell injection of patients with PAD who presented with intermittent claudication. Forty PAD patients who presented with intermittent claudication will be randomized into 2 groups. The control group will be treated by medication and walking exercise 3 times/ week. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication and walking exercise 3 times/ week. Ankle brachial index(ABI), Toe brachial index (TBI) and transcutaneous oxygen measurement will be evaluated at the day of randomization, 1 , 3, 6 and 12 months

Detailed Description
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This study will investigate the efficacy of G-CSF mobilized mononuclear cell injection of patients with PAD who presented with intermittent claudication. Forty PAD patients who presented with intermittent claudication will be randomized into 2 groups. The control group will be treated by medication and walking exercise 3 times/ week. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication and walking exercise 3 times/ week. Ankle brachial index(ABI), Toe brachial index (TBI) and transcutaneous oxygen measurement will be evaluated at the day of randomization, 1 , 3, 6 and 12 months in the control group and day of randomization, 1 , 3, 6 and 12 months after injection of PB-MNC in the experiment group. Pain free walking distance will be evaluated at the day of randomization, 1 , 3, 6 and 12 months by pedometer.

Official Title
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Treatment of Intermittent Claudication by G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells

Conditions
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PAD, Intermittent Claudication, Atherosclerotic Ischemic Disease

Intervention / Treatment
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* Procedure: PB-MNC therapy
* Drug: No PB-MNC therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chronic arterial occlusive disease who presented with intermittent claudication Exclusion Criteria: Recent myocardial infarction Severe valvular heart disease After organ transplantation Cardiomyopthy( EF< 25%) Liver failure Coagulopathy HIV Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PB-MNC therapy<br>The patientsin PB-MNC therapy group will be injected with G-CSF mobilized PB-MNC into calf or thigh muscle of ischemic limb, Aspirin 81 mg/day, cilostazol 200 mg/day and walking exercise 3 times per week. | Procedure: PB-MNC therapy<br>* The patients will receive subcutaneous injection of Granulocyte colony stimulating factor (G-CSF) for 3 day. The mononuclear cell will be collected by blood cell separator. The 120 cc of cell solution will be injected into calf or thigh of ischemic limb (1cc per site) with needle no. 25 gauge. Patients will receive ASA 81 mg once daily and walking exercise 3 times/ week<br>|
| Active Comparator: No PB-MNC therapy<br>In patients in No PB-MNC therapy, they will receive aspirin 81 mg/day, cilostazol 200 mg/day and walking exercise 3 times per week. | Drug: No PB-MNC therapy<br>* Patients will receive ASA 81 mg once daily and walking exercise 3 times/ week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain free walking distance | the maximum distance which patient could walk without pain | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle brachial index (ABI) | Ankle brachial indexThe Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm. It has been shown to be a specific and sensitive metric for the diagnosis of Peripheral Arterial Disease (PAD) | 1,3,6,12 month | 
| Toe brachial index (TBI) | Toe brachial indexThe toe brachial index is the ratio between toe pressure and the highest of the two brachial pressures | 1,3,6,12 month | 
| Transcutaneous oxygen measurement (TCOM) | Transcutaneous oxygen measurement | 1,3,6,12 month | 
| 36-Item Short Form Health Survey (SF36) | SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting. | 1,3,6,12 month | 
| Pain free walking distance | the maximum distance which patient could walk without pain | 1,6,12 month |