Treatment of No-option CLI 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 no-option CLI. Forty no-option CLI patients who presented with rest pain, non-healing ischemic ulcer or gangrene will be randomized into 2 groups. The control group will be treated by medication and supportive treatment. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication. Amputation free survival,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 no-option CLI. Forty no-option CLI patients who presented with rest pain, non-healing ischemic ulcer or gangrene will be randomized into 2 groups. The control group will be treated by medication and supportive treatment. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication. 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. Amputation free survival will be evaluated at , 1 , 3, 6 and 12 months after PB-MNC therapy.

Official Title
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Treatment of No-option CLI Patients by G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells

Conditions
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PAD, Critical Limb Ischemia, 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 no-option CLI who presented with rest pain , non-healing ischemic ulcer and toe gangrene for 3 months Exclusion Criteria: Recent myocardial infarction Severe valvular heart disease After organ transplantation Cardiomyopthy( EF< 25%) Liver failure Coagulopathy HIV

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: None (Open Label)


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 and Aspirin 81 mg/day and supportive treatment including wound care and pain killer drug. | 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 wound care and pain killer drug<br>|
| Active Comparator: No PB-MNC therapy<br>In patients in No PB-MNC therapy, they will receive aspirin 81 mg/day and supportive treatment including wound care and pain killer drug. | Drug: No-PB-MNC therapy<br>* Patients will receive ASA 81 mg once daily and wound care and pain killer drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amputation free survival | Rate of non amputated limb | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amputation free survival | Rate of non amputated limb | 1,6,12 month | 
| 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 |