Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cells Implantation in Patients With Critical Limb Ischemia

Study Overview
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Brief Summary
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The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with critical limb ischemia

Official Title
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Effects of Adipose Tissue Derived Stem Cells Implantation in Patients With Critical Limb Ischemia

Conditions
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Critical Limb Ischemia

Intervention / Treatment
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* Procedure: Autologous Adipose Tissue derived MSCs Transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 6 months since the onset CLI(Chronic ASO or Buerger disease) Patients with luminal stenosis > 50% by leg angiography Age is between 20 and 80 Patients whose Rutherford's class is II-4, III-5 or III-6 (Patients with rest pain or ischemic ulcer/necrosis) Patients for whom angioplasty and bypass surgery are not indicated because of anatomical or procedural reasons or frequent reocclusion/restenosis following traditional revascularization Patients who can give informed consent themselves in writing Exclusion Criteria: Previous or current history of neoplasm or comorbidity that could impact the patient's survival Detection of proximal source of emboli including atrial fibrillation Primary hematologic disease, including hypercoagulable states Detection of proliferative retinopathy Entrapment syndrome Alcohol abuse, cocaine amphetamine etc. Detection of osteomyelitis Uncontrolled DM

Ages Eligible for Study
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Minimum Age: 20 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Autologous Adipose Tissue derived MSCs Transplantation|Intramuscular injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e8  3x10e8 cells|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Events Analysis (MAEs) | To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle-Brachial Index (ABI) | To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs. | 48 weeks | 
| Digital subtraction angiography (DSA) | To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs. | 48 weeks | 
| Thermography | To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs. | 48 weeks | 
| Wong-Baker FACES Pain Rating Score | To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs. | 48 weeks | 
| Treadmill test | To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs. | 48 weeks |