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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-04-30

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

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Detailed Description

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Conditions

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Critical Limb Ischemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Autologous Adipose Tissue derived MSCs Transplantation

Intramuscular injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e8 \~3x10e8 cells

Intervention Type PROCEDURE

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No