Autologous Adipose Derived MSCs Transplantation in Patient With Spinal Cord Injury.

Study Overview
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Brief Summary
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This study is designed to assess the safety of intravenous autologous adipose derived mesenchymal stem cells transplant in spinal cord injury patients.

Detailed Description
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Adipose derived mesenchymal stem cells (AdMSCs) represent an attractive and ethical cell source for stem cell therapy. With the recent demonstration of MSC homing properties, intravenous aplications of MSCs to cell-damaged diseases have increased. In a human clinical trial, eight male patients who had suffered a spinal cord injury were intravenously administered autologous hAdMSCs (4×10e8 cells) one time.

Official Title
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Safety of Autologous Adipose Derived Mesenchymal Stem Cells in Patients With Spinal Cord Injury

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Other: Autologous Adipose Derived Mesenchymal Stem Cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who understand and sign the consent form for this study. Age :19-60, males Clinical diagnosis of spinal cord injury(American Spinal Injury Association[ASIA] Impairment Scale[AIS] grade A or B or C) Duration of injury : > 2 months Exclusion Criteria: Subjects who must put on a respirator Subjects who had malignant tumor within 5 years Subjects with a infectious disease include HIV and hepatitis Subjects who injured brain or spinal cord before spinal cord injury Subjects who has high body temperature more than 38℃ or acute disorder Subjects with anemia or thrombocytopenia Subjects with angina pectoris, myocardial infarction, cardiomyopathy, occlusive disease, chronic renal failure, glomerular disease and chronic obstructive pulmonary disease Subjects with congenital or acquired immunodeficiency disorders Subjects with muscular dystrophy or articular rigidity Patients with clouded consciousness or speech disorder treat with cytotoxic medications(immunosuppressive drug, corticosteroid and cytotoxic drug) during clinical trials participating another clinical trials within 3 months other serious disease or disorder that could seriously affect ability to participate in the study

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Autologous Adipose Derived Mesenchymal Stem Cells|Intravenous infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 4 x 10e8 cells|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety evaluation | Safety evaluate through physical examination, vital sign and laboratory test after RNL-Astrostem injected | 12weeks |