Intrathecal Transplantation Of Autologous Adipose Tissue Derived MSC in the Patients With Spinal Cord Injury

Study Overview
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Brief Summary
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The effect of intrathecal transplantation of autologous adipose tissue derived mesenchymal stem cells in the patients with spinal cord injury, Phase I Clinical study.

Official Title
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The Effect of Intrathecal Transplantation of Autologous Adipose Tissue Derived Mesenchymal Stem Cells in the Patients With Spinal Cord Injury, Phase I Clinical Study

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Drug: autologous adipose tissue derived mesenchymal stem cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient who don't have any possiblity of improving neurological function despite performed the optimal treatment after spinal cord injury No change in neurological function for 4weeks interval by at least 2 clincal medical specialists Patient who is able to give written informed consent of clinical trial about stemcells treatment Exclusion Criteria: Patient who is under 19 years and over 70years Patient who must use the mechanical ventilator Patient who have a history of malignant tumor within 5 years Patient who is having a infectious disease of including current hepatitis and HIV Patient who had the brain or spinal cord injury before the spinal cord injury (confirm subject's history from their medical history) Patient who is having a acute disease judged by principle investigator or having a fever over 38.0 ℃ at the vaccination day Patient who is having an anemia or thrombopenia Patient who is having an angina, myocardial infarct, myocardiopathy, obstructive vessel disease, chronic renal failure, glomerulopathy and chronic obstruent lung disease (confirm subject's history from their medical history) Patient who is having a Congenital Immune Deficiency Syndrome or AIDS (confirm subject's history from their medical history) Patient who is having an amyotrophia or joint atrophy Patient who is having an disturbanace of consciousness or dysphrasia Patient who is taking an immunosuppressive agents or corticosteroids agents or cytotoxic agents or needed administration Patient who have experienced another clinical trials within 3 months involving this clinical trial Patient who can't participate in this clinical trial having any opinion regarded as clinical significance judged by principle investigator

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 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
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: autologous adipose tissue derived mesenchymal stem cells|autologous adipose tissue derived mesenchymal stem cells 9x107cells / 3mL Day 1 and Month 1&2|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant MRI Change before and after intervention |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant neurologic funtion Change before and after intervention |  | 6 month | 
| Significant Electrophysiological Change before and after intervention |  | 6 month | 
| Adverse event |  | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autologous adipose tissue