Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Lumbar Intervertebral Disc Degeneration

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 lumbar intervertebral disc degeneration.

Official Title
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Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Lumbar Intervertebral Disc Degeneration

Conditions
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Lumbar Intervertebral Disc Degeneration

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: Subjects who understand and sign the consent form for this study Age :19-70, males and females Have chronic low back pain for at least 1 year Have failed 1 year of non-operative low back pain management Have degenerated intervertebral disc on T2-weighted MR images confirmed by positive discography Have significant lumbar instability at degenerated intervertebral disc Exclusion Criteria: Have significant lumbar herniated intervertebral disc Women who are pregnant or breast feeding or planning to become pregnant during the study History or current evidence of alcohol or drug abuse or is a recreational user of illicit drugs or prescription medications Serious pre-existing medical conditions like Cardiovascular Diseases, Renal Diseases, Liver Diseases, Endocrine Diseases, Cancer and Diabetes Mellitus Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AdMSC<br>Autologous Adipose Tissue derived Mesenchymal Stem Cells | Procedure: Autologous Adipose Tissue derived MSCs Transplantation<br>* Into lumbar intervertebral disc infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 4x10e7 cells/1mL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnetic Resonance Imaging | To evaluate the change of treated lumbar intervertebral discs using Magnetic Resonance Imaging (MRI) at 6 months post injection of MSCs. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Neurological Functions | To evaluate the change of treated lumbar intervertebral discs using Muscle Test, Somatosensory Test, Deep Tendon Reflex and VAS (Visual Analogue Scale Score 0-10) at 6 months post injection of MSCs. | 24 weeks | 
| Safety evaluation | To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests. | 24 weeks |