Transplantation of Autologous Adipose Derived Stem Cells (ADSCs) in Spinal Cord Injury Treatment

Study Overview
=================
Brief Summary
-----------------
This study is designed to assess the safety and effect of autologous adipose derived stem cell (ADSCs) transplantation in acute spinal cord injury patients. To assess the safety of autologous ADSCs transplantation in acute spinal cord injury and the complication after ADSCs transplantation. To evaluate the effect of ADSCs isolation and expansion procedure. To determine if functional outcome is improved following ADSCs transplantation in acute spinal cord injury patient, using pre-transplantation spinal cord function as the control.

Detailed Description
-----------------
The research has carried out in Phase II which is designed as randomized controlled trials. Selection of patients began in Feb,2013, 48 patients are divided in two group according to a 2:1 ratio (the number of candidates as treated: the candidates as control). The effectiveness of preliminary trial are evaluated by assessing Frankel/ASIA motor grade, measuring electrophysiological parameters, enhanced MRI and urinary and bowel function.

Official Title
-----------------
A Phase II Study of Transplantation of Autologous Adipose Derived Stem Cells (ADSCs) in Completely Acute Spinal Cord Injury.

Conditions
-----------------
Acute Spinal Cord Injury

Intervention / Treatment
-----------------
* Device: Laminectomy
* Device: Intradural space
* Device: Intrathecal
* Device: Intravenous


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be able to give voluntary (patients may not be able to write) consent. Must be able to understand study information provided to him. Patients with complete spinal cord < 2 weeks in acute category The level of spinal cord injury must be categorized at A level in terms of ASIA Impairment scale. Age should be between 19-60 years Both male and female Exclusion Criteria: Support respiration by machine Melanoma within 5 years Infectious diseases including HIV and Hepatitis B, C Brain damage or multiple trauma Body temperature higher 38 ℃ or acute disorder Anemia or thrombocytopenia Angina , myocardial infarction , heart disease , embolic disease , chronic renal failure, glomerular disease and chronic obstructive pulmonary disease. Congenital or acquired immunodeficiency disorder Muscular dystrophy or muscle stiffness Non-conscious or voice disorders Treatment with cytotoxic drugs ( immunosuppressive drugs , corticosteroids and cytotoxic drugs) during the clinical trials . Participating in another clinical trial within 3 months Other serious disease or disorder can seriously affect the ability to participate in research. Women who are pregnant or lactating . Allergy to antibiotics and anesthetics . Do not agree to participate in research

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with ADSCs transplantation<br>4 Intervention: laminectomy, intradural space at damage site, intrathecal at lumbar puncture, intravenous | Device: Laminectomy<br>* surgical laminectomy with glial scar resection<br>Device: Intradural space<br>* ADSCs injection into Intradural space at damage site<br>Device: Intrathecal<br>* ADSCs Intrathecal into lumbar puncture<br>Device: Intravenous<br>* ADSCs intravenous<br>|
| No Intervention: Treatment without ADSCs transplantation<br>Only intervention: laminectomy | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with adverse events after transplantation. | Number of Participants with adverse events is as a measure of safety and tolerability after ADSC transplantation. Adverse events can be impaired liver and kidney, immunosuppression or immune deficiency, hypersensitivity, anaphylactic shock, meningitis symptoms, etc. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of spinal cord edema in the MRI at the lesion site | Patients take MRI at the lesion site before each injection and after transplantation 6 months, 12 months, 24 months. MRI at the lesion site shows spinal cord edema level is reduced or not. | 24 months | 
| Urinary and bowel function Improvement | Bladder pressure monitory to assess ability to feel and control urination and bowel. | 24 months | 
| Muscle contraction force measurement | Comparison the electromyography (EMG) score during contraction of given muscles before each injection and after transplantation 6 months, 12 months and 24 months. | 24 months | 
| Significant clinical improvement in ASIA impairment scale and general condition. | Patients are assess improvement level based on American Spinal Injury Assessment scale of A,B,C,D or E before and after transplantation. | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Spinal cord Injury, Adipose derived stem cells