This study is designed to assess the safety and effect of autologous adipose derived stem cell (ADSCs) transplantation in acute spinal cord injury patients. 1. To assess the safety of autologous ADSCs transplantation in acute spinal cord injury and the complication after ADSCs transplantation. 2. To evaluate the effect of ADSCs isolation and expansion procedure. 3. 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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
surgical laminectomy with glial scar resection
ADSCs injection into Intradural space at damage site
ADSCs Intrathecal into lumbar puncture
Vietnamese- German Hospital
Hanoi, Hanoi, Vietnam
RECRUITINGNumber 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.
Time frame: 24 months
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.
Time frame: 24 months
Urinary and bowel function Improvement
Bladder pressure monitory to assess ability to feel and control urination and bowel.
Time frame: 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.
Time frame: 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.
Time frame: 24 months
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ADSCs intravenous