Acute Spinal Cord Injury Clinical Trial
Official title:
A Phase II Study of Transplantation of Autologous Adipose Derived Stem Cells (ADSCs) in Completely Acute Spinal Cord Injury.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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