Transplantation of Autologous Adipose Derived Stem Cells (ADSCs) in Spinal Cord Injury Treatment
|ClinicalTrials.gov Identifier: NCT02034669|
Recruitment Status : Unknown
Verified January 2014 by Tri Phuoc Biotechnology., JSC.
Recruitment status was: Recruiting
First Posted : January 13, 2014
Last Update Posted : January 13, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Spinal Cord Injury||Device: Laminectomy Device: Intradural space Device: Intrathecal Device: Intravenous||Phase 1 Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Transplantation of Autologous Adipose Derived Stem Cells (ADSCs) in Completely Acute Spinal Cord Injury.|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||March 2015|
Experimental: Treatment with ADSCs transplantation
4 Intervention: laminectomy, intradural space at damage site, intrathecal at lumbar puncture, intravenous
surgical laminectomy with glial scar resection
Device: Intradural space
ADSCs injection into Intradural space at damage site
ADSCs Intrathecal into lumbar puncture
No Intervention: Treatment without ADSCs transplantation
Only intervention: laminectomy
- Number of Participants with adverse events after transplantation. [ Time Frame: 24 months ]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.
- Changes of spinal cord edema in the MRI at the lesion site [ Time Frame: 24 months ]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.
- Urinary and bowel function Improvement [ Time Frame: 24 months ]Bladder pressure monitory to assess ability to feel and control urination and bowel.
- Muscle contraction force measurement [ Time Frame: 24 months ]Comparison the electromyography (EMG) score during contraction of given muscles before each injection and after transplantation 6 months, 12 months and 24 months.
- Significant clinical improvement in ASIA impairment scale and general condition. [ Time Frame: 24 months ]Patients are assess improvement level based on American Spinal Injury Assessment scale of A,B,C,D or E before and after transplantation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034669
|Contact: Phuc Ba Duong, MDfirstname.lastname@example.org|
|Contact: Hoa D Nguyen, MDemail@example.com|
|Principal Investigator:||Phuc Ba Duong, MD||Tri Phuoc Biotechnology., JSC|
|Principal Investigator:||Hoa D Nguyen, MD||Vietnamese- German Hospital|