Transplantation of Autologous Adipose Derived Stem Cells (ADSCs) in Spinal Cord Injury Treatment
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|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 resectionDevice: Intradural space
ADSCs injection into Intradural space at damage siteDevice: Intrathecal
ADSCs Intrathecal into lumbar punctureDevice: Intravenous
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034669
|Contact: Phuc Ba Duong, MDemail@example.com|
|Contact: Hoa D Nguyen, MDfirstname.lastname@example.org|
|Vietnamese- German Hospital||Recruiting|
|Contact: Phuc Ba Duong, MD +17143607716 email@example.com|
|Contact: Hoa D Nguyen, MSc, MD +84904613833 firstname.lastname@example.org|
|Principal Investigator:||Phuc Ba Duong, MD||Tri Phuoc Biotechnology., JSC|
|Principal Investigator:||Hoa D Nguyen, MD||Vietnamese- German Hospital|