Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is designed to assess the safety and effect of autologous adipose derived stem cell (ADSCs) transplantation in acute spinal cord injury patients.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with ADSCs transplantation | Experimental | 4 Intervention: laminectomy, intradural space at damage site, intrathecal at lumbar puncture, intravenous |
|
| Treatment without ADSCs transplantation | No Intervention | Only intervention: laminectomy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laminectomy | Device | surgical laminectomy with glial scar resection |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Phuc Ba Duong, MD | Contact | +17143607716 | triphuocbio@gmail.com | |
| Hoa D Nguyen, MD | Contact | +84904613833 | dinhhoaykhoa@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Phuc Ba Duong, MD | Tri Phuoc Biotechnology., JSC | Principal Investigator |
| Hoa D Nguyen, MD | Vietnamese- German Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vietnamese- German Hospital | Recruiting | Hanoi | Hanoi | Vietnam |
Not provided
| ID | Term |
|---|---|
| D007796 | Laminectomy |
| D007278 | Injections, Spinal |
| ID | Term |
|---|---|
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D019299 | Decompression, Surgical |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Intradural space | Device | ADSCs injection into Intradural space at damage site |
|
| Intrathecal | Device | ADSCs Intrathecal into lumbar puncture |
|
| Intravenous | Device | ADSCs intravenous |
|
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 |
| D019635 | Neurosurgical Procedures |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |