Transplantation of Autologous Adipose Derived Stem Cells (ADSCs) in Spinal Cord Injury Treatment
NCT ID: NCT02034669
Last Updated: 2014-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
48 participants
INTERVENTIONAL
2013-02-28
2015-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment with ADSCs transplantation
4 Intervention: laminectomy, intradural space at damage site, intrathecal at lumbar puncture, intravenous
Laminectomy
surgical laminectomy with glial scar resection
Intradural space
ADSCs injection into Intradural space at damage site
Intrathecal
ADSCs Intrathecal into lumbar puncture
Intravenous
ADSCs intravenous
Treatment without ADSCs transplantation
Only intervention: laminectomy
No interventions assigned to this group
Interventions
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Laminectomy
surgical laminectomy with glial scar resection
Intradural space
ADSCs injection into Intradural space at damage site
Intrathecal
ADSCs Intrathecal into lumbar puncture
Intravenous
ADSCs intravenous
Eligibility Criteria
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Inclusion Criteria
* Must be able to understand study information provided to him.
* Patients with complete spinal cord \< 2 weeks in acute category
* The level of spinal cord injury must be categorized at A level in terms of ASIA Impairment scale.
* Age should be between 19-60 years
* Both male and female
Exclusion Criteria
* Melanoma within 5 years
* Infectious diseases including HIV and Hepatitis B, C
* Brain damage or multiple trauma
* Body temperature higher 38 ℃ or acute disorder
* Anemia or thrombocytopenia
* Angina , myocardial infarction , heart disease , embolic disease , chronic renal failure, glomerular disease and chronic obstructive pulmonary disease.
* Congenital or acquired immunodeficiency disorder
* Muscular dystrophy or muscle stiffness
* Non-conscious or voice disorders
* Treatment with cytotoxic drugs ( immunosuppressive drugs , corticosteroids and cytotoxic drugs) during the clinical trials .
* Participating in another clinical trial within 3 months
* Other serious disease or disorder can seriously affect the ability to participate in research.
* Women who are pregnant or lactating .
* Allergy to antibiotics and anesthetics .
* Do not agree to participate in research
19 Years
60 Years
ALL
No
Sponsors
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Tri Phuoc Biotechnology., JSC
OTHER
Responsible Party
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Principal Investigators
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Phuc Ba Duong, MD
Role: PRINCIPAL_INVESTIGATOR
Tri Phuoc Biotechnology., JSC
Hoa D Nguyen, MD
Role: PRINCIPAL_INVESTIGATOR
Vietnamese- German Hospital
Locations
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Vietnamese- German Hospital
Hanoi, Hanoi, Vietnam
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TP-VD-2012
Identifier Type: -
Identifier Source: org_study_id
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