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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
Sponsor:
Information provided by (Responsible Party):
Tri Phuoc Biotechnology., JSC

Study Description
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Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Acute Spinal Cord Injury Device: Laminectomy Device: Intradural space Device: Intrathecal Device: Intravenous Phase 1 Phase 2

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment with ADSCs transplantation
4 Intervention: laminectomy, intradural space at damage site, intrathecal at lumbar puncture, intravenous
 Device: Laminectomy
surgical laminectomy with glial scar resection

Device: Intradural space
ADSCs injection into Intradural space at damage site

Device: Intrathecal
ADSCs Intrathecal into lumbar puncture

Device: Intravenous
ADSCs intravenous
No Intervention: Treatment without ADSCs transplantation
Only intervention: laminectomy


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Urinary and bowel function Improvement [ Time Frame: 24 months ]
    Bladder pressure monitory to assess ability to feel and control urination and bowel.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be able to give voluntary (patients may not be able to write) consent.
  • 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:

  • Support respiration by machine
  • 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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Phuc Ba Duong, MD +17143607716 triphuocbio@gmail.com
Contact: Hoa D Nguyen, MD +84904613833 dinhhoaykhoa@yahoo.com

Locations
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Vietnam
Vietnamese- German Hospital Recruiting
Hanoi, Vietnam
Contact: Phuc Ba Duong, MD    +17143607716    triphuocbio@gmail.com   
Contact: Hoa D Nguyen, MSc, MD    +84904613833    dinhhoaykhoa@yahoo.com   
Sponsors and Collaborators
Tri Phuoc Biotechnology., JSC
Investigators
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Principal Investigator: Phuc Ba Duong, MD Tri Phuoc Biotechnology., JSC
Principal Investigator: Hoa D Nguyen, MD Vietnamese- German Hospital
More Information
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Responsible Party: Tri Phuoc Biotechnology., JSC
ClinicalTrials.gov Identifier: NCT02034669     History of Changes
Other Study ID Numbers: TP-VD-2012
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: January 13, 2014
Last Verified: January 2014
Keywords provided by Tri Phuoc Biotechnology., JSC:
Acute Spinal cord Injury, Adipose derived stem cells
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System