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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

Tracking Information
First Submitted Date  ICMJE January 6, 2014
First Posted Date  ICMJE January 13, 2014
Last Update Posted Date January 13, 2014
Study Start Date  ICMJE February 2013
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transplantation of Autologous Adipose Derived Stem Cells (ADSCs) in Spinal Cord Injury Treatment
Official Title  ICMJE A Phase II Study of Transplantation of Autologous Adipose Derived Stem Cells (ADSCs) in Completely Acute Spinal Cord Injury.
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Spinal Cord Injury
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Treatment with ADSCs transplantation
    4 Intervention: laminectomy, intradural space at damage site, intrathecal at lumbar puncture, intravenous
    Interventions:
    • Device: Laminectomy
    • Device: Intradural space
    • Device: Intrathecal
    • Device: Intravenous
  • No Intervention: Treatment without ADSCs transplantation
    Only intervention: laminectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 10, 2014)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2015
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02034669
Other Study ID Numbers  ICMJE TP-VD-2012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tri Phuoc Biotechnology., JSC
Study Sponsor  ICMJE Tri Phuoc Biotechnology., JSC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Phuc Ba Duong, MD Tri Phuoc Biotechnology., JSC
Principal Investigator: Hoa D Nguyen, MD Vietnamese- German Hospital
PRS Account Tri Phuoc Biotechnology., JSC
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP