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Treatment of Sequelae Caused by Severe Brain Injury With Autologous Adipose-derived Mesenchymal Stem Cells

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01649700
Recruitment Status : Completed
First Posted : July 25, 2012
Last Update Posted : September 12, 2014
Sponsor:
Information provided by (Responsible Party):
Oscar Kuang-Sheng Lee, National Yang Ming University

Tracking Information
First Submitted Date  ICMJE April 9, 2012
First Posted Date  ICMJE July 25, 2012
Last Update Posted Date September 12, 2014
Study Start Date  ICMJE October 2011
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2012)
Safety evaluation [ Time Frame: 16 months ]
Safety evaluate through vital signs, the results of clinical lab tests and adverse events (AEs).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01649700 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2012)
  • Positron emission tomography [ Time Frame: 13 months ]
    18F-FDG used for the assessment of glucose metabolism in the brain
  • Magnetic Resonance Imaging [ Time Frame: 16 months ]
    changes in the volume of brain lesions
  • Electroencephalogram [ Time Frame: 16 months ]
    improvement of continuous slow-waves and irritative features
  • Neuropsychological assessment [ Time Frame: 16 months ]
  • Electrodiagnostic Testing [ Time Frame: 16 months ]
    improvement of subjects' sensory neurologic pathways
  • Assessment of language and swallowing functions [ Time Frame: 16 months ]
    changes in levels of severity: normal/slight/mild/moderate/severe
  • Measure of the severity of disability [ Time Frame: 16 months ]
  • Assessment of spasticity and strength [ Time Frame: 16 months ]
  • Assessment of brain motor control [ Time Frame: 16 months ]
    measurement of the electrical activities in the muscles during specific testing procedures
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 Treatment of Sequelae Caused by Severe Brain Injury With Autologous Adipose-derived Mesenchymal Stem Cells
Official Title  ICMJE Treatment of Sequelae Caused by Severe Brain Injury With Autologous Adipose-derived Mesenchymal Stem Cells
Brief Summary The study is to investigate the efficacy and safety of autologous transplantation of adipose-derived mesenchymal stem cells in patients with the sequelae caused by severe brain injury.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE The Sequelae Caused by Severe Brain Injury
Intervention  ICMJE Biological: autologous adipose-derived mesenchymal stem cells
Patients will receive five infusions, one month apart, each comprising 5-7x10^7 cells of autologous adipose-derived mesenchymal stem cells.
Study Arms  ICMJE Experimental: Mesenchymal stem cells treatment
All subjects will receive autologous adipose-derived mesenchymal stem cells
Intervention: Biological: autologous adipose-derived mesenchymal stem cells
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 Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2014)
1
Original Estimated Enrollment  ICMJE
 (submitted: July 22, 2012)
2
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject has a confirmed diagnosis of a brain AVM (arteriovenous malformation).
  • Stroke-like symptoms, including paralysis, caused by brain AVM hemorrhage.
  • Subject's modified Rankin scale (mRS) grades IV~V.
  • Ages between 20~40 years.
  • Estimated life expectancy must be greater than 2 months.
  • Signed informed consent from the subject.

Exclusion Criteria:

  • Pregnancy test positive.
  • Subject infected with hepatitis C, HIV or syphilis.
  • Subject not suitable for liposuction surgery.
  • Subject not eligible for PET or MRI.
  • Subject enrolled in any other cell therapy studies within the past 30 days.
  • Subject deemed to be not suitable for the study by the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01649700
Other Study ID Numbers  ICMJE SB-VGH-201101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oscar Kuang-Sheng Lee, National Yang Ming University
Study Sponsor  ICMJE National Yang Ming University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Yang Ming University
Verification Date September 2014

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