We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01649700
First Posted: July 25, 2012
Last Update Posted: September 12, 2014
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.
Information provided by (Responsible Party):
Oscar Kuang-Sheng Lee, National Yang Ming University
April 9, 2012
July 25, 2012
September 12, 2014
October 2011
May 2013   (Final data collection date for primary outcome measure)
Safety evaluation [ Time Frame: 16 months ]
Safety evaluate through vital signs, the results of clinical lab tests and adverse events (AEs).
Same as current
Complete list of historical versions of study NCT01649700 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Treatment of Sequelae Caused by Severe Brain Injury With Autologous Adipose-derived Mesenchymal Stem Cells
Treatment of Sequelae Caused by Severe Brain Injury With Autologous Adipose-derived Mesenchymal Stem Cells
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.
Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
The Sequelae Caused by Severe Brain Injury
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.
Experimental: Mesenchymal stem cells treatment
All subjects will receive autologous adipose-derived mesenchymal stem cells
Intervention: Biological: autologous adipose-derived mesenchymal stem cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
May 2013
May 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 40 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT01649700
SB-VGH-201101
No
Not Provided
Not Provided
Oscar Kuang-Sheng Lee, National Yang Ming University
National Yang Ming University
Not Provided
Not Provided
National Yang Ming University
September 2014

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