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

This study has been completed.
Information provided by (Responsible Party):
Oscar Kuang-Sheng Lee, National Yang Ming University Identifier:
First received: April 9, 2012
Last updated: September 11, 2014
Last verified: September 2014
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.

Condition Intervention Phase
The Sequelae Caused by Severe Brain Injury
Biological: autologous adipose-derived mesenchymal stem cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Sequelae Caused by Severe Brain Injury With Autologous Adipose-derived Mesenchymal Stem Cells

Resource links provided by NLM:

Further study details as provided by National Yang Ming University:

Primary Outcome Measures:
  • Safety evaluation [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]
    Safety evaluate through vital signs, the results of clinical lab tests and adverse events (AEs).

Secondary Outcome Measures:
  • Positron emission tomography [ Time Frame: 13 months ] [ Designated as safety issue: No ]
    18F-FDG used for the assessment of glucose metabolism in the brain

  • Magnetic Resonance Imaging [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    changes in the volume of brain lesions

  • Electroencephalogram [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    improvement of continuous slow-waves and irritative features

  • Neuropsychological assessment [ Time Frame: 16 months ] [ Designated as safety issue: No ]
  • Electrodiagnostic Testing [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    improvement of subjects' sensory neurologic pathways

  • Assessment of language and swallowing functions [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    changes in levels of severity: normal/slight/mild/moderate/severe

  • Measure of the severity of disability [ Time Frame: 16 months ] [ Designated as safety issue: No ]
  • Assessment of spasticity and strength [ Time Frame: 16 months ] [ Designated as safety issue: No ]
  • Assessment of brain motor control [ Time Frame: 16 months ] [ Designated as safety issue: No ]
    measurement of the electrical activities in the muscles during specific testing procedures

Enrollment: 1
Study Start Date: October 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mesenchymal stem cells treatment
All subjects will receive autologous adipose-derived mesenchymal stem cells
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.


Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01649700

Taipei Veterans General Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Yang Ming University
  More Information

Responsible Party: Oscar Kuang-Sheng Lee, Director of Stem Cell Research Centre, National Yang Ming University Identifier: NCT01649700     History of Changes
Other Study ID Numbers: SB-VGH-201101 
Study First Received: April 9, 2012
Last Updated: September 11, 2014
Health Authority: Taiwan : Food and Drug Administration

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries processed this record on May 24, 2016