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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oscar Kuang-Sheng Lee, National Yang Ming University
ClinicalTrials.gov Identifier:
NCT01649700
First received: April 9, 2012
Last updated: September 11, 2014
Last verified: September 2014
  Purpose
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: 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

Further study details as provided by Oscar Kuang-Sheng Lee, National Yang Ming University:

Primary Outcome Measures:
  • Safety evaluation [ Time Frame: 16 months ]
    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 ]
    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


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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649700

Locations
Taiwan
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
ClinicalTrials.gov Identifier: NCT01649700     History of Changes
Other Study ID Numbers: SB-VGH-201101
Study First Received: April 9, 2012
Last Updated: September 11, 2014

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 16, 2017