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

This study is currently recruiting participants.
Verified July 2012 by National Yang Ming University
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: July 22, 2012
Last verified: July 2012
History of Changes
  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: 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:

U.S. FDA Resources

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


Estimated Enrollment: 2
Study Start Date: October 2011
Estimated Study Completion Date: November 2013
Estimated 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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01649700

Contacts
Contact: Bing-Wen Soong, MD/PhD 886-2871-2121 ext 3178 bwsoong@ym.edu.tw
Contact: Oscar Kuang-sheng Lee, MD/PhD 886-2875-7391 kslee@vghtpe.gov.tw

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

No publications provided

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: July 22, 2012
Health Authority: Taiwan : Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 21, 2013