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Completed

NCT Number: NCT01649700

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.

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Key information

Conditions

The Sequelae Caused by Severe Brain Injury

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Taipei Veterans General Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autologous adipose-derived mesenchymal stem cells

Biological

Patients will receive five infusions, one month apart, each comprising 5-7x10^7 cells of autologous adipose-derived mesenchymal stem cells.

Primary outcomes

  1. Safety evaluation

    Time frame: 16 months

    Safety evaluate through vital signs, the results of clinical lab tests and adverse events (AEs).

Secondary outcomes

  1. Positron emission tomography

    Time frame: 13 months

    18F-FDG used for the assessment of glucose metabolism in the brain

  2. Magnetic Resonance Imaging

    Time frame: 16 months

    changes in the volume of brain lesions

  3. Electroencephalogram

    Time frame: 16 months

    improvement of continuous slow-waves and irritative features

  4. Neuropsychological assessment

    Time frame: 16 months

  5. Electrodiagnostic Testing

    Time frame: 16 months

    improvement of subjects' sensory neurologic pathways

  6. Assessment of language and swallowing functions

    Time frame: 16 months

    changes in levels of severity: normal/slight/mild/moderate/severe

  7. Measure of the severity of disability

    Time frame: 16 months

  8. Assessment of spasticity and strength

    Time frame: 16 months

  9. Assessment of brain motor control

    Time frame: 16 months

    measurement of the electrical activities in the muscles during specific testing procedures

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 25, 2012
Registry last updated
Sep 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.