Treatment of Sequelae Caused by Severe Brain Injury With Autologous Adipose-derived Mesenchymal Stem Cells
Phase 1
Completed
- Conditions
- The Sequelae Caused by Severe Brain Injury
- Interventions
- Biological: autologous adipose-derived mesenchymal stem cells
- Registration Number
- NCT01649700
- Lead Sponsor
- National Yang Ming Chiao Tung University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mesenchymal stem cells treatment autologous adipose-derived mesenchymal stem cells All subjects will receive autologous adipose-derived mesenchymal stem cells
- Primary Outcome Measures
Name Time Method Safety evaluation 16 months Safety evaluate through vital signs, the results of clinical lab tests and adverse events (AEs).
- Secondary Outcome Measures
Name Time Method Positron emission tomography 13 months 18F-FDG used for the assessment of glucose metabolism in the brain
Magnetic Resonance Imaging 16 months changes in the volume of brain lesions
Electroencephalogram 16 months improvement of continuous slow-waves and irritative features
Neuropsychological assessment 16 months Electrodiagnostic Testing 16 months improvement of subjects' sensory neurologic pathways
Assessment of language and swallowing functions 16 months changes in levels of severity: normal/slight/mild/moderate/severe
Measure of the severity of disability 16 months Assessment of brain motor control 16 months measurement of the electrical activities in the muscles during specific testing procedures
Assessment of spasticity and strength 16 months
Trial Locations
- Locations (1)
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan