The Sequelae Caused by Severe Brain Injury
Conditions
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.
Interventions
Patients will receive five infusions, one month apart, each comprising 5-7x10\^7 cells of autologous adipose-derived mesenchymal stem cells.
Sponsors
National Yang Ming Chiao Tung University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety evaluation | 16 months | Safety evaluate through vital signs, the results of clinical lab tests and adverse events (AEs). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Positron emission tomography | 13 months | 18F-FDG used for the assessment of glucose metabolism in the brain |
| Measure of the severity of disability | 16 months | — |
| Assessment of spasticity and strength | 16 months | — |
| Assessment of brain motor control | 16 months | measurement of the electrical activities in the muscles during specific testing procedures |
| Assessment of language and swallowing functions | 16 months | changes in levels of severity: normal/slight/mild/moderate/severe |
Countries
Taiwan
Outcome results
None listed