The Sequelae Caused by Severe Brain Injury Clinical Trial
Official title:
Treatment of Sequelae Caused by Severe Brain Injury With Autologous Adipose-derived Mesenchymal Stem Cells
| Verified date | September 2014 |
| Source | National Yang Ming University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Taiwan : Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1 |
| Est. completion date | May 2013 |
| Est. primary completion date | May 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 40 Years |
| Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | Taipei Veterans General Hospital | Taipei |
| Lead Sponsor | Collaborator |
|---|---|
| National Yang Ming University |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety evaluation | Safety evaluate through vital signs, the results of clinical lab tests and adverse events (AEs). | 16 months | Yes |
| Secondary | Positron emission tomography | 18F-FDG used for the assessment of glucose metabolism in the brain | 13 months | No |
| Secondary | Magnetic Resonance Imaging | changes in the volume of brain lesions | 16 months | No |
| Secondary | Electroencephalogram | improvement of continuous slow-waves and irritative features | 16 months | No |
| Secondary | Neuropsychological assessment | 16 months | No | |
| Secondary | Electrodiagnostic Testing | improvement of subjects' sensory neurologic pathways | 16 months | No |
| Secondary | Assessment of language and swallowing functions | changes in levels of severity: normal/slight/mild/moderate/severe | 16 months | No |
| Secondary | Measure of the severity of disability | 16 months | No | |
| Secondary | Assessment of spasticity and strength | 16 months | No | |
| Secondary | Assessment of brain motor control | measurement of the electrical activities in the muscles during specific testing procedures | 16 months | No |