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

Study Overview
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Brief Summary
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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.

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

Conditions
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The Sequelae Caused by Severe Brain Injury

Intervention / Treatment
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* Biological: autologous adipose-derived mesenchymal stem cells


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesenchymal stem cells treatment<br>All subjects will receive autologous adipose-derived mesenchymal stem cells | Biological: autologous adipose-derived mesenchymal stem cells<br>* Patients will receive five infusions, one month apart, each comprising 5-7x10^7 cells of autologous adipose-derived mesenchymal stem cells.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluation | Safety evaluate through vital signs, the results of clinical lab tests and adverse events (AEs). | 16 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positron emission tomography | 18F-FDG used for the assessment of glucose metabolism in the brain | 13 months | 
| Magnetic Resonance Imaging | changes in the volume of brain lesions | 16 months | 
| Electroencephalogram | improvement of continuous slow-waves and irritative features | 16 months | 
| Neuropsychological assessment |  | 16 months | 
| Electrodiagnostic Testing | improvement of subjects' sensory neurologic pathways | 16 months | 
| Assessment of language and swallowing functions | changes in levels of severity: normal/slight/mild/moderate/severe | 16 months | 
| Measure of the severity of disability |  | 16 months | 
| Assessment of spasticity and strength |  | 16 months | 
| Assessment of brain motor control | measurement of the electrical activities in the muscles during specific testing procedures | 16 months |