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

National Yang Ming Chiao Tung University1 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

The Sequelae Caused by Severe Brain Injury

Interventions

autologous adipose-derived mesenchymal stem cellsBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

Safety evaluation

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

Time frame: 16 months

Secondary Outcomes

Positron emission tomography

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

Time frame: 13 months

Magnetic Resonance Imaging

changes in the volume of brain lesions

Time frame: 16 months

Electroencephalogram

improvement of continuous slow-waves and irritative features

Time frame: 16 months

Neuropsychological assessment

Time frame: 16 months

Electrodiagnostic Testing

improvement of subjects' sensory neurologic pathways

Time frame: 16 months

Assessment of language and swallowing functions

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

Time frame: 16 months

Measure of the severity of disability

Time frame: 16 months

Assessment of spasticity and strength

Time frame: 16 months

Assessment of brain motor control

Data from ClinicalTrials.gov

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