The purpose of study is to evaluate the safety and efficacy of autologous bone marrow-derived stem cells therapy in patients with anaerobic (hypoxic) brain injury. Stem cell therapy is an emerging alternative treatment modality in incurable and intractable neurological disorders. This pilot study aims to evaluate the feasibility and safety of stem cells in anaerobic brain injury.
Various treatment modalities to minimize the neurological deficits of anoxic brain injury, including lower consciousness, abnormal movement disorders, and abnormal behavior, have been tried, but so far there have been no effective proven method for chronic patients. This study is the investigator initiated trial to verify the safety and feasibility of stem cells therapy in patients with anoxic brain injury.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Intrathecal injection with 1ml/10kg of body weight at an interval of 26 days.
Hanyang University Hospital
Seoul, South Korea
RECRUITINGsafety assessment
Each visit physical examination, neurological examination, and adverse reactions through the follow-up to the expression of new symptoms. week 1,3,5,7 conducted Hematological week 4,7 conducted MRI, PET
Time frame: week 1, 3, 4, 5, 7
Glasgow Coma Scale(GCS)
assess level of consciousness after head injury
Time frame: Week 1, 4, 5, 6, 7
FOUR score
The FOUR Score is a clinical grading scale designed for use by medical professionals in the assessment of patients with impaired level of consciousness.
Time frame: Week 1, 4, 5, 6, 7
Functional Independence Measure(FIM)
The Functional Independence Measure (FIM™) instrument is a basic indicator of patient disability.
Time frame: Week 1, 4, 5, 6, 7
Disability Rating Scale(DRS)
The Disability Rating Scale (DRS) is primarily used to assess impairment, disability, and handicap of an individual.
Time frame: Week 1, 4, 5, 6, 7
Cerebral Performance Category(CPC)scale
The Cerebral Performance Category score is to use measure of functional outcome after cardiac arrest.
Time frame: Week 1, 4, 5, 6, 7
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