Safety and Efficacy Assessment of Autologous Bone-marrow Derived Adult Mesenchymal Stem Cell Therapy in Patients With Anoxic(or Hypoxic) Brain Injury Pilot Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Open-label, Safety and Efficacy Assessment of Autologous Bone-marrow Derived Mesenchymal Stem Cell Therapy in Anoxic (or Hypoxic) Brain Injury.

Conditions
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Anoxic Brain Injury

Intervention / Treatment
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* Biological: HYNR-CS inj.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 14 days after the index event occurs in an oxygen-free brain injury patients Severe disability or moderate due to anoxic brain injury 18 years to 75 years Patients was 7 points less than Glasgow coma scale (GCS) After the resumption of blood flow circulation. anaerobic unexpected (hypoxic) cerebral ischemia Encephalopathy (It should not be a hypoxic brain ischemia was induced due to heart surgery, which is scheduled) Subjects agreed in writing that it will be participating in clinical research, as viewed from the legal representative (patient) Exclusion Criteria: Patients who require ventilator continued Patients who had extracorporeal membrane oxygenation(ECMO) index event occurs at the time Patients who had a history of cardiac arrest prior to the occurrence of Index event End-stage people of less than 12 months is expected (incurable) disease patients Patients with cardiac arrest occurred due to brain trauma severe Patients with damage to other organs of severe Patients with bleeding or malignant current Pregnant patient Patients with central nervous system tumors undergoing radiation therapy or chemotherapy If the patient or are participating in other clinical trials, you are planning to participate, or patients three months after the end is not passed to participate in other clinical trials

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Single arm<br>Experimental: HYNR-CS inj. Treatment group with HYNR-CS inj. | Biological: HYNR-CS inj.<br>* Intrathecal injection with 1ml/10kg of body weight at an interval of 26 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety 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 | week 1, 3, 4, 5, 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow Coma Scale(GCS) | assess level of consciousness after head injury | 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. | Week 1, 4, 5, 6, 7 | 
| Functional Independence Measure(FIM) | The Functional Independence Measure (FIM™) instrument is a basic indicator of patient disability. | 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. | 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. | Week 1, 4, 5, 6, 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anoxic Brain Injury, Autologous bone marrow derived stem cell, stoke