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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | Experimental: HYNR-CS inj. Treatment group with HYNR-CS inj. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HYNR-CS inj. | Biological | Intrathecal injection with 1ml/10kg of body weight at an interval of 26 days. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyun Young Kim, MD,. PhD. | Contact | +82-2-2290-8373 | hyoungkim1@hanyang.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Hyun Young Kim, MD.,PhD. | Hanyang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanyang University Hospital | Recruiting | Seoul | 133-792 | South Korea |
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| Label | URL |
|---|---|
| Hanyang University Medical Center | View source |
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| Week 1, 4, 5, 6, 7 |
| Functional Independence Measure(FIM) | The Functional Independence Measure (FIMâ„¢) 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 |
| ID | Term |
|---|---|
| D020925 | Hypoxia-Ischemia, Brain |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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