Safety and Efficacy Assessment of Autologous Bone-marrow Derived Adult Mesenchymal Stem Cell Therapy in Patients With Anoxic(or Hypoxic) Brain Injury Pilot Trial
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|ClinicalTrials.gov Identifier: NCT02210624|
Recruitment Status : Recruiting
First Posted : August 7, 2014
Last Update Posted : August 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Anoxic Brain Injury||Biological: HYNR-CS inj.||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Safety and Efficacy Assessment of Autologous Bone-marrow Derived Mesenchymal Stem Cell Therapy in Anoxic (or Hypoxic) Brain Injury.|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Single arm
Experimental: HYNR-CS inj.
Treatment group with HYNR-CS inj.
Biological: HYNR-CS inj.
Intrathecal injection with 1ml/10kg of body weight at an interval of 26 days.
- safety assessment [ Time Frame: week 1, 3, 4, 5, 7 ]
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
- Glasgow Coma Scale(GCS) [ Time Frame: Week 1, 4, 5, 6, 7 ]assess level of consciousness after head injury
- FOUR score [ Time Frame: Week 1, 4, 5, 6, 7 ]The FOUR Score is a clinical grading scale designed for use by medical professionals in the assessment of patients with impaired level of consciousness.
- Functional Independence Measure(FIM) [ Time Frame: Week 1, 4, 5, 6, 7 ]The Functional Independence Measure (FIM™) instrument is a basic indicator of patient disability.
- Disability Rating Scale(DRS) [ Time Frame: Week 1, 4, 5, 6, 7 ]The Disability Rating Scale (DRS) is primarily used to assess impairment, disability, and handicap of an individual.
- Cerebral Performance Category(CPC)scale [ Time Frame: Week 1, 4, 5, 6, 7 ]The Cerebral Performance Category score is to use measure of functional outcome after cardiac arrest.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210624
|Contact: Hyun Young Kim, MD,. PhD.||+firstname.lastname@example.org|
|Korea, Republic of|
|Hanyang University Hospital||Recruiting|
|Seoul, Korea, Republic of, 133-792|
|Principal Investigator: Hyun Young Kim, MD,. PhD.|
|Principal Investigator:||Hyun Young Kim, MD.,PhD.||Hanyang University|