Clinical Trial: 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 Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

Brief Summary: 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 Summary:

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.


Sponsor: Hyun Young Kim

Current Primary Outcome: 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



Original Primary Outcome: safety assessment [ Time Frame: each time ]

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



Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Hanyang University Seoul Hospital

Dates:
Date Received: July 31, 2014
Date Started: March 2013
Date Completion: December 2015
Last Updated: August 6, 2014
Last Verified: August 2014