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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02210624
Recruitment Status : Unknown
Verified August 2017 by Hyun Young Kim, Hanyang University Seoul Hospital.
Recruitment status was:  Recruiting
First Posted : August 7, 2014
Last Update Posted : August 10, 2017
Information provided by (Responsible Party):
Hyun Young Kim, Hanyang University Seoul Hospital

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.

Condition or disease Intervention/treatment Phase
Anoxic Brain Injury Biological: HYNR-CS inj. Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Glasgow Coma Scale(GCS) [ Time Frame: Week 1, 4, 5, 6, 7 ]
    assess level of consciousness after head injury

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02210624

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Contact: Hyun Young Kim, MD,. PhD. +82-2-2290-8373

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Korea, Republic of
Hanyang University Hospital Recruiting
Seoul, Korea, Republic of, 133-792
Principal Investigator: Hyun Young Kim, MD,. PhD.         
Sponsors and Collaborators
Hyun Young Kim
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Principal Investigator: Hyun Young Kim, MD.,PhD. Hanyang University

Additional Information:
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Responsible Party: Hyun Young Kim, seong joon kwon, Hanyang University Seoul Hospital Identifier: NCT02210624     History of Changes
Other Study ID Numbers: HYNR_CS_ABI001
First Posted: August 7, 2014    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017
Keywords provided by Hyun Young Kim, Hanyang University Seoul Hospital:
Anoxic Brain Injury
Autologous bone marrow derived stem cell
Additional relevant MeSH terms:
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Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System