- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02210624
Safety and Efficacy Assessment of Autologous Bone-marrow Derived Adult Mesenchymal Stem Cell Therapy in Patients With Anoxic(or Hypoxic) Brain Injury Pilot Trial
An Open-label, Safety and Efficacy Assessment of Autologous Bone-marrow Derived Mesenchymal Stem Cell Therapy in Anoxic (or Hypoxic) Brain Injury.
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hyun Young Kim, MD,. PhD.
- Phone Number: +82-2-2290-8373
- Email: hyoungkim1@hanyang.ac.kr
Study Locations
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-
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Seoul, Korea, Republic of, 133-792
- Recruiting
- Hanyang University Hospital
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Principal Investigator:
- Hyun Young Kim, MD,. PhD.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single arm
Experimental: HYNR-CS inj. Treatment group with HYNR-CS inj. |
Intrathecal injection with 1ml/10kg of body weight at an interval of 26 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
week 1, 3, 4, 5, 7
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glasgow Coma Scale(GCS)
Time Frame: Week 1, 4, 5, 6, 7
|
assess level of consciousness after head injury
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Week 1, 4, 5, 6, 7
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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.
|
Week 1, 4, 5, 6, 7
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Functional Independence Measure(FIM)
Time Frame: Week 1, 4, 5, 6, 7
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The Functional Independence Measure (FIM™) instrument is a basic indicator of patient disability.
|
Week 1, 4, 5, 6, 7
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Disability Rating Scale(DRS)
Time Frame: Week 1, 4, 5, 6, 7
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The Disability Rating Scale (DRS) is primarily used to assess impairment, disability, and handicap of an individual.
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Week 1, 4, 5, 6, 7
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Cerebral Performance Category(CPC)scale
Time Frame: Week 1, 4, 5, 6, 7
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The Cerebral Performance Category score is to use measure of functional outcome after cardiac arrest.
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Week 1, 4, 5, 6, 7
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hyun Young Kim, MD.,PhD., Hanyang University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HYNR_CS_ABI001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anoxic Brain Injury
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Central Hospital, Nancy, FranceNot yet recruitingCardiac Arrest | Anoxic Brain Injury | Post-Anoxic Coma
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Polish Mother Memorial Hospital Research InstitutePoznan University of Medical SciencesCompleted
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University of AarhusUnknownSubarachnoid Hemorrhage | Anoxic Brain Injury | Severe Traumatic Brain InjuryDenmark
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University of AarhusUnknownCraniocerebral Trauma | Traumatic Brain Injury | Subarachnoid Hemorrhage | Anoxic Brain InjuryDenmark
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Erasme University HospitalNot yet recruitingCardiac Arrest | Ischemia Reperfusion Injury | Anoxic Brain Injury
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Massachusetts General HospitalCompletedComa | Anoxic Brain Injury | Consciousness, Level Altered | Brain Injury Traumatic Severe (Diagnosis)United States
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Colin GrissomActive, not recruitingStroke | Traumatic Brain Injury | Acute Brain Injury | Intracerebral Hemorrhage | Cerebral Edema | Anoxic Brain InjuryUnited States
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Lawson Health Research InstituteWestern University, CanadaCompletedCardiac Arrest | Anoxic Brain InjuryCanada
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University of PennsylvaniaCompletedIschemic Stroke | Traumatic Brain Injury | Subarachnoid Hemorrhage | Intracerebral Hemorrhage | Acute Anoxic EncephalopathyUnited States
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Jens Rikardt AndersenRigshospitalet, DenmarkCompletedStroke | Brain Injuries | Traumatic Brain Injury | Subarachnoid Hemorrhage | Anoxic Brain Injury | NeuroinfectionsDenmark
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