Safety and Efficacy Assessment of Autologous Bone-marrow Derived Adult Mesenchymal Stem Cell Therapy in Patients With Anoxic(or Hypoxic) Brain Injury Pilot Trial
Primary Purpose
Anoxic Brain Injury
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HYNR-CS inj.
Sponsored by
About this trial
This is an interventional treatment trial for Anoxic Brain Injury focused on measuring Anoxic Brain Injury, Autologous bone marrow derived stem cell, stoke
Eligibility Criteria
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
Sites / Locations
- Hanyang University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm
Arm Description
Experimental: HYNR-CS inj. Treatment group with HYNR-CS inj.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Glasgow Coma Scale(GCS)
assess level of consciousness after head injury
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.
Functional Independence Measure(FIM)
The Functional Independence Measure (FIM™) instrument is a basic indicator of patient disability.
Disability Rating Scale(DRS)
The Disability Rating Scale (DRS) is primarily used to assess impairment, disability, and handicap of an individual.
Cerebral Performance Category(CPC)scale
The Cerebral Performance Category score is to use measure of functional outcome after cardiac arrest.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02210624
Brief Title
Safety and Efficacy Assessment of Autologous Bone-marrow Derived Adult Mesenchymal Stem Cell Therapy in Patients With Anoxic(or Hypoxic) Brain Injury Pilot Trial
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 Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hyun Young Kim
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anoxic Brain Injury
Keywords
Anoxic Brain Injury, Autologous bone marrow derived stem cell, stoke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Experimental
Arm Description
Experimental: HYNR-CS inj.
Treatment group with HYNR-CS inj.
Intervention Type
Biological
Intervention Name(s)
HYNR-CS inj.
Intervention Description
Intrathecal injection with 1ml/10kg of body weight at an interval of 26 days.
Primary Outcome Measure Information:
Title
safety assessment
Description
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
Time Frame
week 1, 3, 4, 5, 7
Secondary Outcome Measure Information:
Title
Glasgow Coma Scale(GCS)
Description
assess level of consciousness after head injury
Time Frame
Week 1, 4, 5, 6, 7
Title
FOUR score
Description
The FOUR Score is a clinical grading scale designed for use by medical professionals in the assessment of patients with impaired level of consciousness.
Time Frame
Week 1, 4, 5, 6, 7
Title
Functional Independence Measure(FIM)
Description
The Functional Independence Measure (FIM™) instrument is a basic indicator of patient disability.
Time Frame
Week 1, 4, 5, 6, 7
Title
Disability Rating Scale(DRS)
Description
The Disability Rating Scale (DRS) is primarily used to assess impairment, disability, and handicap of an individual.
Time Frame
Week 1, 4, 5, 6, 7
Title
Cerebral Performance Category(CPC)scale
Description
The Cerebral Performance Category score is to use measure of functional outcome after cardiac arrest.
Time Frame
Week 1, 4, 5, 6, 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun Young Kim, MD,. PhD.
Phone
+82-2-2290-8373
Email
hyoungkim1@hanyang.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun Young Kim, MD.,PhD.
Organizational Affiliation
Hanyang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hanyang University Hospital
City
Seoul
ZIP/Postal Code
133-792
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun Young Kim, MD,. PhD.
12. IPD Sharing Statement
Links:
URL
https://seoul.hyumc.com/
Description
Hanyang University Medical Center
Learn more about this 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
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