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

Sponsor

Hyun Young Kim (Other)

Overall Status

Unknown status

CT.gov ID

NCT02210624

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anoxic Brain Injury	Biological: HYNR-CS inj.	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

4 participants

Allocation:

N/A

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 :

Mar 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

safety assessment [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

Glasgow Coma Scale(GCS) [Week 1, 4, 5, 6, 7]
assess level of consciousness after head injury
FOUR score [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) [Week 1, 4, 5, 6, 7]
The Functional Independence Measure (FIM™) instrument is a basic indicator of patient disability.
Disability Rating Scale(DRS) [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 [Week 1, 4, 5, 6, 7]
The Cerebral Performance Category score is to use measure of functional outcome after cardiac arrest.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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