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.

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.

Study Overview

• Status: Unknown
• Conditions: Anoxic Brain Injury
• Intervention / Treatment: Biological: HYNR-CS inj.

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: Interventional
• Enrollment (Anticipated): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	week 1, 3, 4, 5, 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glasgow Coma Scale(GCS)	assess level of consciousness after head injury	Week 1, 4, 5, 6, 7
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.	Week 1, 4, 5, 6, 7
Functional Independence Measure(FIM)	The Functional Independence Measure (FIM™) instrument is a basic indicator of patient disability.	Week 1, 4, 5, 6, 7
Disability Rating Scale(DRS)	The Disability Rating Scale (DRS) is primarily used to assess impairment, disability, and handicap of an individual.	Week 1, 4, 5, 6, 7
Cerebral Performance Category(CPC)scale	The Cerebral Performance Category score is to use measure of functional outcome after cardiac arrest.	Week 1, 4, 5, 6, 7

Collaborators and Investigators

• Sponsor: Hyun Young Kim
• Investigators: Principal Investigator: Hyun Young Kim, MD.,PhD., Hanyang University

Publications and helpful links

Helpful Links

• Hanyang University Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: July 31, 2014
• First Submitted That Met QC Criteria: August 6, 2014
• First Posted (Estimate): August 7, 2014

Study Record Updates

• Last Update Posted (Actual): August 10, 2017
• Last Update Submitted That Met QC Criteria: August 8, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Anoxic Brain Injury; Autologous bone marrow derived stem cell; stoke
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: HYNR_CS_ABI001