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

Anoxic Brain Injury Clinical 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02210624
• Other study ID #: HYNR_CS_ABI001
• Status: Recruiting
• Phase: N/A
• First received: July 31, 2014
• Last updated: August 8, 2017
• Start date: March 2013
• Est. completion date: December 2018

Study information

• Verified date: August 2017
• Source: Hanyang University Seoul Hospital
• Contact: Hyun Young Kim, MD,. PhD.
• Phone: +82-2-2290-8373
• Email: hyoungkim1[@]hanyang.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anoxic Brain Injury
• Brain Injuries
• Hypoxia, Brain
• Wounds and Injuries

Intervention

Biological:
• HYNR-CS inj.
Intrathecal injection with 1ml/10kg of body weight at an interval of 26 days.

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hyun Young Kim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Glasgow Coma Scale(GCS)	assess level of consciousness after head injury	Week 1, 4, 5, 6, 7
Secondary	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
Secondary	Functional Independence Measure(FIM)	The Functional Independence Measure (FIM™) instrument is a basic indicator of patient disability.	Week 1, 4, 5, 6, 7
Secondary	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
Secondary	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

External Links

•   Hanyang University Medical Center