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

NCT ID: NCT02210624

Last Updated: 2017-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2018-12-31

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.

Conditions

Anoxic Brain Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm

Experimental: HYNR-CS inj.

Treatment group with HYNR-CS inj.

Group Type: EXPERIMENTAL

HYNR-CS inj.

Intervention Type: BIOLOGICAL

Intrathecal injection with 1ml/10kg of body weight at an interval of 26 days.

Interventions

HYNR-CS inj.

Intrathecal injection with 1ml/10kg of body weight at an interval of 26 days.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hyun Young Kim

OTHER

Sponsor Role: lead

Responsible Party

Hyun Young Kim

seong joon kwon

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hyun Young Kim, MD.,PhD.

Role: PRINCIPAL_INVESTIGATOR

Hanyang University

Locations

Hanyang University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Hyun Young Kim, MD,. PhD.

Role: CONTACT

hyoungkim1@hanyang.ac.kr

+82-2-2290-8373

Other Identifiers

HYNR_CS_ABI001

Identifier Type: -

Identifier Source: org_study_id