NCT02210624

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 10, 2017

Status Verified

August 1, 2017

Enrollment Period

5.8 years

First QC Date

July 31, 2014

Last Update Submit

August 8, 2017

Conditions

Anoxic Brain Injury

Keywords

Anoxic Brain InjuryAutologous bone marrow derived stem cellstoke

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Glasgow Coma Scale(GCS)

    Week 1, 4, 5, 6, 7

  • FOUR score

    Week 1, 4, 5, 6, 7

  • Functional Independence Measure(FIM)

    Week 1, 4, 5, 6, 7

  • Disability Rating Scale(DRS)

    Week 1, 4, 5, 6, 7

  • Cerebral Performance Category(CPC)scale

    Week 1, 4, 5, 6, 7

Study Arms (1)

Single arm

EXPERIMENTAL

Experimental: HYNR-CS inj. Treatment group with HYNR-CS inj.

Biological: HYNR-CS inj.

Interventions

HYNR-CS inj.BIOLOGICAL

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

Single arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanyang University Hospital

Seoul, 133-792, South Korea

RECRUITING

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesCardiovascular DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hyun Young Kim, MD.,PhD.

    Hanyang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun Young Kim, MD,. PhD.

CONTACT

+82-2-2290-8373hyoungkim1@hanyang.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
seong joon kwon

Study Record Dates

First Submitted

July 31, 2014

First Posted

August 7, 2014

Study Start

March 1, 2013

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

August 10, 2017

Record last verified: 2017-08

Locations

KR(1)