Anoxic Brain InjuryNCT02210624
Safety and Efficacy Assessment of Autologous Bone-marrow Derived Adult Mesenchymal Stem Cell Therapy in Patients With Anoxic(or Hypoxic) Brain Injury Pilot Trial
A study testing HYNR-CS inj. in people with Anoxic Brain Injury, run by Hyun Young Kim at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anoxic Brain Injury
- What is being tested?
- HYNR-CS inj.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2013to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hanyang University Hospital
Seoul, 133-792
Hyun Young Kim, MD,. PhD.
About this study
Official title: 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.
Read the 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
- Being tested
- HYNR-CS inj.
- Keywords
- Anoxic Brain Injury, Autologous bone marrow derived stem cell, stoke
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HYNR-CS inj.Biological
Intrathecal injection with 1ml/10kg of body weight at an interval of 26 days.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Experimental: HYNR-CS inj.
Treatment group with HYNR-CS inj. Receives: Biological: HYNR-CS inj. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: week 1, 3, 4, 5, 7
Secondary outcomes (5)
Glasgow Coma Scale(GCS)
assess level of consciousness after head injury
Measured: 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.
Measured: Week 1, 4, 5, 6, 7
Functional Independence Measure(FIM)
The Functional Independence Measure (FIM™) instrument is a basic indicator of patient disability.
Measured: 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.
Measured: 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.
Measured: Week 1, 4, 5, 6, 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startMar 2013
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anoxic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hyun Young Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hyun Young Kim, Hanyang University Seoul Hospital
- Investigators
- Hyun Young Kim, MD.,PhD., Principal investigator, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210624
- Sponsor's protocol ID
- HYNR_CS_ABI001
- Status last verified
- Aug 2017
- First submitted
- 31 Jul 2014
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Safety and Efficacy Assessment of Autologous Bone-marrow Derived Mesenchymal Stem Cell Therapy in Anoxic (or Hypoxic) Brain Injury.
- ClinicalTrials.gov ID
- NCT02210624
- Acronym / sponsor ID
- HYNR_CS_ABI001
- Conditions
- Anoxic Brain Injury
- Keywords
- Anoxic Brain Injury, Autologous bone marrow derived stem cell, stoke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Hyun Young KimUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 7 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Biological: HYNR-CS inj.Experimental: HYNR-CS inj. Treatment group with HYNR-CS inj. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HYNR-CS inj.Intrathecal injection with 1ml/10kg of body weight at an interval of 26 days. | Biological | Single arm |
Primary outcome
safety assessment
Time frame: 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
5 secondary outcomes
Glasgow Coma Scale(GCS)
Time frame: Week 1, 4, 5, 6, 7
FOUR score
Time frame: Week 1, 4, 5, 6, 7
Functional Independence Measure(FIM)
Time frame: Week 1, 4, 5, 6, 7
Disability Rating Scale(DRS)
Time frame: Week 1, 4, 5, 6, 7
Cerebral Performance Category(CPC)scale
Time frame: Week 1, 4, 5, 6, 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- Hanyang University Medical CenterLink provided by the sponsor.
Related trials for Anoxic Brain Injury
RecruitingPhase 2/3
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-Ischemic Encephalopathy
Active, not recruitingObservational study
Florida Cerebrovascular Disease Biorepository and Genomics Center
Cerebrovascular Disease, Ischemic Stroke
Active, not recruiting
Implementation of Neuro Lung Protective Ventilation
Acute Brain Injury, Traumatic Brain Injury
Enrolling by invitationObservational study
Intranasal AAV9-PHP.eB Gene Therapy in Cerebral Palsy (CP) & Hypoxic Ischemic Encephalopathy (HIE)
Hypoxic Brain Damage, Hypoxic Ischaemic Encephalopathy (HIE)
RecruitingObservational study
Biomarkers Study in Infants With Prior Neonatal Brain Injury
HIE - Hypoxic - Ischemic Encephalopathy, Perinatal Anoxic-ischemic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyun Young Kim, MD.,PhD. principal investigator
Hanyang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HYNR-CS inj. in people with Anoxic Brain Injury, run by Hyun Young Kim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun Young Kim, MD,. PhD. (+82-2-2290-8373, hyoungkim1@hanyang.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety assessment (time frame: week 1, 3, 4, 5, 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2017.