Traumatic Brain InjuryNCT01451528
Allogeneic Umbilical Cord Blood Therapy for Chronic TBI
A study testing Allogeneic Umbilical Cord Blood in people with Traumatic Brain Injury, run by Bundang CHA Hospital at 1 site in South Korea.
Trial summary
This open label trial is conducted to investigate the efficacy and safety of umbilical cord blood therapy for chronic traumatic brain injury patients. The study hypothesis is that the participants will show significant improvement in cognition and function after Umbilical cord blood (UCB) transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Allogeneic Umbilical Cord Blood
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Traumatic Brain Injury Patient (onset duration: over 6 months)
- Glasgow Outcome Scale: 2, 3, 4, 5
Who cannot join
- High risk of pneumonia or renal function deterioration after immunosuppressant
- Possibility of drug hypersensitivity which is related to this study remedy
- Intractable seizure disorder
- Poor cooperation of guardian,including inactive attitude for rehabilitation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, 463-712
About this study
Official title: The Efficacy and Safety of Allogeneic Umbilical Cord Blood Therapy for Chronic Traumatic Brain Injury Patients
This open label trial is conducted to investigate the efficacy and safety of umbilical cord blood therapy for chronic traumatic brain injury patients.
The study hypothesis is that the participants will show significant improvement in cognition and function after Umbilical cord blood (UCB) transplantation.
Read the detailed description
Traumatic brain injury patients have been increasing due to various accidents. After acute therapeutic intervention, rehabilitation is the conventional main treatment with medication. However, in chronic stage, there seems to be some limitation in obtaining functional improvement in spite of comprehensive rehabilitation. Cell therapy like Umbilical cord blood (UCB) transplantation has showed promising results in many animal studies. The mechanism of such neurological improvement is not fully understood. Stem cells included in UCB are expected to secrete neurotrophic factors to enhance brain function. In addition, anti-inflammatory effects of UCB are suggested. Autologous UCB are not available in most of the cases in fact. The aim of this clinical trial is to determine the safety and efficacy of allogeneic UCB.
- Conditions
- Traumatic Brain Injury
- Being tested
- Allogeneic Umbilical Cord Blood
- Keywords
- Umbilical Cord Blood, Allogeneic, Traumatic Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Umbilical Cord BloodBiological
Also called Umbilical Cord Blood
Allogeneic Umbilical Cord Blood Transplantation via Intravenous or Intraarterial route
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic Umbilical Cord Blood | Experimental | Allogeneic Umbilical Cord Blood Transplantation Receives: Biological: Allogeneic Umbilical Cord Blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Short-term Memory Function
Measured: Baseline - 6 months
Secondary outcomes (10)
Changes in Global Outcome
Measured: Baseline - 6 months
Changes in Intelligence
Measured: Baseline - 6 months
Changes in Frontal Lobe Function
Measured: Baseline - 6 months
Changes in Traumatic Brain Injury-related Symptoms
Measured: Baseline - 6 months
Changes in Attention
Measured: Baseline - 6 months
Changes in Behavior
Measured: Baseline - 6 months
Changes in Emotion and Personality
Measured: Baseline - 6 months
Changes in Motor Function and Activities of Daily Living
Measured: Baseline - 6 months
Changes in Brain Structure
Measured: Baseline - 6 months
Changes in Brain Glucose Metabolism
Measured: Baseline - 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2011 (estimated)
- Study startJul 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: The research fund, which is yet to be raised and expected to take for a while
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bundang CHA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MinYoung Kim, M.D., Bundang CHA Hospital
- Investigators
- Minyoung Kim, M.D., Ph.D., Principal investigator, CHA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451528
- Sponsor's protocol ID
- TBIUCB
- Other IDs
- 2011-141
- Status last verified
- Apr 2014
- First submitted
- 11 Oct 2011
- Last updated
- 3 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Allogeneic Umbilical Cord Blood Therapy for Chronic Traumatic Brain Injury Patients
- ClinicalTrials.gov ID
- NCT01451528
- Acronym / sponsor ID
- TBIUCB
- Conditions
- Traumatic Brain Injury
- Keywords
- Umbilical Cord Blood, Allogeneic, Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The research fund, which is yet to be raised and expected to take for a while
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bundang CHA HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 13 Oct 2011 (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.
This open label trial is conducted to investigate the efficacy and safety of umbilical cord blood therapy for chronic traumatic brain injury patients.
The study hypothesis is that the participants will show significant improvement in cognition and function after Umbilical cord blood (UCB) transplantation.
Detailed description
Traumatic brain injury patients have been increasing due to various accidents. After acute therapeutic intervention, rehabilitation is the conventional main treatment with medication. However, in chronic stage, there seems to be some limitation in obtaining functional improvement in spite of comprehensive rehabilitation. Cell therapy like Umbilical cord blood (UCB) transplantation has showed promising results in many animal studies. The mechanism of such neurological improvement is not fully understood. Stem cells included in UCB are expected to secrete neurotrophic factors to enhance brain function. In addition, anti-inflammatory effects of UCB are suggested. Autologous UCB are not available in most of the cases in fact. The aim of this clinical trial is to determine the safety and efficacy of allogeneic UCB.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allogeneic Umbilical Cord Blood | Experimental | Biological: Allogeneic Umbilical Cord BloodAllogeneic Umbilical Cord Blood Transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic Traumatic Brain Injury Patient (onset duration: over 6 months)
- Glasgow Outcome Scale: 2, 3, 4, 5
Key exclusion criteria (4 listed)
- High risk of pneumonia or renal function deterioration after immunosuppressant
- Possibility of drug hypersensitivity which is related to this study remedy
- Intractable seizure disorder
- Poor cooperation of guardian,including inactive attitude for rehabilitation
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 |
|---|---|---|
| Allogeneic Umbilical Cord BloodAlso: Umbilical Cord BloodAllogeneic Umbilical Cord Blood Transplantation via Intravenous or Intraarterial route | Biological | Allogeneic Umbilical Cord Blood |
Primary outcome
Changes in Short-term Memory Function
Time frame: Baseline - 6 months
10 secondary outcomes
Changes in Global Outcome
Time frame: Baseline - 6 months
Changes in Intelligence
Time frame: Baseline - 6 months
Changes in Frontal Lobe Function
Time frame: Baseline - 6 months
Changes in Traumatic Brain Injury-related Symptoms
Time frame: Baseline - 6 months
Changes in Attention
Time frame: Baseline - 6 months
Changes in Behavior
Time frame: Baseline - 6 months
Changes in Emotion and Personality
Time frame: Baseline - 6 months
Changes in Motor Function and Activities of Daily Living
Time frame: Baseline - 6 months
Changes in Brain Structure
Time frame: Baseline - 6 months
Changes in Brain Glucose Metabolism
Time frame: Baseline - 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2014.
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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.
Minyoung Kim, M.D., Ph.D. principal investigator
CHA 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 Allogeneic Umbilical Cord Blood in people with Traumatic Brain Injury, run by Bundang CHA Hospital 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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 3 Apr 2014. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Short-term Memory Function (time frame: Baseline - 6 months). 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 3 Apr 2014.