- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01451528
Allogeneic Umbilical Cord Blood Therapy for Chronic TBI
April 2, 2014 updated by: MinYoung Kim, M.D., Bundang CHA Hospital
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeonggi-do
-
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
- CHA Bundang Medical Center, CHA University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Chronic Traumatic Brain Injury Patient (onset duration: over 6 months)
- Glasgow Outcome Scale: 2, 3, 4, 5
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Allogeneic Umbilical Cord Blood
Allogeneic Umbilical Cord Blood Transplantation
|
Allogeneic Umbilical Cord Blood Transplantation via Intravenous or Intraarterial route
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in Short-term Memory Function
Time Frame: Baseline - 6 months
|
Baseline - 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in Global Outcome
Time Frame: Baseline - 6 months
|
Baseline - 6 months
|
Changes in Intelligence
Time Frame: Baseline - 6 months
|
Baseline - 6 months
|
Changes in Frontal Lobe Function
Time Frame: Baseline - 6 months
|
Baseline - 6 months
|
Changes in Traumatic Brain Injury-related Symptoms
Time Frame: Baseline - 6 months
|
Baseline - 6 months
|
Changes in Attention
Time Frame: Baseline - 6 months
|
Baseline - 6 months
|
Changes in Behavior
Time Frame: Baseline - 6 months
|
Baseline - 6 months
|
Changes in Emotion and Personality
Time Frame: Baseline - 6 months
|
Baseline - 6 months
|
Changes in Motor Function and Activities of Daily Living
Time Frame: Baseline - 6 months
|
Baseline - 6 months
|
Changes in Brain Structure
Time Frame: Baseline - 6 months
|
Baseline - 6 months
|
Changes in Brain Glucose Metabolism
Time Frame: Baseline - 2 weeks
|
Baseline - 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (ANTICIPATED)
December 1, 2015
Study Completion (ANTICIPATED)
December 1, 2015
Study Registration Dates
First Submitted
October 11, 2011
First Submitted That Met QC Criteria
October 11, 2011
First Posted (ESTIMATE)
October 13, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
April 3, 2014
Last Update Submitted That Met QC Criteria
April 2, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TBIUCB
- 2011-141 (OTHER: IRB of CHA Bundang Medical Center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Traumatic Brain Injury
-
Fondazione per la Ricerca Ospedale MaggioreCompletedBrain Injuries, Traumatic | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateItaly
-
Toronto Rehabilitation InstituteCentre for Aging and Brain Health Innovation; Ontario Neurotrauma FoundationUnknownBrain Injuries, Traumatic | Brain Injury, Chronic | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateCanada
-
Hospital Sirio-LibanesUniversity of Sao Paulo; Ministry of Health, Brazil; Hospital Sao Rafael; PROAD... and other collaboratorsRecruitingBrain Injury Traumatic Severe | Brain Injury Traumatic Moderate | Post Traumatic EpilepsyBrazil
-
University of TurkuTurku University Hospital; The Finnish Funding Agency for Technology and Innovation... and other collaboratorsCompletedBrain Injuries | TBI (Traumatic Brain Injury) | Brain Injuries, Traumatic | Traumatic Brain Injury | Injury, Brain, TraumaticFinland
-
Children's Hospital Medical Center, CincinnatiUniversity of CincinnatiCompletedBrain Injury Traumatic MildUnited States
-
BrainScope Company, Inc.RecruitingTBI (Traumatic Brain Injury) | Concussion, Brain | MTBI - Mild Traumatic Brain Injury | Closed Head InjuryUnited States
-
Institut National de la Santé Et de la Recherche...Institut National de Recherche en Informatique et en AutomatiqueNot yet recruitingTBI (Traumatic Brain Injury)France
-
University of Sao Paulo General HospitalUnknownTraumatic Brain Injury | Severe Brain Injury | Closed Traumatic Brain InjuryBrazil
-
Queen Mary University of LondonCompleted
-
Northeastern UniversityBrandeis UniversityRecruitingTraumatic Brain Injury | Mild Traumatic Brain Injury | TBI | Moderate Traumatic Brain InjuryUnited States
Clinical Trials on Allogeneic Umbilical Cord Blood
-
MinYoung Kim, M.D.CHA UniversityCompletedGlobal Developmental DelayKorea, Republic of
-
MinYoung Kim, M.D.CHA UniversityCompleted
-
MinYoung Kim, M.D.Completed
-
BHI Therapeutic SciencesUnknownAcute Ischemic StrokeUnited States
-
Joanne Kurtzberg, MDThe Marcus FoundationCompleted
-
Pomeranian Medical University SzczecinUnknownNecrotizing Enterocolitis | Intracranial Hemorrhages | Retinopathy of Prematurity | Respiratory Distress Syndrome, Newborn | Anemia, Neonatal | Bronchopulmonary DysplasiaPoland
-
Sklifosovsky Institute of Emergency CareNational Medical Research Center for Cardiology, Ministry of Health of Russian...CompletedSpinal Cord ContusionRussian Federation
-
Bundang CHA HospitalWithdrawnCerebral PalsyKorea, Republic of
-
MinYoung Kim, M.D.Completed