Back to resultsAllogeneic Umbilical Cord Blood Therapy for Chronic TBI
Primary Purpose
Traumatic Brain Injury
Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Allogeneic Umbilical Cord Blood
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Umbilical Cord Blood, Allogeneic, Traumatic Brain Injury
Eligibility Criteria
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
Sites / Locations
- CHA Bundang Medical Center, CHA University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Allogeneic Umbilical Cord Blood
Arm Description
Allogeneic Umbilical Cord Blood Transplantation
Outcomes
Primary Outcome Measures
Changes in Short-term Memory Function
Secondary Outcome Measures
Changes in Global Outcome
Changes in Intelligence
Changes in Frontal Lobe Function
Changes in Traumatic Brain Injury-related Symptoms
Changes in Attention
Changes in Behavior
Changes in Emotion and Personality
Changes in Motor Function and Activities of Daily Living
Changes in Brain Structure
Changes in Brain Glucose Metabolism
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01451528
Brief Title
Allogeneic Umbilical Cord Blood Therapy for Chronic TBI
Official Title
The Efficacy and Safety of Allogeneic Umbilical Cord Blood Therapy for Chronic Traumatic Brain Injury Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Withdrawn
Why Stopped
The research fund, which is yet to be raised and expected to take for a while
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bundang CHA Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Umbilical Cord Blood, Allogeneic, Traumatic Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Allogeneic Umbilical Cord Blood
Arm Type
Experimental
Arm Description
Allogeneic Umbilical Cord Blood Transplantation
Intervention Type
Biological
Intervention Name(s)
Allogeneic Umbilical Cord Blood
Other Intervention Name(s)
Umbilical Cord Blood
Intervention Description
Allogeneic Umbilical Cord Blood Transplantation via Intravenous or Intraarterial route
Primary Outcome Measure Information:
Title
Changes in Short-term Memory Function
Time Frame
Baseline - 6 months
Secondary Outcome Measure Information:
Title
Changes in Global Outcome
Time Frame
Baseline - 6 months
Title
Changes in Intelligence
Time Frame
Baseline - 6 months
Title
Changes in Frontal Lobe Function
Time Frame
Baseline - 6 months
Title
Changes in Traumatic Brain Injury-related Symptoms
Time Frame
Baseline - 6 months
Title
Changes in Attention
Time Frame
Baseline - 6 months
Title
Changes in Behavior
Time Frame
Baseline - 6 months
Title
Changes in Emotion and Personality
Time Frame
Baseline - 6 months
Title
Changes in Motor Function and Activities of Daily Living
Time Frame
Baseline - 6 months
Title
Changes in Brain Structure
Time Frame
Baseline - 6 months
Title
Changes in Brain Glucose Metabolism
Time Frame
Baseline - 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minyoung Kim, M.D., Ph.D.
Organizational Affiliation
CHA University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHA Bundang Medical Center, CHA University
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-712
Country
Korea, Republic of
12. IPD Sharing Statement
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Allogeneic Umbilical Cord Blood Therapy for Chronic TBI
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