Back to resultsUCB Therapy in Acquired Brain Injury
Primary Purpose
Acquired Brain Injury
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Umbilical cord blood therapy
Sponsored by
About this trial
This is an interventional treatment trial for Acquired Brain Injury focused on measuring Umbilical cord blood, Acquired brain injury
Eligibility Criteria
Inclusion Criteria:
- Acquired brain injury
- Duration: over 12 months
- Willing to comply with all study procedure
Exclusion Criteria:
- Medical instability including pneumonia or renal function at enrollment
- Uncontrolled persistent epilepsy
- Poor cooperation of guardian,including inactive attitude for rehabilitation and visits for follow-up
- Not eligible according to the principal investigator
Sites / Locations
- CHA Bundang Medical Center, CHA University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Umbilical cord blood therapy
Arm Description
Umbilical cord blood therapy
Outcomes
Primary Outcome Measures
Monitoring adverse events
Secondary Outcome Measures
Changes in standardized gross motor function
GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales; lying & rolling, sitting, crawling & kneeling, standing, walking, running & jumping (range: 0~100 , Higher value means better gross motor function.)
Changes in motor performance
GMPM (Gross Motor Performance Measure) as a standardized measurement tool for assessing quality of movement regarding 3 properties of 5 ones; alignment, coordination, dissociated movement, stability, and weight shift (range: 0~100, Higher value means better motor quality.)
Changes in cognitive neurodevelopmental outcome
Korean version of Bayley Scale of Infant Development-II Mental Scales (Higher value means better cognitive function: raw score 0 - worst, 178 - best.)
Changes in motor neurodevelopmental outcome
Korean version of Bayley Scale of Infant Development-II Motor Scales (Higher value means better motor function: raw score 0 - worst, 112 - best)
Changes in functional performance in daily activities
Pediatric Evaluation of Disability Inventory (PEDI) for assessing functional performance in daily activities in children (All values are adjusted and higher value means better functional performance, 0 - worst, 100 - best.)
Changes in brain glucose metabolism
FDG (fludeoxyglucose)-PET (positron emission tomography)
Changes in brain white matter integrity
diffusion tensor imaging
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01885663
Brief Title
UCB Therapy in Acquired Brain Injury
Official Title
Umbilical Cord Blood Therapy for Patients With Acquired Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
MinYoung Kim, M.D.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This open label trial is conducted to investigate the efficacy and safety of allogeneic umbilical cord blood (UCB) therapy for patients with acquired brain injury.
Detailed Description
Acquired brain injury (ABI) means brain damage caused by events after birth, rather than as part of a genetic or congenital disorders. Those with ABI suffer from cognitive, physical, or behavioral impairments limiting their activity and participation in society. ABI results from traumatic or non-traumatic brain injury due to internal or external source (e.g. infection, brain tumor, hypoxia). Preclinical studies regarding cell therapy in animal models of ABI showed improvements of neurological dysfunction. UCB possess various stem or progenitor cells and is known to secrete neurotrophic factors to repair injured brain. This clinical research aims to determine the safety and efficacy of allogeneic UCB for patients with ABI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Brain Injury
Keywords
Umbilical cord blood, Acquired brain injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
UCB therapy for TBI patient
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Umbilical cord blood therapy
Arm Type
Experimental
Arm Description
Umbilical cord blood therapy
Intervention Type
Procedure
Intervention Name(s)
Umbilical cord blood therapy
Intervention Description
Intravascular umbilical cord blood therapy
Primary Outcome Measure Information:
Title
Monitoring adverse events
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Changes in standardized gross motor function
Description
GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales; lying & rolling, sitting, crawling & kneeling, standing, walking, running & jumping (range: 0~100 , Higher value means better gross motor function.)
Time Frame
Baseline - 1 month - 3 months - 6 months - 12 months
Title
Changes in motor performance
Description
GMPM (Gross Motor Performance Measure) as a standardized measurement tool for assessing quality of movement regarding 3 properties of 5 ones; alignment, coordination, dissociated movement, stability, and weight shift (range: 0~100, Higher value means better motor quality.)
Time Frame
Baseline - 1 month - 3 months - 6 months - 12 months
Title
Changes in cognitive neurodevelopmental outcome
Description
Korean version of Bayley Scale of Infant Development-II Mental Scales (Higher value means better cognitive function: raw score 0 - worst, 178 - best.)
Time Frame
Baseline - 1 month - 3 months - 6 months - 12 months
Title
Changes in motor neurodevelopmental outcome
Description
Korean version of Bayley Scale of Infant Development-II Motor Scales (Higher value means better motor function: raw score 0 - worst, 112 - best)
Time Frame
Baseline - 1 month - 3 months - 6 months - 12 months
Title
Changes in functional performance in daily activities
Description
Pediatric Evaluation of Disability Inventory (PEDI) for assessing functional performance in daily activities in children (All values are adjusted and higher value means better functional performance, 0 - worst, 100 - best.)
Time Frame
Baseline - 1 month - 3 months - 6 months - 12 months
Title
Changes in brain glucose metabolism
Description
FDG (fludeoxyglucose)-PET (positron emission tomography)
Time Frame
Baseline - 12 months
Title
Changes in brain white matter integrity
Description
diffusion tensor imaging
Time Frame
Baseline - 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acquired brain injury
Duration: over 12 months
Willing to comply with all study procedure
Exclusion Criteria:
Medical instability including pneumonia or renal function at enrollment
Uncontrolled persistent epilepsy
Poor cooperation of guardian,including inactive attitude for rehabilitation and visits for follow-up
Not eligible according to the principal investigator
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
Learn more about this trial
UCB Therapy in Acquired Brain Injury
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