UCB Therapy in Acquired Brain Injury
- Conditions
- Acquired Brain Injury
- Interventions
- Procedure: Umbilical cord blood therapy
- Registration Number
- NCT01885663
- Lead Sponsor
- MinYoung Kim, M.D.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3
- Acquired brain injury
- Duration: over 12 months
- Willing to comply with all study procedure
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Umbilical cord blood therapy Umbilical cord blood therapy Umbilical cord blood therapy
- Primary Outcome Measures
Name Time Method Monitoring adverse events 12 months
- Secondary Outcome Measures
Name Time Method Changes in motor neurodevelopmental outcome Baseline - 1 month - 3 months - 6 months - 12 months 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 brain glucose metabolism Baseline - 12 months FDG (fludeoxyglucose)-PET (positron emission tomography)
Changes in cognitive neurodevelopmental outcome Baseline - 1 month - 3 months - 6 months - 12 months 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 functional performance in daily activities Baseline - 1 month - 3 months - 6 months - 12 months 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 white matter integrity Baseline - 12 months diffusion tensor imaging
Changes in standardized gross motor function Baseline - 1 month - 3 months - 6 months - 12 months 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 Baseline - 1 month - 3 months - 6 months - 12 months 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.)
Trial Locations
- Locations (1)
CHA Bundang Medical Center, CHA University
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of