Acquired Brain Injury
Conditions
Keywords
Umbilical cord blood, Acquired brain injury
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.
Interventions
PROCEDUREUmbilical cord blood therapy
Intravascular umbilical cord blood therapy
Sponsors
MinYoung Kim, M.D.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
UCB therapy for TBI patient
Eligibility
Sex/Gender
ALL
Age
5 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Monitoring adverse events | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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.) |
| 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 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 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 brain glucose metabolism | Baseline - 12 months | FDG (fludeoxyglucose)-PET (positron emission tomography) |
| Changes in brain white matter integrity | Baseline - 12 months | diffusion tensor imaging |
| 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.) |
Countries
South Korea
Outcome results
None listed