Umbilical Cord Blood Therapy for Patients With Acquired Brain Injury
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acquired Brain Injury
- Sponsor
- MinYoung Kim, M.D.
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Monitoring adverse events
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
MinYoung Kim, M.D.
Professor
Bundang CHA Hospital
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
Outcomes
Primary Outcomes
Monitoring adverse events
Time Frame: 12 months
Secondary Outcomes
- Changes in motor neurodevelopmental outcome(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in brain glucose metabolism(Baseline - 12 months)
- Changes in cognitive neurodevelopmental outcome(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in brain white matter integrity(Baseline - 12 months)
- Changes in functional performance in daily activities(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in standardized gross motor function(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in motor performance(Baseline - 1 month - 3 months - 6 months - 12 months)