Overview

This trial is active, not recruiting.

Condition acquired brain injury
Treatment umbilical cord blood therapy
Phase phase 1
Sponsor MinYoung Kim, M.D.
Start date June 2013
End date December 2014
Trial size 3 participants
Trial identifier NCT01885663, UCBABI

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Umbilical cord blood therapy
umbilical cord blood therapy
Intravascular umbilical cord blood therapy

Primary Outcomes

Measure
Monitoring adverse events
time frame: 12 months

Secondary Outcomes

Measure
Changes in standardized gross motor function
time frame: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in motor performance
time frame: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in cognitive neurodevelopmental outcome
time frame: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in motor neurodevelopmental outcome
time frame: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in functional performance in daily activities
time frame: Baseline - 1 month - 3 months - 6 months - 12 months
Changes in brain glucose metabolism
time frame: Baseline - 12 months
Changes in brain white matter integrity
time frame: Baseline - 12 months

Eligibility Criteria

Male or female participants from 5 years up to 15 years old.

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

Additional Information

Official title Umbilical Cord Blood Therapy for Patients With Acquired Brain Injury
Principal investigator MinYoung Kim, M.D., Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by Bundang CHA Hospital.