UCB Therapy in Acquired Brain Injury

Umbilical Cord Blood Therapy for Patients With Acquired Brain Injury

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.

Study Overview

• Status: Completed
• Conditions: Acquired Brain Injury
• Intervention / Treatment: Procedure: Umbilical cord blood therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
      • CHA Bundang Medical Center, CHA University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Umbilical cord blood therapy	Procedure: Umbilical cord blood therapy; Intravascular umbilical cord blood therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Monitoring adverse events	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.)	Baseline - 1 month - 3 months - 6 months - 12 months
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.)	Baseline - 1 month - 3 months - 6 months - 12 months
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.)	Baseline - 1 month - 3 months - 6 months - 12 months
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)	Baseline - 1 month - 3 months - 6 months - 12 months
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.)	Baseline - 1 month - 3 months - 6 months - 12 months
Changes in brain glucose metabolism	FDG (fludeoxyglucose)-PET (positron emission tomography)	Baseline - 12 months
Changes in brain white matter integrity	diffusion tensor imaging	Baseline - 12 months

Collaborators and Investigators

• Sponsor: MinYoung Kim, M.D.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: June 20, 2013
• First Submitted That Met QC Criteria: June 21, 2013
• First Posted (Estimate): June 25, 2013

Study Record Updates

• Last Update Posted (Actual): October 12, 2017
• Last Update Submitted That Met QC Criteria: October 10, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Acquired brain injury; Umbilical cord blood
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: UCBABI