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OpenTrials
Completed

NCT Number: NCT01885663

UCB Therapy in 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.

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Key information

Conditions

Acquired Brain Injury Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggi-do, 463-712, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Umbilical Cord Blood therapy

Procedure

Intravascular umbilical cord blood therapy

Primary outcomes

  1. Monitoring adverse events

    Time frame: 12 months

Secondary outcomes

  1. Changes in standardized gross motor function

    Time frame: 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.)

  2. Changes in motor performance

    Time frame: 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.)

  3. Changes in cognitive neurodevelopmental outcome

    Time frame: 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.)

  4. Changes in motor neurodevelopmental outcome

    Time frame: 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)

  5. Changes in functional performance in daily activities

    Time frame: 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.)

  6. Changes in brain glucose metabolism

    Time frame: Baseline - 12 months

    FDG (fludeoxyglucose)-PET (positron emission tomography)

  7. Changes in brain white matter integrity

    Time frame: Baseline - 12 months

    diffusion tensor imaging

Sponsors and collaborators

Lead sponsor

MinYoung Kim, M.D.

Other

Registry information

Official study title

Umbilical Cord Blood Therapy for Patients With Acquired Brain Injury

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 25, 2013
Registry last updated
Oct 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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