UCB Therapy in Acquired Brain Injury

Acquired Brain Injury Clinical Trial

Official title:

Umbilical Cord Blood Therapy for Patients With Acquired Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01885663
• Other study ID #: UCBABI
• Status: Completed
• Phase: Phase 1
• First received: June 20, 2013
• Last updated: October 10, 2017
• Start date: June 2013
• Est. completion date: September 2016

Study information

• Verified date: October 2017
• Source: Bundang CHA Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Wounds and Injuries

Intervention

Procedure:
• Umbilical cord blood therapy
Intravascular umbilical cord blood therapy

Locations

Country	Name	City	State
Korea, Republic of	CHA Bundang Medical Center, CHA University	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
MinYoung Kim, M.D.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monitoring adverse events		12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in brain glucose metabolism	FDG (fludeoxyglucose)-PET (positron emission tomography)	Baseline - 12 months
Secondary	Changes in brain white matter integrity	diffusion tensor imaging	Baseline - 12 months