NCT01885663

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2013

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 25, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 12, 2017

Status Verified

October 1, 2017

Enrollment Period

3.3 years

First QC Date

June 20, 2013

Last Update Submit

October 10, 2017

Conditions

Acquired Brain Injury

Keywords

Umbilical cord bloodAcquired brain injury

Outcome Measures

Primary Outcomes (1)

  • Monitoring adverse events

    12 months

Secondary Outcomes (7)

  • 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

  • Changes in cognitive neurodevelopmental outcome

    Baseline - 1 month - 3 months - 6 months - 12 months

  • Changes in motor neurodevelopmental outcome

    Baseline - 1 month - 3 months - 6 months - 12 months

  • Changes in functional performance in daily activities

    Baseline - 1 month - 3 months - 6 months - 12 months

  • +2 more secondary outcomes

Study Arms (1)

Umbilical cord blood therapy

EXPERIMENTAL

Umbilical cord blood therapy

Procedure: Umbilical cord blood therapy

Interventions

Umbilical cord blood therapyPROCEDURE

Intravascular umbilical cord blood therapy

Umbilical cord blood therapy

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Acquired brain injury
  • Duration: over 12 months
  • Willing to comply with all study procedure

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHA Bundang Medical Center, CHA University

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

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • MinYoung Kim, M.D., Ph.D.

    CHA University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: UCB therapy for TBI patient
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 20, 2013

First Posted

June 25, 2013

Study Start

June 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

October 12, 2017

Record last verified: 2017-10

Locations

KR(1)