NCT01451528

Brief Summary

This open label trial is conducted to investigate the efficacy and safety of umbilical cord blood therapy for chronic traumatic brain injury patients. The study hypothesis is that the participants will show significant improvement in cognition and function after Umbilical cord blood (UCB) transplantation.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2011

Completed
2.7 years until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 3, 2014

Status Verified

April 1, 2014

Enrollment Period

1.4 years

First QC Date

October 11, 2011

Last Update Submit

April 2, 2014

Conditions

Traumatic Brain Injury

Keywords

Umbilical Cord BloodAllogeneicTraumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • Changes in Short-term Memory Function

    Baseline - 6 months

Secondary Outcomes (10)

  • Changes in Global Outcome

    Baseline - 6 months

  • Changes in Intelligence

    Baseline - 6 months

  • Changes in Frontal Lobe Function

    Baseline - 6 months

  • Changes in Traumatic Brain Injury-related Symptoms

    Baseline - 6 months

  • Changes in Attention

    Baseline - 6 months

  • +5 more secondary outcomes

Study Arms (1)

Allogeneic Umbilical Cord Blood

EXPERIMENTAL

Allogeneic Umbilical Cord Blood Transplantation

Biological: Allogeneic Umbilical Cord Blood

Interventions

Allogeneic Umbilical Cord BloodBIOLOGICAL

Allogeneic Umbilical Cord Blood Transplantation via Intravenous or Intraarterial route

Also known as: Umbilical Cord Blood
Allogeneic Umbilical Cord Blood

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic Traumatic Brain Injury Patient (onset duration: over 6 months)
  • Glasgow Outcome Scale: 2, 3, 4, 5

You may not qualify if:

  • High risk of pneumonia or renal function deterioration after immunosuppressant
  • Possibility of drug hypersensitivity which is related to this study remedy
  • Intractable seizure disorder
  • Poor cooperation of guardian,including inactive attitude for rehabilitation

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, Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

  • Minyoung Kim, M.D., Ph.D.

    CHA University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 11, 2011

First Posted

October 13, 2011

Study Start

July 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 3, 2014

Record last verified: 2014-04

Locations

KR(1)