Allogeneic Umbilical Cord Blood Therapy for Chronic TBI

April 2, 2014 updated by: MinYoung Kim, M.D., Bundang CHA Hospital

The Efficacy and Safety of Allogeneic Umbilical Cord Blood Therapy for Chronic Traumatic Brain Injury Patients

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.

Study Overview

Status

Withdrawn

Detailed Description

Traumatic brain injury patients have been increasing due to various accidents. After acute therapeutic intervention, rehabilitation is the conventional main treatment with medication. However, in chronic stage, there seems to be some limitation in obtaining functional improvement in spite of comprehensive rehabilitation. Cell therapy like Umbilical cord blood (UCB) transplantation has showed promising results in many animal studies. The mechanism of such neurological improvement is not fully understood. Stem cells included in UCB are expected to secrete neurotrophic factors to enhance brain function. In addition, anti-inflammatory effects of UCB are suggested. Autologous UCB are not available in most of the cases in fact. The aim of this clinical trial is to determine the safety and efficacy of allogeneic UCB.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Allogeneic Umbilical Cord Blood
Allogeneic Umbilical Cord Blood Transplantation
Allogeneic Umbilical Cord Blood Transplantation via Intravenous or Intraarterial route
Other Names:
  • Umbilical Cord Blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in Short-term Memory Function
Time Frame: Baseline - 6 months
Baseline - 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in Global Outcome
Time Frame: Baseline - 6 months
Baseline - 6 months
Changes in Intelligence
Time Frame: Baseline - 6 months
Baseline - 6 months
Changes in Frontal Lobe Function
Time Frame: Baseline - 6 months
Baseline - 6 months
Changes in Traumatic Brain Injury-related Symptoms
Time Frame: Baseline - 6 months
Baseline - 6 months
Changes in Attention
Time Frame: Baseline - 6 months
Baseline - 6 months
Changes in Behavior
Time Frame: Baseline - 6 months
Baseline - 6 months
Changes in Emotion and Personality
Time Frame: Baseline - 6 months
Baseline - 6 months
Changes in Motor Function and Activities of Daily Living
Time Frame: Baseline - 6 months
Baseline - 6 months
Changes in Brain Structure
Time Frame: Baseline - 6 months
Baseline - 6 months
Changes in Brain Glucose Metabolism
Time Frame: Baseline - 2 weeks
Baseline - 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2015

Study Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

October 11, 2011

First Submitted That Met QC Criteria

October 11, 2011

First Posted (ESTIMATE)

October 13, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 3, 2014

Last Update Submitted That Met QC Criteria

April 2, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trials on Allogeneic Umbilical Cord Blood

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