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UCB Therapy in Acquired Brain Injury

NCT ID: NCT01885663

Last Updated: 2017-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acquired Brain Injury

Keywords

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Umbilical cord blood Acquired brain injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

UCB therapy for TBI patient
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Umbilical cord blood therapy

Umbilical cord blood therapy

Group Type EXPERIMENTAL

Umbilical cord blood therapy

Intervention Type PROCEDURE

Intravascular umbilical cord blood therapy

Interventions

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Umbilical cord blood therapy

Intravascular umbilical cord blood therapy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MinYoung Kim, M.D.

OTHER

Sponsor Role lead

Responsible Party

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MinYoung Kim, M.D.

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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MinYoung Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

CHA University

Locations

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CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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UCBABI

Identifier Type: -

Identifier Source: org_study_id