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Umbilical Cord Blood Therapy for Children With Cerebral Palsy

NCT ID: NCT01639404

Last Updated: 2013-08-12

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

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-03-31

Brief Summary

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This study aims to evaluate the efficacy of umbilical cord blood therapy for children with cerebral palsy.

Detailed Description

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Cerebral palsy is a disorder of movement and posture resulted from a non-progressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability.

Many experimental animal studies have revealed that umbilical cord blood is useful to repair neurological injury in brain.

On the basis of many experimental studies, umbilical cord blood is suggested as a potential therapy for cerebral palsy.

Conditions

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Cerebral Palsy

Keywords

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Cerebral Palsy Umbilical Cord Blood Rehabilitation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Umbilical Cord Blood and Rehabilitation

Allogeneic Umbilical Cord Blood Administration and Active Rehabilitation

Group Type EXPERIMENTAL

Umbilical Cord Blood Administration

Intervention Type PROCEDURE

The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.

Active Rehabilitation

Intervention Type OTHER

All subjects should participate in active rehabilitation. They will receive two physical and occupational therapy sessions per day. Post discharge, each participant should continue to receive rehabilitation therapy at least 3 days per week until the study completion.

Interventions

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Umbilical Cord Blood Administration

The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.

Intervention Type PROCEDURE

Active Rehabilitation

All subjects should participate in active rehabilitation. They will receive two physical and occupational therapy sessions per day. Post discharge, each participant should continue to receive rehabilitation therapy at least 3 days per week until the study completion.

Intervention Type OTHER

Other Intervention Names

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Donated Umbilical Cord Blood Units from Affiliated Cord Blood Bank

Eligibility Criteria

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Inclusion Criteria

* Cerebral Palsy with abnormal muscle tone
* Gross Motor Function Classification System (GMFCS): I, II, III, IV, V
* Willing to comply with all study procedure

Exclusion Criteria

* Medical illnesses including pneumonia or renal function at enrollment
* Presence of known genetic disease
* Presence of drug hypersensitivity which is related to this study remedy
* Poor cooperation of guardian,including inactive attitude for rehabilitation and visits for follow-up
* Decision by the principal investigator when there are unexpected events that may affect the outcomes
Minimum Eligible Age

6 Months

Maximum Eligible Age

20 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.

Associate 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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CPUCB

Identifier Type: -

Identifier Source: org_study_id