Umbilical Cord Blood Therapy for Children With Global Developmental Delay

NCT ID: NCT01601158

Last Updated: 2014-01-09

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-08-31

Brief Summary

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This open-label study aims to evaluate the safety and efficacy of umbilical cord blood therapy for children with global developmental delay.

Detailed Description

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Global developmental delay (GDD) is a subset of developmental disabilities defined as significant delay in two or more of the following developmental domains: gross/fine motor, speech/language, cognition, social/personal, and activities of daily living.

Umbilical cord blood has been used for inherited metabolic diseases that feature global developmental delay and many experimental animal studies have revealed umbilical cord blood is useful to repair neurological impairments in brain.

Conditions

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Global Developmental Delay

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 infusion and Active Rehabilitation

Group Type EXPERIMENTAL

Umbilical Cord Blood administration

Intervention Type BIOLOGICAL

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 BIOLOGICAL

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

* Global developmental delay
* Willing to comply with all study procedure

Exclusion Criteria

* Medical instability including pneumonia or renal function at enrollment
* Poor cooperation of guardian,including inactive attitude for rehabilitation and visits for follow-up
* Uncontrolled persistent epilepsy
* Not eligible according to the principal investigator
Minimum Eligible Age

6 Months

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.

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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GDDUCB

Identifier Type: -

Identifier Source: org_study_id

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