NCT01601158

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

January 9, 2014

Status Verified

January 1, 2014

Enrollment Period

1.3 years

First QC Date

May 16, 2012

Last Update Submit

January 8, 2014

Conditions

Global Developmental Delay

Keywords

Global developmental delayUmbilical cord bloodRehabilitation

Outcome Measures

Primary Outcomes (2)

  • Changes in Cognition

    Korean Wechsler Preschool and Primay Scale of Intelligence (K-WPPSI) (Higher value means better cognitive function (K-WPPSI: below 70 - worst, over 130 - best). The investigators will report K-WPPSI at each assessment time points.

    Baseline - 6 months - 12 months

  • Changes in Cognitive Neurodevelopmental Outcome

    Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Mental Scales (Higher value means better cognitive function, K-BSID-II mental scale raw score: 0 - worst, 178 - best). The investigators will report K-BSID-II Mental Scale raw scores at each assessment time points.

    Baseline - 1 month - 3 months - 6 months - 12 months

Secondary Outcomes (8)

  • Changes in Motor Performance

    Baseline - 1 month - 3 months - 6 months - 12 months

  • Changes in Standardized Gross Motor Function

    Baseline - 1 month - 3 months - 6 months - 12 months

  • Changes in Motor Neurodevelopmental Outcome

    Baseline - 1 month - 3 months - 6 months - 12 months

  • Changes in Functional Independence in Daily Activities

    Baseline - 1 month - 3 months - 6 months - 12 months

  • Changes in Visual Perception Test

    Baseline - 1 month - 3 months - 6 months - 12 months

  • +3 more secondary outcomes

Study Arms (1)

Umbilical Cord Blood and Rehabilitation

EXPERIMENTAL

Allogeneic Umbilical Cord Blood infusion and Active Rehabilitation

Biological: Umbilical Cord Blood administrationOther: Active Rehabilitation

Interventions

Umbilical Cord Blood administrationBIOLOGICAL

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

Also known as: Donated Umbilical Cord Blood Units from Affiliated Cord Blood Bank
Umbilical Cord Blood and Rehabilitation
Active RehabilitationOTHER

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.

Umbilical Cord Blood and Rehabilitation

Eligibility Criteria

Age6 Months - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

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

Learning Disabilities

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Minyoung Kim, M.D., Ph.D.

    CHA University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 16, 2012

First Posted

May 17, 2012

Study Start

May 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

January 9, 2014

Record last verified: 2014-01

Locations

KR(1)