NCT01769716

Brief Summary

This open-label study aims to evaluate the safety and efficacy of autologous or allogeneic 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
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

5 years

First QC Date

January 15, 2013

Last Update Submit

January 22, 2018

Conditions

Global Developmental Delay

Keywords

Global developmental delayUmbilical cord bloodRehabilitation

Outcome Measures

Primary Outcomes (2)

  • Changes in Cognition

    Korean Wechsler Preschool and Primary Scale of Intelligence (K-WPPSI) (Higher value means better cognitive function (K-WPPSI: below 70 - worst, over 130 - best)

    Baseline - 6 months - 12 months

  • Changes in Cognitive Neurodevelopmental Outcome

    Korean version of Bayley Scale of Infant Development-II Mental Scales (Higher value means better cognitive function: raw score 0 - worst, 178 - best.)

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

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (1)

Umbilical cord blood transplantation

EXPERIMENTAL

Allogeneic umbilical cord blood will be administered intravenously or intraarterially under non-myeloablative immunosuppression. In case of autologous umbilical cord blood, immunosuppression is not required.

Procedure: Umbilical cord blood transplantation

Interventions

Umbilical cord blood transplantationPROCEDURE
Also known as: Autologous or Allogeneic Umbilical Cord Blood
Umbilical cord blood transplantation

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

Related Publications (1)

  • Cha B, Kwak H, Bang JI, Jang SJ, Suh MR, Choi JI, Kim M. Safety and Efficacy of Allogeneic Umbilical Cord Blood Therapy for Global Development Delay and Intellectual Disability. Stem Cells Dev. 2023 Apr;32(7-8):170-179. doi: 10.1089/scd.2022.0252. Epub 2023 Mar 20.

    PMID: 36734415DERIVED

MeSH Terms

Conditions

Learning Disabilities

Interventions

Cord Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Stem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

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
Model Details: allogeneic cord blood transplantation for children with developmental delay
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 17, 2013

Study Start

December 1, 2012

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

KR(1)