AzTrials
AzTrials

Global Developmental DelayNCT01769716

Umbilical Cord Blood Therapy for Global Developmental Delay

A study testing Umbilical cord blood transplantation in people with Global Developmental Delay, run by MinYoung Kim, M.D. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 6 months to 15 years
Conditions the study is for
Global Developmental Delay
What is being tested?
Umbilical cord blood transplantation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteSouth Korea
Study dates
Dec 2012to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, Gyeonggi-do, 463-712

Other trials in South Korea

About this study

Official title: Umbilical Cord Blood Therapy for Children With Global Developmental Delay

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.

Read the detailed description

Global developmental delay is 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.

Being tested
Umbilical cord blood transplantation
Keywords
Global developmental delay, Umbilical cord blood, Rehabilitation
Medical subject headings
Learning Disabilities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Umbilical cord blood transplantationProcedure or surgery

    Also called Autologous or Allogeneic Umbilical Cord Blood

Study groups in NCT01769716
Study groupRoleWhat they receive
Umbilical cord blood transplantationExperimentalAllogeneic umbilical cord blood will be administered intravenously or intraarterially under non-myeloablative immunosuppression. In case of autologous umbilical cord blood, immunosuppression is not required.
Receives: Procedure: Umbilical cord blood transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Baseline - 6 months - 12 months

  2. 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.)

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

Secondary outcomes (9)

  1. Changes in Motor Performance

    GMPM (Gross Motor Performance Measure) as a standardized measurement tool for assessing quality of movement regarding 3 properties of 5 ones; alignment, coordination, dissociated movement, stability, and weight shift (range: 0~100, Higher value means better motor quality.)

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

  2. Changes in Standardized Gross Motor Function

    GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales; lying \& rolling, sitting, crawling \& kneeling, standing, walking, running \& jumping (range: 0~100 , Higher value means better gross motor function.)

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

  3. Changes in Motor Neurodevelopmental Outcome

    Korean version of Bayley Scale of Infant Development-II Motor Scales (Higher value means better motor function: raw score 0 - worst, 112 - best)

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

  4. Changes in Functional Independence in Daily Activities

    WeeFIM (Functional Independence Measure for Children) measures functional independence in daily activities. WeeFIM contains 18 items and each item is ranked from complete dependence (scored as 1) to complete independence (scored as 7). The range is from 18 to 126 and higher scores mean more independent performance in daily activities.

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

  5. Changes in Visual Perception Test

    Visual perception function is evaluated with one of three measures: DTVP (Developmental Test of Visual Perception), MVPT (Motor-free Visual Perception Test), and VMI (Visual-Motor Integration). All can be scored as percentile rank from 0 to 100. Higher values mean better visual perception ability.

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

  6. Changes in Muscle Strength

    Summation of MMT (manual muscle testing): summated scores of the manual muscle strength test (zero=0, trace=1, poor=2, fair=3, good=4, normal=5) for flexors, extensors, abductors, and adductors of bilateral shoulder and hip joints; flexors and extensors of bilateral elbow, wrist, and knee; dorsiflexors and plantar flexors of the ankles (range: 0 ~ 160). Higher scores mean better muscle strength.

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

  7. Changes in Functional Performance in Daily Activities

    Pediatric Evaluation of Disability Inventory (PEDI) for assessing functional performance in daily activities in children (All values are adjusted and higher value means better functional performance, 0 - worst, 100 - best.)

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

  8. Changes in Language Evaluation

    Sequenced Language Scale for Infant (SELSI), Preschool Receptive-Expressive Language Scale (PRES) or Korean Western Aphasia Battery (K-WAB)

    Measured: Baseline - 6 months - 12 months

  9. Changes in Brain glucose metabolism

    FDG-PET

    Measured: Baseline - 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2013 (estimated)
  2. Study startDec 2012
  3. Primary completionDec 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
allogeneic cord blood transplantation for children with developmental delay
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01769716
Sponsor's protocol ID
UCBGDD
Status last verified
Jan 2018
First submitted
15 Jan 2013
Last updated
23 Jan 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 36734415

Questions about this trial

What is this clinical trial studying?

A study testing Umbilical cord blood transplantation in people with Global Developmental Delay, run by MinYoung Kim, M.D. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Cognition (time frame: Baseline - 6 months - 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01769716, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in