Clinical trial NCT01769716: Umbilical Cord Blood Therapy for Global Developmental Delay
Official title: Umbilical Cord Blood Therapy for Children With Global Developmental Delay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Global Developmental Delay
Keywords: Global developmental delay
Umbilical cord blood
Rehabilitation
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
Collaborators: name: CHA University
First posted: 2013-01-17
Enrollment: 14
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: allogeneic cord blood transplantation for children with developmental delay
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Cognition
timeFrame: Baseline - 6 months - 12 months
measure: Changes in Cognitive Neurodevelopmental Outcome
timeFrame: Baseline - 1 month - 3 months - 6 months - 12 months
Secondary outcomes:
measure: Changes in Motor Performance
timeFrame: Baseline - 1 month - 3 months - 6 months - 12 months
measure: Changes in Standardized Gross Motor Function
timeFrame: Baseline - 1 month - 3 months - 6 months - 12 months
measure: Changes in Motor Neurodevelopmental Outcome
timeFrame: Baseline - 1 month - 3 months - 6 months - 12 months
measure: Changes in Functional Independence in Daily Activities
timeFrame: Baseline - 1 month - 3 months - 6 months - 12 months
measure: Changes in Visual Perception Test
timeFrame: Baseline - 1 month - 3 months - 6 months - 12 months
measure: Changes in Muscle Strength
timeFrame: Baseline - 1 month - 3 months - 6 months - 12 months
measure: Changes in Functional Performance in Daily Activities
timeFrame: Baseline - 1 month - 3 months - 6 months - 12 months
measure: Changes in Language Evaluation
timeFrame: Baseline - 6 months - 12 months
measure: Changes in Brain glucose metabolism
timeFrame: Baseline - 12 months
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggi-do
Study officials:
affiliation: CHA University
name: MinYoung Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: