Safety and Efficacy of Allogeneic Umbilical Cord Blood Therapy for Children With Global Developmental Delay
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Changes in Cognitive Neurodevelopmental Outcome
Study Overview
Brief Summary
This open-label study aims to evaluate the safety and efficacy of umbilical cord blood therapy for children with global developmental delay.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Months to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Changes in Cognitive Neurodevelopmental Outcome
Time Frame: Baseline - 1 month - 3 months - 6 months - 12 months
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.
Changes in Cognition
Time Frame: Baseline - 6 months - 12 months
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.
Secondary Outcomes
- Changes in Visual Perception Test(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in Muscle Strength(Baseline - 1 month - 3 months - 6 months - 12 months)
- Changes in Language Evaluation(Baseline - 6 months - 12 months)
- 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 Functional Independence in Daily Activities(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 Performance in Daily Activities(Baseline - 1 month - 3 months - 6 months - 12 months)
Investigators
MinYoung Kim, M.D.
Associate Professor
Bundang CHA Hospital