NCT01601158

Umbilical Cord Blood Therapy for Children With Global Developmental Delay

Safety and Efficacy of Allogeneic Umbilical Cord Blood Therapy for Children With Global Developmental Delay

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: MinYoung Kim, M.D. · Academic / Other
• Sex: All
• Age: 6 Months – 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Global Developmental Delay

Interventions

Type	Name	Description
BIOLOGICAL	Umbilical Cord Blood administration	The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.
OTHER	Active Rehabilitation	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.

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2012-05-17
• Last updated: 2014-01-09

Locations

1 site across 1 country: South Korea