NCT01991145

Allogeneic UCB Therapy With EPO in Children With CP

Safety and Efficacy of Allogeneic Umbilical Cord Blood Therapy Combined With Erythropoietin in Children With Cerebral Palsy: a Double-blind, Randomized, Placebo-controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: MinYoung Kim, MD, PhD · Academic / Other
• Sex: All
• Age: 10 Months – 6 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled study aims to evaluate the efficacy and safety of allogeneic umbilical cord blood therapy combined with erythropoietin for children with cerebral palsy.

Detailed description

Cerebral palsy (CP) is a group of neurodevelopmental conditions with abnormal movement and posture resulted from a non-progressive cerebral disturbance. It is the most common cause of motor disability in childhood. Most therapies are palliative rather than restorative. Umbilical cord blood (UCB) and erythropoetin (EPO) may be used as restorative approach for children with CP. Many experimental animal studies have revealed that UCB is beneficial to improve and repair neurological injuries. EPO is also known to have neuroprotective effects. Based on animal studies and some clinical trials, UCB is suggested as a potential therapy for children with CP. EPO is combined to add synergistic effects to UCB therapy.

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
PROCEDURE	Umbilical Cord Blood therapy	HLA (Human Leukocyte Antigen) typing
BIOLOGICAL	Erythropoietin alfa
OTHER	Rehabilitation	Active rehabilitation
PROCEDURE	Placebo UCB
BIOLOGICAL	Placebo EPO

Timeline

• Start date: 2013-11-26
• Primary completion: 2017-06-24
• Completion: 2017-06-24
• First posted: 2013-11-25
• Last updated: 2020-01-18

Locations

1 site across 1 country: South Korea