NCT01147653

A Randomized Study of Autologous Umbilical Cord Blood Reinfusion in Children With Cerebral Palsy

Is Autologous Umbilical Cord Blood Reinfusion Beneficial in Children With Cerebral Palsy: A Randomized, Blinded, Placebo-Controlled, Crossover Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Joanne Kurtzberg, MD · Academic / Other
• Sex: All
• Age: 12 Months – 6 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy of a single intravenous infusion of autologous umbilical cord blood (UCB) for the treatment of pediatric patients with spastic cerebral palsy.

Detailed description

Cerebral palsy results from in utero or perinatal injury to the developing brain, often through stroke, hypoxic insult or hemorrhage. Currently available treatments for patients with cerebral palsy are supportive, but not curative. Umbilical cord blood (UCB) has been shown to lessen the clinical and radiographic impact of hypoxic brain injury and stroke in animal models. UCB also engrafts and differentiates in brain, facilitating neural cell repair, in animal models and human patients with inborn errors of metabolism undergoing allogeneic, unrelated donor UCB transplantation. We hypothesize that, in the setting of brain injury, infusion of autologous UCB will facilitate neural cell repair resulting in improved function in pediatric patients with cerebral palsy.

Conditions

• Cerebral Palsy
• CP
• Spastic Cerebral Palsy

Interventions

Type	Name	Description
BIOLOGICAL	Autologous UCB Reinfusion	Autologous umbilical cord blood (UCB) reinfusion
OTHER	Placebo	Placebo

Timeline

• Start date: 2010-06-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2010-06-22
• Last updated: 2023-01-04
• Results posted: 2017-06-12

Locations

1 site across 1 country: United States