NCT03087110

Stem Cells in Umbilical Blood Infusion for CP

Safety Study of Sibling Cord Blood Cell Infusion to Children With Cerebral Palsy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Murdoch Childrens Research Institute · Academic / Other
• Sex: All
• Age: 1 Year – 16 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the safety of single dose intravenous infusion of cord blood cells which were cryopreserved after the birth of a brother or sister to a child with cerebral palsy.

Detailed description

Cerebral palsy (CP) is the most common physical disability of childhood, affecting 2 per 1000 live births across the world. CP describes permanent non-progressive motor disorders arising from damage to the developing brain. Preclinical studies of different types of stem cells in models of acute brain injury similar to CP have shown significant functional improvement. The variety of stem cells available in umbilical cord blood (UCB), an ethically uncomplicated source of stem cells, has led to a focus on UCB stem cell therapy as a quick-to-clinic option. Previous studies indicate that autologous or unrelated donor UCBC infusion is safe and feasible for children with CP, and may lead to improved motor functioning, but there is no information about the safety and effects of matched sibling cord blood. Therefore, this trial will study the safety of infusing matched sibling cord blood cells to children with cerebral palsy.

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
BIOLOGICAL	Matched sibling donor cord blood cell infusion	Single dose intravenous infusion of 12/12 HLA matched sibling donor cord blood cells (\>1x10\^7 cells/kg)

Timeline

• Start date: 2016-03-01
• Primary completion: 2019-09-01
• Completion: 2020-12-01
• First posted: 2017-03-22
• Last updated: 2021-01-20

Locations

2 sites across 1 country: Australia