Trial | NCT03087110  Report issue

Title

Stem Cells in Umbilical Blood Infusion for CP
Safety Study of Sibling Cord Blood Cell Infusion to Children With Cerebral Palsy

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    12
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.
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.
Study Started
Mar 31
2016
Primary Completion
Sep 30
2019
Study Completion
Dec 31
2020
Last Update
Jan 20
2021

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)

Cord blood infusion Experimental

Matched sibling donor cord blood cell infusion

Criteria 

Inclusion Criteria:

Diagnosis of any type of CP
CP of any severity
A record of sibling CBU in storage at a TGA accredited private cord blood bank
Ability to travel to one of the trial centres
Ability to participate in assessments
Informed consent by parent/guardian

Exclusion Criteria:

presence of progressive neurological disease
known genetic disorder
known brain dysplasia
immune system disorder or immune deficiency syndrome
infectious disease markers showing up on virology screen
evidence of cord blood unit contamination, or fewer than 10^7 cells/kg body mass
ventilator support
ill health, or if the participant's medical condition does not allow safe travel
previous cell therapy
Botulinum toxin A within 3 months before or after infusion
surgery within 3 months before or after infusion
cannot obtain parent/guardian consent
No Results Posted