Matched sibling donor cord blood cell infusion
BiologicalSingle dose intravenous infusion of 12/12 HLA matched sibling donor cord blood cells (>1x10^7 cells/kg)
NCT Number: NCT03087110
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.
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Notify Me1 year–16 year
All sexes
Interventional
Phase 1
Lady Cilento Children's Hospital, Brisbane, Queensland, Australia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single dose intravenous infusion of 12/12 HLA matched sibling donor cord blood cells (>1x10^7 cells/kg)
Time frame: 12 months
Safety
Time frame: Baseline, 3 months
Gross Motor Function Measure (GMFM-66)
Time frame: Baseline, 12 months
Gross Motor Function Measure (GMFM-66)
Time frame: Baseline, 3 months
Quality of Upper Extremity Skills Test (QUEST)
Time frame: Baseline, 12 months
Quality of Upper Extremity Skills Test (QUEST)
Time frame: Baseline, 12 months
Age appropriate cognitive testing: Bayley Scales of Infant and Toddler Development (BSID-III), Wechsler Preschool Primary Scale of Intelligence (WPPSI-IV), Wechsler Intelligence Scale for Children (WISC-V). Change from baseline will be compared using z-scores across measures.
Time frame: Baseline, 3 months
Cerebral Palsy Quality of Life (CP-QoL-CHILD)
Time frame: Baseline,12 months
Cerebral Palsy Quality of Life (CP-QoL-CHILD)
Time frame: 3 months
Chimerism study to detect the longevity of infused cells
Murdoch Childrens Research Institute
Other
Safety Study of Sibling Cord Blood Cell Infusion to Children With Cerebral Palsy
Acronym: SCUBI-CP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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