ArticleEBioMedicine2025
Feasibility and safety of autologous cord blood derived cell administration in extremely preterm infants: a single-centre, open-label, single-arm, phase I trial (CORD-SaFe study).
Article in EBioMedicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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Who cites it
12 citing papers in PubMed.
- Mesenchymal Stem Cell (MSC)-based therapies for neonatal lung and brain injury - one size fits all?Molecular and cellular pediatrics · 2026Review
- From oxidative stress to epigenetic regulation: Molecular mechanisms of preterm brain injury and neuroprotective strategies (Review).Molecular medicine reports · 2026Review
- Cumulative caffeine exposure predicts neurodevelopmental outcomes in premature infants.Pediatric research · 2026Article
- Progress in cell therapies for neonatal conditions: Proceedings of the Third Neonatal Cell Therapies Symposium (2025).Pediatric research · 2026Article
- Intravenous administration of ex vivo expanded human umbilical cord blood-derived CD34⁺ cells in a preterm hypoxic-ischemic encephalopathy mouse model.Scientific reports · 2026Article
- Highlighting the CORD-SaFe Trial From Melbourne-Progress Toward Cellular Therapy in Extremely Preterm Newborns.Pediatric discovery · 2025Article
- Unraveling Optimal Dose and Responsive Markers for Human Cord Blood Derived Mononuclear Cells in Alleviating Bronchopulmonary Dysplasia in Neonatal Mice.International journal of stem cells · 2025Article
- Promising Preventive Strategies for Intraventricular Hemorrhage in Preterm Neonates: A Critical Review.Journal of clinical medicine · 2025Review
- Updates on neonatal cell and novel therapeutics: Proceedings of the Second Neonatal Cell Therapies Symposium (2024).Pediatric research · 2025Article
- Early Neurodevelopment of Extremely Preterm Infants Administered Autologous Cord Blood Cell Therapy: Secondary Analysis of a Nonrandomized Clinical Trial.JAMA network open · 2025Article
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEvidence from preclinical studies in small and large animal models has shown neuroprotective effects of intravenous administration of umbilical cord blood derived cells (UCBCs). This study aimed to evaluate the feasibility of umbilical cord blood (UCB) collection, extraction of UCBCs, and subsequent safety of intravenous autologous administration of UCBCs in extremely preterm infants (born <28 weeks gestation).
methodsA single-centre, open-label, single-arm, safety and feasibility clinical intervention trial was conducted at Monash Medical Centre and Monash Children's Hospital, Melbourne, Australia. Participants were extremely preterm infants born at less than 28 weeks completed gestation, and exclusions included major congenital malformation, maternal blood-borne virus infection, and severe brain injury on postnatal cranial ultrasound. UCB was collected at birth, and UCBCs were characterised (total nucleated cell count (TNC), mononuclear cell count (MNC), CD34+ cell count) and cryopreserved. Infants were reinfused with autologous UCBCs (25-50 million MNCs/kg) intravenously in the second postnatal week. Primary outcomes included feasibility: sufficient UCB volume (>7 mL) and UCBC numbers following processing (>25 × 10
findingsForty-four UCB collections were attempted and sufficient UCB volume/UCBC extraction was demonstrated in 37 (84.1%) infants. Good Manufacturing Practice (GMP) grade cells were obtained in 31/44 (70.4%) of infants. Median (IQR) TNCs and MNCs collected were 130 (67-207) x 10
interpretationThis phase-1 clinical trial has shown UCBC collection and reinfusion was feasible in approximately 70% of extremely preterm infants and was well tolerated without any serious adverse events.
fundingFunding to support this study was obtained from National Health and Medical Research Council of Australia, Cerebral Palsy Alliance, National Stem Cell Foundation of Australia, and Lions Cord Blood Foundation.
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