Feasibility of intranasal human milk as stem cell therapy in preterm infants with intraventricular hemorrhage

Rebecca Hoban; Alessia Gallipoli; Marisa Signorile; Poonam Mander; Andree Gauthier-Fisher; Clifford Librach; Diane Wilson; Sharon Unger

doi:10.1038/s41372-024-01982-8

Feasibility of intranasal human milk as stem cell therapy in preterm infants with intraventricular hemorrhage

J Perinatol. 2024 Apr 30. doi: 10.1038/s41372-024-01982-8. Online ahead of print.

Authors

Rebecca Hoban^{1

2}, Alessia Gallipoli³, Marisa Signorile⁴, Poonam Mander⁵, Andree Gauthier-Fisher⁵, Clifford Librach^{5

6

7}, Diane Wilson³, Sharon Unger⁸

Affiliations

¹ Division of Neonatology, The Hospital for Sick Children/University of Toronto, Toronto, ON, Canada. rebecca.hoban@seattlechildrens.org.
² Division of Neonatology, University of Washington, Seattle, WA, USA. rebecca.hoban@seattlechildrens.org.
³ Division of Neonatology, The Hospital for Sick Children/University of Toronto, Toronto, ON, Canada.
⁴ Ted Rogers Computational Program, Peter Munk Cardiac Centre, University Health Network, Toronto, ON, Canada.
⁵ CReATe Fertility Centre, Toronto, ON, Canada.
⁶ Department of Obstetrics and Gynecology, IMS and Physiology, University of Toronto, Toronto, ON, Canada.
⁷ Sunnybrook Research Institute, Toronto, ON, Canada.
⁸ Department of Paediatrics, Izaak Walton Killam Hospital, Halifax, NS, Canada.

PMID: 38688998
DOI: 10.1038/s41372-024-01982-8

Abstract

Objective: Intraventricular hemorrhage (IVH) is a common cause of preterm brain injury. Fresh parent's own milk (POM) contains pluripotent stem cells (SCs) that produce neuronal cells in-vitro. The permeable neonatal blood brain barrier potentially allows SC delivery. We performed the first prospective trial (clinicaltrials.gov NCT04225286) of feasibility of intranasal POM (IPOM) in preterm infants with IVH and described SC content of POM samples.

Study design: 37 Infants (mean gestation 27.7 ± 2.6 weeks, birthweight 1030 ± 320 g) with IVH (35.1% grade IV) were recruited from two tertiary Toronto NICUs. IPOM was given ideally twice daily until 28 days of age. Tolerance and adverse reactions were collected and 162 administering providers surveyed.

Results: There were no major adverse reactions. Provider surveys suggested acceptability, although potential provider and subject stress requires further study. Milk cell analysis suggests wide variability between parents.

Conclusions: This phase 1 study demonstrated IPOM was tolerated and feasible in preterm infants.

Associated data

ClinicalTrials.gov/NCT04225286