Safety of Intratracheal Administration of Human Umbilical Cord Blood Derived Mesenchymal Stromal Cells in Extremely Low Birth Weight Preterm Infants

Steven B Powell; Jean M Silvestri

doi:10.1016/j.jpeds.2019.02.029

Safety of Intratracheal Administration of Human Umbilical Cord Blood Derived Mesenchymal Stromal Cells in Extremely Low Birth Weight Preterm Infants

J Pediatr. 2019 Jul:210:209-213.e2. doi: 10.1016/j.jpeds.2019.02.029. Epub 2019 Apr 13.

Authors

Steven B Powell¹, Jean M Silvestri²

Affiliations

¹ Department of Pediatrics, Rush University Children's Hospital, Chicago, IL. Electronic address: steven_powell@rush.edu.
² Department of Pediatrics, Rush University Children's Hospital, Chicago, IL.

PMID: 30992220
DOI: 10.1016/j.jpeds.2019.02.029

Abstract

In a phase 1 dose-escalation trial at 2 dosing levels, we assessed the safety of intratracheal administration of a single-dose of human umbilical cord blood-derived mesenchymal stromal cells in 12 extremely low birth weight infants <28 weeks of gestation and <1000 g at birth at 5-14 days of life. The treatment was well tolerated and appears to be safe and feasible, and warrants a larger randomized-controlled blinded study. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02381366.

Keywords: BPD; MSCs; NICU; chronic lung disease; neonatal; neonatal intensive care unit; newborn; prematurity; stem cells.

Publication types

Clinical Trial, Phase I
Research Support, Non-U.S. Gov't

MeSH terms

Bronchopulmonary Dysplasia / prevention & control*
Cord Blood Stem Cell Transplantation / methods*
Female
Humans
Infant, Extremely Low Birth Weight*
Infant, Newborn
Infant, Premature*
Intensive Care Units, Neonatal
Intubation, Intratracheal
Male
Mesenchymal Stem Cell Transplantation / methods*
Severity of Illness Index

Associated data

ClinicalTrials.gov/NCT02381366