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.

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