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

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

Steven B Powell  1 , Jean M Silvestri  2
Affiliations
Clinical Trial

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

Steven B Powell et al. J Pediatr. 2019 Jul.

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.

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