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

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.