Department of Pediatrics, Rush University Children's Hospital, Chicago, IL.
Department of Pediatrics, Rush University Children's Hospital, Chicago, IL.
J Pediatr. 2019 Jul;210:209-213.e2. doi: 10.1016/j.jpeds.2019.02.029. Epub 2019 Apr 13.
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.
在一项 2 个剂量水平的 1 期剂量递增试验中，我们评估了在 5 至 14 天龄的 12 名极早早产儿（<28 周妊娠且出生体重<1000 克）中单次气管内给予人脐带血源性间充质基质细胞的安全性。该治疗方法具有良好的耐受性，似乎是安全可行的，值得进行更大规模的随机对照盲法研究。临床试验注册：ClinicalTrials.gov: NCT02381366。
