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

医学 支气管肺发育不良 脐带 间充质干细胞 低出生体重 临床试验 随机对照试验 脐带血 出生体重 妊娠期 产科 儿科 胎龄 怀孕 外科 内科学 免疫学 病理 生物 遗传学
作者
Steven B. Powell,Jean M. Silvestri
出处
期刊:The Journal of Pediatrics [Elsevier]
卷期号:210: 209-213.e2 被引量:83
标识
DOI:10.1016/j.jpeds.2019.02.029
摘要

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. 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. ClinicalTrials.gov: NCT02381366. So You Want to Give Stem Cells to Babies? Neonatologists and Parents’ Views to Optimize Clinical TrialsThe Journal of PediatricsVol. 210PreviewTo identify barriers and enablers that may influence parents' and neonatologists’ participation in clinical trials of mesenchymal stromal cells for bronchopulmonary dysplasia. Full-Text PDF Stem cells for bronchopulmonary dysplasia: A promising yet challenging journey lies aheadThe Journal of PediatricsVol. 212PreviewWe congratulate the authors for their commendable effort in conducting a phase I clinical trial on stem cell in prevention of bronchopulmonary dysplasia (BPD).1 With increased survival of extremely low birth weight infants, BPD has emerged as a major morbidity in this population.2 Regenerative medicine in the form of stem cell therapy seems to be a promising solution for healing the affected lungs in this population. Full-Text PDF
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