Human Umbilical Cord-Derived Mesenchymal Stem Cells for Acute Respiratory Distress Syndrome

Hon Kan Yip, Wen Feng Fang, Yi Chen Li, Fan Yen Lee, Chen Hsiang Lee, Sung Nan Pei, Ming Chun Ma, Kuan Hung Chen, Pei Hsun Sung*, Mel S. Lee

*Corresponding author for this work

Research output: Contribution to journalJournal Article peer-review

68 Scopus citations

Abstract

Objectives: To investigate the safety, feasibility, and possible adverse events of single-dose human umbilical cord-derived mesenchymal stem cells in patients with moderate-to-severe acute respiratory distress syndrome. Design: Prospective phase I clinical trial. Setting: Medical center in Kaohsiung, Taiwan. Patients: Moderate-to-severe acute respiratory distress syndrome with a Pao2/Fio2ratio less than 200. Interventions: Scaling for doses was required by Taiwan Food and Drug Administration as follows: the first three patients received low-dose human umbilical cord-derived mesenchymal stem cells (1.0 × 106cells/kg), the next three patients with intermediate dose (5.0 × 106cells/kg), and the final three patients with high dose (1.0 × 107cells/kg) between December 2017 and August 2019. Measurements and Main Results: Nine consecutive patients were enrolled into the study. In-hospital mortality was 33.3% (3/9), including two with recurrent septic shock and one with ventilator-induced severe pneumomediastinum and subcutaneous emphysema. No serious prespecified cell infusion-associated or treatment-related adverse events was identified in any patient. Serial flow-cytometric analyses of circulating inflammatory biomarkers (CD14+CD33+/CD11b+CD16+/CD16+MPO+/CD11b+MPO+/CD14dimCD33+) and mesenchymal stem cell markers (CD26+CD45-/CD29+CD45-/CD34+CD45-/CD44+CD45-/CD73+CD45-/CD90+CD45-/CD105+CD45-/CD26+CD45-) were notably progressively reduced (p for trend < 0.001), whereas the immune cell markers (Helper-T-cellCD3+CD4+/Cytotoxity-T-cellCD3+CD8+/Regulatory-T-cellCD4+CD25+FOXp3+) were notably increased (p for trend < 0.001) after cell infusion. Conclusions: The result of this phase I clinical trial showed that a single-dose IV infusion of human umbilical cord-derived mesenchymal stem cells was safe with favorable outcome in nine acute respiratory distress syndrome patients.

Original languageEnglish
Pages (from-to)E391-E399
JournalCritical Care Medicine
Volume48
Issue number5
DOIs
StatePublished - 01 05 2020

Bibliographical note

Publisher Copyright:
© 2020 Lippincott Williams and Wilkins. All rights reserved.

Keywords

  • acute respiratory distress syndrome
  • allogenic mesenchymal stem cells
  • in-hospital mortality
  • inflammation
  • sepsis

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