Feasibility Study of Cord Tissue Derived Mesenchymal Stromal Cells in COVID-19-Related Acute Respiratory Distress Syndrome

Beth H. Shaz, Bryan D. Kraft, Jesse D. Troy, Emily Poehlein, Lingye Chen, Lynn Cheatham, Raha Manyara, Khalid Hanafy, Linda Brown, Margaret Scott, Ralph Palumbo, Frank Vrionis, Joanne Kurtzberg

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

Abstract

BACKGROUND: Treatment options for patients with COVID-19-related acute respiratory distress syndrome (ARDS) are desperately needed. Allogeneic human umbilical cord derived mesenchymal stromal cells (hCT-MSCs) have potential therapeutic benefits in these critically ill patients, but feasibility and safety data are lacking. MATERIALS AND METHODS: In this phase I multisite study, 10 patients with COVID-19-related ARDS were treated with 3 daily intravenous infusions of hCT-MSCs (1 million cells/kg, maximum dose 100 million cells). The primary endpoint assessed safety. RESULTS: Ten patients (7 females, 3 males; median age 62 years (range 39-79)) were enrolled at 2 sites and received a total of 30 doses of study product. The average cell dose was 0.93 cells/kg (range 0.56-1.45 cells/kg and total dose range 55-117 million cells) with 5/30 (17%) of doses lower than intended dose. Average cell viability was 85% (range 63%-99%) with all but one meeting the >70% release criteria. There were no infusion-related reactions or study-related adverse events, 28 non-serious adverse events in 3 unique patients, and 2 serious adverse events in 2 unique patients, which were expected and unrelated to the study product. Five patients died: 3 by day 28 and 5 by day 90 of the study (median 27 days, range 7-76 days). All deaths were determined to be unrelated to the hCT-MSCs. CONCLUSION: We were able to collect relevant safety outcomes for the use of hCT-MSCs in patients with COVID-19-related ARDS. Future studies to explore their safety and efficacy are warranted.

Original languageEnglish
Pages (from-to)185-193
Number of pages9
JournalStem Cells Translational Medicine
Volume12
Issue number4
DOIs
StatePublished - Apr 17 2023

Keywords

  • COVID
  • acute respiratory distress syndrome
  • cord blood
  • mesenchymal stromal cells

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