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Abstract <p>The safety of an extracellular vesicle (EV) enriched secretome from bone marrow mesenchymal stem cells (BM-MSCs) was evaluated in a multi-site, prospective, expanded access trial as potential treatment for respiratory failure due to COVID-19. Subjects (103) received up to three doses of 15 mL IP every 72&#xa0;h. The primary outcome was all cause 60-day mortality. Secondary outcomes included serious adverse events. One TEAE (grade 1 hyperpigmentation at the infusion site) related to IP occurred. 60-day mortality was 29% for all patients, 22.4% in patients &lt; 65 years and 41.7% in patients ≥ 65 years. Mean ventilation free days was 40.8 for all patients, 44.7 days in patients &lt; 65 years and 33.4 days in patients ≥ 65 years. Median time to hospital (IQR) discharge by Kaplan-Meier was 11 (5.0-NR) days in all patients, 9 (5.0-NR) days in patients &lt; 65 years and 19 (5.5-NR) days in patients ≥ 65 years. The IP (15 mL dose) is safe in patients with severe or critical COVID-19 respiratory failure.</p> Trial registration <p>ClinicalTrials.gov Identifier: NCT04657458 (2020-12-08).</p> Graphical Abstract <p></p>

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Bone Marrow Mesenchymal Stem Cell Extracellular Vesicle Treatment of Respiratory Failure from COVID-19: Endpoint Analysis of Expanded Access Safety Trial

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年5月11日

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  • Vikram Sengupta,
  • Sascha Qian,
  • John T. Ransom,
  • Sam Suzuki,
  • David J. Park,
  • Timothy I. Melson,
  • Brian P. Williams,
  • James J. Walsh,
  • Mustafa Awili,
  • Jack M. Mann,
  • Timothy A. Moseley

摘要

Abstract

The safety of an extracellular vesicle (EV) enriched secretome from bone marrow mesenchymal stem cells (BM-MSCs) was evaluated in a multi-site, prospective, expanded access trial as potential treatment for respiratory failure due to COVID-19. Subjects (103) received up to three doses of 15 mL IP every 72 h. The primary outcome was all cause 60-day mortality. Secondary outcomes included serious adverse events. One TEAE (grade 1 hyperpigmentation at the infusion site) related to IP occurred. 60-day mortality was 29% for all patients, 22.4% in patients < 65 years and 41.7% in patients ≥ 65 years. Mean ventilation free days was 40.8 for all patients, 44.7 days in patients < 65 years and 33.4 days in patients ≥ 65 years. Median time to hospital (IQR) discharge by Kaplan-Meier was 11 (5.0-NR) days in all patients, 9 (5.0-NR) days in patients < 65 years and 19 (5.5-NR) days in patients ≥ 65 years. The IP (15 mL dose) is safe in patients with severe or critical COVID-19 respiratory failure.

Trial registration

ClinicalTrials.gov Identifier: NCT04657458 (2020-12-08).

Graphical Abstract