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The DOI matches its Crossref record; 49 of the 49 references it cites were found in a registry or an index.

Umbilical cord mesenchymal stem cells for COVID-19 acute respiratory distress syndrome: A double-blind, phase 1/2a, randomized controlled trial

Open access
Lanzoni, Giacomo, Linetsky, Elina, Correa, Diego, Messinger Cayetano, Shari, Alvarez, Roger A., Kouroupis, Dimitrios, Alvarez Gil, Ana, Poggioli, Raffaella, Ruiz, Phillip, Marttos, Antonio C., Hirani, Khemraj, Bell, Crystal A., Kusack, Halina, Rafkin, Lisa, Baidal, David, Pastewski, Andrew, Gawri, Kunal, Leñero, Clarissa, Mantero, Alejandro M. A., Metalonis, Sarah W., Wang, Xiaojing, Roque, Luis, Masters, Burlett, Kenyon, Norma S., Ginzburg, Enrique, Xu, Xiumin, Tan, Jianming, Caplan, Arnold I., Glassberg, Marilyn K., Alejandro, Rodolfo, Ricordi, Camillo·2021·Stem Cells Translational Medicine

Abstract

Acute respiratory distress syndrome (ARDS) in COVID-19 is associated with high mortality. Mesenchymal stem cells are known to exert immunomodulatory and anti-inflammatory effects and could yield beneficial effects in COVID-19 ARDS. The objective of this study was to determine safety and explore efficacy of umbilical cord mesenchymal stem cell (UC-MSC) infusions in subjects with COVID-19 ARDS. A double-blind, phase 1/2a, randomized, controlled trial was performed. Randomization and stratification by ARDS severity was used to foster balance among groups. All subjects were analyzed under intention to treat design. Twenty-four subjects were randomized 1:1 to either UC-MSC treatment (n = 12) or the control group (n = 12). Subjects in the UC-MSC treatment group received two intravenous infusions (at day 0 and 3) of 100 ± 20 × 106 UC-MSCs; controls received two infusions of vehicle solution. Both groups received best standard of care. Primary endpoint was safety (adverse events [AEs]) within 6 hours; cardiac arrest or death within 24 hours postinfusion). Secondary endpoints included patient survival at 31 days after the first infusion and time to recovery. No difference was observed between groups in infusion-associated AEs. No serious adverse events (SAEs) were observed related to UC-MSC infusions. UC-MSC infusions in COVID-19 ARDS were found to be safe. Inflammatory cytokines were significantly decreased in UC-MSC-treated subjects at day 6. Treatment was associated with significantly improved patient survival (91% vs 42%, P = .015), SAE-free survival (P = .008), and time to recovery (P = .03). UC-MSC infusions are safe and could be beneficial in treating subjects with COVID-19 ARDS.

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Metadata

Authors
Lanzoni, G., Linetsky, E., Correa, D., Messinger Cayetano, S., Alvarez, R. A., Kouroupis, D., Alvarez Gil, A., Poggioli, R., Ruiz, P., Marttos, A. C., Hirani, K., Bell, C. A., Kusack, H., Rafkin, L., Baidal, D., Pastewski, A., Gawri, K., Leñero, C., Mantero, A. M. A., Metalonis, S. W., Wang, X., Roque, L., Masters, B., Kenyon, N. S., Ginzburg, E., Xu, X., Tan, J., Caplan, A. I., Glassberg, M. K., Alejandro, R., & Ricordi, C.
Venue
Stem Cells Translational Medicine
Published
2021-01-05
Volume
10
Issue
5
Pages
660-673
ISSN
  • 2157-6564 (ISSN-L)
  • 2157-6580
OpenAlex
W3120463228
Cited by
404
References
49
FWCI
38.22
Type
journal article
Language
en
Open access
gold

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CoChat. (2026). Citation check: Umbilical cord mesenchymal stem cells for COVID-19 acute respiratory distress syndrome: A double-blind, phase 1/2a, randomized controlled trial. https://app.cochat.ai/papers/10.1002/sctm.20-0472
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Lanzoni, G., Linetsky, E., Correa, D., Messinger Cayetano, S., Alvarez, R. A., Kouroupis, D., Alvarez Gil, A., Poggioli, R., Ruiz, P., Marttos, A. C., Hirani, K., Bell, C. A., Kusack, H., Rafkin, L., Baidal, D., Pastewski, A., Gawri, K., Leñero, C., Mantero, A. M. A., . . . Ricordi, C. (2021). Umbilical cord mesenchymal stem cells for COVID-19 acute respiratory distress syndrome: A double-blind, phase 1/2a, randomized controlled trial. Stem Cells Translational Medicine. https://doi.org/10.1002/sctm.20-0472

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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.