Evidence map›Paper›PMID 36929827›Full record

ArticleStem cells translational medicine2023

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 and 3 more

Open access · goldAbstract read
In one paragraph

Article in Stem cells translational medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.2field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 2 institutions in 1 country.

Beth H ShazMarcus Center for Cellular Cures, Duke University, Durham, NC, USA.ORCID 0000-0002-2270-4821
Bryan D KraftDepartment of Medicine, Duke University, Durham, NC, USA.
Jesse D TroyMarcus Center for Cellular Cures, Duke University, Durham, NC, USA.
Emily PoehleinMarcus Center for Cellular Cures, Duke University, Durham, NC, USA.
Lingye ChenDepartment of Medicine, Duke University, Durham, NC, USA.
Lynn CheathamMarcus Center for Cellular Cures, Duke University, Durham, NC, USA.
Raha ManyaraMarcus Center for Cellular Cures, Duke University, Durham, NC, USA.
Khalid HanafyBoca Raton Regional Hospital, Boca Raton, FL, USA.
Linda BrownMarcus Center for Cellular Cures, Duke University, Durham, NC, USA.
Margaret ScottBoca Raton Regional Hospital, Boca Raton, FL, USA.
Ralph PalumboBoca Raton Regional Hospital, Boca Raton, FL, USA.
Frank VrionisBoca Raton Regional Hospital, Boca Raton, FL, USA.
Joanne KurtzbergMarcus Center for Cellular Cures, Duke University, Durham, NC, USA.ORCID 0000-0002-3370-0703
Duke University · USBoca Raton Regional Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTreatment 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

methodsIn 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.

resultsTen 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.

conclusionWe 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.

Indexed as

COVID-19Mesenchymal Stem CellsMesenchymal Stem Cell TransplantationRespiratory Distress SyndromeAdultAgedFeasibility StudiesFemaleHumansMaleMiddle Agedacute respiratory distress syndromecord bloodCOVIDmesenchymal stromal cells

Identifiers

PMID36929827
PMCPMC10108718
OpenAlexW4327679295

What OpenQuestion holds

Textmetadata
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.