Evidence map›Paper›PMID 42113080›Full record

ArticleStem cell reviews and reports2026

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

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 and 1 more

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in Stem cell reviews and reports, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04657458 (Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

NCT04657458 no longer availablenot on this map

Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment: Expanded Access Protocol for Patients With COVID-19 Associated ARDS

Typeexpanded_accessSponsorDirect Biologics, LLCConditionsCovid19, ARDS, Hypoxia, Cytokine StormArmsExoFlo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

11 authors.

Vikram SenguptaDirect Biologics, LLC, 5301, Southwest Pkwy, Austin, TX, 78735, USA.
Sascha QianDirect Biologics, LLC, 5301, Southwest Pkwy, Austin, TX, 78735, USA.
John T RansomDirect Biologics, LLC, 5301, Southwest Pkwy, Austin, TX, 78735, USA.
Sam SuzukiDirect Biologics, LLC, 5301, Southwest Pkwy, Austin, TX, 78735, USA.
David J ParkProvidence St. Jude Medical Center/Providence Medical Foundation, Fullerton, CA, 92835, USA.
Timothy I MelsonHelen Keller Hospital, Sheffield, AL, 35660, USA.
Brian P WilliamsCovenant Health, Lubbock, TX, 79410, USA.
James J WalshDonald Guthrie Foundation, Sayre, PA, 18840, USA.
Mustafa AwiliPRX Research, Mesquite, TX, 75149, USA.
Jack M MannNew York Presbyterian Queens, Queens, NY, 11355, USA.
Timothy A MoseleyDirect Biologics, LLC, 5301, Southwest Pkwy, Austin, TX, 78735, USA. tmoseley@directbiologics.com.ORCID 0000-0003-1352-6610

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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

Indexed as

COVID-19Extracellular VesiclesMesenchymal Stem CellsMesenchymal Stem Cell TransplantationRespiratory InsufficiencyAgedBone Marrow CellsFemaleHumansMaleMiddle AgedProspective StudiesSARS-CoV-2Bone marrow mesenchymal stem cellCOVID-19EfficacyExtracellular vesicleSafety

Identifiers

PMID42113080
PMCPMC13241438

What OpenQuestion holds

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Registered trials

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.