Evidence map›Paper›PMID 30455077›Full record

Trial reportThe Lancet. Respiratory medicine2019

Treatment with allogeneic mesenchymal stromal cells for moderate to severe acute respiratory distress syndrome (START study): a randomised phase 2a safety trial.

Michael A Matthay, Carolyn S Calfee, Hanjing Zhuo, B Taylor Thompson, Jennifer G Wilson, Joseph E Levitt, Angela J Rogers, Jeffrey E Gotts, Jeanine P Wiener-Kronish, Ednan K Bajwa and 11 more

3 registry-linked trialsAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Respiratory medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 399 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
399citing papers in PubMed, 10 pooled it
–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.

NCT02097641 phase2completednot on this map

Prospective, Randomized, Multi-center Phase 2 Clinical Trial of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) for the Treatment of Acute Respiratory Distress Syndrome (ARDS)

TypeinterventionalSponsorMichael A. MatthayRan2014 to 2018Enrolled60ConditionsRespiratory Distress Syndrome, AdultArmsAllogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells, Plasma-Lyte A
NCT05658692 phase4unknown statusnot on this mapstarted 2022, after this paper: background citation

Platform Adaptive Embedded Trial for Acute Respiratory Distress Syndrome

TypeinterventionalSponsorSecond Affiliated Hospital, Zhejiang University, School of MedicineRan2022 to 2023Enrolled1,000ConditionsAcute Respiratory Distress SyndromeArmsprotective ventilation, prone position ventilation, glucocorticoid therapy, restrictive fluid resuscitation, Thymosin Alpha
NCT06163833 phase2recruitingnot on this mapstarted 2023, after this paper: background citation

MATRIx: MesenchymAl Stromal Cells for Traumatic bRain Injury

TypeinterventionalSponsorFondazione IRCCS San Gerardo dei TintoriRan2023 to 2026Enrolled78ConditionsTraumatic Brain Injury With Loss of ConsciousnessArmsMesenchymal stromal cell low dosage-80*10^6 cells, Mesenchymal stromal cell low dosage-160*10^6 cells, Placebo-storage solution
3 · Its place in the literature

Who cites it

399 citing papers in PubMed, 10 syntheses or guidelines pooled it.

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339 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors.

Michael A MatthayDepartment of Medicine and Anesthesia, University of California, San Francisco, CA, USA; Cardiovascular Research Institute, University of California, San Francisco, CA, USA. Electronic address: michael.matthay@ucsf.edu.
Carolyn S CalfeeDepartment of Medicine and Anesthesia, University of California, San Francisco, CA, USA; Cardiovascular Research Institute, University of California, San Francisco, CA, USA.
Hanjing ZhuoCardiovascular Research Institute, University of California, San Francisco, CA, USA.
B Taylor ThompsonDepartment of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Jennifer G WilsonDepartment of Emergency Medicine, Stanford University, Stanford, CA, USA.
Joseph E LevittDepartment of Medicine, Stanford University, Stanford, CA, USA.
Angela J RogersDepartment of Medicine, Stanford University, Stanford, CA, USA.
Jeffrey E GottsDepartment of Medicine and Anesthesia, University of California, San Francisco, CA, USA.
Jeanine P Wiener-KronishDepartment of Anesthesiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Ednan K BajwaDepartment of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Michael P DonahoeDepartment of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
Bryan J McVerryDepartment of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
Luis A OrtizDepartment of Environmental and Occupational Health, University of Pittsburgh, Pittsburgh, PA, USA.
Matthew ExlineDepartment of Medicine, Ohio State University Medical Center, Columbus, OH, USA.
John W ChristmanDepartment of Medicine, Ohio State University Medical Center, Columbus, OH, USA.
Jason AbbottCardiovascular Research Institute, University of California, San Francisco, CA, USA.
Kevin L DelucchiDepartment of Psychiatry, University of California, San Francisco, CA, USA.
Lizette CaballeroBone and Marrow Transplant Laboratory, University of California, San Francisco, CA, USA.
Melanie McMillanBone and Marrow Transplant Laboratory, University of California, San Francisco, CA, USA.
David H McKennaUniversity of Minnesota, Molecular and Cellular Therapeutics, Saint Paul, MN, USA.
Kathleen D LiuDepartment of Medicine and Anesthesia, University of California, San Francisco, CA, USA; Cardiovascular Research Institute, University of California, San Francisco, CA, USA.

Funding

Allogeneic Human Mesenchymal Stem Cells for the Treatment of Acute Lung InjuryU01HL108713 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI MATTHAY, MICHAEL A. · 2011 to 2015
$5.1M
NHLBI NIH HHS HHSN268201000008CNHLBI NIH HHS U01 HL108713
6 · The paper itself

Abstract

backgroundTreatment with bone-marrow-derived mesenchymal stromal cells (MSCs) has shown benefits in preclinical models of acute respiratory distress syndrome (ARDS). Safety has not been established for administration of MSCs in critically ill patients with ARDS. We did a phase 2a trial to assess safety after administration of MSCs to patients with moderate to severe ARDS.

methodsWe did a prospective, double-blind, multicentre, randomised trial to assess treatment with one intravenous dose of MSCs compared with placebo. We recruited ventilated patients with moderate to severe ARDS (ratio of partial pressure of oxygen to fractional inspired oxygen <27 kPa and positive end-expiratory pressure [PEEP] ≥8 cm H

findingsFrom March 24, 2014, to Feb 9, 2017 we screened 1038 patients, of whom 60 were eligible for and received treatment. No patient experienced any of the predefined MSC-related haemodynamic or respiratory adverse events. One patient in the MSC group died within 24 h of MSC infusion, but death was judged to be probably unrelated. 28-day mortality did not differ between the groups (30% in the MSC group vs 15% in the placebo group, odds ratio 2·4, 95% CI 0·5-15·1). At baseline, the MSC group had numerically higher mean scores than the placebo group for Acute Physiology and Chronic Health Evaluation III (APACHE III; 104 [SD 31] vs 89 [33]), minute ventilation (11·1 [3·2] vs 9·6 [2·4] L/min), and PEEP (12·4 [3·7] vs 10·8 [2·6] cm H

interpretationOne dose of intravenous MSCs was safe in patients with moderate to severe ARDS. Larger trials are needed to assess efficacy, and the viability of MSCs must be improved.

fundingNational Heart, Lung, and Blood Institute.

Indexed as

Hospital MortalityPatient SafetyAcademic Medical CentersAdultAgedDisease-Free SurvivalDouble-Blind MethodFemaleHumansMaleMesenchymal Stem Cell TransplantationMiddle AgedMultivariate AnalysisProportional Hazards ModelsProspective StudiesRespiratory Distress Syndrome

Identifiers

PMID30455077
PMCPMC7597675

What OpenQuestion holds

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Read underepoch 390

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.