Evidence map›Paper›PMID 33400390›Full record

Trial reportStem cells translational medicine2021

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

Giacomo Lanzoni, Elina Linetsky, Diego Correa, Shari Messinger Cayetano, Roger A Alvarez, Dimitrios Kouroupis, Ana Alvarez Gil, Raffaella Poggioli, Phillip Ruiz, Antonio C Marttos and 21 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Stem cells translational medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06163833 (MATRIx), which is not on this map. Cited by 275 papers, 23 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
275citing papers in PubMed, 23 pooled it
79.2field-weighted citation impact, top 1% 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.

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

275 citing papers in PubMed, 23 syntheses or guidelines pooled it, 429 citations in OpenAlex.

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

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

31 authors at 7 institutions in 2 countries.

Giacomo LanzoniDiabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.ORCID 0000-0003-3996-4803
Elina LinetskyDiabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
Diego CorreaDiabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
Shari Messinger CayetanoDivision of Biostatistics, Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, Florida, USA.
Roger A AlvarezDepartment of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA.
Dimitrios KouroupisDiabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.ORCID 0000-0002-3892-9013
Ana Alvarez GilDiabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
Raffaella PoggioliDiabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
Phillip RuizDepartment of Surgery, University of Miami Miller School of Medicine, Miami, Florida, USA.
Antonio C MarttosDepartment of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA.
Khemraj HiraniDiabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
Crystal A BellDepartment of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA.
Halina KusackDepartment of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA.
Lisa RafkinDiabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
David BaidalDiabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
Andrew PastewskiJackson Health System, Miami, Florida, USA.
Kunal GawriDepartment of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA.
Clarissa LeñeroDiabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
Alejandro M A ManteroDivision of Biostatistics, Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, Florida, USA.
Sarah W MetalonisDivision of Biostatistics, Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, Florida, USA.
Xiaojing WangDiabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
Luis RoqueDiabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
Burlett MastersDiabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
Norma S KenyonDiabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
Enrique GinzburgDepartment of Surgery, University of Miami Miller School of Medicine, Miami, Florida, USA.
Xiumin XuDiabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
Jianming TanThe Second Affiliated Hospital of Hainan Medical University, Haikou, Hainan, People's Republic of China.
Arnold I CaplanSkeletal Research Center, Case Western Reserve University, Cleveland, Ohio, USA.
Marilyn K GlassbergUniversity of Arizona College of Medicine, Tucson, Arizona, USA.
Rodolfo AlejandroDiabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
Camillo RicordiDiabetes Research Institute, Cell Transplant Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
University of Miami · USMiami Transplant Institute · USUniversity of Miami Health System · USCase Western Reserve University · USHainan Medical University · CNJackson Health System · USUniversity of Arizona · US

Funding

Miami Clinical and Translational Science InstituteUL1TR002736 · NCATS · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI CARRASQUILLO, OLVEEN, KOBETZ, ERIN N · 2018 to 2022
$23.2M
Miami Clinical and Translational Science InstituteUL1TR000460 · NCATS · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI SACCO, RALPH L. · 2012 to 2016
$16.9M
Barilla Group and FamilyDiabetes Research Institute Foundation (DRIF)Fondazione Silvio Tronchetti ProveraNCATS NIH HHS UL1 TR000460NCATS NIH HHS UL1TR000460NCATS NIH HHS UL1 TR002736NCATS NIH HHS UL1TR002736North America's Building Trades Unions (NABTU)Simkins Family FoundationThe Cure AllianceUgo Colombo
6 · The paper itself

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 × 10

Indexed as

Anti-Inflammatory AgentsCOVID-19CytokinesDouble-Blind MethodFemaleHumansMaleMesenchymal Stem CellsMesenchymal Stem Cell TransplantationMiddle AgedSARS-CoV-2Severity of Illness IndexTreatment OutcomeUmbilical CordAnti-Inflammatory AgentsCytokinescell transplantationcellular therapyclinical trialsmesenchymal stem cellsrespiratory tracttransplantationumbilical cord

Identifiers

PMID33400390
PMCPMC8046040
OpenAlexW3120463228

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.