Evidence map›Paper›PMID 31989101›Full record

ArticleEClinicalMedicine2020

Cell therapy with intravascular administration of mesenchymal stromal cells continues to appear safe: An updated systematic review and meta-analysis.

Mary Thompson, Shirley H J Mei, Dianna Wolfe, Josée Champagne, Dean Fergusson, Duncan J Stewart, Katrina J Sullivan, Emily Doxtator, Manoj Lalu, Shane W English and 8 more

2 registry-linked trialsAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in EClinicalMedicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 170 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
170citing papers in PubMed, 15 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.

NCT04744051 phase1unknown statusnot on this mapstarted 2021, after this paper: background citation

ATCell™ Expanded Autologous, Adipose-Derived Mesenchymal Stem Cells Deployed Via Intravenous Infusion for the Treatment of Post Concussion Syndrome (PCS) in Retired Military and Athletes

TypeinterventionalSponsorAmerican CryoStem CorporationRan2021 to 2024Enrolled20ConditionsPost-Concussion SyndromeArms50 Adipose Derived Stem Cell Infusion, 150 Adipose Derived Stem Cell Infusion, 300 Adipose Derived Stem Cell Infusion, Placebo Infusion
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

170 citing papers in PubMed, 15 syntheses or guidelines pooled it.

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110 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

18 authors.

Mary ThompsonClinical Epidemiology Program (CEP), Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Shirley H J MeiRegenerative Medicine Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Dianna WolfeClinical Epidemiology Program (CEP), Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Josée ChampagneClinical Epidemiology Program (CEP), Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Dean FergussonClinical Epidemiology Program (CEP), Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Duncan J StewartRegenerative Medicine Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Katrina J SullivanClinical Epidemiology Program (CEP), Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Emily DoxtatorClinical Epidemiology Program (CEP), Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Manoj LaluDepartment of Anesthesiology and Pain Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada.
Shane W EnglishClinical Epidemiology Program (CEP), Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
John GrantonDepartment of Medicine (Critical Care), University of Toronto, Toronto, Ontario, Canada.
Brian HuttonClinical Epidemiology Program (CEP), Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
John MarshallDepartment of Surgery (Critical Care), University of Toronto, Toronto, Ontario, Canada.
Alies MaybeePatient Advisors Network, Toronto, Ontario, Canada.
Keith R WalleyCentre for Heart Lung Innovation, University of British Columbia, Vancouver, British Columbia, Canada.
Claudia Dos SantosDepartment of Surgery (Critical Care), University of Toronto, Toronto, Ontario, Canada.
Brent WinstonDepartment of Critical Care, Medicine, and Biochemistry and Microbiology, University of Calgary, Calgary, Alberta, Canada.
Lauralyn McIntyreClinical Epidemiology Program (CEP), Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCharacterization of the mesenchymal stromal cell (MSC) safety profile is important as this novel therapy continues to be evaluated in clinical trials for various inflammatory conditions. Due to an increase in published randomized controlled trials (RCTs) from 2012-2019, we performed an updated systematic review to further characterize the MSC safety profile.

methodsMEDLINE, EMBASE, Cochrane Central Register of Controlled Trials and Web of Science (to May 2018) were searched. RCTs that compared intravascular delivery of MSCs to controls in adult populations were included. Pre-specified adverse events were grouped according to: (1) immediate, (2) infection, (3) thrombotic/embolic, and (4) longer-term events (mortality, malignancy). Adverse events were pooled and meta-analyzed by fitting inverse-variance binary random effects models. Primary and secondary clinical efficacy endpoints were summarized descriptively.

findings7473 citations were reviewed and 55 studies met inclusion criteria ( INTERPRETATIONS: MSC therapy continues to exhibit a favourable safety profile. Future trials should continue to strengthen study rigor, reporting of MSC characterization, and adverse events.

fundingStem Cell Network, Ontario Institute for Regenerative Medicine and Ontario Research Fund.

Indexed as

Adverse eventsMesenchymal stem cellsSafetySystematic review

Identifiers

PMID31989101
PMCPMC6970160

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.