Evidence map›Paper›PMID 39580717›Full record

ArticleCytotherapy2025

Delphi-driven consensus definition for mesenchymal stromal cells and clinical reporting guidelines for mesenchymal stromal cell-based therapeutics.

Laurent Renesme, Kelly D Cobey, Manoj M Lalu, Tania Bubela, Raghavan Chinnadurai, John De Vos, Rod Dunbar, Dean Fergusson, Daniel Freund, Jacques Galipeau and 14 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Cytotherapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 67 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 2 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.

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

67 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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7 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

24 authors.

Laurent RenesmeSinclair Center for Regenerative Medicine, Ottawa Hospital Research Institute, Ottawa, Canada; Neonatology, Department of Pediatrics, Children's Hospital of Eastern Ontario, Ottawa, Canada.
Kelly D CobeyUniversity of Ottawa Heart Institute, Ottawa, Canada.
Manoj M LaluDepartment of Anesthesiology and Pain Medicine, The Ottawa Hospital, Ottawa, Canada; Clinical Epidemiology Program and Regenerative Medicine Program, Ottawa Hospital Research Institute, Ottawa, Canada; Department of Cellular and Molecular Medicine, University of Ottawa, Ottawa, Canada.
Tania BubelaFaculty of Health Sciences, Simon Fraser University, Burnaby, Canada.
Raghavan ChinnaduraiDepartment of Biomedical Sciences, Mercer University School of Medicine, Savannah, Georgia, USA.
John De VosInstitute for Regenerative Medicine and Biotherapy, Montpellier University, Montpellier, France.
Rod DunbarSchool of Biological Sciences and Maurice Wilkins Centre, University of Auckland, Auckland, New Zealand.
Dean FergussonDepartment of Medicine, University of Ottawa, Ottawa, Canada; Ottawa Hospital Research Institute, Ottawa, Canada.
Daniel FreundDepartment of Neonatology and Pediatric Critical Care Medicine, Dresden University of Technology, Dresden, Germany; Center for Regenerative Therapies Dresden, Dresden University of Technology, Dresden, Germany.
Jacques GalipeauUniversity of Wisconsin School of Medicine and Public Health, University of Wisconsin, Madison, Wisconsin, USA.
Edwin HorwitzWinship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia, USA.
Maxime LêPatient Partner, Ottawa Hospital Research Institute, Ottawa, Canada.
Michael MatthayCardiovascular Research Institute, Departments of Medicine and Anesthesia, University of California, San Francisco, California, USA.
David MoherOttawa Methods Centre, Ottawa Hospital Research Institute, Ottawa, Canada.
Jan NoltaInstitute for Regenerative Cures, University of California Davis Health, Sacramento, California, USA.
Graham ParkerDepartment of Pediatrics, Wayne State University School of Medicine, Detroit, Michigan, USA.
Donald G PhinneyDepartment of Molecular Medicine, The Herbert Wertheim UF Scripps Institute for Biomedical Innovation and Technology, Jupiter, Florida, USA.
Mahendra RaoVita Therapeutics, Baltimore, Maryland, USA.
John E J RaskoDepartment of Cell and Molecular Therapies, Royal Prince Alfred Hospital, Sydney, Australia; Faculty of Medicine and Health, University of Sydney, Sydney, Australia.
Patricia R M RoccoLaboratory of Pulmonary Investigation, Carlos Chagas Filho Institute of Biophysics, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil; National Institute of Science and Technology for Regenerative Medicine, Rio de Janeiro, Brazil.
Fabio RossiBiomedical Research Centre, University of British Columbia, Vancouver, Canada.
Michael Rosu MylesBiologic and Radiopharmaceutical Drugs Directorate, Health Products and Food Branch, Health Canada, Ottawa, Canada.
Sowmya ViswanathanSchroeder Arthritis Institute, University Health Network, Toronto, Canada; Krembil Research Institute, University Health Network, Toronto, Canada; Institute of Biomedical Engineering, University of Toronto, Toronto, Canada; Department of Medicine, University of Toronto, Toronto, Canada.
Bernard ThébaudSinclair Center for Regenerative Medicine, Ottawa Hospital Research Institute, Ottawa, Canada; Neonatology, Department of Pediatrics, Children's Hospital of Eastern Ontario, Ottawa, Canada; Department of Cellular and Molecular Medicine, University of Ottawa, Ottawa, Canada; Children's Hospital of Eastern Ontario Research Institute, Ottawa, Canada. Electronic address: bthebaud@toh.ca.

Funding

Translational Research Support CoreP30ES036084 · NIEHS · WAYNE STATE UNIVERSITY · PI Melissa A Runge-Morris · 2024 to 2026
$5.2M
NIEHS NIH HHS P30 ES036084
6 · The paper itself

Abstract

BACKGROUND

aimsDespite promising results in pre-clinical studies, mesenchymal stromal cells (MSCs) face significant challenges in clinical translation. A scoping review by our group highlighted two key issues contributing to this gap: (i) lack of a clear and consensus definition for MSCs and (ii) under-reporting of critical parameters in MSC clinical studies. To address these issues, we conducted a modified Delphi study to establish and implement a consensus definition for MSCs and develop reporting guidelines for MSC clinical studies.

methodsA steering committee of 22 international experts, including stakeholders from different MSC research fields, participated in the three Delphi rounds. For the first round, to obtain a broad perspective, additional investigators recommended by the steering committee were invited to participate. The first two rounds consisted of online surveys, whereas the third round took the form of a virtual meeting. Participants were asked to rate a series of potential defining characteristics of MSCs and items for reporting guidelines. Consensus was defined as at least 80% of the participants rating the item in the same category of importance.

resultsEighty-seven international participants participated in the first round survey (spring 2023), 17 participants participated in the second online survey (fall 2023) and 15 participants participated in the final virtual consensus meeting (January 2024). For the MSC definition, 20 items were considered and nine reached consensus. Items included terminology (one item), cell marker expression (five items), tissue origin (one item), stemness (one item) and description of critical quality attributes (one item). For the reporting guidelines, with the 28 initial items and the additional items suggested during round 1, a total of 33 items to report were included. This included items on MSC intervention group and control (e.g., MSC product, dose and administration), MSC characteristics (e.g., MSC provenance, "fitness," viability and immune compatibility) and MSC culture conditions (e.g., oxygen environment, culture medium and use of serum).

conclusionsBy applying a Delphi method to establish a consensus definition for MSCs and reporting guidelines for MSC-based clinical trials, this work represents a significant advance in improving transparency and reproducibility in the conduct and reporting of MSC research.

Indexed as

Cell- and Tissue-Based TherapyMesenchymal Stem CellsMesenchymal Stem Cell TransplantationConsensusDelphi TechniqueGuidelines as TopicHumansconsensus definitionDelphi methodmesenchymal stromal cellsreporting guidelines

Identifiers

PMID39580717
PMCPMC12931451

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.