Evidence map›Paper›PMID 23133515›Full record

SynthesisPloS one2012

Safety of cell therapy with mesenchymal stromal cells (SafeCell): a systematic review and meta-analysis of clinical trials.

Manoj M Lalu, Lauralyn McIntyre, Christina Pugliese, Dean Fergusson, Brent W Winston, John C Marshall, John Granton, Duncan J Stewart, Canadian Critical Care Trials Group

5 registry-linked trialsOpen access · goldAbstract readMeta-AnalysisSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in PloS one, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 614 papers, 17 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
614citing papers in PubMed, 17 pooled it
33.0field-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.

NCT02866721 phase1completednot on this mapstarted 2016, after this paper: background citation

A Phase I, Single Center, Open Label, Single Dose, Dose Escalation Study Assessing the Safety and Tolerability of AllogeneiC MEsenchymAl Stem CEll Infusion in Adults With Cystic Fibrosis-CEASE CF

TypeinterventionalSponsorUniversity Hospitals Cleveland Medical CenterRan2016 to 2020Enrolled14ConditionsCystic FibrosisArmsMesenchymal Stem Cells
NCT03692221 early_phase1withdrawnnot on this mapstarted 2019, after this paper: background citation

Percutaneous Image Guided Delivery of Autologous Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Symptomatic Degenerated Intervertebral Disc Disease

TypeinterventionalSponsorUniversity Hospitals Cleveland Medical CenterRan2019 to 2022Enrolled0ConditionsDisc DegenerationArmsMSC Treatment group 1 (low dose), MSC Treatment group 2 (high dose), Healthy Control (no treatment)
NCT04011059 phase1 / phase2unknown statusnot on this mapstarted 2019, after this paper: background citation

Randomized Study as Proof of Concept of Coronary Revascularization Surgery With Injection of Wharton's Jelly-derived Mesenchymal Cells and Placement of an Epicardial Extracellular Matrix Patch Seeded With WJ-MSCs in Patients With Ischemic Cardiomyopathy

TypeinterventionalSponsorHospital San Vicente FundaciónRan2019 to 2023Enrolled40ConditionsCardiovascular Diseases, Heart Failure, Coronary Artery Disease, Mesenchymal Stem Cell TransplantationArmsWharton's jelly-derived mesenchymal cells
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
NCT07018739 phase1 / phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Efficacy of Using Mesenchymal Stem Cells With Therapeutic Hypothermia in Infants With Perinatal Hypoxic-Ischemic Encephalopathy: A Double Blind, Randomized Controlled Trial

TypeinterventionalSponsorMahidol UniversityRan2026 to 2033Enrolled40ConditionsHypoxic-Ischemic Encephalopathy, Neonatal, Brain Injuries, Hypoxic-IschemicArmsWharton's jelly-derived mesenchymal stem cells, 0.9 % Normal Saline
3 · Its place in the literature

Who cites it

614 citing papers in PubMed, 17 syntheses or guidelines pooled it, 1,129 citations in OpenAlex.

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  18. Baseline CD4Journal of blood medicine · 2025
    Trial
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554 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

9 authors at 4 institutions in 2 countries.

Manoj M LaluDepartment of Anesthesiology, University of Ottawa, Ottawa, Canada.
Lauralyn McIntyre
Christina Pugliese
Dean Fergusson
Brent W Winston
John C Marshall
John Granton
Duncan J Stewart
Canadian Critical Care Trials Group
Ottawa Hospital Research InstituteUniversity of Toronto · CAUniversity of Calgary · CAUniversity of Ottawa · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMesenchymal stromal cells (MSCs, "adult stem cells") have been widely used experimentally in a variety of clinical contexts. There is interest in using these cells in critical illness, however, the safety profile of these cells is not well known. We thus conducted a systematic review of clinical trials that examined the use MSCs to evaluate their safety. METHODS AND

findingsMEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (to June 2011), were searched. Prospective clinical trials that used intravascular delivery of MSCs (intravenously or intra-arterially) in adult populations or mixed adult and pediatric populations were identified. Studies using differentiated MSCs or additional cell types were excluded. The primary outcome adverse events were grouped according to immediate events (acute infusional toxicity, fever), organ system complications, infection, and longer term adverse events (death, malignancy). 2347 citations were reviewed and 36 studies met inclusion criteria. A total of 1012 participants with clinical conditions of ischemic stroke, Crohn's disease, cardiomyopathy, myocardial infarction, graft versus host disease, and healthy volunteers were included. Eight studies were randomized control trials (RCTs) and enrolled 321 participants. Meta-analysis of the RCTs did not detect an association between acute infusional toxicity, organ system complications, infection, death or malignancy. There was a significant association between MSCs and transient fever.

conclusionsBased on the current clinical trials, MSC therapy appears safe. However, further larger scale controlled clinical trials with rigorous reporting of adverse events are required to further define the safety profile of MSCs.

Indexed as

Clinical Trials as TopicAdolescentAdultAgedCardiomyopathiesCell- and Tissue-Based TherapyGraft vs Host DiseaseHumansMaleMesenchymal Stem CellsMiddle AgedMyocardial InfarctionMyocardial IschemiaPatient SafetyProspective StudiesRandomized Controlled Trials as Topic

Identifiers

PMID23133515
PMCPMC3485008
OpenAlexW2031790029

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.