Evidence map›Paper›PMID 38764070›Full record

SynthesisStem cell research & therapy2024

The safety profile of mesenchymal stem cell therapy administered through intrathecal injections for treating neurological disorders: a systematic review and meta-analysis of randomised controlled trials.

Luz Estella Mesa Bedoya, Jhyld Carolaind Camacho Barbosa, Lucas López Quiceno, Freddy Barrios Arroyave, Karolynn Halpert, Julián Andrés España Peña, Juan Carlos Salazar Uribe

Abstract readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in Stem cell research & therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–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

11 citing papers in PubMed.

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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

7 authors.

Luz Estella Mesa BedoyaBioXcellerator/ BioXscience Advanced Therapies and Translational Medicine, Medellín, Antioquia, Colombia.
Jhyld Carolaind Camacho BarbosaBioXcellerator/ BioXscience Advanced Therapies and Translational Medicine, Medellín, Antioquia, Colombia. jhyld.camacho@bioxcellerator.com.ORCID 0000-0003-4405-3713
Lucas López QuicenoBioXcellerator/ BioXscience Advanced Therapies and Translational Medicine, Medellín, Antioquia, Colombia.
Freddy Barrios ArroyaveBioXcellerator/ BioXscience Advanced Therapies and Translational Medicine, Medellín, Antioquia, Colombia.
Karolynn HalpertBioXcellerator/ BioXscience Advanced Therapies and Translational Medicine, Medellín, Antioquia, Colombia.
Julián Andrés España PeñaBioXcellerator/ BioXscience Advanced Therapies and Translational Medicine, Medellín, Antioquia, Colombia.
Juan Carlos Salazar UribeUniversidad Nacional de Colombia, Medellín, Antioquia, Colombia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBased on previous in vivo studies and human trials, intrathecal cell delivery is a safe and relevant therapeutic tool for improving patient's quality of life with neurological conditions. We aimed to characterise the safety profile of intrathecally delivered Mesenchymal stem cells (MSCs).

methodsOvid MEDLINE, Embase, Scopus, Cochrane Library, KCI-Korean Journal Database, and Web of Science. Databases were searched from their inception until April 13, 2023. Randomised Controlled Trials (RCTs) that compared intrathecal delivery of MSCs to controls in adult populations were included. Adverse events (AEs) were pooled and meta-analysed using DerSimonian-Laird random effects models with a correction factor 0.5 added to studies with zero count cells. Pooled AEs were described using Risk ratio (RR) and 95% confidence intervals (95% CI). Then, a random-effects meta-regress model on study-level summary data was performed to explore the relationship between the occurrence of AEs and covariates thought to modify the overall effect estimate. Finally, publication bias was assessed.

results303 records were reviewed, and nine RCTs met the inclusion criteria and were included in the quantitative synthesis (n = 540 patients). MSCs delivered intrathecally, as compared to controls, were associated with an increased probability of AEs of musculoskeletal and connective tissue disorders (categorised by Common Terminology Criteria for Adverse Events-CTCAE version 5.0) (RR: 1.61, 95% CI 1.19-2.19, I

conclusionsIntrathecal delivery of MSCs was associated with a slight increase in AEs associated with musculoskeletal and connective tissue disorders, albeit without serious AEs. We conclude that intrathecal MSCs delivery is safe for patients with neurological conditions. However, further high-quality, large-scale RCTs are needed to confirm these findings.

Indexed as

Injections, SpinalMesenchymal Stem CellsMesenchymal Stem Cell TransplantationNervous System DiseasesRandomized Controlled Trials as TopicHumansIntrathecal deliveryMesenchymal stem cellsMeta-analysisSafety profileSystematic review

Identifiers

PMID38764070
PMCPMC11103979

What OpenQuestion holds

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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.