Evidence map›Paper›PMID 38925685›Full record

SynthesisBMJ open2024

Compliance with requirements for registration and reporting of results in trials of mesenchymal stromal cells for musculoskeletal disorders: a systematic review.

Robin Holtedahl, Jens Ivar Brox

Abstract readSystematic Review
In one paragraph

Synthesis in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. From pathogenesis to therapy: extracellular vesicles in osteoarthritis.Frontiers in bioengineering and biotechnology · 2026
    Review
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

2 authors.

Robin HoltedahlSondrevegen 7, Oslo, Norway.ORCID 0000-0002-8436-4519
Jens Ivar BroxPhys med & rehab, Oslo University Hospital and Medical Faculty, University in Oslo, Oslo, Norway j.i.brox@medisin.uio.no.ORCID 0000-0002-2507-1812

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess compliance with statutory requirements to register and report outcomes in interventional trials of mesenchymal stromal cells (MSCs) for musculoskeletal disorders and to describe the trials' clinical and design characteristics.

designA systematic review of published trials and trials submitted to public registries. DATA SOURCES: The databases Medline, Cochrane Library and McMaster; six public clinical registries. All searches were done until 31 January 2023. ELIGIBILITY CRITERIA: Trials submitted to registries and completed before January 2021. Prospective interventional trials published in peer-reviewed journals. DATA EXTRACTION AND SYNTHESIS: The first author searched for trials that had (1) posted trial results in a public registry, (2) presented results in a peer-reviewed publication and (3) submitted a pretrial protocol to a registry before publication. Other extracted variables included trial design, number of participants, funding source, follow-up duration and cell type.

resultsIn total 124 trials were found in registries and literature databases. Knee osteoarthritis was the most common indication. Of the 100 registry trials, 52 trials with in total 2 993 participants had neither posted results in the registry nor published results. Fifty-two of the registry trials submitted a protocol retrospectively. Forty-three of the 67 published trials (64%) had registered a pretrial protocol. Funding source was not associated with compliance with reporting requirements. A discrepancy between primary endpoints in the registry and publication was found in 16 of 25 trials. In 28% of trials, the treatment groups used adjuvant therapies. Only 39% of controlled trials were double-blinded.

conclusionsA large proportion of trials failed to comply with statutory requirements for the registration and reporting of results, thereby increasing the risk of bias in outcome assessments. To improve confidence in the role of MSCs for musculoskeletal disorders, registries and medical journals should more rigorously enforce existing requirements for registration and reporting.

Indexed as

Mesenchymal Stem Cell TransplantationMusculoskeletal DiseasesRegistriesClinical Trials as TopicGuideline AdherenceHumansMesenchymal Stem CellsResearch Designclinical trialsmesenchymal stem cellsmusculoskeletal disordersorthopaedic & trauma surgeryprotocols & guidelinessystematic review

Identifiers

PMID38925685
PMCPMC11202644

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.