Evidence map›Paper›PMID 40394561›Full record

Trial reportBMC ophthalmology2025

Efficacy of topical mesenchymal stem cell exosome in Sjögren's syndrome-related dry eye: a randomized clinical trial.

Azam Habibi, Amir Khosravi, Masoud Soleimani, Mahmood Nejabat, Mahintaj Dara, Negar Azarpira

Abstract readRandomized Controlled TrialClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in BMC ophthalmology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 3 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

24 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  7. [Advances in stem cell and exosome-based therapies for dry eye disease].Sheng wu yi xue gong cheng xue za zhi = Journal of biomedical engineering = Shengwu yixue gongchengxue zazhi · 2026
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  16. Exosomes in corneal diseases: advances in diagnosis and therapy.Frontiers in cell and developmental biology · 2026
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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

6 authors.

Azam HabibiStudent Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.
Amir KhosraviPostiche Ophthalmology Research Center, Department of Ophthalmology School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.
Masoud SoleimaniDepartment of Tissue Engineering and Applied Cell Science, School of Advanced Technologies in Medicine, Shaheed Beheshti University of Medical Sciences, Tehran, Iran.
Mahmood NejabatPostiche Ophthalmology Research Center, Department of Ophthalmology School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.
Mahintaj DaraStem Cells Technology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
Negar AzarpiraTransplant Research Center, Shiraz University of Medical Sciences, P.O. Box: 7193711351, Shiraz, Iran. negarazarpira@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSjögren's syndrome (SS) is a chronic inflammatory autoimmune disorder affecting salivary and lacrimal glands, leading to distressing ocular symptoms. Existing therapeutic approaches for SS-associated dry eye syndrome (DES) show insufficient efficacy. This study investigates the use of topical MSC-derived exosomes in primary SS-related DES.

methodsIn phase 1 and 2, triple-blinded, randomized trial, two vials of eye drops are given to each participant, one with code A and one with code B and only the supervisor knows the content of each vial. The treatment group (n = 8 eyes) received 10 µg of MSC-derived exosomes twice daily for two weeks and the control group (n = 8 eyes) received Phosphate buffered saline(PBS) for their respective eyes. Safety was assessed through ophthalmic exams, while DES assessment tests evaluated treatment effectiveness. Non-parametric tests employed to examine assumptions. The differences of ocular examination results between day 0 and month 3 were analyzed using a paired Student's t test. Measurement data that were not normally distributed are represented by the median (interquartile range), and comparisons were performed using the Wilcoxon rank-sum test.

resultsThe treatment showed promising results, with significant improvements observed in various indicators such as reduced Ocular Surface Disease Index scores, increased tear secretion, lower fluorescein scores, and longer tear-film break-up time before and after treatment and between the controls and the treated groups. Our results showed a significant increase in multifunctional proteins such as Epidermal Growth Factor and thrombospondin-1 and conversely, the levels of pro-inflammatory cytokines, including interleukin-6 and Matrix metalloproteinase-9 significantly decreased in tear of participant before and after treatment and between the controls and the treated groups.

conclusionsOur study underscores the safety and substantial therapeutic potential of using MSC-derived extracellular exosomes eye drops to treat SS-associated DES.

trial registrationIRCT20211102052948N1 The study protocol has been approved in Iranian Registry of Clinical Trials at 2022-04-20.

Indexed as

Dry Eye SyndromesExosomesMesenchymal Stem CellsSjogren's SyndromeAdultAgedFemaleHumansMaleMiddle AgedOphthalmic SolutionsTearsTreatment OutcomeOphthalmic SolutionsDry eyeExosomesMesenchymal stem cellSjögren's syndrome

Identifiers

PMID40394561
PMCPMC12090426

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.