Evidence map›Paper›PMID 39465400›Full record

Trial reportBMC musculoskeletal disorders2024

Safety and efficacy of placental mesenchymal stromal cells-derived extracellular vesicles in knee osteoarthritis: a randomized, triple-blind, placebo-controlled clinical trial.

Najmeh Sadat Bolandnazar, Seyed Ahmad Raeissadat, Hamidreza Haghighatkhah, Seyed Mansoor Rayegani, Rasa Salmani Oshnari, Saeed Heidari Keshel, Mohammad Zahraei, Kianmehr Aalipour, Marzieh Babaee, Amir Zamani and 3 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC musculoskeletal disorders, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 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, 1 synthesis or guideline pooled it.

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  10. Clinical Applications of Extracellular Vesicles: Promises and Pitfalls.International journal of molecular sciences · 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

13 authors.

Najmeh Sadat BolandnazarPhysical Medicine and Rehabilitation Research Center, Medical and Educational Center of Taleghani Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Seyed Ahmad RaeissadatPhysical Medicine and Rehabilitation Department, Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Hamidreza HaghighatkhahRadiology Department, Shohada-e-Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Seyed Mansoor RayeganiPhysical Medicine and Rehabilitation Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Rasa Salmani OshnariPhysical Medicine and Rehabilitation Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. rasa_salmani@yahoo.com.
Saeed Heidari KeshelDepartment of Tissue Engineering and Applied Cell Sciences, School of Advanced Technologies in Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Mohammad ZahraeiMedical Nanotechnology and Tissue Engineering Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Kianmehr AalipourPhysical Medicine and Rehabilitation Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Marzieh BabaeePhysical Medicine and Rehabilitation Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Amir ZamaniRadiology Department, Shohada-e-Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Zahra Besharati RadBabol University of Medical Sciences, Babol, Iran.
Masoud SoleimaniDepartment of Tissue Engineering and Applied Cell Sciences, School of Advanced Technologies in Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Farshid SefatDepartment of Biomedical and Electronics Engineering, School of Engineering, University of Bradford, Bradford, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundKnee osteoarthritis causes pain and disability in many people worldwide, for which no definitive treatment has yet been proposed. In this study, we investigated the safety and efficacy of placental mesenchymal stromal cells-derived extracellular vesicles in patients with knee osteoarthritis.

methodsThis triple-blind, randomized clinical trial included patients suffering from bilateral knee osteoarthritis with grade 2 or 3. The knees of each patient were randomized to intervention and control. For the intervention knee, 5 cc of placental mesenchymal stromal cells-derived extracellular vesicles were injected, and for the control knee, 5 cc of normal saline was injected. The patients' symptoms were evaluated before the intervention and 2 and 6 months after the intervention using VAS, WOMAC questionnaire, and Lequesne index. MRI was performed before the intervention and 6 months after the intervention to evaluate retropatellar and tibiofemoral cartilage volume, medial and lateral meniscal disintegrity, ACL injury, and effusion-synovitis.

results62 knees (31 patients) were enrolled in this study. There were 31 knees as intervention and 31 knees as control. Finally, the data of 58 knees (29 patients) were analyzed, including 28 women and 1 man. The mean age of the patients was 55.38 ± 6.07 years. No statistically significant difference was detected between the two groups in clinical outcomes (including VAS, WOMAC, and Lequesne scores) before treatment and 2 and 6 months after treatment. Also, no statistically significant difference was detected between the two groups in MRI findings before treatment and 6 months after treatment. No systemic complications or severe local reactions occurred in the patients.

conclusionA single intra-articular injection of placental mesenchymal stromal cells-derived extracellular vesicles (5 cc, 7 × 10

Indexed as

Extracellular VesiclesMesenchymal Stem CellsMesenchymal Stem Cell TransplantationOsteoarthritis, KneePlacentaAgedDouble-Blind MethodFemaleHumansInjections, Intra-ArticularMagnetic Resonance ImagingMaleMiddle AgedPregnancyTreatment OutcomeExtracellular vesiclesKnee osteoarthritisMRI

Identifiers

PMID39465400
PMCPMC11514941

What OpenQuestion holds

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Registered trials

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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.