Evidence map›Paper›PMID 34845081›Full record

ArticleBMJ open2021

Efficacy and cost-effectiveness of Stem Cell injections for symptomatic relief and strUctural improvement in people with Tibiofemoral knee OsteoaRthritis: protocol for a randomised placebo-controlled trial (the SCUlpTOR trial).

Xiaoqian Liu, Sarah Robbins, Xia Wang, Sonika Virk, Karen Schuck, Leticia A Deveza, Win Min Oo, Kirsty Carmichael, Benny Antony, Felix Eckstein and 11 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
2.9field-weighted citation impact, top 8% 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.

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

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 25 citations in OpenAlex.

  1. Stem cell injections for osteoarthritis of the knee.The Cochrane database of systematic reviews · 2025
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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

21 authors at 6 institutions in 4 countries.

Xiaoqian LiuDepartment of Rheumatology, Royal North Shore Hospital, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.ORCID 0000-0002-6375-1800
Sarah RobbinsDepartment of Rheumatology, Royal North Shore Hospital, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
Xia WangDepartment of Rheumatology, Royal North Shore Hospital, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.ORCID 0000-0003-3172-9390
Sonika VirkDepartment of Rheumatology, Royal North Shore Hospital, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
Karen SchuckDepartment of Rheumatology, Royal North Shore Hospital, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
Leticia A DevezaDepartment of Rheumatology, Royal North Shore Hospital, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
Win Min OoDepartment of Rheumatology, Royal North Shore Hospital, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
Kirsty CarmichaelMenzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.
Benny AntonyMenzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.
Felix EcksteinInstitute of Anatomy and Cell Biology and Ludwig Boltzmann Institute for Arthritis and Rehabilitation, Paracelsus Medical University Salzburg, Salzburg, Austria.
Wolfgang WirthInstitute of Anatomy and Cell Biology and Ludwig Boltzmann Institute for Arthritis and Rehabilitation, Paracelsus Medical University Salzburg, Salzburg, Austria.
Christopher LittleRaymond Purves Bone and Joint Research Labs, Kolling Institute of Medical Research, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
James LinklaterCastlereagh Imaging, St Leonards, Sydney, New South Wales, Australia.
Anthony HarrisCentre for Health Economics, Monash University, Clayton, Victoria, Australia.ORCID 0000-0003-1641-3320
David HumphriesSchool of Medicine, College of Health and Medicine, University of Tasmania Faculty of Health, Hobart, Tasmania, Australia.
R O'ConnellNHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.
Gillian HellerNHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.
Thomas ButtelRepresentative of People with Knee Osteoarthritis, Sydney, New South Wales, Australia.
Stefan LohmanderDepartment of Clinical Sciences Lund, Orthopaedics, Lund University, Lund, Sweden.ORCID 0000-0002-5424-9448
Changhai DingMenzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.
David J HunterDepartment of Rheumatology, Royal North Shore Hospital, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia david.hunter@sydney.edu.au.ORCID 0000-0003-3197-752X
The University of Sydney · AUUniversity of Tasmania · AUParacelsus Medical University · ATArthritis Australia · AULund University · SEMonash University · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionKnee osteoarthritis (KOA) is a highly prevalent disabling joint disease. Intra-articular stem cell therapy is increasingly being used for treating KOA with little high-quality evidence to support its use. The aim of this study is to investigate the efficacy, safety and cost-effectiveness of allogeneic mesenchymal stem cells (Cymerus MSCs) for treating symptomatic tibiofemoral KOA and improving knee structure over 24 months. METHODS AND ANALYSIS: The Stem Cell injections for symptomatic relief and strUctural improvement in people with Tibiofemoral knee OsteoaRthritis study is a phase III, multi-centre, parallel, superiority, randomised, double-blind, placebo-controlled trial, which will be conducted in Sydney and Hobart, Australia. 440 participants (220 per arm) aged over 40 years with painful KOA and mild to moderate structural change on X-ray (Kellgren and Lawrence grade 2 or 3) with medial minimum joint space width between 1 and 4 mm in the study knee will be recruited from the community and randomly allocated to receive either intra-articular MSCs or saline at baseline, week 3 and week 52. The coprimary outcomes will be the proportion of participants achieving patient-acceptable symptom state for knee pain at 24 months and quantitative central medial femorotibial compartment cartilage thickness change from baseline to 24 months. Main secondary outcomes include change in knee pain, Patient Global Assessment, physical function, quality of life and other structural changes. Additional data for cost-effectiveness analysis will also be recorded. Adverse events will be monitored throughout the study. The primary analysis will be conducted using modified intention-to-treat. ETHICS AND DISSEMINATION: This protocol has been approved by The University of Sydney (USYD) Human Research Ethics Committee (HREC) #: 2020/119 and The University of Tasmania (UTAS) HREC #: H0021868. All participants will be required to provide informed consent. Dissemination will occur through conferences, social media, and scientific publications. TRIAL REGISTRATION NUMBERS: Australian New Zealand Clinical Trials Registry (ACTRN12620000870954); U1111-1234-4897.

Indexed as

Osteoarthritis, KneeAgedAustraliaCost-Benefit AnalysisDouble-Blind MethodEquivalence Trials as TopicHumansMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as TopicStem CellsTreatment Outcomeclinical trialskneerheumatology

Identifiers

PMID34845081
PMCPMC8633994
OpenAlexW3217176039

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.