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Efficacy and cost-e...
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)
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- Liu, Xiaoqian (författare)
- University of Sydney
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- Robbins, Sarah (författare)
- University of Sydney
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- Wang, Xia (författare)
- University of Sydney
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- Virk, Sonika (författare)
- University of Sydney
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- Schuck, Karen (författare)
- University of Sydney
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- Deveza, Leticia A. (författare)
- University of Sydney
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- Oo, Win Min (författare)
- University of Sydney
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- Carmichael, Kirsty (författare)
- University of Tasmania
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- Antony, Benny (författare)
- University of Tasmania
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- Eckstein, Felix (författare)
- Chondrometrics GmbH,Paracelsus Private Medical University of Salzburg
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- Wirth, Wolfgang (författare)
- Chondrometrics GmbH,Paracelsus Private Medical University of Salzburg
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- Little, Christopher (författare)
- University of Sydney
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- Linklater, James (författare)
- Castlereagh Imaging
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Harris, Anthony (författare)
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- Humphries, David (författare)
- University of Tasmania
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- O'Connell, R. (författare)
- University of Sydney
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- Heller, Gillian (författare)
- University of Sydney
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- Buttel, Thomas (författare)
- Monash University
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- Lohmander, Stefan (författare)
- Lund University,Lunds universitet,Lund OsteoArthritis Division - Nedbrytning av ledbrosk: en biologisk process som leder till artros,Forskargrupper vid Lunds universitet,Lund OsteoArthritis Division - Molecular marker research group,Lund University Research Groups
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- Ding, Changhai (författare)
- Southern Medical University,University of Tasmania
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- Hunter, David J. (författare)
- University of Sydney,Southern Medical University
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(creator_code:org_t)
- 2021-11-29
- 2021
- Engelska.
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Ingår i: BMJ Open. - : BMJ. - 2044-6055. ; 11:11
- Relaterad länk:
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http://dx.doi.org/10... (free)
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https://bmjopen.bmj....
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- Introduction Knee 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.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Reumatologi och inflammation (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Rheumatology and Autoimmunity (hsv//eng)
Nyckelord
- clinical trials
- knee
- rheumatology
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- art (ämneskategori)
- ref (ämneskategori)
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Liu, Xiaoqian
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Robbins, Sarah
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Wang, Xia
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Virk, Sonika
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Schuck, Karen
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Deveza, Leticia ...
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visa fler...
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Oo, Win Min
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Carmichael, Kirs ...
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Antony, Benny
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Eckstein, Felix
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Wirth, Wolfgang
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Little, Christop ...
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Linklater, James
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Harris, Anthony
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Humphries, David
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O'Connell, R.
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Heller, Gillian
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Buttel, Thomas
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Lohmander, Stefa ...
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Ding, Changhai
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Hunter, David J.
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