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)
(2021) In BMJ Open 11(11).- Abstract
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,... (More)
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.
(Less)
- author
- Liu, Xiaoqian
; Robbins, Sarah
; Wang, Xia
; Virk, Sonika
; Schuck, Karen
; Deveza, Leticia A.
; Oo, Win Min
; Carmichael, Kirsty
; Antony, Benny
; Eckstein, Felix
; Wirth, Wolfgang
; Little, Christopher
; Linklater, James
; Harris, Anthony
; Humphries, David
; O'Connell, R.
; Heller, Gillian
; Buttel, Thomas
; Lohmander, Stefan
LU
; Ding, Changhai
and Hunter, David J.
(Less) - organization
- publishing date
- 2021-11-29
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- clinical trials, knee, rheumatology
- in
- BMJ Open
- volume
- 11
- issue
- 11
- article number
- e056382
- publisher
- BMJ Publishing Group
- external identifiers
-
- pmid:34845081
- scopus:85121036977
- ISSN
- 2044-6055
- DOI
- 10.1136/bmjopen-2021-056382
- language
- English
- LU publication?
- yes
- additional info
- Publisher Copyright: © 2021 Author(s) (or their employer(s)). Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
- id
- 80f38cd2-4630-4d50-85d7-dfb6808ad61c
- date added to LUP
- 2022-01-31 12:02:55
- date last changed
- 2024-04-20 19:45:14
@article{80f38cd2-4630-4d50-85d7-dfb6808ad61c,
abstract = {{<p>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.</p>}},
author = {{Liu, Xiaoqian and Robbins, Sarah and Wang, Xia and Virk, Sonika and Schuck, Karen and Deveza, Leticia A. and Oo, Win Min and Carmichael, Kirsty and Antony, Benny and Eckstein, Felix and Wirth, Wolfgang and Little, Christopher and Linklater, James and Harris, Anthony and Humphries, David and O'Connell, R. and Heller, Gillian and Buttel, Thomas and Lohmander, Stefan and Ding, Changhai and Hunter, David J.}},
issn = {{2044-6055}},
keywords = {{clinical trials; knee; rheumatology}},
language = {{eng}},
month = {{11}},
number = {{11}},
publisher = {{BMJ Publishing Group}},
series = {{BMJ Open}},
title = {{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)}},
url = {{http://dx.doi.org/10.1136/bmjopen-2021-056382}},
doi = {{10.1136/bmjopen-2021-056382}},
volume = {{11}},
year = {{2021}},
}