James B Richardson
Efficacy and safety of autologous cell therapies for knee cartilage defects (autologous stem cells, chondrocytes or the two): randomized controlled trial design.
Richardson, James B; Wright, Karina T; Wales, Johanna; Herman Kuiper, Jan; McCarthy, Helen S; Gallacher, Peter; Harrison, Paul E; Roberts, Sally
Authors
Karina Wright k.t.wright@keele.ac.uk
Johanna Wales
Jan Kuiper j.h.kuiper@keele.ac.uk
Helen McCarthy h.s.mccarthy@keele.ac.uk
Peter Gallacher
Paul E Harrison
Sally Roberts
Abstract
AIM: The main aim of this trial is to test the safety and efficacy of autologous stromal/stem cells, chondrocytes or the two combined in the treatment of knee cartilage defects. PATIENTS & METHODS: Patients with symptomatic chondral/osteochondral defects will be randomized to cell therapy treatment with one of three cell populations (1:1:1). The primary efficacy outcome is a functional knee score (Lysholm) at 15 months post-treatment and the primary safety outcome is the incidence of adverse events. Secondary objectives are to analyze repair tissues, quality of life and cost-utility assessments. Exploratory objectives are to identify predictors for success/potency and dose-response relationships. RESULTS & CONCLUSION: This trial has been carefully designed so that valuable scientific and clinical information can be gathered throughout and in the final analysis.
Journal Article Type | Article |
---|---|
Acceptance Date | May 19, 2017 |
Online Publication Date | Jun 21, 2017 |
Publication Date | Jul 1, 2017 |
Publicly Available Date | May 26, 2023 |
Journal | Regenerative Medicine |
Print ISSN | 1746-0751 |
Publisher | Future Medicine |
Peer Reviewed | Peer Reviewed |
Volume | 12 |
Issue | 5 |
Pages | 493-501 |
DOI | https://doi.org/10.2217/rme-2017-0032 |
Keywords | biomarkers, cartilage repair, cell-based therapy, cell potency, chondrocytes, clinical trial protocol, functional outcome measures, MSC, reverse translational research |
Publisher URL | http://www.futuremedicine.com/doi/10.2217/rme-2017-0032 |
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https://creativecommons.org/licenses/by/4.0/
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