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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

Efficacy and safety of autologous cell therapies for knee cartilage defects (autologous stem cells, chondrocytes or the two): randomized controlled trial design. Thumbnail


Authors

James B Richardson

Johanna Wales

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 Mar 29, 2024
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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