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

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.

Citation

Richardson, J. B., Wright, K. T., Wales, J., Herman Kuiper, J., McCarthy, H. S., Gallacher, P., …Roberts, S. (2017). Efficacy and safety of autologous cell therapies for knee cartilage defects (autologous stem cells, chondrocytes or the two): randomized controlled trial design. Regenerative Medicine, 12(5), 493-501. https://doi.org/10.2217/rme-2017-0032

• 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