Richardson, JB, Wright, KT, Wales, J, Kuiper, JH, McCarthy, HS, Gallacher, P, Harrison, PE and 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). pp. 493-501.

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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.

Item Type: Article
Uncontrolled Keywords: biomarkers, cartilage repair, cell-based therapy, cell potency, chondrocytes, clinical trial protocol, functional outcome measures, MSC, reverse translational research
Subjects: R Medicine > R Medicine (General)
Divisions: Faculty of Medicine and Health Sciences > Institute for Science and Technology in Medicine
Related URLs:
Depositing User: Symplectic
Date Deposited: 03 Jul 2017 11:07
Last Modified: 21 Sep 2017 13:34

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