Richardson, JB and Wright, KT and Wales, J and Kuiper, JH and McCarthy, HS and Gallacher, P and 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. ISSN 1746-076X

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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.

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: ?? MSCs ??
R Medicine > R Medicine (General)
?? biomarkers ??
?? cartilage repair ??
?? cell potency ??
?? cell-based therapy ??
?? chondrocytes ??
?? clinical trial protocol ??
?? functional outcome measures ??
?? reverse translational research ??
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: 03 Jul 2017 11:07
URI: http://eprints.keele.ac.uk/id/eprint/3702

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