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Erschienen in: Current Reviews in Musculoskeletal Medicine 4/2020

28.05.2020 | Stem Cells in Orthopaedic Surgery (J Dragoo and KJ Jones, Section Editors)

Ethical and Practical Considerations for Integrating Cellular (“Stem Cell”) Therapy into Clinical Practice

verfasst von: Nicolas S. Piuzzi, Ahmed Emara, Jorge Chahla, Bert R. Mandelbaum

Erschienen in: Current Reviews in Musculoskeletal Medicine | Ausgabe 4/2020

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Abstract

Purpose of Review

Cellular therapies, also known as “stem cell” interventions (SCI), have undergone a rapid popularization in the USA and worldwide. The current review aimed at outlining (1) the ethical challenges facing the implementation of SCI; (2) the applicability of the currently available SCI; and (3) recommendations to achieve ethical, well-regulated incorporation of SCI in the clinical setting.

Recent Findings

Concerns regarding the inadequate characterization, poor adverse effects disclosure, and unorthodox, often inappropriate, market practices have engendered a genuine concern regarding the SCI compliance with ethical standards. Six instances of litigation on the basis of misrepresentation or inappropriate informed consent were recorded between 2012 and 2018. Such concerns have been furthered by the loopholes in the regulatory aspect governing the use of SCI coupled with the unclear literature-reported efficacy and diverse spectrum of profess indications. Similarly, the application of SCI in the clinical field is yet to prove its value. The uncertain efficacy, coupled with obscure true-costs of utilization, impedes a value-based assessment.

Summary

A multidisciplinary approach involving legislative and medical professional societies should continue to advance regulations that govern SCI. A well-regulated system that allows for the ethical integration of SCI with appositely evidenced-based described benefits and risks should be sought.
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Metadaten
Titel
Ethical and Practical Considerations for Integrating Cellular (“Stem Cell”) Therapy into Clinical Practice
verfasst von
Nicolas S. Piuzzi
Ahmed Emara
Jorge Chahla
Bert R. Mandelbaum
Publikationsdatum
28.05.2020
Verlag
Springer US
Erschienen in
Current Reviews in Musculoskeletal Medicine / Ausgabe 4/2020
Elektronische ISSN: 1935-9748
DOI
https://doi.org/10.1007/s12178-020-09647-7

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