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Review
. 2020 Aug;13(4):525-529.
doi: 10.1007/s12178-020-09647-7.

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

Nicolas S Piuzzi  1 , Ahmed Emara  2 , Jorge Chahla  3 , Bert R Mandelbaum  4
Affiliations
Review

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

Nicolas S Piuzzi et al. Curr Rev Musculoskelet Med. 2020 Aug.

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. 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.

Keywords: Clinical applications; Direct-to-consumer marketing; Efficacy; Ethics; Legislation; Litigation; Stem cells.

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Conflict of interest statement

Nicolas S. Piuzzi has the following declarations: ISCT: board or committee member; Journal of Hip Surgery: editorial or governing board; Journal of Knee Surgery: editorial or governing board; Orthopaedic Research Society: board or committee member; RegenLab: research support; Zimmer: research support. Ahmed K. Emara has no conflict of interest. Jorge Chahla has the following declarations: Arthrex, Inc.: unpaid consultant; CONMED Linvatec: unpaid consultant; Smith & Nephew: unpaid consultant. Bert R. Mandelbaum has the following declarations: AJSM, cartilage: editorial or governing board; Arthrex, Inc.: IP royalties; paid consultant; Chairman CONCACAF Medical Committee: board or committee member; DePuy, A Johnson & Johnson Company: paid consultant; Exactech, Inc.: PAID consultant; Kerlan Jobe Institute: board or committee member.

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