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Cited by 21Biomedical Ethics and RegulationEthics in Clinical ResearchEthics and bioethics in healthcare

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

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Piuzzi, Nicolas S., Emara, Ahmed, Chahla, Jorge, Mandelbaum, Bert R.·2020·Current Reviews in Musculoskeletal Medicine
DOI 10.1007/s12178-020-09647-7PMC PMC7340700
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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. 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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Metadata

Authors
Piuzzi, N. S., Emara, A., Chahla, J., & Mandelbaum, B. R.
Affiliations
  • Cleveland Clinic (US)
  • Rush University Medical Center (US)
  • Cedars-Sinai Kerlan-Jobe Institute (US)
Corresponding author
Piuzzi, Nicolas S.
ORCID
Venue
Current Reviews in Musculoskeletal Medicine
Publisher
Springer Science and Business Media LLC
Published
2020-05-28
Volume
13
Issue
4
Pages
525-529
ISSN
  • 1935-973X (ISSN-L)
  • 1935-9748
DOI
10.1007/s12178-020-09647-7
PMC
PMC7340700
OpenAlex
W3028909859
Cited by
21
References
0
Citations by year
2026: 4 · 2025: 8 · 2024: 4 · 2021: 5
FWCI
0.16
Type
journal article
Language
en
Open access
Licence
Locations
  • Current Reviews in Musculoskeletal Medicine (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Nursing › Issues, ethics and legal aspects › Biomedical Ethics and Regulation
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
Keywords
cell therapy, stem cell therapy, informed consent, stem cell regulation, litigation, clinical implementation

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