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Orthobiologics: Regulation in Different Parts of the World

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Bio-orthopaedics

Abstract

A biologic product is broadly defined by the 1902 Biologics Control Act as “any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment, or cure of disease or injuries of man” [1]. The term “orthobiologics” refers to a biologic product used in the orthopedic setting to augment biological healing or alter the natural course of an orthopedic disease. A number of products fall under this umbrella including hyaluronic acid, growth factors, cytokines, platelet-rich plasma (PRP), allografts, stem cell therapy, and a variety of other cellular- and tissue-based products [2–4]. A full review of all of these products is beyond the scope of this chapter. However, we will discuss stem cell therapy and its related issues so that we can more clearly understand the regulatory environment.

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Authors and Affiliations

  1. Kerlan-Jobe Orthopaedic Clinic, Los Angeles, CA, 90045, USA

    Jason A. Grieshober M.D. & Ralph A. Gambardella M.D.

  2. Vericel Corporation, Cambridge, MA, 02139, USA

    Eyitayo Fakunle Ph.D.

Authors
  1. Jason A. Grieshober M.D.
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  2. Eyitayo Fakunle Ph.D.
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  3. Ralph A. Gambardella M.D.
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Corresponding author

Correspondence to Ralph A. Gambardella M.D. .

Editor information

Editors and Affiliations

  1. O.A.S.I. Bioresearch Foundation NPO, Milan, Italy

    Alberto Gobbi

  2. Clínica do Dragão, Espregueira-Mendes Sports Centre – FIFA Medical Centre of Excellence, Porto, Portugal

    João Espregueira-Mendes

  3. Musculoskeletal and Joint Research Foundation, San Diego, California, USA

    John G. Lane

  4. Department of Orthopedics, Acibadem University, Istanbul, Turkey

    Mustafa Karahan

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Grieshober, J.A., Fakunle, E., Gambardella, R.A. (2017). Orthobiologics: Regulation in Different Parts of the World. In: Gobbi, A., Espregueira-Mendes, J., Lane, J., Karahan, M. (eds) Bio-orthopaedics. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-54181-4_4

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  • DOI: https://doi.org/10.1007/978-3-662-54181-4_4

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