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J Knee Surg 2015; 28(01): 051-054
DOI: 10.1055/s-0034-1396016
Special Focus Section
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

European Definitions, Current Use, and EMA Stance of Platelet-Rich Plasma in Sports Medicine

Stefano Fiorentino
1   Fiorentino Law Firm, Verona, Italy
,
Alice Roffi
2   Nano-Biotechnology Laboratory, Rizzoli Orthopaedic Institute, Bologna, Italy
,
Giuseppe Filardo
3   II Clinic–Biomechanics Laboratory and Nano-Biotechnology Laboratory, Rizzoli Orthopaedic Institute, Bologna, Italy
,
Maurilio Marcacci
3   II Clinic–Biomechanics Laboratory and Nano-Biotechnology Laboratory, Rizzoli Orthopaedic Institute, Bologna, Italy
,
Elizaveta Kon
3   II Clinic–Biomechanics Laboratory and Nano-Biotechnology Laboratory, Rizzoli Orthopaedic Institute, Bologna, Italy
› Author Affiliations
Further Information

Publication History

09 June 2014

11 October 2014

Publication Date:
24 November 2014 (online)

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Abstract

Platelet-rich plasma has been the focus of much attention over the last few years as an appealing biological approach to favor the healing of tissues otherwise doomed by a low healing potential. In Europe, the regulatory framework concerning the blood system is currently disciplined by Directive 2002/98/EC of the European Parliament and Council of January 27, 2003, which sets out quality and safety rules for collecting, controlling, processing, preserving, and distributing human blood and its components, acknowledged in the various States of the Union with internal regulations. This lack of homogeneity in the European legal landscape will probably lead the Community legislature to intervene in the near future, to even out the “rules of engagement” of this peculiar class of biomaterials.

Keywords

PRP - European regulation - European definitions - sports medicine