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Journal of Regenerative Medicine ISSN: 2325-9620

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Letter to Editor, J Regen Med Vol: 3 Issue: 1

Platelet-Rich Plasma Therapies:In the Right Pathway to Find their Regulatory Niche

Eduardo Anitua, Roberto Prado and Gorka Orive*
Eduardo Anitua Foundation, Spain
Corresponding author : Dr. Gorka Orive
Eduardo Anitua Foundation, Vitoria, Spain, Jacinto Quincoces, 39, 01007 Vitoria (Álava). Spain
Tel: +34 945 160 653,
E-mail: [email protected]
Received: July 10, 2013 Accepted: August 01, 2014 Published: August 06, 2014
Citation: Orive G (2014) Platelet-Rich Plasma Therapies: In the Right Pathway to Find their Regulatory Niche. J Regen Med 3:1 doi:10.4172/2325-9620.1000112

Abstract

Platelet-Rich Plasma Therapies:In the Right Pathway to Find their Regulatory Niche

The Spanish Agency of Medicines and Medical Devices (AEMPS) has recently regulated the use of platelet-rich plasma (PRP), that is,patient’s own plasma enriched in platelets and therefore in proteins and growth factors, as a human use drug. It is the first time that one regulatory agency worldwide categorizes these types of therapeutic therapies. According to AEMPS, PRP approaches cannot be considered as an advanced-therapy medicinal product. PRPs are classified as non-industrial biological medicines, being subjected to a strict regulation in terms of production, validation, efficacy and safety.

Keywords:

The Spanish Agency of Medicines and Medical Devices (AEMPS) has recently regulated the use of platelet-rich plasma (PRP), that is, patient’s own plasma enriched in platelets and therefore in proteins and growth factors, as a human use drug [1]. It is the first time that one regulatory agency worldwide categorizes these types of therapeutic therapies. According to AEMPS, PRP approaches cannot be considered as an advanced-therapy medicinal product. PRPs are classified as non-industrial biological medicines, being subjected to a strict regulation in terms of production, validation, efficacy and safety. The latter will open new avenues for a multimillion-dollar field that is expanding through the States and Europe.
Although it is a groundbreaking new and relevant advance for the biologics, there are several concerns and challenges that we would like to address. For example, it would be desirable that other regulatory bodies would regulate the use of PRP, because depending on the country, this type of advanced regulation is unclear or absent. Another important issue is the regulatory framework that must govern the use of PRP in the ex vivo procedures in stem cell therapy [2], such as supplements for stem cell culture medium. A recently randomized controlled trial published in The Lancet [3] used as a supplement in the culture medium in the expansion of adipose-derived stem cells a type of PRP as a substitute for fetal calf serum. It is feasible to remove all xenogeneic substances using PRP in such procedures. The PRP is a substitute for fetal bovine serum (FBS) thereby removing all concerns of use in humans because of its animal origin [4]. Furthermore, a more strict definition and rules of the requirements related to efficacy and safety based on clinical trials would be desirable.

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