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Literature DB >> 26319248

Closing regulatory gaps: new ground rules for platelet-rich plasma.

Eduardo Anitua¹, Roberto Prado², Gorka Orive³.

Abstract

The Spanish Agency of Medicines and Medical Devices (AEMPS) has drawn up a comprehensive report and resolution that regulates for the first time the use of platelet-rich plasma (PRP) as a human-use medicinal product. This regulatory framework offers emerging challenges to adapt the use of PRP to the new requirements of safety and efficacy. The heterogeneity of the different products can hinder their regulation, which today differs substantially in the different worldwide regulatory frameworks.

Entities: Species

Keywords: medicinal product; platelet-rich plasma; regulatory framework

Mesh：

Year: 2015 PMID： 26319248 DOI： 10.1016/j.tibtech.2015.07.002

Source DB: PubMed Journal: Trends Biotechnol ISSN： 0167-7799 Impact factor: 19.536

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Cited

11 in total

1. Treatment of patients with neurotrophic keratitis stages 2 and 3 with plasma rich in growth factors (PRGF-Endoret) eye-drops.

Authors: Ronald Mauricio Sanchez-Avila; Jesus Merayo-Lloves; Ana Cristina Riestra; Luis Fernandez-Vega Cueto; Eduardo Anitua; Leire Begoña; Francisco Muruzabal; Gorka Orive
Journal: Int Ophthalmol Date: 2017-06-15 Impact factor: 2.031

2. Optimized platelet rich plasma releasate (O-rPRP) repairs galactosemia-induced ovarian follicular loss in rats by activating mTOR signaling and inhibiting apoptosis.

Authors: Wesam El Bakly; Marwa Medhat; Mohamed Shafei; Reham Tash; Mohamed Elrefai; Yousef Shoukry; Nesreen Nabil Omar
Journal: Heliyon Date: 2020-09-21

3. [Standardized management of platelet derivatives for tissue regeneration research and applications].

Authors: Xingqin Xie; Yi Zhang; Xinxin Zhao; Tongxin Liu; Liping Sun
Journal: Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi Date: 2021-03-15

4. An optimised protocol for platelet-rich plasma preparation to improve its angiogenic and regenerative properties.

Authors: Julia Etulain; Hebe A Mena; Roberto P Meiss; Gustavo Frechtel; Susana Gutt; Soledad Negrotto; Mirta Schattner
Journal: Sci Rep Date: 2018-01-24 Impact factor: 4.379

Review 5. Comprehensive Quality Control of the Regenerative Therapy Using Platelet Concentrates: The Current Situation and Prospects in Japan.

Authors: Tomoyuki Kawase; Kazuhiro Okuda
Journal: Biomed Res Int Date: 2018-05-21 Impact factor: 3.411

6. Clinical Response After Treatment of Knee Osteoarthritis With a Standardized, Closed-System, Low-Cost Platelet-Rich Plasma Product: 1-Year Outcomes.

Authors: Judit Fernández-Fuertes; Tamara Arias-Fernández; Andrea Acebes-Huerta; Marlene Álvarez-Rico; Laura Gutiérrez
Journal: Orthop J Sports Med Date: 2022-03-31

7. Plasma rich in growth factors eye drops to treat secondary ocular surface disorders in patients with glaucoma.

Authors: Ronald M Sánchez-Avila; Jesus Merayo-Lloves; Maria Laura Fernández; Luis Alberto Rodríguez-Gutiérrez; Pedro Pablo Rodríguez-Calvo; Andres Fernández-Vega Cueto; Francisco Muruzabal; Gorka Orive; Eduardo Anitua
Journal: Int Med Case Rep J Date: 2018-05-01