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Development of Autologous Platelet-Rich Plasma Mixed-Microfat as an Advanced Therapy Medicinal Product for Intra-Articular Injection of Radio-Carpal Osteoarthritis: From Validation Data to Preliminary Clinical Results

Wrist osteoarthritis (OA) is one of the most common conditions encountered by hand surgeons with limited efficacy of non-surgical treatments. The purpose of this study is to describe the Platelet-Rich Plasma (PRP) mixed-microfat biological characteristics of an experimental Advanced Therapy Medicina...

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Autores principales: Mayoly, Alice, Iniesta, Aurélie, Curvale, Caroline, Kachouh, Najib, Jaloux, Charlotte, Eraud, Julia, Vogtensperger, Marie, Veran, Julie, Grimaud, Fanny, Jouve, Elisabeth, Casanova, Dominique, Sabatier, Florence, Legré, Régis, Magalon, Jérémy
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6429478/
https://www.ncbi.nlm.nih.gov/pubmed/30841510
http://dx.doi.org/10.3390/ijms20051111
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author Mayoly, Alice
Iniesta, Aurélie
Curvale, Caroline
Kachouh, Najib
Jaloux, Charlotte
Eraud, Julia
Vogtensperger, Marie
Veran, Julie
Grimaud, Fanny
Jouve, Elisabeth
Casanova, Dominique
Sabatier, Florence
Legré, Régis
Magalon, Jérémy
author_facet Mayoly, Alice
Iniesta, Aurélie
Curvale, Caroline
Kachouh, Najib
Jaloux, Charlotte
Eraud, Julia
Vogtensperger, Marie
Veran, Julie
Grimaud, Fanny
Jouve, Elisabeth
Casanova, Dominique
Sabatier, Florence
Legré, Régis
Magalon, Jérémy
author_sort Mayoly, Alice
collection PubMed
description Wrist osteoarthritis (OA) is one of the most common conditions encountered by hand surgeons with limited efficacy of non-surgical treatments. The purpose of this study is to describe the Platelet-Rich Plasma (PRP) mixed-microfat biological characteristics of an experimental Advanced Therapy Medicinal Product (ATMP) needed for clinical trial authorization and describe the clinical results obtained from our first three patients 12 months after treatment (NCT03164122). Biological characterization of microfat, PRP and mixture were analysed in vitro according to validated methods. Patients with stage four OA according to the Kellgren Lawrence classification, with failure to conservative treatment and a persistent daily painful condition >40 mm according to the visual analog scale (VAS) were treated. Microfat-PRP ATMP is a product with high platelet purity, conserved viability of stromal vascular fraction cells, chondrogenic differentiation capacity in vitro and high secretion of IL-1Ra anti-inflammatory cytokine. For patients, the only side effect was pain at the adipose tissue harvesting sites. Potential efficacy was observed with a pain decrease of over 50% (per VAS score) and the achievement of minimal clinically important differences for DASH and PRWE functional scores at one year in all three patients. Microfat-PRP ATMP presented a good safety profile after an injection in wrist OA. Efficacy trials are necessary to assess whether this innovative strategy could delay the necessity to perform non-conservative surgery.
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spelling pubmed-64294782019-04-10 Development of Autologous Platelet-Rich Plasma Mixed-Microfat as an Advanced Therapy Medicinal Product for Intra-Articular Injection of Radio-Carpal Osteoarthritis: From Validation Data to Preliminary Clinical Results Mayoly, Alice Iniesta, Aurélie Curvale, Caroline Kachouh, Najib Jaloux, Charlotte Eraud, Julia Vogtensperger, Marie Veran, Julie Grimaud, Fanny Jouve, Elisabeth Casanova, Dominique Sabatier, Florence Legré, Régis Magalon, Jérémy Int J Mol Sci Article Wrist osteoarthritis (OA) is one of the most common conditions encountered by hand surgeons with limited efficacy of non-surgical treatments. The purpose of this study is to describe the Platelet-Rich Plasma (PRP) mixed-microfat biological characteristics of an experimental Advanced Therapy Medicinal Product (ATMP) needed for clinical trial authorization and describe the clinical results obtained from our first three patients 12 months after treatment (NCT03164122). Biological characterization of microfat, PRP and mixture were analysed in vitro according to validated methods. Patients with stage four OA according to the Kellgren Lawrence classification, with failure to conservative treatment and a persistent daily painful condition >40 mm according to the visual analog scale (VAS) were treated. Microfat-PRP ATMP is a product with high platelet purity, conserved viability of stromal vascular fraction cells, chondrogenic differentiation capacity in vitro and high secretion of IL-1Ra anti-inflammatory cytokine. For patients, the only side effect was pain at the adipose tissue harvesting sites. Potential efficacy was observed with a pain decrease of over 50% (per VAS score) and the achievement of minimal clinically important differences for DASH and PRWE functional scores at one year in all three patients. Microfat-PRP ATMP presented a good safety profile after an injection in wrist OA. Efficacy trials are necessary to assess whether this innovative strategy could delay the necessity to perform non-conservative surgery. MDPI 2019-03-05 /pmc/articles/PMC6429478/ /pubmed/30841510 http://dx.doi.org/10.3390/ijms20051111 Text en © 2019 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Mayoly, Alice
Iniesta, Aurélie
Curvale, Caroline
Kachouh, Najib
Jaloux, Charlotte
Eraud, Julia
Vogtensperger, Marie
Veran, Julie
Grimaud, Fanny
Jouve, Elisabeth
Casanova, Dominique
Sabatier, Florence
Legré, Régis
Magalon, Jérémy
Development of Autologous Platelet-Rich Plasma Mixed-Microfat as an Advanced Therapy Medicinal Product for Intra-Articular Injection of Radio-Carpal Osteoarthritis: From Validation Data to Preliminary Clinical Results
title Development of Autologous Platelet-Rich Plasma Mixed-Microfat as an Advanced Therapy Medicinal Product for Intra-Articular Injection of Radio-Carpal Osteoarthritis: From Validation Data to Preliminary Clinical Results
title_full Development of Autologous Platelet-Rich Plasma Mixed-Microfat as an Advanced Therapy Medicinal Product for Intra-Articular Injection of Radio-Carpal Osteoarthritis: From Validation Data to Preliminary Clinical Results
title_fullStr Development of Autologous Platelet-Rich Plasma Mixed-Microfat as an Advanced Therapy Medicinal Product for Intra-Articular Injection of Radio-Carpal Osteoarthritis: From Validation Data to Preliminary Clinical Results
title_full_unstemmed Development of Autologous Platelet-Rich Plasma Mixed-Microfat as an Advanced Therapy Medicinal Product for Intra-Articular Injection of Radio-Carpal Osteoarthritis: From Validation Data to Preliminary Clinical Results
title_short Development of Autologous Platelet-Rich Plasma Mixed-Microfat as an Advanced Therapy Medicinal Product for Intra-Articular Injection of Radio-Carpal Osteoarthritis: From Validation Data to Preliminary Clinical Results
title_sort development of autologous platelet-rich plasma mixed-microfat as an advanced therapy medicinal product for intra-articular injection of radio-carpal osteoarthritis: from validation data to preliminary clinical results
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6429478/
https://www.ncbi.nlm.nih.gov/pubmed/30841510
http://dx.doi.org/10.3390/ijms20051111
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