Development of extracellular vesicle-based medicinal products: A position paper of the group “Extracellular Vesicle translatiOn to clinicaL perspectiVEs – EVOLVE France” - IMoPA - Ingénierie Moléculaire et Physiopathologie Articulaire Accéder directement au contenu
Article Dans Une Revue Advanced Drug Delivery Reviews Année : 2021

Development of extracellular vesicle-based medicinal products: A position paper of the group “Extracellular Vesicle translatiOn to clinicaL perspectiVEs – EVOLVE France”

1 MSC - Matière et Systèmes Complexes
2 ICGM - Institut Charles Gerhardt Montpellier - Institut de Chimie Moléculaire et des Matériaux de Montpellier
3 Interactions cellules souches-niches : physiologie, tumeurs et réparation tissulaire
4 HIPI (UMR_S_976 / U976) - Immunologie humaine, physiopathologie & immunothérapie
5 IMoPA - Ingénierie Moléculaire et Physiopathologie Articulaire
6 PARCC (UMR_S 970/ U970) - Paris-Centre de Recherche Cardiovasculaire
7 Cellules Souches, Plasticité Cellulaire, Médecine Régénératrice et Immunothérapies (IRMB)
8 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]
9 Irset - Institut de recherche en santé, environnement et travail
10 FEMTO-ST - Franche-Comté Électronique Mécanique, Thermique et Optique - Sciences et Technologies (UMR 6174)
11 PCC - Laboratoire Physico-Chimie Curie [Institut Curie]
12 HEGP - Hôpital Européen Georges Pompidou [APHP]
13 STROMALab
14 GGB - Génétique, génomique fonctionnelle et biotechnologies (UMR 1078)
15 IECM - Immuno-Endocrinologie Cellulaire et Moléculaire
16 CSPBAT - Chimie, Structures et Propriétés de Biomatériaux et d'Agents Thérapeutiques
17 U1064 Inserm - CRTI - Centre de Recherche en Transplantation et Immunologie
18 IRSN/PSE-SANTE/SERAMED/LRMed - Laboratoire de Radiobiologie des expositions médicales
19 CRI (UMR_S_1149 / ERL_8252 / U1149) - Centre de recherche sur l'Inflammation
20 UPCité - Université Paris Cité
21 I3 - Immunologie - Immunopathologie - Immunothérapie [CHU Pitié Salpêtrière]
Kelly Aubertin
Olivier Favre-Bulle
  • Fonction : Auteur
Florence Gazeau

Résumé

Extracellular vesicles (EV) are emergent therapeutic effectors that have reached clinical trial investigation. To translate EV-based therapeutic to clinic, the challenge is to demonstrate quality, safety, and efficacy, as required for any medicinal product. EV research translation into medicinal products is an exciting and challenging perspective. Recent papers, provide important guidance on regulatory aspects of pharmaceutical development, defining EVs for therapeutic applications and critical considerations for the development of potency tests. In addition, the ISEV Task Force on Regulatory Affairs and Clinical Use of EV-based Therapeutics as well as the Exosomes Committee from the ISCT are expected to contribute in an active way to the development of EV-based medicinal products by providing update on the scientific progress in EVs field, information to patients and expert resource network for regulatory bodies. The contribution of our work group "Extracellular Vesicle translatiOn to clinicaL perspectiVEs - EVOLVE France", created in 2020, can be positioned in complement to all these important initiatives. Based on complementary scientific, technical, and medical expertise, we provide EV-specific recommendations for manufacturing, quality control, analytics, non-clinical development, and clinical trials, according to current European legislation. We especially focus on early phase clinical trials concerning immediate needs in the field. The main contents of the investigational medicinal product dossier, marketing authorization applications, and critical guideline information are outlined for the transition from research to clinical development and ultimate market authorization.
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Dates et versions

hal-03412034 , version 1 (14-12-2021)

Licence

Paternité - Pas d'utilisation commerciale

Identifiants

Citer

Amanda K.A. Silva, Marie Morille, Max Piffoux, Surendar Arumugam, Phlippe Mauduit, et al.. Development of extracellular vesicle-based medicinal products: A position paper of the group “Extracellular Vesicle translatiOn to clinicaL perspectiVEs – EVOLVE France”. Advanced Drug Delivery Reviews, 2021, 179, pp.114001. ⟨10.1016/j.addr.2021.114001⟩. ⟨hal-03412034⟩
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