Design and clinical application of injectable hydrogels for musculoskeletal therapy
Abstract Musculoskeletal defects are an enormous healthcare burden and source of pain and disability for individuals. With an aging population, the proportion of individuals living with these medical indications will increase. Simultaneously, there is pressure on healthcare providers to source effic...
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Format: | Article |
Language: | English |
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Wiley
2022-05-01
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Series: | Bioengineering & Translational Medicine |
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Online Access: | https://doi.org/10.1002/btm2.10295 |
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author | Øystein Øvrebø Giuseppe Perale Jonathan P. Wojciechowski Cécile Echalier Jonathan R. T. Jeffers Molly M. Stevens Håvard J. Haugen Filippo Rossi |
author_facet | Øystein Øvrebø Giuseppe Perale Jonathan P. Wojciechowski Cécile Echalier Jonathan R. T. Jeffers Molly M. Stevens Håvard J. Haugen Filippo Rossi |
author_sort | Øystein Øvrebø |
collection | DOAJ |
description | Abstract Musculoskeletal defects are an enormous healthcare burden and source of pain and disability for individuals. With an aging population, the proportion of individuals living with these medical indications will increase. Simultaneously, there is pressure on healthcare providers to source efficient solutions, which are cheaper and less invasive than conventional technology. This has led to an increased research focus on hydrogels as highly biocompatible biomaterials that can be delivered through minimally invasive procedures. This review will discuss how hydrogels can be designed for clinical translation, particularly in the context of the new European Medical Device Regulation (MDR). We will then do a deep dive into the clinically used hydrogel solutions that have been commercially approved or have undergone clinical trials in Europe or the United States. We will discuss the therapeutic mechanism and limitations of these products. Due to the vast application areas of hydrogels, this work focuses only on treatments of cartilage, bone, and the nucleus pulposus. Lastly, the main steps toward clinical translation of hydrogels as medical devices are outlined. We suggest a framework for how academics can assist small and medium MedTech enterprises conducting the initial clinical investigation and post‐market clinical follow‐up required in the MDR. It is evident that the successful translation of hydrogels is governed by acquiring high‐quality pre‐clinical and clinical data confirming the device mechanism of action and safety. |
first_indexed | 2024-12-12T05:24:03Z |
format | Article |
id | doaj.art-33983d573e9e499893d9fb21324b1ee6 |
institution | Directory Open Access Journal |
issn | 2380-6761 |
language | English |
last_indexed | 2024-12-12T05:24:03Z |
publishDate | 2022-05-01 |
publisher | Wiley |
record_format | Article |
series | Bioengineering & Translational Medicine |
spelling | doaj.art-33983d573e9e499893d9fb21324b1ee62022-12-22T00:36:32ZengWileyBioengineering & Translational Medicine2380-67612022-05-0172n/an/a10.1002/btm2.10295Design and clinical application of injectable hydrogels for musculoskeletal therapyØystein Øvrebø0Giuseppe Perale1Jonathan P. Wojciechowski2Cécile Echalier3Jonathan R. T. Jeffers4Molly M. Stevens5Håvard J. Haugen6Filippo Rossi7Department of Chemistry, Materials and Chemical Engineering “Giulio Natta” Politecnico di Milano Milano ItalyIndustrie Biomediche Insubri SA Mezzovico‐Vira SwitzerlandDepartment of Materials Imperial College London London UKDepartment of Materials Imperial College London London UKDepartment of Mechanical Engineering Imperial College London London UKDepartment of Materials Imperial College London London UKDepartment of Biomaterials Institute of Clinical Dentistry, University of Oslo Oslo NorwayDepartment of Chemistry, Materials and Chemical Engineering “Giulio Natta” Politecnico di Milano Milano ItalyAbstract Musculoskeletal defects are an enormous healthcare burden and source of pain and disability for individuals. With an aging population, the proportion of individuals living with these medical indications will increase. Simultaneously, there is pressure on healthcare providers to source efficient solutions, which are cheaper and less invasive than conventional technology. This has led to an increased research focus on hydrogels as highly biocompatible biomaterials that can be delivered through minimally invasive procedures. This review will discuss how hydrogels can be designed for clinical translation, particularly in the context of the new European Medical Device Regulation (MDR). We will then do a deep dive into the clinically used hydrogel solutions that have been commercially approved or have undergone clinical trials in Europe or the United States. We will discuss the therapeutic mechanism and limitations of these products. Due to the vast application areas of hydrogels, this work focuses only on treatments of cartilage, bone, and the nucleus pulposus. Lastly, the main steps toward clinical translation of hydrogels as medical devices are outlined. We suggest a framework for how academics can assist small and medium MedTech enterprises conducting the initial clinical investigation and post‐market clinical follow‐up required in the MDR. It is evident that the successful translation of hydrogels is governed by acquiring high‐quality pre‐clinical and clinical data confirming the device mechanism of action and safety.https://doi.org/10.1002/btm2.10295bone regenerationcartilage regenerationclinical translationhydrogelsmedical devicesregenerative medicine |
spellingShingle | Øystein Øvrebø Giuseppe Perale Jonathan P. Wojciechowski Cécile Echalier Jonathan R. T. Jeffers Molly M. Stevens Håvard J. Haugen Filippo Rossi Design and clinical application of injectable hydrogels for musculoskeletal therapy Bioengineering & Translational Medicine bone regeneration cartilage regeneration clinical translation hydrogels medical devices regenerative medicine |
title | Design and clinical application of injectable hydrogels for musculoskeletal therapy |
title_full | Design and clinical application of injectable hydrogels for musculoskeletal therapy |
title_fullStr | Design and clinical application of injectable hydrogels for musculoskeletal therapy |
title_full_unstemmed | Design and clinical application of injectable hydrogels for musculoskeletal therapy |
title_short | Design and clinical application of injectable hydrogels for musculoskeletal therapy |
title_sort | design and clinical application of injectable hydrogels for musculoskeletal therapy |
topic | bone regeneration cartilage regeneration clinical translation hydrogels medical devices regenerative medicine |
url | https://doi.org/10.1002/btm2.10295 |
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