Design and clinical application of injectable hydrogels for musculoskeletal therapy
Author(s)
Type
Journal Article
Abstract
Musculoskeletal defects are an enormous healthcare burden and source of pain and disability for individuals. With an ageing population, the proportion 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 US. 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 towards 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 (PMCF) 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.
Date Issued
2022-05
Date Acceptance
2022-01-18
Citation
Bioengineering and Translational Medicine, 2022, 7 (2), pp.1-21
ISSN
2380-6761
Publisher
Wiley Open Access
Start Page
1
End Page
21
Journal / Book Title
Bioengineering and Translational Medicine
Volume
7
Issue
2
Copyright Statement
© 2022 The Authors. Bioengineering & Translational Medicine published by Wiley Periodicals LLC on behalf of American Institute of Chemical Engineers.
This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
License URL
Sponsor
Engineering & Physical Science Research Council (EPSRC)
Engineering & Physical Science Research Council (EPSRC)
Engineering & Physical Science Research Council (EPSRC)
Medical Research Council (MRC)
National Institute for Health Research
Identifier
https://aiche.onlinelibrary.wiley.com/doi/epdf/10.1002/btm2.10295
Grant Number
EP/K027549/1
EP/N025059/1
EP/R042721/1
MR/R015651/1
NIHR300013
Subjects
Science & Technology
Life Sciences & Biomedicine
Technology
Biotechnology & Applied Microbiology
Engineering, Biomedical
Pharmacology & Pharmacy
Engineering
bone regeneration
cartilage regeneration
clinical translation
hydrogels
medical devices
regenerative medicine
viscosupplementation
DEMINERALIZED BONE-MATRIX
HYALURONIC-ACID
EXTRACELLULAR-MATRIX
KNEE OSTEOARTHRITIS
HIP FRACTURE
CHONDROCYTE TRANSPLANTATION
HISTOLOGIC EVALUATION
LUBRICATING HYDROGEL
INTERVERTEBRAL DISC
EXCESS MORTALITY
bone regeneration
cartilage regeneration
clinical translation
hydrogels
medical devices
regenerative medicine
viscosupplementation
Publication Status
Published
Article Number
ARTN e10295
Date Publish Online
2022-01-29