Cargando…

Leaping the hurdles in developing regenerative treatments for the intervertebral disc from preclinical to clinical

Chronic back and neck pain is a prevalent disability, often caused by degeneration of the intervertebral disc. Because current treatments for this condition are less than satisfactory, a great deal of effort is being applied to develop new solutions, including regenerative strategies. However, the p...

Descripción completa

Detalles Bibliográficos
Autores principales: Thorpe, Abbey A., Bach, Frances C., Tryfonidou, Marianna A., Le Maitre, Christine L., Mwale, Fackson, Diwan, Ashish D., Ito, Keita
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Inc. 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6686834/
https://www.ncbi.nlm.nih.gov/pubmed/31463447
http://dx.doi.org/10.1002/jsp2.1027
_version_ 1783442635154784256
author Thorpe, Abbey A.
Bach, Frances C.
Tryfonidou, Marianna A.
Le Maitre, Christine L.
Mwale, Fackson
Diwan, Ashish D.
Ito, Keita
author_facet Thorpe, Abbey A.
Bach, Frances C.
Tryfonidou, Marianna A.
Le Maitre, Christine L.
Mwale, Fackson
Diwan, Ashish D.
Ito, Keita
author_sort Thorpe, Abbey A.
collection PubMed
description Chronic back and neck pain is a prevalent disability, often caused by degeneration of the intervertebral disc. Because current treatments for this condition are less than satisfactory, a great deal of effort is being applied to develop new solutions, including regenerative strategies. However, the path from initial promising idea to clinical use is fraught with many hurdles to overcome. Many of the keys to success are not necessarily linked to science or innovation. Successful translation to clinic will also rely on planning and awareness of the hurdles. It will be essential to plan your entire path to clinic from the outset and to do this with a multidisciplinary team. Take advice early on regulatory aspects and focus on generating the proof required to satisfy regulatory approval. Scientific demonstration and societal benefits are important, but translation cannot occur without involving commercial parties, which are instrumental to support expensive clinical trials. This will only be possible when intellectual property can be protected sufficiently to support a business model. In this manner, commercial, societal, medical, and scientific partners can work together to ultimately improve patient health. Based on literature surveys and experiences of the co‐authors, this opinion paper presents this pathway, highlights the most prominent issues and hopefully will aid in your own translational endeavors.
format Online
Article
Text
id pubmed-6686834
institution National Center for Biotechnology Information
language English
publishDate 2018
publisher John Wiley & Sons, Inc.
record_format MEDLINE/PubMed
spelling pubmed-66868342019-08-28 Leaping the hurdles in developing regenerative treatments for the intervertebral disc from preclinical to clinical Thorpe, Abbey A. Bach, Frances C. Tryfonidou, Marianna A. Le Maitre, Christine L. Mwale, Fackson Diwan, Ashish D. Ito, Keita JOR Spine Perspectives Chronic back and neck pain is a prevalent disability, often caused by degeneration of the intervertebral disc. Because current treatments for this condition are less than satisfactory, a great deal of effort is being applied to develop new solutions, including regenerative strategies. However, the path from initial promising idea to clinical use is fraught with many hurdles to overcome. Many of the keys to success are not necessarily linked to science or innovation. Successful translation to clinic will also rely on planning and awareness of the hurdles. It will be essential to plan your entire path to clinic from the outset and to do this with a multidisciplinary team. Take advice early on regulatory aspects and focus on generating the proof required to satisfy regulatory approval. Scientific demonstration and societal benefits are important, but translation cannot occur without involving commercial parties, which are instrumental to support expensive clinical trials. This will only be possible when intellectual property can be protected sufficiently to support a business model. In this manner, commercial, societal, medical, and scientific partners can work together to ultimately improve patient health. Based on literature surveys and experiences of the co‐authors, this opinion paper presents this pathway, highlights the most prominent issues and hopefully will aid in your own translational endeavors. John Wiley & Sons, Inc. 2018-08-02 /pmc/articles/PMC6686834/ /pubmed/31463447 http://dx.doi.org/10.1002/jsp2.1027 Text en © 2018 The Authors. JOR Spine published by Wiley Periodicals, Inc. on behalf of Orthopaedic Research Society This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Perspectives
Thorpe, Abbey A.
Bach, Frances C.
Tryfonidou, Marianna A.
Le Maitre, Christine L.
Mwale, Fackson
Diwan, Ashish D.
Ito, Keita
Leaping the hurdles in developing regenerative treatments for the intervertebral disc from preclinical to clinical
title Leaping the hurdles in developing regenerative treatments for the intervertebral disc from preclinical to clinical
title_full Leaping the hurdles in developing regenerative treatments for the intervertebral disc from preclinical to clinical
title_fullStr Leaping the hurdles in developing regenerative treatments for the intervertebral disc from preclinical to clinical
title_full_unstemmed Leaping the hurdles in developing regenerative treatments for the intervertebral disc from preclinical to clinical
title_short Leaping the hurdles in developing regenerative treatments for the intervertebral disc from preclinical to clinical
title_sort leaping the hurdles in developing regenerative treatments for the intervertebral disc from preclinical to clinical
topic Perspectives
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6686834/
https://www.ncbi.nlm.nih.gov/pubmed/31463447
http://dx.doi.org/10.1002/jsp2.1027
work_keys_str_mv AT thorpeabbeya leapingthehurdlesindevelopingregenerativetreatmentsfortheintervertebraldiscfrompreclinicaltoclinical
AT bachfrancesc leapingthehurdlesindevelopingregenerativetreatmentsfortheintervertebraldiscfrompreclinicaltoclinical
AT tryfonidoumariannaa leapingthehurdlesindevelopingregenerativetreatmentsfortheintervertebraldiscfrompreclinicaltoclinical
AT lemaitrechristinel leapingthehurdlesindevelopingregenerativetreatmentsfortheintervertebraldiscfrompreclinicaltoclinical
AT mwalefackson leapingthehurdlesindevelopingregenerativetreatmentsfortheintervertebraldiscfrompreclinicaltoclinical
AT diwanashishd leapingthehurdlesindevelopingregenerativetreatmentsfortheintervertebraldiscfrompreclinicaltoclinical
AT itokeita leapingthehurdlesindevelopingregenerativetreatmentsfortheintervertebraldiscfrompreclinicaltoclinical