Abstract

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.

Highlights

  • This document is the author deposited version

  • This review aims to map out the important aspects to consider during the development of regenerative therapies for the intervertebral disc (IVD)

  • Over the last two decades, there has been a vast amount of published literature on the preclinical development of novel therapies for IVD degeneration

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Summary

Expenses for animal experiments

This needs to be validated for other species, as well as how the spinal phenotypes present in animal models relate to human pathology to improve translation Another major concern regarding MRI analysis is that there is a need for validation of regenerative process, since quantitative MRI has been validated for IVD degeneration, but not for regeneration, which does not necessarily follow an identical reverse process.

In vitro
Minimum outcome measures Pain Disability Quality of life Radiological
Autologous disc cells
Autologous bone marrow concentrate cells
BIOSTAT BIOLOGX
Samumed LLC
| DISCUSSION
Findings
Authors contribution
Full Text
Published version (Free)

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