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Preclinical translation of mesenchymal stem cell therapies

Published on November 28, 2021   32 min

Other Talks in the Series: Periodic Reports: Advances in Clinical Interventions and Research Platforms

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Hello, I am Peter Childs, a Chancellor's Fellow in Biomedical Engineering at the University of Strathclyde. Today I will be speaking about the pre-clinical translation of mesenchymal stem cell therapies. My own research focuses on the development of bone graft materials using mesenchymal stem cells.
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In this lecture, I will discuss mesenchymal stem cells, including their characteristics, and some examples of how we might go about controlling their phenotype for clinical use. I will then discuss some of the considerations when moving to manufacture these cells for clinical use, and some of the testing strategies which need to be considered at the pre-clinical stages. Surrounding these topics are regulatory frameworks which vary from country to country, and must be considered when seeking approval to develop a clinical product, and enter into clinical trials.
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Within Europe and the UK, stem cell therapies fall under the category of advanced therapy medicinal products, or ATMPs. These are regulated through a set of directives developed over the past 20 years. The first directive of relevance introduced somatic cell therapy medicinal products as a class of medicinal agent, along with gene therapies. Refinements to the regulations later introduced definitions for tissue-engineered products, and also combination ATMPs, where cells are combined with a medical device (for example, the use of a biomaterial scaffold as a carrier for the cells). Within the USA, the FDA regulates the use of human cells as a therapeutic under its HCT/P regulation, with two key sections being of interest when considering mesenchymal stem cells. Section 361 regulates products which are used in a homologous manner, such as demineralised bone matrix which contains stem cells, and then is applied for bone repair. In practicality, the difference between these two regulatory categories can mean the difference between a full pre-market review or not drastically altering the pre-clinical development, and the final price of the therapy. Recent introduction of the RMAT designation allows for expedited development of new therapies, where they tackle life-threatening conditions or meet significant clinical needs. In all cases, an early understanding of the appropriate regulatory framework will help the development of a pre-clinical and manufacturing development plan, even at the academic stage.

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Preclinical translation of mesenchymal stem cell therapies

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