Lessons learnt, and still to learn, in first in human stem cell trials

Developing cellular therapies is not straightforward. This Perspective summarizes the experience of a group of academic stem cell investigators working in different clinical areas and aims to share insight into what we wished we knew before starting. These include (1) choosing the stem cell line and...

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Autores principales: Barker, Roger A., Carpenter, Melissa, Jamieson, Catriona H.M., Murry, Charles E., Pellegrini, Graziella, Rao, Rajesh C., Song, Jihwan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2022
Materias:
Perspective
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10444539/
https://www.ncbi.nlm.nih.gov/pubmed/36563687
http://dx.doi.org/10.1016/j.stemcr.2022.11.019
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author Barker, Roger A.
Carpenter, Melissa
Jamieson, Catriona H.M.
Murry, Charles E.
Pellegrini, Graziella
Rao, Rajesh C.
Song, Jihwan
author_facet Barker, Roger A.
Carpenter, Melissa
Jamieson, Catriona H.M.
Murry, Charles E.
Pellegrini, Graziella
Rao, Rajesh C.
Song, Jihwan
author_sort Barker, Roger A.
collection PubMed
description Developing cellular therapies is not straightforward. This Perspective summarizes the experience of a group of academic stem cell investigators working in different clinical areas and aims to share insight into what we wished we knew before starting. These include (1) choosing the stem cell line and assessing the genome of both the starting and final product, (2) familiarity with GMP manufacturing, reagent validation, and supply chain management, (3) product delivery issues and the additional regulatory challenges, (4) the relationship between clinical trial design and preclinical studies, and (5) the market approval requirements, pathways, and partnerships needed.
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spelling pubmed-104445392023-08-23 Lessons learnt, and still to learn, in first in human stem cell trials Barker, Roger A. Carpenter, Melissa Jamieson, Catriona H.M. Murry, Charles E. Pellegrini, Graziella Rao, Rajesh C. Song, Jihwan Stem Cell Reports Perspective Developing cellular therapies is not straightforward. This Perspective summarizes the experience of a group of academic stem cell investigators working in different clinical areas and aims to share insight into what we wished we knew before starting. These include (1) choosing the stem cell line and assessing the genome of both the starting and final product, (2) familiarity with GMP manufacturing, reagent validation, and supply chain management, (3) product delivery issues and the additional regulatory challenges, (4) the relationship between clinical trial design and preclinical studies, and (5) the market approval requirements, pathways, and partnerships needed. Elsevier 2022-12-22 /pmc/articles/PMC10444539/ /pubmed/36563687 http://dx.doi.org/10.1016/j.stemcr.2022.11.019 Text en © 2022 The Authors https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Perspective
Barker, Roger A.
Carpenter, Melissa
Jamieson, Catriona H.M.
Murry, Charles E.
Pellegrini, Graziella
Rao, Rajesh C.
Song, Jihwan
Lessons learnt, and still to learn, in first in human stem cell trials
title Lessons learnt, and still to learn, in first in human stem cell trials
title_full Lessons learnt, and still to learn, in first in human stem cell trials
title_fullStr Lessons learnt, and still to learn, in first in human stem cell trials
title_full_unstemmed Lessons learnt, and still to learn, in first in human stem cell trials
title_short Lessons learnt, and still to learn, in first in human stem cell trials
title_sort lessons learnt, and still to learn, in first in human stem cell trials
topic Perspective
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10444539/
https://www.ncbi.nlm.nih.gov/pubmed/36563687
http://dx.doi.org/10.1016/j.stemcr.2022.11.019
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