Current status and perspectives on stem cell-based therapies undergoing clinical trials for regenerative medicine: case studies

BACKGROUND. Apart from haematopoietic stem cell transplantation for haematological disorders many stem cell-based therapies are experimental. However, with only 12 years between human embryonic stem cell isolation and the first clinical trial, development of stem cell products for regenerative medic...

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Main Authors:	Elizabeth Ratcliffe, Katie Glen, May W. Naing, David Williams
Format:	Default Article
Published:	2013
Subjects:	Mechanical engineering not elsewhere classified Stem cell-based therapy Regenerative medicine Clinical trials Regulation Commercialisation Mechanical Engineering not elsewhere classified
Online Access:	https://hdl.handle.net/2134/26156
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id	rr-article-9547637
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spelling	rr-article-95476372013-01-01T00:00:00Z Current status and perspectives on stem cell-based therapies undergoing clinical trials for regenerative medicine: case studies Elizabeth Ratcliffe (1250265) Katie Glen (1255023) May W. Naing (7206416) David Williams (1248024) Mechanical engineering not elsewhere classified Stem cell-based therapy Regenerative medicine Clinical trials Regulation Commercialisation Mechanical Engineering not elsewhere classified BACKGROUND. Apart from haematopoietic stem cell transplantation for haematological disorders many stem cell-based therapies are experimental. However, with only 12 years between human embryonic stem cell isolation and the first clinical trial, development of stem cell products for regenerative medicine has been rapid and numerous clinical trials have begun to investigate their therapeutic potential. SOURCE OF DATA. This review summarizes key clinical trial data, current and future perspectives on stem cell-based products undergoing clinical trials, based on literature search and author research. AREAS OF AGREEMENT. It is widely recognized that the ability to stimulate stem cell differentiation into specialized cells for use as cellular therapies will revolutionize health care and offer major hope for numerous diseases for which there are limited or no therapeutic options. AREAS OF CONTROVERSY. Stem cell-based products are unique and cover a large range of disorders to be treated; therefore, there is significant potential for variation in cell source, type, processing manipulation, the bioprocessing approach and scalability, the cost and purity of manufacture, final product quality and mode of action. As such there are gaps in regulatory and manufacturing frameworks and technologies, only a small number of products are currently within late phase clinical trials and few products have achieved commercialization. GROWING POINTS. Recent developments are encouraging acceleration through the difficulties encountered en route to clinical trials and commercialization of stem cell therapies. AREAS TIMELY FOR DEVELOPING RESEARCH. The field is growing year on year with the first clinical trial using induced pluripotent stem cells anticipated by end 2013. 2013-01-01T00:00:00Z Text Journal contribution 2134/26156 https://figshare.com/articles/journal_contribution/Current_status_and_perspectives_on_stem_cell-based_therapies_undergoing_clinical_trials_for_regenerative_medicine_case_studies/9547637 CC BY-NC-ND 4.0
institution	Loughborough University
collection	Figshare
topic	Mechanical engineering not elsewhere classified Stem cell-based therapy Regenerative medicine Clinical trials Regulation Commercialisation Mechanical Engineering not elsewhere classified
spellingShingle	Mechanical engineering not elsewhere classified Stem cell-based therapy Regenerative medicine Clinical trials Regulation Commercialisation Mechanical Engineering not elsewhere classified Elizabeth Ratcliffe Katie Glen May W. Naing David Williams Current status and perspectives on stem cell-based therapies undergoing clinical trials for regenerative medicine: case studies
description	BACKGROUND. Apart from haematopoietic stem cell transplantation for haematological disorders many stem cell-based therapies are experimental. However, with only 12 years between human embryonic stem cell isolation and the first clinical trial, development of stem cell products for regenerative medicine has been rapid and numerous clinical trials have begun to investigate their therapeutic potential. SOURCE OF DATA. This review summarizes key clinical trial data, current and future perspectives on stem cell-based products undergoing clinical trials, based on literature search and author research. AREAS OF AGREEMENT. It is widely recognized that the ability to stimulate stem cell differentiation into specialized cells for use as cellular therapies will revolutionize health care and offer major hope for numerous diseases for which there are limited or no therapeutic options. AREAS OF CONTROVERSY. Stem cell-based products are unique and cover a large range of disorders to be treated; therefore, there is significant potential for variation in cell source, type, processing manipulation, the bioprocessing approach and scalability, the cost and purity of manufacture, final product quality and mode of action. As such there are gaps in regulatory and manufacturing frameworks and technologies, only a small number of products are currently within late phase clinical trials and few products have achieved commercialization. GROWING POINTS. Recent developments are encouraging acceleration through the difficulties encountered en route to clinical trials and commercialization of stem cell therapies. AREAS TIMELY FOR DEVELOPING RESEARCH. The field is growing year on year with the first clinical trial using induced pluripotent stem cells anticipated by end 2013.
format	Default Article
author	Elizabeth Ratcliffe Katie Glen May W. Naing David Williams
author_facet	Elizabeth Ratcliffe Katie Glen May W. Naing David Williams
author_sort	Elizabeth Ratcliffe (1250265)
title	Current status and perspectives on stem cell-based therapies undergoing clinical trials for regenerative medicine: case studies
title_short	Current status and perspectives on stem cell-based therapies undergoing clinical trials for regenerative medicine: case studies
title_full	Current status and perspectives on stem cell-based therapies undergoing clinical trials for regenerative medicine: case studies
title_fullStr	Current status and perspectives on stem cell-based therapies undergoing clinical trials for regenerative medicine: case studies
title_full_unstemmed	Current status and perspectives on stem cell-based therapies undergoing clinical trials for regenerative medicine: case studies
title_sort	current status and perspectives on stem cell-based therapies undergoing clinical trials for regenerative medicine: case studies
publishDate	2013
url	https://hdl.handle.net/2134/26156
_version_	1796738981595971584

Current status and perspectives on stem cell-based therapies undergoing clinical trials for regenerative medicine: case studies

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