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
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Published: 2013
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Online Access:https://hdl.handle.net/2134/26156
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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
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