Lessons Learned from Pioneering Neural Stem Cell Studies
As stem cell products are increasingly entering early stage clinical trials, we are learning from experience about how cell products may be best assessed for safety and efficacy. In two papers published in this issue of Stem Cell Reports, a human neural stem cell product, HuCNS-SC, failed to demonst...
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2017-02-01
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doaj-7bad8861743442dca63dc3b921563c302020-11-24T21:04:24ZengElsevierStem Cell Reports2213-67112017-02-018219119310.1016/j.stemcr.2017.01.024Lessons Learned from Pioneering Neural Stem Cell StudiesSally Temple0Lorenz Studer1Neural Stem Cell Institute, Rensselaer, NY 12144, USAMemorial Sloan Kettering Cancer Center, Center for Stem Cell Biology, New York, NY 10065, USAAs stem cell products are increasingly entering early stage clinical trials, we are learning from experience about how cell products may be best assessed for safety and efficacy. In two papers published in this issue of Stem Cell Reports, a human neural stem cell product, HuCNS-SC, failed to demonstrate efficacy in central nervous system repair in two different animal models (Anderson et al., 2017; Marsh et al., 2017), although closely related research-grade cell products showed evidence of efficacy. This indicates the need for increased cell characterization to determine comparability of lots proposed for pre-clinical and clinical use. Without such improvements, pre-clinical data supporting a clinical study might not adequately reflect the performance of subsequent batches of cells intended for use in patients.http://www.sciencedirect.com/science/article/pii/S2213671117300401 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Sally Temple Lorenz Studer |
spellingShingle |
Sally Temple Lorenz Studer Lessons Learned from Pioneering Neural Stem Cell Studies Stem Cell Reports |
author_facet |
Sally Temple Lorenz Studer |
author_sort |
Sally Temple |
title |
Lessons Learned from Pioneering Neural Stem Cell Studies |
title_short |
Lessons Learned from Pioneering Neural Stem Cell Studies |
title_full |
Lessons Learned from Pioneering Neural Stem Cell Studies |
title_fullStr |
Lessons Learned from Pioneering Neural Stem Cell Studies |
title_full_unstemmed |
Lessons Learned from Pioneering Neural Stem Cell Studies |
title_sort |
lessons learned from pioneering neural stem cell studies |
publisher |
Elsevier |
series |
Stem Cell Reports |
issn |
2213-6711 |
publishDate |
2017-02-01 |
description |
As stem cell products are increasingly entering early stage clinical trials, we are learning from experience about how cell products may be best assessed for safety and efficacy. In two papers published in this issue of Stem Cell Reports, a human neural stem cell product, HuCNS-SC, failed to demonstrate efficacy in central nervous system repair in two different animal models (Anderson et al., 2017; Marsh et al., 2017), although closely related research-grade cell products showed evidence of efficacy. This indicates the need for increased cell characterization to determine comparability of lots proposed for pre-clinical and clinical use. Without such improvements, pre-clinical data supporting a clinical study might not adequately reflect the performance of subsequent batches of cells intended for use in patients. |
url |
http://www.sciencedirect.com/science/article/pii/S2213671117300401 |
work_keys_str_mv |
AT sallytemple lessonslearnedfrompioneeringneuralstemcellstudies AT lorenzstuder lessonslearnedfrompioneeringneuralstemcellstudies |
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