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...

Full description

Bibliographic Details
Main Authors: Sally Temple, Lorenz Studer
Format: Article
Language:English
Published: Elsevier 2017-02-01
Series:Stem Cell Reports
Online Access:http://www.sciencedirect.com/science/article/pii/S2213671117300401
id doaj-7bad8861743442dca63dc3b921563c30
record_format Article
spelling 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
_version_ 1716771193423396864