Lessons Learned from Pioneering Neural Stem Cell Studies
- PMID: 28199825
- PMCID: PMC5312267
- DOI: 10.1016/j.stemcr.2017.01.024
Lessons Learned from Pioneering Neural Stem Cell Studies
Abstract
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.
Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.
Comment on
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HuCNS-SC Human NSCs Fail to Differentiate, Form Ectopic Clusters, and Provide No Cognitive Benefits in a Transgenic Model of Alzheimer's Disease.Stem Cell Reports. 2017 Feb 14;8(2):235-248. doi: 10.1016/j.stemcr.2016.12.019. Stem Cell Reports. 2017. PMID: 28199828 Free PMC article.
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Preclinical Efficacy Failure of Human CNS-Derived Stem Cells for Use in the Pathway Study of Cervical Spinal Cord Injury.Stem Cell Reports. 2017 Feb 14;8(2):249-263. doi: 10.1016/j.stemcr.2016.12.018. Stem Cell Reports. 2017. PMID: 28199829 Free PMC article.
References
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- International Society for Stem Cell Research (2016). Guidelines for Stem Cell Research and Translation. http://www.isscr.org/guidelines2016.
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