Lessons Learned from Pioneering Neural Stem Cell Studies
Open accessAbstract
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.
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There is a lack of reproducibility of transplants of fetal neural stem cells for spinal-cord repair in humans.
“An example concerns the lack of reproducibility of transplants of fetal neural stem cells for spinal-cord repair in humans87.”
From How to design preclinical studies in nanomedicine and cell therapy to maximize the prospects of clinical translation (2018) · cites this paper as [87]
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Setting Global Standards for Stem Cell Research and Clinical Translation: The 2016 ISSCR Guidelines
Daley, G. Q., Hyun, I., Apperley, J. F., Barker, R. A., Benvenisty, N., Bredenoord, A. L., Breuer, C. K., Caulfield, T., Cedars, M. I., Frey-Vasconcells, J. L., et al. (2016) · Stem Cell Reports · doi:10.1016/j.stemcr.2016.05.001 · Cited by 223 · see citing works
Self-citationAger, R. R., Davis, J. L., Agazaryan, A., Benavente, F., Poon, W. W., LaFerla, F. M., & Blurton-Jones, M. M. (2014) · Hippocampus · doi:10.1002/hipo.22405 · Cited by 212 · see citing works
Anderson, A. J., Piltti, K. M., Hooshmand, M. J., Nishi, R. A., & Cummings, B. J. (2017) · Stem Cell Reports · doi:10.1016/j.stemcr.2016.12.018 · Cited by 92 · see citing works
Marsh, S. E., Yeung, S. T., Torres, M., Lau, L., Davis, J. L., Monuki, E. S., Poon, W. W., & Blurton-Jones, M. M. (2017) · Stem Cell Reports · doi:10.1016/j.stemcr.2016.12.019 · Cited by 69 · see citing works
Anderson, A. J., & Cummings, B. J. (2016) · The Journal of Law Medicine & Ethics · doi:10.1177/1073110516667937 · Cited by 11 · see citing works
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Ioannidis, J. P. A., Kim, B. Y. S., & Trounson, A. (2018) · Nature Biomedical Engineering · doi:10.1038/s41551-018-0314-y · Cited by 175 · see citing works
- Authors
- Temple, S., & Studer, L.
- Affiliations
- Neural Stem Cell Institute (US)
- Memorial Sloan Kettering Cancer Center (US)
- Corresponding author
- Temple, Sally
- Venue
- Stem Cell Reports
- Publisher
- Elsevier BV
- Published
- 2017-02
- Volume
- 8
- Issue
- 2
- Pages
- 191-193
- ISSN
- 2213-6711 (ISSN-L)
- PMC
- PMC5312267
- OpenAlex
- W2588406234
- Cited by
- 29
- References
- 5
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 4 · 2023: 3 · 2022: 2 · 2021: 5 · 2020: 3 · 2019: 3 · 2018: 4 · 2017: 2
- FWCI
- 1.34
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Stem Cell Reports (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- National Cancer Institute (P30CA008748)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Pluripotent Stem Cells Research
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Life Sciences › Neuroscience › Developmental Neuroscience › Neurogenesis and neuroplasticity mechanisms
- Keywords
- neural stem cells, stem cell therapy, central nervous system repair, preclinical efficacy, clinical trials
- MeSH terms
- Alzheimer Disease, Animals, Central Nervous System, Humans, Neural Stem Cells
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