Authors: | Tabar, V.; Barker, R. A. |
Title: | Sham surgery for the trialing of cell-based therapies to the CNS may not be necessary |
Abstract: | Sham surgery is often required for cell therapies adopting a randomized placebo-controlled double-blinded trial design. Using the case of dopamine neuron therapy for Parkinson's disease, we argue that alternative trial designs should be considered instead, for several reasons relating to ethics, patient burden, ease of unblinding, and cost. © 2023 |
Keywords: | controlled study; placebo; note; randomized controlled trial; central nervous system; cell therapy; biological therapy; parkinson disease; dopaminergic nerve cell; randomized controlled trial (topic); study design; dopaminergic neurons; humans; human; cell- and tissue-based therapy |
Journal Title: | Cell Stem Cell |
Volume: | 31 |
Issue: | 2 |
ISSN: | 1934-5909 |
Publisher: | Cell Press |
Date Published: | 2024-02-01 |
Start Page: | 158 |
End Page: | 160 |
Language: | English |
DOI: | 10.1016/j.stem.2023.12.004 |
PUBMED: | 38306992 |
PROVIDER: | scopus |
DOI/URL: | |
Notes: | Note -- Source: Scopus |