1. Sham surgery for the trialing of cell-based therapies to the CNS may not be necessary.
- Author
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Tabar V and Barker RA
- Subjects
- Humans, Dopaminergic Neurons, Randomized Controlled Trials as Topic, Cell- and Tissue-Based Therapy, Parkinson Disease therapy
- 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., Competing Interests: Declaration of interests V.T. is a co-founder, advisor, and recipient of research support from BlueRock Therapeutics. R.A.B. is a consultant for NovoNordisk, Aspen Neuroscience, Bayer, Transine Therapeutics, Rinri Therapeutics, and UCB on patient-related outcome measures., (Crown Copyright © 2023. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
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