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- W1997660362 abstract "A first-in-human, stem-cell-based trial for Parkinson's disease raises specific ethical issues. We analyze three challenges: participant selection, informed consent, and sham surgery. Phase I–II studies should recruit patients under 70 years of age with levodopa-responsive main features, free of nonmotor, levodopa-resistant symptoms and of complications of long-term dopamine replacement therapy. Recruitment should avoid the first months following diagnosis and exclude candidates for deep brain stimulation. A shorter overall life expectancy would be preferable to minimize cumulative risks of tumorigenesis. Participants should understand that research participation would not be a “last chance” scenario. Sham surgery would be unjustified as a placebo control in Phase I–II but may be required as a standardized negative, requiring intracranial injection, in Phase III trials. Potential participants fulfilling these conditions exist. Provided special precautions are taken with the design of first-in-human studies, such trials can be conducted in an ethically justified manner." @default.
- W1997660362 created "2016-06-24" @default.
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- W1997660362 date "2015-01-02" @default.
- W1997660362 modified "2023-10-18" @default.
- W1997660362 title "Ethical Criteria for Human Trials of Stem-Cell-Derived Dopaminergic Neurons in Parkinson's Disease" @default.
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- W1997660362 doi "https://doi.org/10.1080/21507740.2014.990544" @default.
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