Biomedical Ethics Unit, STREAM Research Group, McGill University, Montreal, Canada.
Nat Med. 2019 Jul;25(7):1037-1044. doi: 10.1038/s41591-019-0511-6. Epub 2019 Jul 3.
The process of developing new and complex stem-cell-based therapeutics is incremental and requires decades of sustained collaboration among different stakeholders. In this Perspective, we address key ethical and policy challenges confronting the clinical translation of stem-cell-based interventions (SCBIs), including premature diffusion of SCBIs to clinical practice, assessment of risk in trials, obtaining valid informed consent for research participants, balanced and complete scientific reporting and public communications, regulation, and equitable access to treatment. We propose a way forward for translating these therapies with the above challenges in mind.
开发新的和复杂的基于干细胞的疗法是一个渐进的过程，需要不同利益相关者之间数十年的持续合作。在本观点中，我们探讨了临床转化基于干细胞的干预措施（SCBI）所面临的关键伦理和政策挑战，包括 SCBI 过早向临床实践扩散、试验风险评估、为研究参与者提供有效的知情同意、平衡和完整的科学报告和公众交流、监管以及公平获得治疗的机会。我们提出了一种考虑到上述挑战的方法，以推进这些疗法的临床转化。
