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Ethical Perspectives on Stem Cell-based Cellular Therapies for Neurodegenerative Diseases

Mette Ebbesen, Finn Skou Pedersen, Svend Andersen and Thomas G. Jensen

The effect of stem cell-based therapies for neurodegenerative diseases such as Alzheimer disease, Huntington disease, and Parkinson disease are currently being investigated. Here we specify possible therapeutic effects and possible side effects for patients and conclude that cellular therapies may have benefits for patients. The side effect described most commonly in the literature is the risk of tumor formation by stem cells not fully differentiated into neurons when transplanted or following viral transduction and subsequent differentiation to create induced pluripotent stem cells. This risk may be avoided by differentiating stem cells in culture before transplantation.
 
Here we argue that the following ethical considerations are important for clinical trials: Informed consent of research subjects or patients, specification of possible therapeutic effects, risk analysis of possible side effects, equitable access of patients to clinical trials, and adequate compensation should be paid to research subjects or patients. We clarify that the related ethical principles are respect for autonomy, beneficence, nonmaleficence, and justice and that the ethical theory of the American ethicists Tom L. Beauchamp and James F. Childress is based on these principles. We show that this theory is useful for analyzing complex ethical cases of biomedicine by using cellular therapy for neurodegenerative diseases as a model system. We go through the three steps in an ethical case analysis using Beauchamp and Childress’ principles.
 
We explain that the ethical issues of using stem cells for therapies for neurodegenerative diseases often referred to in the literature are related to the moral status of the blastocyst and the developing embryo. We believe that these are to be seen as potential human life with increasing moral status during development. We propose that they should be treated with increasing respect and only used for research where no other cells as source for transplantation are available.