Marita V. Reyes
DOST National Ethics Committee
https://doi.org/10.57043/transnastphl.2013.3221
ABSTRACT
Success in bone marrow transplantation and the discovery of pluripotent embryonic cells have fueled much scientific interest in the potential therapeutic uses of stem cells. The recent development of techniques to grow human embryonic stem cells in culture and an increased understanding of the pathways of cell differentiation have expanded the clinical prospects for the use of stem cells.
The term “stem cell-based products” is used to refer to products intended to be administered to a patient and that contain or are derived from stem cells. “Stem-cell-based products” may not always contain stem cells. In some cases, multipotent cells might be transplanted, which would give rise to terminally differentiated cells in vivo (direct administration). In other cases, it might be desirable to allow the cells to differentiate fully in culture before transplanting them or to transplant a mixture of multipotent cells and differentiated cells (tissue engineering).
Claims of clinical effectiveness must show that the cells home to the diseased or injured tissue. They must engraft, not just fuse with cells that are already there. They have to function. They must persist.
The use of embryonic stem cells is controversial because of the lack of agreement regarding the personhood of emb1yos. The discovery of the multipotential charateristics of adult stem cells has relegated this issue to the fringes. The main ethical issue is the difficulty of balancing risks and benefits because of cell cuture techniques being potential sources of undesirable agents causing harm and because of the uncertainty of risks and long-term effects of stem cell administration. Moreover, there is lack of good animal models for target diseases so that the first in human trials is very difficult to justify and put up. Ethical review of stem cell research protocols has thus become very complicated.
Ethical issues arise from the vulnerability of people in resource-poor countries cognitively, deferentially, medically, allocationally and infrastructurally. Further – there is no quality assurance system in place. Conflict of interest situations exist when the stem cell producer is also the health care provider. Finally, social justice needs to be addressed to ensure that the divide in health care service between the rich and the poor is not widened when stem cell therapy is integrated into the health system.
It is recommended that wider consultations and conversations with the community be conducted so that a better understanding of the stakes in stem cell use is generated. A quality assurance system must be put in place to ensure quality stem cell products. Scientific and ethical review systems must be strengthened in all institutions so that conflict of interest situations may be effectively addressed. Publication of positive and negative experiences in the use of stem cells should be mandated. Finally, a national policy on the use of stem cells must take into consideration social justice.