Ethical Questions Raised by in utero Therapeutics with Stem Cells and Gene Therapy

Abstract

The plasticity of living beings is limitless and our guidelines are constantly upset. Several ethical questions arise with this new in utero therapeutic approach: (1) The possibility of a mother giving truly informed consent when she is divided between a proposal to terminate her pregnancy and resignation to the birth of an abnormal child. How can she choose between three therapeutic proposals, when two of them are unbearable and only one carries some hope? (2) If a dead fetus is used as a donor of hepatic or hematologic stem cells, should this be based on the mother’s consent? If so, what status is given to this fetus? Is it possible to take into consideration at the same time the growing demand to recognize the fetus as a person and his gift? (3) It is important to separate the services that receive dead fetuses from those that perform the injection of fetal stem cells so that the fetus does not become a mere therapeutic tool. (4) Even if the technique is not very difficult, can ex vivo transduction of mesenchymatous cells be performed as a kind of gene therapy without causing great anxiety over the embryo’s germinal future? The main question is that even though surgery and medical therapeutics for the fetus have made great progress and become commonplace, the use of stem cell transplantations and eventually gene therapy privileges experimental medicine and research that are more and more difficult to conceive on an ethical level. If indeed fetal therapeutics seems to hold out promise for the future, the very speed with which we pass from conception to its experimental realization with a child must necessarily challenge our thinking.

A new ethical framework to determine acceptable risks in fetal therapy trials

“…Many frameworks propose categorical requirements for all studies irrespective of their distinctive features. Several frameworks require, for example, that anticipated fetal benefits be above a certain threshold (e.g., only interventions with the prospect of alleviating life‐threatening or serious and irreversible diseases) 3, 9, 11, 12, 14–25 . Absolute risk limits for pregnant persons are also common (e.g., low or manageable risks) 11, 12, 15–19, 21, 26–28 .…”

“…Several frameworks require, for example, that anticipated fetal benefits be above a certain threshold (e.g., only interventions with the prospect of alleviating life-threatening or serious and irreversible diseases). 3,9,11,12,[14][15][16][17][18][19][20][21][22][23][24][25] Absolute risk limits for pregnant persons are also common (e.g., low or manageable risks). 11, 12, 15-19, 21, 26-28 We think these criteria are inappropriately strict and rule out important research studies.…”