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Kirillova, et al.
problems [24,25] . The “cell” is the most important religious beliefs may disagree with the use of cells
component of bioprinting. The type of cells used of certain animal species.
plays a key role in determining the characteristics The emerging possibilities of reprogramming
of the bioprinted tissue. In the case of allogeneic differentiated cells and producing induced
cell transplantation, we face classical ethical pluripotent stem cells (iPSCs) eliminate the ethical
problems associated with donation: (1) The donor issues of using ESCs or xenogeneic cells. IPSCs can
confidentiality, (2) the informed donor consent, (3) be purposefully differentiated into any specific adult
the possible invasive cell production procedure, body cell types, ranging from skin cells to cardiac
and (4) donor cell ownership. There is still no cells and neurons. However, we believe that the
verdict among clinicians and researchers regarding technology of 3D printing of human organs using
one of the basic rules of medical ethics – Primum autologous iPSC in bioink is not ethically neutral.
non nocere (First, do no harm). The principle of It also has a number of problematic aspects, even
misuse takes into account the moral nature of if the bioinks are derived from the patient’s own
the action, the intention of the agent, the means cells. The technology of cell reprogramming is
of action, the possible adverse effects, and the also very far from perfect. Today, one of the main
proportionality between good and bad effects. challenges is to develop the methods that will
Stem cells are often used as “building blocks” ensure correct differentiation of all stem cells before
for human tissue and organ biofabrication. The transplantation. The risk of tumorigenicity is a major
main ethical issue with regard to stem cells is its problem when using iPSC [31-33] . To provide safety of
“source.” The use of human embryonic stem cells iPSC-based therapies, genetic testing of stem cell
(ESCs) has been heavily criticized and has relevant lines potentially suitable for clinical application has
limitations, both legal [26,27] and moral [28,29] . The main to be performed [34-36] . However, it brings additional
source of these cells are embryos or fetuses, so the ethical and legal issues related to the personal
problem of obtaining ESC is at the intersection of genetic information collection, storage, and use.
bioethical problems of determining the moral status Data exchange for research purposes increases
of an embryo, legal pregnancy termination, and the number of individuals who can access
human participation in the experiments. In addition personal genomic data which, in turn, increases
to the ethical and legal issues associated with the the likelihood of data leakage and its malicious
use of ESCs, other factors may influence the ethical use, including for the purpose of committing a
acceptability of using bioinks from allogeneic cells. crime. In 2012, The Presidential Commission for
For instance, the issues of obtaining stem cells the Study of Bioethical Issues published “Privacy
from donors who have been pressured, coerced, or and Progress in Whole Genome sequencing”
have not given informed consent should be taken report in the United States . This report gives
[37]
into consideration. Moreover, there are barriers for recommendations for individual’s privacy
commercialization and therefore, the application of protection while allowing exchanging genetic
3D printing technology on the basis of ESC as “use data. The Russian legislation does not regulate the
of human embryos in industrial and commercial organization and conducts of research related to
purposes cannot be the objects for patent rights” human genome data and activities of the relevant
according to the subclause 3 of Clause 4 of Article genetic companies. Requirements for obtaining
1349 of the Civil Code of the Russian Federation. consent from a donor for participation in research,
Another option for the cell source for as well as requirements for the processing and
bioprinting is xenogeneic cells. In this case, it is transfer of genetic information as a special category
necessary to take into consideration the social of personal data, are not defined in the existing
and religious aspects of animal cell utilization. legislation. Additionally, current legislation does
Patients with xenotransplantation might not regulate the circulation of biological materials
experience psychosocial problems associated with seized from donors for the purpose of conducting
their personal identity . Moreover, patients with scientific research, does not provide guarantees of
[30]
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