Biomedical Engineering Reference
In-Depth Information
16
Ethical issues in bone repair and bone
tissue engineering
L. TrommeLmans, J. seLLing and K. DiericKx,
Katholieke Universiteit Leuven, Belgium
Abstract
: of the approaches toward bone repair, bone tissue engineering
elicits some of the more complex ethical questions, owing to the
incorporation of living, considerably altered cells in the product. We discuss
three areas where ethical issues occur: cell sourcing, clinical trials and
therapy. cells are key components of all bone tissue engineered products.
embryonic stem cells may be used in the future, but this remains ethically
controversial. non-embryonic cells are not controversial but cell donation
and the informed consent procedure accompanying it raises questions: both
the cells' material value and their informational value for the donor need
to be examined when deciding on the conditions of cell donation for tissue
engineering purposes. regeneration through the creation and implantation
of metabolically active constructs is a new medical approach which requires
a profound analysis of the implications of the new approach for the design
of clinical trials and of therapy to protect the safety and autonomy of
vulnerable persons. This includes assessments of efficacy, risks and safety.
it also requires an evaluation of informed consent procedures. This may not
only benefit bone tissue engineering, but other bone repair interventions
as well. a third issue is safeguarding the access of patients. The economic
thresholds for this therapy will be considerable. However, the presence of
living cells may also create a biological threshold owing to immunological
requirements. Tissue engineered products may be unavailable for some
persons, unless biological diversity is taken into account from the design
of bone tissue engineered products and through accurate cell sourcing
strategies.
Key words
: bone, cell donation, clinical trials, ethics, informed consent,
patient follow-up, regenerative medicine, stem cells, therapy, tissue
engineering.
16.1 Introduction: the ethical analysis of
bone repair
The notion of good science and good medicine has an ethical undertone:
the pursuit of human enrichment through science, engineering and medicine
is an unquestionable good and should be encouraged. most persons would
also claim that this end does not justify any means. science and medicine
conducted at the expense of human dignity or causing needless suffering is
considered to be bad science and bad medicine and is therefore widely and
rightly condemned.
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