Biomedical Engineering Reference
In-Depth Information
16.3 Clinical trials with bone tissue
engineered products
16.3.1 Introduction
innovative research on human volunteers through clinical trials is both necessary
and risky, given the possible negative (side) effects for the participants. To avoid
exploitation, general guidance for trials has been developed and incorporated
in a number of conventions and guidelines (national commission for the
Protection of Human subjects of Biomedical and Behavioral research, 1979;
World medical association, 1997; emea, 2002; council of europe, 2005).
These have to be adapted to the context of particular innovations such as
bone tissue engineering. in this way research subjects are not merely used
but treated with respect, while at the same time contributing to generalisable
biological knowledge and/or the improvement of health. emanuel
et al
. (2000)
discern seven ethical requirements for every clinical trial: (1) value, that is
a better understanding of health or knowledge as a result of the research;
(2) scientific validity, i.e. the research should be methodologically rigorous
in order to make the results valid outside of the trial conditions; (3) fair
subject selection; (4) favourable risk-benefit ratio; (5) independent review;
(6) informed consent and (7) respect for enrolled subjects.
Testing BTePs under the controlled circumstances of clinical trials
following these seven criteria will advance the development of BTePs, while
simultaneously showing respect for participants. appropriate regulation is
therefore being developed both in the Usa (Halme and Kessler, 2006) and
in europe (emea, 2007).
16.3.2 Preclinical testing
The fundamental requirement for the initiation of clinical trials is that sufficient
evidence about the expected efficacy, possible benefits and foreseeable
risks of the product or intervention under consideration is collected through
preclinical tests and animal trials. The value of animal trials depends on
the relevant knowledge that they provide. The limited relevance of animal
models in tissue engineering is a serious hindrance (Tawqeer
et al
., 2004;
giannoni
et al
., 2005). Furthermore, the application of BTePs on healthy
volunteers is problematic. These two elements may have as a consequence
that a number of issues pertaining to the efficacy, the safety and risks of the
BTeP will remain unanswered before clinical trials are initiated.
16.3.3 Complexity of bone tissue engineered products
it would be inaccurate to think of BTePs as highly sophisticated medical devices
that happen to contain human or animal derived cells. The incorporation of
