Ex-vivo tissue engineering is an emerging medical technology. Its aim is to regenerate tissues and organs and to restore them to full physiological activity. Some clinical trials with human tissue engineered products (HTEPs) have been conducted and others will follow. These trials not only have to confirm the therapeutic value of the HTEP, they also have to provide insight in its regenerative activity, its safety and long-term effects. The development of these trials is aggravated by the complexity of the tissue engineering process and product. This paper investigates how this complexity influences the ethical conduct of clinical trials with HTEPs. We focus on the value and validity of the trial, the risk-benefit ratio and the protection of the trial participant. We argue that trials with HTEPs need a robust methodology. The risk-benefit ratio of a new HTEP must be determined and compared with available efficacious therapies. This requires the identification and minimisation of risks associated with tissue engineering. Finally a process as complex as tissue engineering presents serious challenges for the informed consent process, and for the protection of the trial participant during and after the trial.
Single crystals of undoped or europium-doped barium chloride, bromide, and iodide were investigated under x-ray and ␥-ray excitations. The Eu 2+ -related x-ray excited luminescence found in the Eu-doped barium halides occurs at 402, 404, and 425 nm for the chloride, bromide, and iodide, respectively. BaCl 2 :Eu 2+ shows the best scintillation properties of the systems investigated. The light yield is about 20 000± 2000 photons per MeV of absorbed ␥-ray energy, the energy resolution for the 662 keV photopeak is 8.8% ± 0.9%, and the scintillation decay time is 390± 40 ns.
Ex-vivo tissue engineering is a quickly developing medical technology aiming to regenerate tissue through the introduction of an ex-vivo created tissue construct instead of restoring the damaged tissue to some level of functionality. Tissue engineering is considered by some as a new medical paradigm. We analyse this claim and identify tissue engineering's fundamental characteristics, focusing on the aim of the intervention and on the complexity and continuity of the process. We inquire how these features have an impact not only on the scientific research itself but also on the ethical evaluation of this research. We suggest that viewing tissue engineering as a new medical paradigm allows us to develop a wider perspective for successful investigation instead of focusing on isolated steps of the tissue engineering process in an anecdotal way, which may lead to an inadequate ethical evaluation. We argue that the concept of tissue engineering as a paradigm may benefit the way we address the ethical challenges presented by tissue engineering.
Ex vivo tissue-engineered products are increasingly entered into clinical trials. To allow prospective participants to make a fully informed, autonomous decision on their participation, we have to adapt the informed consent process by taking the specific aspects of tissue engineering into consideration. New elements in ex vivo tissue engineering are the source and manipulation of the cells in the product, the implantation of the product and the additional risks and benefits due to the construction of the product and its activity in the body. They are the result of the delicate nature of some cell types and of the complexity of the tissue engineering process. The process of informing the participant should be designed in such a way that the participant's capacity to understand the intervention and its implications is enhanced. Crucial issues, such as the aim and procedure of the trial, the risks and benefits involved and the role of the investigator, have to be clarified. We suggest that participants' understanding of the trial can be enhanced through the use of audiovisual material, by developing a simple questionnaire to direct the information process further, and by the assistance of informed third parties to help participants in their decision-making processes.
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