TABLE 4.

Points to consider in relation to risk-benefit assessment.

Points to consider in relation to risk-benefit assessment
- Researchers should provide robust pre-clinical data (i.e. safety and efficacy of the product should be rigorously demonstrated in laboratory tests and animal models)
- Personalization of the bio-artificial organ makes the product variable; therefore, the quality control and safety requirements of mass manufacturing do not apply
- Researchers should monitor and follow up participants for a long time after the study
- Efforts should be made not only to minimize the risks, but also to maximize the scientific and social value of a trial, in order to improve the risk-benefit ratio
- Clinical teams who conduct clinical trials of bioartificial organs should have experience with regenerative medicine technologies and with post-trial follow-up care