Features of ethical expertise in planning and conducting clinical research in regenerative medicine



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Abstract

Nowadays we are dealing with a new level of biomedical
science, that is «regenerative medicine», which provides
opportunities for new treatments and the prolongation of
human life. It demands that new evaluative criteria, both
ethic and regulatory should be worked out and the society,
scientific institutions and local authorities should respond in a
quick and adequate way.
The authors, who are working in the frame of Megagrant
Project of the Russian Government on creating Research,
Education and Clinical Center of Regenerative Medicine,
consider that one of the major tasks is regenerative medicine
approaches to be governed by precise ethical guidelines,
and social and cultural aspects. So, the first target of this
collaboration is to define regulations and address ethical
issues governing the field of bioengineered organs and tissues
(simple or complex), both in the field of research and clinic.
They present information about clinical application of tissue
engineering in the world together with the summary of
experience how regulations and authorities in Europe involving
regenerative medicine approaches for Human Subjects.
The authors presented the list of ethical rules for scientific
research and clinical application in the field of regenerative
medicine.

About the authors

P Macchiarini

Advanced Center of Translational Regenerative Medicine, Karolinska Institute, Stockholm, Sweden

Advanced Center of Translational Regenerative Medicine, Karolinska Institute, Stockholm, Sweden

E Kondratieva

Kuban State Medical University of the Ministry of Healthcare and Social Development of the Russian Federation, Krasnodar

Kuban State Medical University of the Ministry of Healthcare and Social Development of the Russian Federation, Krasnodar

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