ABSTRACT
A medicina regenerativa implica em uma mudança de paradigma, a regeneração do organismo ao nível celular ou tecidual – um assunto contemporâneo controverso e de difícil estandardização. O artigo apresenta um resumo das tendências científicas, econômicas, sociais e de regulamentação global nessa área, analisadas em relação a dilemas teóricos relevantes em antropologia médica e sociologia da ciência e da saúde. Em especial, aqueles que tratam da construção de um ‘aparato coletivo de sentido’ para as novas entidades biológicas e ontológicas, a formação da cidadania biológica e a governança pela incerteza. Apresentam-se, também, evidências empíricas sobre um fenômeno chave para a governança e a regulamentação, qual seja a instalação de uma nova demanda transnacional em pesquisa e saúde através de mercados paralelos de óvulos e de terapias celulares em experimentação. Utilizam-se dados qualitativos coletados para uma pesquisa mais abrangente, resenhas jornalísticas e entrevistas com lideranças internacionais. Conclui-se com uma reflexão sobre a importância da governança internacional em ensaios clínicos e dos caminhos a serem explorados, visando uma harmonização da diversidade de práticas normativas.
Regenerative medicine involves a paradigm change due to organism regeneration at cellular and tissue level – a controversial contemporary issue and difficult to regulate. This article presents a summary of the main scientific, economic, social and regulatory global trends, analyzed according to relevant theoretical dilemmas in medical anthropology and in the sociology of science and health. This is especially true of the construction of a ‘collective frame of reference’ on the new biological and ontological entities, the shaping of biological citizenship, and governance through uncertainty. Empirical evidence is also presented on a key aspect in regulation and governance, namely the emergence of a new transnational demand in health research through the establishment of parallel markets for ova and experimental cellular therapies. Qualitative data collected for a broader research paper is analyzed, as well as journal reviews and information gathered during interviews with international leaders. The paper concludes with a discussion on the importance on international governance of clinical trials and on further exploration, towards a multilevel harmonization of a diversity of normative practices.
Subject(s)
Humans , Animals , Male , Female , Adult , Mice , Adherens Junctions/metabolism , Cadherins/metabolism , Hair Cells, Auditory/metabolism , Postural Balance/physiology , Saccule and Utricle/metabolism , Adherens Junctions/ultrastructure , Animals, Newborn , Cell Count , Cells, Cultured , Hair Cells, Auditory/cytology , Hair Cells, Auditory/ultrastructure , Hair Cells, Vestibular/cytology , Hair Cells, Vestibular/metabolism , Hair Cells, Vestibular/ultrastructure , Mice, Transgenic , Saccule and Utricle/embryology , Saccule and Utricle/ultrastructureABSTRACT
BACKGROUND: Transtympanic administration of gentamicin may be suitable to achieve unilateral vestibular ablation, in order to control unilateral Ménière's disease. In low doses, gentamicin appears to affect selectively the vestibular system, with relative sparing of the cochlea. An experimental study on guinea pigs was conducted to determine what single dose of gentamicin would produce a unilateral vestibular organ lesion when applied to the middle ear. STUDY DESIGN: Experimental and prospective. METHODS: Four groups of guinea pigs received different gentamicin doses (1, 5, 10 and 25 mg) administered to the middle ear. The animals' vestibular organs were then assessed by scanning electron microscopy, in order to quantify the level of vestibular damage. RESULTS: Study of the utricular macula and the ampullar crista of the lateral semicircular canal revealed vestibular neuroepithelial lesions in all infused ears. CONCLUSIONS: The severity of the vestibular neuroepithelial lesions was dose-dependent. Lower gentamicin doses were observed to damage vestibular structures more than cochlear structures.