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    Membrana amniótica para utilização em oftalmologia: aspectos técnicos e regulatórios
    (Universidade Federal de São Paulo (UNIFESP), 2016-01-27) Matarezio, Juliana Cristina Lopes [UNIFESP]; Gomes, Jose Alvaro Pereira [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)
    Amniotic membrane (MAO) human has been widely used in regenerative medicine, particularly in the field of ophthalmology. It is used as a tissue repair to contain various growth factors, macromolecules important in tissue wound healing and anti-inflammatory properties. According to the literature, the MA is used for reconstruction of the ocular surface for treating various diseases such as pterygium, tumor symblepharon, bullous keratopathy, trophic ulcer and limbic stem cell deficiency. More recently, the MA is being used as a substrate for ex vivo expansion of stem cells for cell therapy in ocular surface reconstruction in patients with limbal stem cell deficiency. Objective: To study the technical and regulatory aspects of the tissue bank with MA database implementation purpose for use in ophthalmology. Methods: Study and description of existing guidelines in the resolutions of the executive board, issued by the National Agency of Sanitary Surveillance, ordinances issued by the ministry of health as regards the functioning of all banks of human tissues, standards of the American Association of Tissue Bank , European association standards tissue bank and literature review of scientific papers related to the area. In addition, visits were made in functioning tissue banks for monitoring in situ of the donor screening procedures, capture, preservation and distribution of tissues for transplantation. Results: To provide tissue for transplantation safely and reliably, tissue banks follow manual of good practices internationally recognized and standard operating procedures (SOP) established by banks, respecting their institutional rules and national regulatory agencies. It was observed that the standardization of procedures is very important to ensure the safety of the tissue and the patient. Rules for the structure, suitable area for each processing, the air conditioning system with positive pressure are important factors that must comply with ANVISA. Conclusion: The use of MA has been established as an alternative in the treatment of ocular surface diseases. Despite some differences in the protocols to preserve the MA, the collection, preparation, storage and tracking should follow national and international current regulations to ensure the safety of its use in ophthalmology. To this end, it is imperative to deploy physical and administrative structure appropriate, which should become compulsory in the new tissue bank legislation in the country. Google Tradutor para empresas:Google Toolkit de tradução para appsTradutor de sitesGlobal Market Finder