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The Reason for the Conference

All conferences not only contribute to increase new understandings about a research field, they also establish links among experts and, as a result, consolidate scientific cooperation and exchange among different institutions.
This is even more so about the “Regenerative Surgery” conference, where the topic addressed is an emerging and evolving scientific area. I am sure that in the following years, as statistics forecast, regenerative surgery will revolutionize medicine and surgery, providing solutions to pathologies with chronic and invalidating course that are now incurable.

The conference, given the peculiarity of its theme, will take place in the form of lectures, delivered by the most influential national and international researchers. They will try to evaluate the current situation of research and its clinical applications, and to establish collaborations and scientific information exchanges among young researchers.

To take the stock in terms of stem cell and tissue production - a field of great interest but not entirely mastered yet - is surely important from the research point of view, but also from the clinical and biotechnological ones.
It is necessary, though, to place appropriate and competitive structures at the researches' disposal, especially at the young ones.

The task of the Tissue Banks and GMP Laboratories is to process, procure, preserve and distribute tissues, and to certify that they are suitable and safe. Their optimal catchment area is about 18 millions inhabitants.
Currently, Tissue Banks and GMP Labs are located on the national territory in a small and insufficient number. They are only found in a specific area - the northern part of Florence - thus underlying the problem of a two-speed country. The 31/3/2004 Directive of the European Parliament and European Council recommends that Regions start instituting such high technology centres - either on their own or in case of poor catchment areas, associated in consortiums - and setting the regulation for processing, preserving, storing and distributing human cells and tissues (GMP). Regions should have applied such Directive by April 2006.

The current legislation classifies living cells manipulated in vitro able to carry out therapeutic, diagnostic or preventive functions in human beings as medical products to all intents and purposes. Such a classification implies that these products – whether they are employed as products for clinical research or other clinical performances – should be manufactured by structures authorized or licensed by the competent authority (Agenzia Italiana del Farmaco, AIFA). The manufacturer should comply with the standards established by European guide lines of Good Practice (GMP) about sterile medical products for inoculation.

By 1 January 2009, that is when the European regulation for advanced drugs becomes effective, all advanced medical products – somatic cellular therapy, gene therapy and tissue engineering – should be produced in authorized structures.

In addition to the Bank, the structure designated to preserve and distribute soft tissue-like and skin will be equipped with a Cell Workshop, a Pharmaceutical Production centre suitable for the manipulation of cells and tissues in sterile conditions that will produce advanced medicinal products, both experimental and consolidated ones. It will be an authorized structure complying with the Directive standards for the production of medical products (LD 178, 15/06/1991).
A laboratory for skin culture that is also carrying out research, ensures a technologically advanced therapy for serious pathologies, such as serious burns - patients with third degree burn on 70% body surface who, without a cultivated skin transplant, do not have survival chances – diabetic foot and torpid ulcers.

The latter produce expenses amounting to 3% of total national healthcare costs, without remission of seriously invalidating pathology, while cultivated skin transplant ensures a high percentage of recovery.

Furthermore, the GMP workshop authorized for tissue cultures is useful to revitalize other graft tissues too, like cornea and bone, thus being supportive to cornea and skeletal muscle banks.
Such GMP workshop will be able to develop the production of other tissues - like heart valves and vessels – and research the use of stem cells on solid tumours. In short, the GMP workshop is a support to all Regenerative Medicine and Surgery, which have already become a therapy and will be increasingly developed in the immediate future. The GMP workshop is also a source of advanced research, connecting to the best international institutes working in the field, and it is open to all researchers wishing to commit to cell and tissue culture, especially to the young ones.

This is the frame where the need for developing Regional multifunctional and multidisciplinary structures takes place in; that is, an alliance between public bodies and private companies aiming at prevailing over mutual lacks and magnifying individual benefits.
Such high technology structures will serve as a way to keep us competitive on a domain so highly emergent and evolving, and also to prevent our best young from migrating to other structures.

Honorary Chairman
Prof. C. U. Casciani