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The Tissue Engineering And Regulatory Framework


The enormous advances in knowledge in the field of cell biology and biotechnology has made it possible for the last 15 years, the development of technology for the cultivation and reconstruction “in vitro” of tissues and has made available to the community ‘medical new possibilities’ Therapeutic through the use of products that use cells obtained and / or tissues “ex vivo” from the same patient or donor and, in a smaller number of cases, of animal origin.

These technologies help to define a new branch of biomedical sciences: the tissue engineering. Tissue engineering allows the creation of biological substitutes functional and compatible that are able to restore the structure damaged or missing. The above engineering aims at creating in vitro tissue qualitatively and quantitatively adequate to meet the clinical needs, thereby overcoming the limitations of biomaterials eubiotic (derived from living things) and those xenobiotics (synthetic origin).

It ‘should be noted that products derived from engineering tissue can not be defined as drugs, nor are similar to transplants in the strict sense (eg. heart, kidney, cornea, bone, etc.), nor can be defined as artificial tissues (eg. valve prostheses), in that they are constituted by living cells isolated from tissue, expanded “in vitro”, possibly associated with biomaterials with different characteristics and origin. Skin repair and orthopedics were the first fields of application of the techniques of Tissue Engineering, and is still the area where the tissue-engineered products are more and more common in clinical practice.

Regulatory framework

Only in 1999, transplantation of tissues and cells was regulated by Law 91/99, which for the first time identified as Ttissue Banks regional structures for the collection, handling and distribution of human tissues. In 2003 were issued the “National Guidelines” delegated to the standardization of transplantation, particularly with regard to tissue and cellular manipulation.

Subsequently, in 2004, the European Commission has issued three directives (2004/23/EC, 2006/17/EC and 2006/86/EC), aimed at standardization of biobanking of tissues and cells, currently implemented by legislation in Italian Legislative Decree of 6 November 2007, n. 191 and in the Legislative Decree 25 January 2010, n. 16.

As regards the cell manipulation, have been identified two types of processing:

a)     Relevant manipulation, with which biological characteristics, physiological functions and structural properties of the cells, relevant to the purposes of regeneration, repair or replacement, have been altered.

b)     Manipulation not relevant, as specified in Annex 1 of the EC Regulation 1394/2007,

the products obtained by procedures of manipulation not relevant meet the requirements previously described for cells and tissues for transplantation, while the products obtained after considerable manipulation, based on to EC Regulation 1394/2007, are identified as advanced therapy medicinal products and, more specifically,

a)     medicinal products for gene therapy,

b)     medicinal products, somatic cell therapy and

c)     tissue engineered products.

The other criterion is that the cells are used in the receiver for functions that are not the same that had in the donor (not homologous use), as for example the administration of stem cells isolated from bone marrow and transferred to the patient’s heart (that is, in a home where they are not normally present) after a heart attack, with the aim of repairing the damaged heart tissue. The use not homologous, even if performed in the same patient, or the patient is donor and recipient at the same time, is considered an advanced therapy.

In this framework, the advanced therapy medicinal products are subject to specific regulations of biosafety before they can be marketed. In particular, they must obtain a marketing authorization granted by the European Medicines Agency (EMA), after a scientific assessment of the application, bound the execution of rigorous preclinical and clinical studies. The marketing authorization is valid throughout the European Union, and without prejudice to national laws on ethics that prohibit or restrict the use of specific types of human or animal cells, as well as the sale, supply or ‘use of medicinal products containing, consisting of or derived from these cells.

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