Trapianti ed ingegneria tissutale: Normativa e ricerca in Italia

Translated title of the contribution: Transplantation and tissue engineering: Italian law and research

P. M. Fornasari

Research output: Contribution to journalArticle

Abstract

The treatment with human cells for an increasing group of pathologies represents a field of the medicine in fast evolution, characterized by important clinical potentialities and expectations. The law regulating the field is different for cellular transplant and cell and/or tissue engineering. In the first case the transplant laws are applied (91/99 Italian Law and European Directive 2004/23/EC), while, in the second one, the transplant law applies only for the donation and appraisal of suitability of cells and tissues and the remaining activities answer to the pharmaceutical law being considered drugs for the somatic cellular therapy. Recently, the European Commission has published a proposal of regulation for the medicinal products of advanced therapy that comprises drugs for gene and somatic cell therapies and the products for tissue engineering. Such a proposal will have to be approved by the Parliament and the European Council and will be operative at the end of 2007.

Original languageItalian
Pages (from-to)174-178
Number of pages5
JournalArtroscopia
Volume6
Issue number3
Publication statusPublished - Dec 2005

Fingerprint

Tissue Engineering
Transplantation
Transplants
Research
Cell Engineering
Cell- and Tissue-Based Therapy
Pharmaceutical Preparations
Medicine
Pathology
Drug Therapy
Therapeutics
Genes

ASJC Scopus subject areas

  • Surgery

Cite this

Trapianti ed ingegneria tissutale : Normativa e ricerca in Italia. / Fornasari, P. M.

In: Artroscopia, Vol. 6, No. 3, 12.2005, p. 174-178.

Research output: Contribution to journalArticle

Fornasari, PM 2005, 'Trapianti ed ingegneria tissutale: Normativa e ricerca in Italia', Artroscopia, vol. 6, no. 3, pp. 174-178.
Fornasari, P. M. / Trapianti ed ingegneria tissutale : Normativa e ricerca in Italia. In: Artroscopia. 2005 ; Vol. 6, No. 3. pp. 174-178.
@article{2580500163f14a07a8462d8d5840295b,
title = "Trapianti ed ingegneria tissutale: Normativa e ricerca in Italia",
abstract = "The treatment with human cells for an increasing group of pathologies represents a field of the medicine in fast evolution, characterized by important clinical potentialities and expectations. The law regulating the field is different for cellular transplant and cell and/or tissue engineering. In the first case the transplant laws are applied (91/99 Italian Law and European Directive 2004/23/EC), while, in the second one, the transplant law applies only for the donation and appraisal of suitability of cells and tissues and the remaining activities answer to the pharmaceutical law being considered drugs for the somatic cellular therapy. Recently, the European Commission has published a proposal of regulation for the medicinal products of advanced therapy that comprises drugs for gene and somatic cell therapies and the products for tissue engineering. Such a proposal will have to be approved by the Parliament and the European Council and will be operative at the end of 2007.",
keywords = "Engineered cartilage, Law, Mesenchimal stem cells, Tissue engineering, Transplantation",
author = "Fornasari, {P. M.}",
year = "2005",
month = "12",
language = "Italian",
volume = "6",
pages = "174--178",
journal = "Artroscopia",
issn = "1591-1489",
publisher = "Mattioli 1885 S.p.A.",
number = "3",

}

TY - JOUR

T1 - Trapianti ed ingegneria tissutale

T2 - Normativa e ricerca in Italia

AU - Fornasari, P. M.

PY - 2005/12

Y1 - 2005/12

N2 - The treatment with human cells for an increasing group of pathologies represents a field of the medicine in fast evolution, characterized by important clinical potentialities and expectations. The law regulating the field is different for cellular transplant and cell and/or tissue engineering. In the first case the transplant laws are applied (91/99 Italian Law and European Directive 2004/23/EC), while, in the second one, the transplant law applies only for the donation and appraisal of suitability of cells and tissues and the remaining activities answer to the pharmaceutical law being considered drugs for the somatic cellular therapy. Recently, the European Commission has published a proposal of regulation for the medicinal products of advanced therapy that comprises drugs for gene and somatic cell therapies and the products for tissue engineering. Such a proposal will have to be approved by the Parliament and the European Council and will be operative at the end of 2007.

AB - The treatment with human cells for an increasing group of pathologies represents a field of the medicine in fast evolution, characterized by important clinical potentialities and expectations. The law regulating the field is different for cellular transplant and cell and/or tissue engineering. In the first case the transplant laws are applied (91/99 Italian Law and European Directive 2004/23/EC), while, in the second one, the transplant law applies only for the donation and appraisal of suitability of cells and tissues and the remaining activities answer to the pharmaceutical law being considered drugs for the somatic cellular therapy. Recently, the European Commission has published a proposal of regulation for the medicinal products of advanced therapy that comprises drugs for gene and somatic cell therapies and the products for tissue engineering. Such a proposal will have to be approved by the Parliament and the European Council and will be operative at the end of 2007.

KW - Engineered cartilage

KW - Law

KW - Mesenchimal stem cells

KW - Tissue engineering

KW - Transplantation

UR - http://www.scopus.com/inward/record.url?scp=33645935104&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33645935104&partnerID=8YFLogxK

M3 - Articolo

AN - SCOPUS:33645935104

VL - 6

SP - 174

EP - 178

JO - Artroscopia

JF - Artroscopia

SN - 1591-1489

IS - 3

ER -