The Italian Tissue Engineering (TE) and Regenerative Medicine (RM) Network
The Italian Tissue Engineering(TE) andRegenerative Medicine(RM) Network Claudio Zanon Director of the Piedmont Health Agency Director of the National TE-RM Group
What is Tissue Engineering?Tissue engineering is the development and manipulation of laboratory-grownmolecules, cells, tissues, or organs to replace or support the function ofdefective or injured body parts. It is the field of study that requires input from many types of scientists,including the problem solving expertise of engineers, hence the name: tissueengineering
Regenerative Medicine• Tissue engineering has emerged as a field to replace tissues and organs lost by disease, trauma, or congenital abnormalities.• Attempts have been made to engineer many tissues including skin, cartilage, bone, nerve, cardiovascular valves and conduits, and liver. But the work is in progress……
And more….• We look forward to the development of effective therapies for:1. degenerative diseases, traumatic injuries, and disorders for which limited therapeutic options exist such as esophageal cancer or emphysema.2. The derivation of blood cells from stem cells, the creation of insulin-secreting, glucose-responsive cells for the treatment of diabetes, the constructive functional remodeling of the heart after a myocardial infarction, and the regeneration of nerves after spinal cord injury all represent realistic targets for regenerative medicine.
State of Art• The 1980s and 1990s were the “go-go years” of tissue engineering, but by the turn of the century commercial activity had encountered a variety of problems, including challenging regulatory hurdles and almost nonexistent third-party reimbursement mechanisms needed to sustain the commercialization effort.• In April 2008 U.E. and in Italy the Minister of Health introduced the concept of “Tissue Enginneered Products (TEPs) in the field of the”Advanced Therapy Medicinal Products (ATMPs) already regulated in the 2001, as a indipendent productal class(Tissue Engineered Products) different from somatic cellular therapeutic products and the genetic therapeutic products• Three different products are now described 1) Gene therapy products, 2) Somatic cell therapy products;3) Tissue Engineered Products.• In USA from 2000 is operating the M.A.T.E.S. (Multi-Agency Tissue Engineering Science) to coordinate the national activities in the field of Tissue Engineering e Regenerative medicine.
M.A.T.E.S.• The MultiAgency Tissue Engineering Scienee (MATES) Interagency Working Group (lWG), organized under the auspices.of the Subcommittee on Biotechnology of the National Science and Technology Council (NSTC), is the means by which Federal agencies involved in tissue engineering stay. informed of each others activities and coordinate their efforts in a timely and efficient manner.• The goals of theMATES IWG are:1. • To facilitate communication across departments/agcncies by regular information exchanges and a common website2. • To enhance cooperation through co-sponsorship of scientific meetings and workshops, and facilitation ofthe developrnent of standards3. • To monitor technology by undertaking cooperative assessments of the status of the field4. • To provide for support of tissue engineering research through interagency tissue engineering funding opportunity announcements
Tissue-Net• Tissue –Net is the Italian M.A.T.E.S. born to reach the same goals• The Tissue-Net task is:1. To verify Tissue Engeenering(TE) and Regenerative Medicine (RM) centers operating in the field2. To record the Italian TE-RM clinical trials3. To avoid me too basic and translational researches4. To focus the different centers on different activities5. To distribute the national public funds as the agreed national program6. To verify the skill and the technology of the TE-RM centers7. To integrate our center in an international and/or European network
Italian TE-RM Centers• 1. Tissue Net (10 Italian centers)• 2. Centro di Ingegneria tessutale dell’Università di Pavia• http://cit.unipv.it/cit_it/• 3. Il CENTRO di RICERCA INTERDIPARTIMENTALE sui BIOMATERIALI (CRIB)• http://www.crib.unina.it/• 4. Centro di Nanomedicina e Ingegneria dei Tessuti dal 2008 Ospedale Riguarda Ca’ Granda Milano• http://www.ospedaleniguarda.it/• 5. Struttura Semplice di Patologia Ortopedica e Rigenerazione Tissutale Osteoarticolare Istituto Ortopedico Rizzoli, Via di Barbiano 1/10 40136 Bologna• http://www.ior.it/curarsi-al-rizzoli/patologia-ortopedica-e-rigenerazione-tissutale-osteoarticolare• 6. San Raffaele del Monte Tabor -Ingegneria Tissutale e Biomateriali• http://www.sanraffaele.org/home/ricerca/divisioni_centri_istituti_programmi/BoNetwork/ingegnaria_tissutale_biomateriali.html• 7.Istituto Mario Negri Milano• http://www.marionegri.it/mn/it/sezioni/istituto/strutturaDipa.html• Banche dei tessuti:• Pagina del Ministero della salute• http://www.trapianti.salute.gov.it/cnt/cntDettaglioMenu.jsp?id=59&area=cnt- tessuti&menu=menuPrincipale&sotmenu=istituzioni&label=mti• Fondazione Banca dei tessuti di Treviso• http://www.fbtv-treviso.org/• Associazione Ingegneria dei tessuti ONLUS• http://www.ingegneriatissutale.it/chi-siamo.html
Conclusions• Many centers are active in the TE-RM researches working as “somatic cell therapy products (SCTP)” centers and manufacturing TE product for clinical applications (up to now we don’t register any authorised national phase 1 clinical trials in the TE-RM field)• We are recording the GMP laboratories comparing their activities and sites with the TE-RM or SCTP centers• We are programming the activities of every center to avoid me too researches and the public funds dispersion incouraging national and european collaborations