EuroBioForum 2012 | 18 April 2012 Presentation by Claudio Zanon, Director General of Agency of Regional Health Services – Piedmont

1. The Italian Tissue
Engineering(TE) and
Regenerative Medicine(RM)
Network
Claudio Zanon
Director of the Piedmont Health
Agency
Director of the National TE-RM Group

2. What is Tissue Engineering?
Tissue engineering is the development and manipulation of laboratory-grown
molecules, cells, tissues, or organs to replace or support the function of
defective 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: tissue
engineering

3. Rationale Design of Tissue
Engineering

4. 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……

5. 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.

6. 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.

7. 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 other's 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 website
2. • To enhance cooperation through co-sponsorship of scientific meetings and
workshops, and facilitation ofthe developrnent of standards
3. • To monitor technology by undertaking cooperative assessments of the status
of the field
4. • To provide for support of tissue engineering research through interagency
tissue engineering funding opportunity announcements

8. 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 field
2. To record the Italian TE-RM clinical trials
3. To avoid me too basic and translational researches
4. To focus the different centers on different activities
5. To distribute the national public funds as the agreed
national program
6. To verify the skill and the technology of the TE-RM
centers
7. To integrate our center in an international and/or
European network

9. 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

10. 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