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Tissue engineering Opportunities and challenges in clinical practice

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Tissue and cell banking directive in the spirit of GMP (effective April ... Fascia lata. Skin. Legislation. Tissue engineering directive. under preparation. FDA ... – PowerPoint PPT presentation

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Title: Tissue engineering Opportunities and challenges in clinical practice


1
Tissue engineering- Opportunities and
challenges in clinical practice
  • Prof. Riitta Suuronen, MD, DDS, PhD
  • REGEA - Institute for Regenerative Medicine
  • University of Tampere

2
Tissue engineering
  • Restoring cellular
  • and / or
  • organ functions
  • that have been lost as a result of
  • injuries
  • or
  • other diseases

3
Legislation
  • 2000 / 70 / EC
  • Medical devices incorporating human plasma
    derivatives
  • 2001 / 83 / EC
  • Some cell therapy products
  • 2002 / 98 / EC
  • Blood directive
  • 2004 / 23 / EC
  • Tissue and cell banking directive

4
Current treatment / 1
5
Current treatment / 1
  • prosthetic implants

6
Current treatment / 2
  • tissue grafts
  • autologous

7
Current treatment / 3
  • tissue grafts
  • tissue banks
  • 2004 / 23 / EC
  • Tissue and cell banking directive in the spirit
    of GMP (effective April 1st 2006)
  • Sets standards of quality and safety for the
    donation, procurement, testing, processing,
    preservation, storage and distribution of human
    tissues and cells

8
The Clinical Tissue Bank
  • Bone
  • Cornea
  • Amniotic membrane
  • Cardiac valves, Aortic blocks, Pericardium
  • Cartilage
  • Fascia lata
  • Skin

9
Legislation
  • Tissue engineering directive
  • under preparation
  • FDA
  • regulation of human tissues, cells, and
    cellular-and tissue-based products
  • based on the level of risk
  • minimally manipulated GTP
  • more than minimally manipulated - GMP

10
Tissue engineering- custom made spare parts from
the store?
11
Tissue engineered finger joints
12
In the future
  • Specialized units
  • collaborating networks
  • utilizing each others core knowledge and
    competence

13
Future challenges
  • there is a need for reconstruction of form and
    function
  • close collaboration between clinicians and
    researchers is essential for optimal outcome
  • experts from all fields of tissue engineering are
    needed in the development of the perfect cure

14
Future challenges
  • safety
  • availability
  • logistics
  • surgical expertise
  • Centralized systems
  • quality control
  • Proper legislation
  • not hindering the development of new products
  • not delaying the clinical use of new products

15
Future challenges
  • Funding
  • national and EU focus on tissue engineering
  • major US and Japanese funding

16
Unmet clinical need
S.Freud oral cancer
17
Finland
  • Several research groups working on tissue
    engineering in several cities
  • A close collaboration between engineers, doctors
    and scientists
  • European wide networking is required to achieve
    best results

18
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