Stem Cell Research at EU level

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Stem Cell Research at EU level

• Dr. Gwennaël Joliff-Botrel
• Health Research Directorate
• European Commission

Moscow 16 March 2007
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• SC research funded at EU level
• The case of human embryonic stem cell (hESC)
  research / EU picture / worldwide picture EU
  policy
• The future ? FP7

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SC research funded at EU level
FP5 (1998-2002) ? ? 50 RD projects with at
least one component of SC research / EC
contribution ? 86 million ? Over 95 of
projects only involved somatic SC. ? 2
projects also involved hESC.
FP6 (2002-2006) ? ? 100 RD projects with at
least one component of SC research / EC
contribution ? 500 million ? more than 80
of projects only involved somatic SC. ? 18
projects also involved hESC.
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SC research funded at EU level
Previous ProgrammeFP5 (1998-2002)

• Fundamental research on differentiation
• - neural SCs, mesodermal SCs, insulin-
• producing islets.
• Tissue engineering - cartilage, bone, skin.
• Haematopoietic SC therapy - bone
• marrow cord blood transplantation.
• Ethical, legal social research aspects

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SC research funded at EU level
Current Programme FP6 (2002-2006)

• same research fields than in FP5, but more new
  developments
• in Fundamental research (functional genomics,
  from animal ESC to hESC, epigenetics)
• in Tissue engineering (nanotechnologies)
• towards clinical applications
• 2 new topics drug discovery in vitro
  toxicology

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SC research funded at EU level
Current Programme FP6 (2002-2006) projects
involving hESC

• 1 project targets a technical issue how to
  store stem cells in banks (cryobanking)
• 2 projects aim at evaluating/comparing
  properties of hESC and foetal stem cells from
  umbilical cord blood
• 3 projects only deal with fundamental research
  aspects (study of lymphatic vasculature/characteri
  sation of existing hESC lines/study of regulatory
  RNAs)
• 5 projects target in vitro research in view to
  replace animal experimentation on toxicology
  related to drug testing or drug development.
• 7 projects mix aspects of fundamental research
  and aspects of translational research (from basic
  research to clinical applications) towards
  specific diseases (skin, musculoskeletal,
  neurodegenerative including Huntington's disease,
  heart, hearing impairments, stroke, diabetes).

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SC research funded at EU level
104 FP6 projects involving stem cells
UNDERSTANDING Fundamental knowledge relevant to
human health
DEVELOPING Tools for new therapies and medicines
BUILDING Tissue engineering
MODELLING Mathematical biology
models,alternatives to animals testing
REPAIRING Pre-clinical clinical studies for
diseases and impairements
TREATING Improvement of standard hematopoeitic
SC transplantation
INTEGRATING Ethics, legal, societal aspects,
training
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SC research funded at EU level
FP6 projects type of cells/tissues/organs
Nervous system annexes
Skin/other epithelium tissues
Bone/other connective tissues
Heart vasculature
Digestive urogenital tracts
Blood immune system
Cancer
Heritable Rare Diseases
Basic or horizontal issues
http//europa.eu.int/comm/research/stemcells
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SC research funded at EU level
Changes between FP5 FP6

• Change in size
• significant increase of SC research
• funded at EU level ( X 6)

• Change in nature
• FP6 new instruments (?25 partners / ? 10 million
  /i.e. ? 100 000 per partner/year for 4 years)
  help to
• Comparison of SC from different origins
• Translational research

? Stem cell research is a field where cooperation
at EU is of clear added value
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hESC research

• hES cell research
• the point of discussion

Ref. Anke Guhr, Andreas Kurtz Peter Löser Stem
Cells 2006
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hESC research

• Publication average impact of hESC papers is
  very high (6.03) outstanding interest
• Number of lines ? 414 hESC lines from at least
  20 countries
• Only 43 in peer-reviewed
• H9 the most frequently used, then H1 (in 2005,
  big change)
• Less than 10 free of animal feeder
  animal-derived serum but not animal free or
  xenofree
• 27 hESC lines with genetic defects

Ref. Anke Guhr, Andreas Kurtz Peter Löser Stem
Cells 2006
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hESC research
Citizens Opinion
Extracted from Eurobarometer surveys on
biotechnology published in June 2006 (ref.
Eurobarometer 64.3)
? 59 of the European citizens are supportive
provided it is regulated

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hESC legislation
FI, DK, FR, LV, EE, SI, EL, ES, HU, NL, CZ, PT
CH NO
AT,PL,LU LT,SK,MTCY, IE, BL RO,
BE, SE, UK, Israel
DE, IT
European Picture
No research on hESC
Broader research on hESC
Brazil Canada Taiwan
USA non-federal funds China, India Singapore,
Japan South Korea, Australia
USA federal funds
non-EU Member States
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hESC research EU overview
The other 14 EU-Member States have no specific
legislation on this issue
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hESC research EU policy

• EU has no legal competency to regulate in this
  sector of ethics

• The Commission has the responsibility to
  implement the EU research programs even where
  some areas of research raise important ethical
  issues.

• Respect of national rules is a fundamental
  principle ? no research forbidden in a Member
  State supported by EU funds there

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hESC research EU policy

• Ethical framework
• 3 areas are excluded from funding
• Human reproductive cloning
• Intentional Germ line modification
• Creation of human embryos for research (including
  by means of SCNT)

Political compromise research activities
destroying human embryos are excluded from
Community financial support ? hESC in culture
Research relating to cancer of the gonads can
be financed
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hESC research EU policy

• Current Procedure
• Case-by-case evaluation
• Must be scientific justification
• Systematic Ethical review at EU level
• Respect of national law
• Source
• Informed consent
• Protection of personal data
• Nature of financial inducements, if any
• Approval by the Regulatory Committee
• Approval by the relevant national or local ethics
  committees (double ethical review)

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hESC research EU Policy

• Creation of a European hESC registry
• to gather the information on all the European
  lines
• in order to maximise the use of existing ones
• to disseminate the information to all the
  scientific community
• to favour the comparability of results
  (standardisation)

Consortium with a representative from all EU
Member States where this research is performed
(including Turkey, Israël and Switzerland) ? FP6
Project that started March 2007
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SC Research the Future FP7 (2007-2013)

• Collaborative research
• Health (6.1 billion)
• Basic research and applied research (emphasis on
  translational research)
• Nanonosciences, nanotechnologies,
• Materials/New Production
• Technologies (3.5 billion)
• ?Tissue engineering
• European Technology Platform on Nanomedicines ?
  strategic research agenda that includes
  Regenerative Medicine http//cordis.europa.eu/nano
  technology/nanomedicine.htm

European Research Council