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FEAM Stem Cells final document/consensus Conclusions: -Consensus document to be approved in Lisbon -Questions to the today speakers -Document sent to the Natl Academies -Final document in Lisbon [cohordinated by L. Frati] i.Experimental/embryonic [van Steirteghem] ii.Somatic/Bone marrow/etc./Therapeutic [Frati] iii.Ethical [Soares, Lachaman] iv.Legal [Soares, Lachman]
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Questions to send to the speakers of the sessions about perspectives-rules for hSTs therapy 1.Experimental/embryonic: -European registry: celle lines selected, modified [asking to SANCO for a FEAM independent representative?] - FEAM consensus on… i.toxicology/tumor risk: on SCID mice? [standardization: how many mice, how long time: 3-6 months? amounts of cells] ii.effectiveness/efficacy on…: neurodegenerative diseases, heart, genetic diseases [model]
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Questions…. 2. No-embryonic [adult/somatic, cord blood, bone marrow, amniotic fluid]: European registry [to SANCO: FEAM independent representative?]: -toxicology/tumor risk/SCID mice [standardization] -efficacy: mandatory in large animals [dogs, sheeps, pigs] [see the guidelines of US Natl Acad Sci, International Stem Cell Forum] -Clinical outcome measures: standardization -Therapy rules: Like orphan drug? Or cell [blood, bone marrow] transfusion-transplantation -Ethical aspects -Legal aspect -SANCO or EMEA?
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Dinner - Villa Sospisio (Trastevere) [house and gardens – 8.00 p.m.] Via. S. Francesco di Sales 20-23 [one way - may be 200 mt by walking] Bus will leave from Casa dellAviatore, Viale dellUniversità 7.30 p.m. Then, the bus will go to: -Hotel Globus 7.40 p.m. -Casa dellAviatore, Via Spallanzani 7.45 p.m.
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