Deze samenvatting bevat notities aan de hand van de slides uit de lessen van het vak Medische Celbiologie, gegeven door de titularissen Eva Lion, Evelien Smits en Bert Van den Bogerd. De samenvatting is opgesteld in het Nederlands en is specifiek gericht op de afstudeerrichting "Moleculaire Mechani...
1.1.3 Celtherapie: De vierde pijler van de gezondheidszorg ......................................................... 2
1.2 Juridisch kader voor geneesmiddelen voor menselijk gebruik.............................................. 2
1.2.1 54 jaar: mijlpalen in de EU-regelgeving voor geneesmiddelen.............................................. 2
1.2.2 Juridisch kader ATMP van EMA .......................................................................................... 6
1.2.3 Clinical trial...................................................................................................................... 6
1.2.4 Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG) ................. 6
1.3 Advanced Therapy Medicinal Products (ATMPs) .................................................................. 8
1.3.1 ATMP's - Geneesmiddelen voor menselijk gebruik die zijn gebaseerd op genen, weefsels of
cellen 8
1.3.1.4 Gecombineerde ATMPs (cATMP) .................................................................................. 10
1.3.2 Regelgeving voor cel-gebaseerde producten .....................................................................11
1.3.3 Celgebaseerde geneesmiddelen zijn heterogeen ..............................................................13
2.1 Good Manufacturing Practices (GMP) ................................................................................ 14
2.1.1 Regelgeving .....................................................................................................................14
2.1.2 Belangrijke verschillen tussen celgebaseerde therapieën en traditionele geneeskunde.......15
2.1.3 Complexiteit van celtherapie ...........................................................................................17
2.1.3.1 Testen van de karakterisering van celproducten............................................................ 17
2.2 Clinical trials en Good clinical practices (GCP) .................................................................. 20
2.2.1 Overgang van ontdekking naar testen op mensen ..............................................................20
3.2.3.9 Verkrijgen van TX product ............................................................................................ 31
3.2.4 Complicaties ..................................................................................................................32
3.2.5 Effecten op de outcome van allo-HSCT .............................................................................34
3.2.5.1 Het humaan microbioom ............................................................................................. 34
3.2.5.2 Immunologische homeostase in de darm ..................................................................... 34
3.2.5.3 Effecten op de outcome van allo-HSCT ........................................................................ 34
4.2.1.4 Interacties tussen het aangeboren en verworven immuunsysteem als respons op een
infectie 41
4.2.1.5 Wat zijn de stappen in celtherapieprocessen? .............................................................. 41
4.2.2 Cel bron ..........................................................................................................................42
4.2.2.1 Wat zijn de soorten celbronnen? .................................................................................. 42
4.2.2.4 Uitdagingen en tactieken voor autologe en allogene therapieën ..................................... 43
4.2.3 Cel isolatie ......................................................................................................................44
4.3 Strategieën voor immuuncelengineering ........................................................................... 46
4.3.1 Enkele concepten in genetische engineering .....................................................................46
4.3.2 Gen transfer ....................................................................................................................47
4.3.2.1 Classificatie van genengineering strategieën ................................................................ 47
4.3.2.3 Non-virale gen delivery ................................................................................................ 49
4.3.3 Gen editing......................................................................................................................50
5.2 Multiple sclerose (MS) ...................................................................................................... 63
5.2.1 MS symptomen ...............................................................................................................63
5.2.2 Immunopathogenese van MS ...........................................................................................64
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