Farhad HESHMATI, MD. PhD · technique for the treatment of Rheumatoid Arthritis : MNC collection by...
Transcript of Farhad HESHMATI, MD. PhD · technique for the treatment of Rheumatoid Arthritis : MNC collection by...
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Farhad HESHMATI, MD. PhDCochin Hospital, Paris, France
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Conflit d’intérêt dans les 2 dernières années
• Macopharma : Conférencier
Farhad Heshmati, SFH 2018
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Therakos, UVAR 1 device
1986, For the treatment of Sezary
Pr R L Edelson, USA
1982, Extracorporeal
irradiation of Sezary
cells by UVA
Oral Psoralen
Photopheresis
Farhad HESHMATI.DIU aphérèse 2018
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1990,
to improve photopheresis, F
Heshmati & G Andreu
propose the French
technique or VL-Cobe
technique for the treatment
of Rheumatoid Arthritis :
MNC collection by Cobe Spectra
UVA irradiation by Vilber-Lourmat
device
Psoralen directly in the irradiation
bag
Dr F
Heshmati
Extra Corporeal
Photochemotherapy
Farhad HESHMATI.DIU aphérèse 2018
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Techniques off-line
•3 étapes séparées
•Recueil de CMN
•Transformation
•Réinjection
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1ère étape : Cytaphérèse
•Comme un don en cytaphérèse
• 1, à 3 heures (deux masses, une masse, un cycle, ..)
• Séparateurs de cellules disponibles
Plasma
Sang
Cobe
Spectra
Optia
SpectraComtec
AmicusComtec
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Poche de MNC
Off-lin techniqueMerci aux IDE de Cochin
Nombre important de Cellules collectéesRichesse en CMN (> 90%)
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1ère étape : Cytaphérèse
•Comme pour le recueil des cellules souches, on n’utilise pas un kit avec aiguille intégrée ; le système n’est pas entièrement Clos
Farhad Heshmati, SFH 2018
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Techniques off-line : Transformation« Phase problématique »
•Transfert des CMN dans la poche d’illumination
•Addition du 8-MOP
•Ajustement du volume par NaCl physiologique (oui ou non)
• Illumination (irradiation)
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Transfert des CMN dans la poche d’illumination
• Initialement en “ouvert”, mais propre,
•Actuellement: en condition stérile
• Soit dans les labos de TC
• Soit par la connexion stérile
Farhad Heshmati, SFH 2018
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échantillonnage
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Connexion stérile
SFH 2014, Maison Internationale Paris
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13
La soudure
c. Arnaud IDE, 2012
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Transfert des cellules
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8-MOPs disponibles
•Uvadex : réservé pour la technique On-line
•Méthoxalene de chez macopharma : arrêt de fabrication
• SALF : statut de PTA
•8-MOP de Gerot (pas d’autorisation pour la France)
•Fabrication hospitalière : non autorisée
•Forme per-os : non souhaitéFarhad Heshmati, SFH 2018
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Addition du 8-MOP « remarques »
•Un produit cellulaire ouvert peut être utilisé pendant 6 heures sous règles de la transfusion
•Aucune contamination bactérienne par injection directe dans la poche (système on-line, off-line dans les autres pays, et la période initiale)
•Utilisation du filtre anti bactérien
• Il ne faut pas encourager la voie per-os
Farhad Heshmati, SFH 2018
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Ajustement du volume par saline(oui ou non)
• Injection du saline via le filtre anti bactérien de la poche du recueil
•Technique Classique : ajustement du volume pour atteindre 300 ml
•Dans certains centres 150 ml
•Dans la nouvelle variante de « PCE petite volume pas de saline
Farhad Heshmati, SFH 2018
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Transformation: phase d’illumination
• Illuminateurs disponibles:
•Macogenic
• PIT
• Combilight (pas en France)
•Nouveau dispositif italien en cours de marquage CE
Farhad Heshmati, SFH 2018
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Techniques Off-line 1ère génération
•Mise au point en 1990
• Illuminateur Vilbert-Lourmat
•Recueil de cellules : Cobe Spectra
•Poche d’illumination : Macopharma
•Psoralène :
• préparation hydro soluble
• Directement injecté dans la poche
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Techniques Off – line PIT
•PIT : Photo Immuno Therapy
• Illuminateur
• Petit
• Durée d’illumination est calculée par le volume de collecte & et sa densité optique
• Filtre anti bactérien intégré
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Technique « On-line »PIT & cobe Spectra
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3ème étape: Réinjection
•Comme une autotransfusion
•15 à 30 min
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Pourquoi la technique off – line est une TC mais pas celle de « On – Line »• L’Ouverture ?
• Statut de 8-MOP ?
• Uvadex : Médicament
• Méthoxalène : PTA
• Statuts de Dispositif médical de « on – line » ?
• Séparation des étapes ?
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Un système ouvert ou semi- ouvert
• Travail sous PSM « classe A » dans une pièce « Classe D »
• Hémoculture systématique de la poche finale, quelle utilité ?
• Un labo de TC n’est pas disponible dans tous les hopitaux
• Distance, durée de transport, cout, etc.
• Travailler sans autorisation de l’ansm
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PSM agréé par l’afssaps
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MERCI POUR VOTRE ATTENTION
Farhad Heshmati, SFH 2018