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All’avanguardia nelle terapie cellulari : Istituto Cardiocentro Ticino
Per urgenza 24h centralino: +41 (0) 91 805 31 11 info@cardiocentro.org
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All’interno di quest’area troverà tutte le informazioni utili che hanno lo scopo di rendere più confortevole il suo soggiorno all'Istituto Cardiocentro Ticino.

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Grazie alla sinergia di cardiologi, cardiochirurghi e cardioanestesisti, l'Istituto Cardiocentro Ticino mette a disposizione tecniche chirurgiche sempre meno invasive e le più aggiornate procedure interventistiche.

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L'Istituto Cardiocentro Ticino si è da sempre dedicato con impegno alla ricerca e all’innovazione

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In quest’area troverà tutte le notizie e le informazioni relative alle iniziative promosse dal Cardiocentro.

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All’avanguardia nelle terapie cellulari

All’avanguardia nelle terapie cellulari

La ricerca traslazionale sulle cellule staminali, ha avuto inizio al Cardiocentro Ticino nel 2004 quando proprio nella sede dell’istituto luganese venne eseguito il primo trapianto di cellule staminali ricavate da midollo osseo in un paziente colpito da un infarto acuto del miocardio (AMI). Si trattò del primo intervento del genere in Svizzera e uno dei primi in assoluto in Europa.

L’obiettivo dell’intervento era quello di favorire una rigenerazione del tessuto infartuato grazie all’impianto di cellule staminali. L’équipe medica che effettuò il trapianto era guidato dal Prof. Dr. med. Tiziano Moccetti, mentre le cellule venivano preparate dal Laboratorio di diagnostica molecolare (LDM). Da quel primo intervento nel 2004 il panorama regolatorio internazionale è cambiato parecchio.

Se solo qualche anno fa la manipolazione delle cellule poteva essere svolta in semplici laboratori, le più recenti direttive delle autorità regolatorie svizzere (Swissmedic) ed Europee (EMA) impongono agli istituti che intendono lavorare con le cellule staminali di attenersi a controlli e regole di manipolazione molto rigorose. Equiparate a trattamenti farmacologici, dal 2007 i prodotti a base di cellule devono essere sviluppati rispettando le rigide norme GMP, un sistema di qualità utilizzato dall’industria farmaceutica e che consentono di garantire la qualità del prodotto.

I farmaci a base di cellule staminali devono essere elaborati in apposite “Cell factories”, sofisticati laboratori dotati di adeguate “clean room”: ambienti di lavoro sterili dove i parametri di pressione e temperatura, la pulizia ambientale e i rischi di contaminazione sono costantemente controllati.

Determinato a proseguire con lo sviluppo delle proprie terapie innovative basate sulle cellule staminali, Istituto Cardiocentro Ticino ha quindi deciso di dotarsi di una propria Cell Factory dotata di Clean Room che nel 2008 è stata autorizzata da Swissmedic, diventando la prima installazione in Svizzera abilitata alla produzione e allo sviluppo di trattamenti che utilizzano le cellule staminali.

Il lavoro all’interno della Cell Factory dell’Istituto Cardiocentro Ticino è supervisionato da un’apposita “Unità di terapia cellulare” che si occupa di produrre e rilasciare il medicinale per la terapia avanzata. Il team provvede inoltre a controllare la qualità sia dei locali produttivi che dei processi di lavorazione sulle cellule. Un servizio tecnico e ingegneristico garantisce infine la manutenzione e la qualifica degli strumenti utilizzati, garantendo un pronto intervento 24 ore su 24 in caso di eventuali malfunzionamenti.

Con la costruzione di questa infrastruttura, l’Istituto Cardiocentro Ticino si è dotato di una “macchina” che pochi ospedali al mondo possiedono, esplicitamente pensata e progettata per esplorare nuovi orizzonti e contribuire ad un nuovo ed affascinante capitolo nel grande libro della medicina.

Web site:

Lugano Cell Factory


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Istituto Cardiocentro Ticino

Via Tesserete 48
CH-6900 Lugano
info@cardiocentro.org

Approfondimenti
Riferimenti e informazioni

Lugano Cell Factory

 

Prof. Dr. med. Stefanos Demertzis
Primario Cardiochirurgia

Direttore Scientifico