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RNL BIO har anmält en fas II/III klinisk prövning till KFDA för en behandling av cerebral pares med autologa stamceller framställda från fettvävnad
Date:2/9/2013

SEOUL, Sydkorea, 9 feb. 2013 /PRNewswire/ -- RNL BIO CO LTD (RNL) annonserade idag att man har lämnat in en ansökan om ett nytt läkemedel under prövning (IND) till den sydkoreanska livsmedels- och läkemedelsmyndigheten (KFDA) med avsikt att inleda kliniska fas II och III-studier för att utvärdera företagets stamcellspreparat RNL-Astrostem™ hos patienter med cerebral pares. Syftet med studien är att slutgiltigt bedöma hur effektiva stamceller är som behandling av cerebral pares hos 45 patienter över 11 månader.  Studien kommer att genomföras på Kyung Hee universitetssjukhus i Gangdong och THE Bethesda-sjukhuset.

RNL-Astrostem™ har redan genomgått en fas I studie för att bekräfta säkerheten, inklusive tester för att utesluta toxicitet och tumorogenicitet.  Denna prövning genomfördes på Seoul National Universitys kliniska forskningsinstitut.  Dessutom bekräftade fas I-studien säkerheten hos stamceller som ges intravenöst, något som publicerats i en ledande referee-granskad tidskrift, Stem Cells and Development ("Safety of intravenous infusion of human adipose tissue-derived mesenchymal stem cells in animals and humans", februari 2011). Under loppet av lyckade säkerhetsstudier fann forskarna signifikant evidens för att stamceller troligen kan vara effektiva vid behandling av cerebral pares. Dessutom publicerades en fallstudie med tydligt förbättrade resultat i en annan internationellt erkänd tidskrift. RNL BIO tror att man efter lyckade prövningar och godkännande från KFDA kommer att kunna lansera RNL-Astrostem™ år 2014, och därigenom revolutionera våra möjligheter att bota denna obotliga sjukdom som drabbar barn och som endast kan hanteras med befintlig behandling.

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