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RNL BIO Co. Ltd. stellt IND-Antrag, um klinische Phase-II-Studie des RNL-JointStem gegen Arthrose in den Vereinigten Staaten einzuleiten
Date:5/3/2013

GERMANTOWN, Maryland, 3. Mai 2013 /PRNewswire/ -- RNL BIO – ein Stammzellen- und Biotech-Unternehmen, das sich auf die Vermarktung autologer Zelltherapieprodukte für zahlreiche degenerative, ischämische und sonstige Indikationen konzentriert – gab bekannt, dass es bei der Lebensmittel- und Arzneimittelbehörde (FDA) einen IND-Antrag (Investigational New Drug) gestellt habe, um eine klinische Studie des aus fetthaltigen Zellen gewonnenen Produkts RNL-JointStem zur Behandlung von Arthrose (Arthrosis deformans – AD) einzuleiten. Sollte das Center for Biologics Evaluation and Research (CBER) der FDA dem IND-Antrag zustimmen, beabsichtigt RNL BIO, im dritten Quartal 2013 in Sugarland im US-Bundesstaat Texas mit der Durchführung der randomisierten, positiv kontrollierten, klinischen Phase-II-Doppelblindstudie zu beginnen. Dr. Jason Dragoo der Stanford University und Dr. David Alan Fisher der Indiana University waren als Lektoren tätig und haben das Protokoll überprüft, das die FDA derzeit einer Bewertung unterzieht. Klinische Phase-I- und Phase-II-Studien des RNL-JointStem sind bereits unter Aufsicht der koreanischen Lebensmittel- und Arzneimittelbehörde (KFDA) erfolgt.

„Wir sind begeistert, einen IND-Antrag für RNL-JointStem zu stellen, weil er uns der klinischen Studie von RNL-JointStem in den Vereinigten Staaten näher bringt", so Jeong-Chan Ra , der CEO und Vorstandsvorsitzende von RNL BIO. „Mit dieser Studie bezwecken wir, der Welt erfolgreich zu demonstrieren, dass RNL-JointStem eine wirksame Therapieoption ist. Sollte unsere Studie erfolgreich sein, kann sie bei der Behandlung von Arthrose einen echten Paradigmenwechsel auslösen, sodass künftig auf Stammzellenprodukte aus dem eigenen Fettgewebe des Patienten gesetzt wird." Wie aus vorherigen RNL-JointStem-Studien hervo
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SOURCE RNL BIO
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