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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

ssiv zu Lähmungen führt, in erster Linie den Knorpel befällt und mit Veränderungen des Knochens verbunden ist. Knorpel verfügt über eine eingeschränkte intrinsische Heil- und Regenerationsfähigkeit.

Mit dieser Studie

Aufgrund der steigenden Inzidenz degenerativer Arthritis, der alternden Bevölkerung und der ineffizienten Therapieoptionen sind neue Strategien zum Knorpelaufbau erforderlich. Der Markt für ein therapeutisch wirksames Produkt für diese Indikation ist Schätzungen zufolge sehr groß.

Informationen zu IND-Anträgen

Der IND-Antrag (Investigational New Drug) ist Teil eines Zulassungsverfahrens zur Durchführung klinischer Untersuchungen in den Vereinigten Staaten. Ein IND-Antrag ist immer dann erforderlich, wenn die Durchführung einer klinischen Untersuchung in den Vereinigten Staaten beabsichtigt wird. Ein IND-Antrag enthält Informationen über die Qualität, Herstellung und Kontrolle eines Arzneimittelkandidaten sowie Daten aus präklinischen Studien und Angaben bezüglich des beabsichtigten Einsatzzwecks. Eine grundsätzliche Nutzen-Risiko-Bewertung sowie kritische Analysen präklinischer Daten unter Berücksichtigung aller potenziellen Risiken und Vorteile der vorgeschlagenen Studie müssen ebenfalls Teil des IND-Antrags sein.

Informationen zu klinischen Phase-II-Studien

Studien an klinischen Interventionen auf Basis von Biologika, wozu auch autologe, aus menschlichem Fett gewonnene Stammzellen gehören, unterliegen strengsten Kontrollen des Center for Biologics Evaluation and Research (CBER) der FDA. Nachdem das CBER und das örtliche Institutional Review Board (IRB) den Arzneimittelkandidaten für akzeptabel befunden haben, besteht die FDA auf die Durchführung einer Reihe mehrstufiger klinischer Studien. In Phase I ste
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