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RNL BIO Co. Ltd. Files IND To Commence Phase II Clinical Trial Of RNL-JointStem For Osteoarthritis In The United States
Date:5/2/2013

GERMANTOWN, Md., May 2, 2013 /PRNewswire/ -- RNL BIO, a stem cell biotechnology company dedicated to the commercialization of autologous cell therapy products for a variety of degenerative, ischemic and other indications, has announced that it has filed an Investigational New Drug application (IND) with the Food and Drug Administration (FDA) to begin clinical trials with its adipose-derived stem cell product, termed RNL-JointStem, for the treatment of osteoarthritis (OA). Assuming approval of the IND by the Center for Biologics Evaluation and Research (CBER) at the FDA, RNL BIO plans to initiate its double-blinded, randomized, positive-control Phase II clinical trial during the third quarter of 2013 in Sugarland, Texas. Dr. Jason Dragoo of Stanford University and Dr. David Alan Fisher of Indiana University acted as reviewers and completed revision of the protocol now under evaluation by the FDA. Phase I and Phase II clinical trials of RNL-JointStem have already been completed under the authority of the Korean Food and Drug Administration (KFDA).

"We are excited about filing an IND for RNL-JointStem because it brings us closer to a clinical trial with RNL-JointStem in the United States," said Jeong-Chan Ra , CEO and Chairman of RNL BIO. "Our goal for this trial is to achieve global demonstration that RNL-JointStem is efficacious. If our trial is successful it can lead to a paradigm shift in the treatment of osteoarthritis, using stem cell products derived from a patient's own fat tissue." Among the key advantages demonstrated in previous trials of RNL-JointStem is that it is administered in a single injection, unlike the many invasive treatments currently used in the treatment of OA. "Treatments of this painful chronic condition sh
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