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SEOUL, South Korea, May 20, 2013 /PRNewswire/ -- RNL BIO Co. Ltd., a stem cell biotechnology company dedicated to the commercialization of autologous cell therapy products for a variety of degenerative, ischemic and other indications, announces the availability of adult stem cell banking in the United States beginning on June 20, 2013. RNL BIO previously offered these services through another company, but will now provide the latest, safest technologies directly. As the sole global provider of its stem cell banking services, RNL BIO will provide clients with continuous quality assurance and constant innovation in adult stem cell technologies.
RNL BIO operates facilities in Maryland, Los Angeles and a FDA-registered stem cell banking facility in the Houston, Texas metroplex. It has opened a 15,000 square foot GMP laboratory facility in Sugar Land, Texas with extensive, state-of-the-art stem cell research and banking equipment, staffed by highly qualified scientists.
No human mesenchymal stem cell-based drug is presently approved for treatment in the United States. The only pathway to legal stem cell therapy is through FDA-approved clinical trials. RNL BIO has filed an Investigational New Drug application (IND) with the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) to begin clinical trials with its adipose-derived stem cell product, termed Jointstem, for the treatment of osteoarthritis (OA). Phase 2 clinical trials of Jointstem and another autologous stem cell-based biologic Vascostem (for treatment of Buerger’s disease) have been completed under the authority of the Korean Food and Drug Administration (KFDA) in Seoul, Korea. Having reached this stage, RNL BIO filed New Drug Applications (NDA) to authorize the clinical use of these mesenchymal stem cell products in Korea. RNL BIO will be working with the FDA to determine what level of investigational availability is possible for its adult stem cell biologics in certain intractable and incurable diseases where no other therapeutic modality is available.
“We are happy to begin providing clients in the United States with our stem cell banking services,” said Jeong-Chan Ra, Ph.D., the CEO and Chairman of RNL BIO. “We want to advance both banking and FDA-approved uses of stem cell technology.” During 2011-13, RNL BIO has published its studies in more than 20 articles in major peer-reviewed journals. “We are following the pathways to regulatory approval so that our banking program can expand to include approved biologics for use in the United States and Europe.”
ACCESS TO BANKING
RNL BIO provides stem cells to physicians whose patients request that they be obtained, however RNL BIO and Human Biostar are not offering stem cell therapeutics in the United States. RNL BIO is joining with U.S. hospitals and physicians in its banking services and to researchers in its bench and clinical trial activities.
About RNL Bio
RNL BIO is a South Korean biotechnology company focused on the research and development of adult derived stem cell technologies. Its autologous, adipose-derived human mesenchymal stem cell technology, anchored by its unique stem cell culture media, is the subject of patents and patent applications in more than 30 nations and has been the subject of many scientific studies and peer-reviewed publications. The story of RNL BIO, its Chairman and its experiences with the use of stem cells in the clinical setting is the subject of the 2012 book, The grace of stem cells: a story of science and faith by J.C. Ra, available at bookstores and from Amazon.
Safe Harbor:This article may contain forward looking statements including projections and business trends. Actual results may differ materially from the anticipated results and expectations expressed in these forward-looking statements as a result of certain risks and uncertainties. These forward-looking statements are made based upon information available as of the date hereof, and the company assumes no obligation to update such forward-looking statements. Consequently, the reader is cautioned to consider all forward-looking statements in light of the risks to which they are subject.
For more information visit http://www.rnl.co.kr/eng/main.asp, which is not part of this press release.
SOURCE RNL Bio
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