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Department of Research and Development, Hospira Inc., Lake Forest, Illinois, USA, 2Department of Medical Ethics, University of Pennsylvania, Philadelphia, Pennsylvania, USA, 3Advanced Centre for Biochemical Engineering, University College London, London, UK, 4The Stop ALD Foundation, Houston, Texas, USA, 5Interdisciplinary Oncology Program, H. Lee Mofﬁtt Cancer Center & Research Institute, Tampa, Florida, USA, 6Department of Regulatory Affairs, Perkin Elmer Inc., Cambridge, Massachusetts, USA, 7Bone Marrow Transplantation Unit, National Cancer Institute, Rio de Janeiro, Brazil, 8Section of Hematology and Bone Marrow Transplantation Unit, University Hospital, Cremona, Italy, 9Department of Pathology and Laboratory Medicine, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA, 10Department of Cell and Molecular Therapies, Royal Prince Alfred Hospital RPA Hospital and Centenary Institute, Newtown, NSW Australia, 11Research Foundation for , Community Medicine, Tokyo, Japan, and 12Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania, USA Key Words: cell therapy, stem cell, medical tourism, medical ethics, informed consent, regulatory affairs
Perspective Cardiac Stem Cell Therapy and the Promise of Heart Regeneration Jessica C. Garbern1 and Richard T. Lee2,* 1Department of Medicine, Boston Children’s Hospital, Boston, MA 02115, USA Stem Cell Institute, the Brigham Regenerative Medicine Center and the Cardiovascular Division, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA 02115, USA *Correspondence: email@example.com http://dx.doi.org/10.1016/j.stem.2013.05.008 2Harvard Stem cell therapy for cardiac disease is an exciting but highly controversial research area. Strategies such as cell transplantation and reprogramming have demonstrated both intriguing and sobering results. Yet as clinical trials proceed, our incomplete understanding of stem cell behavior is made evident by numerous unresolved matters, such as the mechanisms of cardiomyocyte turnover or the optimal therapeutic strategies to achieve clinical efﬁcacy. In this Perspective, we consider how cardiac stem cell biology has led us into clinical trials, and we suggest that achieving true cardiac regeneration in patients may ultimately require resolution of critical controversies in experimental cardiac regeneration. Introduction The race is on: throughout the world, basic and clinical investigators want to be the ﬁrst to identify new approaches to regenerate cardiac tissue and to prove the effects of these therapies in patients with heart disease. Despite substantial progress in treating many types of heart disease, the worldwide heart failure burden will remain enormous through this century. The potential of stem cells and the scope of the heart failure problem have fueled a stampede to be the ﬁrst to achieve human heart regeneration. Cell transplantation approaches are attractive given their...
Grafix® Demonstrates Overwhelming Efficacy in Landmark Stem Cell Study for the Treatment of Diabetic Foot Ulcers Grafix closes three times as many wounds as standard of care - the largest relative improvement ever reported in a multi-center, randomized, controlled clinical trial for DFU COLUMBIA, Md. - August 13,2013 - Osiris Therapeutics, Inc. (NASDAQ: OSIR), reported today that its multicenter, randomized, controlled clinical trial comparing the safety and effectiveness of Grafix® to standard of care in patients with chronic diabetic foot ulcers had met the pre-specified stopping rules for overwhelming efficacy as determined by the data monitoring committee during a planned interim analysis. For the primary endpoint, 62% of patients receiving Grafix had complete wound closure compared to only 21% (p<0.0001) of patients who received conventional treatment for their wounds - a relative improvement of 191% and the largest ever reported from such a study. A total of 131 patients were enrolled with the interim analysis being conducted on the first 97 to complete the trial. The trial also reached statistical significance in favor of Grafix on all top-line secondary endpoints, demonstrating faster wound closure and a reduction in the number of treatments needed to achieve wound closure. In the crossover phase of the trial, patients whose wounds failed to close after 12 weeks of standard of care had an 80% closure rate when switched to Grafix. Importantly, patients randomized to receive standard of care were 74% more likely to experience an adverse event than those receiving Grafix (p=0.008). As a result, the blinded phase of the trial is being discontinued immediately and all patients randomized to the control arm will be offered treatment with Grafix. “Today, Osiris has established a new standard in diabetic wound care and has demonstrated to the world the tremendous impact stem cell products can have in medicine,” said C. Randal Mills, Ph.D., Chief Executive Officer. “Diabetic foot ulcers afflict 25% of all diabetics and are responsible for more hospitalizations than any other diabetic complication. With 25 million diabetics in the United States, the cost to our health care system is enormous. Through this rigorous study we have shown that Grafix can heal more patients, in less time, and with fewer complications.”
Why Should I Purchase a CCI Laptop? You’ll want to purchase one of the official CCI Laptops because the laptop packages available to you as an entering UNC-Chapel Hill student are the best value anywhere. Our comprehensive program of hardware, software, and support ensures an unparalleled student computing experience. Only with the purchase of a CCI Laptop will you be eligible for all the programs and services below: • A 4-year Comprehensive Protection Plan including: 4 Years of Manufacturer’s Warranty Coverage 4 Years of Accidental Damage Coverage 4 Years of Laptop Insurance Coverage • Computer Support 24 x 7 • An Award-winning On-campus Repair Center with a pool of loaner laptops • An Extensive Software Package • Security Solutions for keeping your computer and data secured When should I place my order? 8 out of 10 Carolina undergraduates choose a CCI Laptop package to fulfill the laptop requirement. CCI Laptop packages can be ordered through the CCI Website starting in early April. Submit your order by May 15 and your laptop will be waiting for you at your New Student Orientation session this summer. Students admitted after May 15 should order as soon as possible and at least 2 weeks before your New Student Orientation. How do I order my CCI Laptop?  Decide which CCI Laptop model you want to purchase  Choose Your Printer  Choose Your Accessories They will get more than award-winning laptops. They will get support, service,  Place Your Order through the CCI website or Call 919-962-8534 Monday-Friday 10am-5pm and software ensuring them an unparalleled student computing experience. How do I pay for my CCI Laptop?  Credit Card (Visa, Mastercard or American Express)  Laptop grant from the University What if I don’t buy a CCI Laptop? Please note that, while students are not required to purchase a CCI Laptop, students are required to have a laptop that meets the minimum requirements specified. Software and operating system support for non-CCI laptops is on a best-effort basis. Hardware support for non-CCI laptops is the responsibility of the owner. Loaner laptops are only available to students who purchase a CCI Laptop through UNC Student Stores. If you have any additional questions please visit our FAQ...