Category Archives: Mesenchymal Stem Cells

COLUMBIA, Md.--(BUSINESS WIRE)-- Osiris Therapeutics, Inc. (OSIR) announced today that it has been notified by Swissmedic, the Swiss agency responsible for the evaluation of drugs, that Prochymal (remestemcel-L) will be evaluated under its Rapid Authorization Procedures. This designation, also known in Switzerland as Fast Track, typically cuts the evaluation period for promising new drugs in half. Swissmedic approved the use of the Rapid Authorization Procedures following an initial review of summary clinical data for Prochymal used for the management of acute graft-versus-host disease (GvHD). Use of the Rapid Authorization Procedures is only permitted if the clinical data demonstrates a high potential for benefit for a severe, disabling or life-threatening disease, and where no alternative treatment option exists. As a result of this decision, Osiris intendeds to promptly submit the full Common Technical Document to Swissmedic in the electronic or eCTD format to facilitate review. The Common Technical Document for Prochymal contains over 90,000 pages of data on the stem cell drug and is similar to the applications filed in Canada and New Zealand. Prochymal is now approved in Canada and New Zealand, and is currently available in seven other countries, including the United States, under an Expanded Access Program. About … Continue reading →

SAN DIEGO, Calif., Sept. 28, 2012 (GLOBE NEWSWIRE) -- via PRWEB - Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development, announced today that the U.S. Food and Drug Administration (FDA) approved its application for an Investigational New Drug (IND) to assess the safety, tolerability and clinical effects of Stemedyne-MSC (Stemedica's human bone marrow-derived ischemia tolerant mesenchymal cells) in subjects with cutaneous photoaging resulting from overexposure to ultraviolet radiation. Curt M. Littler, M.D., F.A.A.D., dermatologist at Sharp Rees-Stealy Medical Group, Inc., is the principal investigator of the study. Dr. Littler commented, "This study is an important step forward in the field of dermatology. Photoaging is a universal condition. Damage from the sun's rays alters the skin's underlying structures, such as collagen, elastin, and blood vessels, and contributes to the creation of abnormal epidermal cells, which can become precancerous. By administering stem cells systemically, this study has the potential to target skin damage throughout the body and promises to pave the way for new treatment approaches for photoaged skin." The IND approval allows Stemedica to initiate a clinical trial at medical centers within the United States. The clinical trial will be a Phase I/IIa multi-center … Continue reading →

ALAMEDA, Calif.--(BUSINESS WIRE)-- BioTime, Inc. (NYSE MKT: BTX), an Alameda-based company engaged in research and development of innovative new products in the field of regenerative medicine utilizing stem cells and related technology, announced today that it has formed a new wholly owned subsidiary, BioTime Acquisition Corporation, to pursue opportunities and acquire assets and businesses in the fields of stem cells and regenerative medicine. Thomas Okarma, PhD, MD, will serve as the Chief Executive Officer and as a member of the board of directors of BioTimes new subsidiary. Dr. Okarma is the former President and Chief Executive Officer of Geron Corporation and served on that companys board of directors. Since 2010, BioTime has expanded the scope of its business through strategic acquisitions and has been continually exploring other acquisition opportunities in its fields of interest. BioTimes strategic acquisitions include: Global advances on multiple fronts of stem cell biology have established the foundation for an integrative business approach to consolidate and translate these discoveries into products that may revolutionize clinical medicine, said Thomas Okarma, the new companys CEO. Living cell therapies can now be scalably manufactured, efficiently distributed to points of care, and tested in controlled clinical trials.The goal of regenerative medicine … Continue reading →

COLUMBIA, Md.--(BUSINESS WIRE)-- Osiris Therapeutics, Inc. (OSIR) today announced the conclusion of its collaboration with Genzyme, a Sanofi company. As the Collaboration Agreement is now ended, all rights to Prochymal and ChondrogenTM worldwide revert back to Osiris. Osiris is now free to commercialize or enter into commercialization agreements for Prochymal and Chondrogen with other parties without limitation. Both parties have agreed to an orderly conclusion of the collaboration, with no further financial responsibilities for either party, and an amicable end to their relationship. Prochymal (remestemcel-L) is a first-in-class mesenchymal stem cell therapy indicated for the treatment of acute graft-vs-host disease (GvHD) in children. In May, Prochymal became the world's first stem cell therapy to be approved by an internationally recognized regulatory authority. Prochymal is now approved in Canada and New Zealand, and is currently available in seven other countries including the United States under an Expanded Access Program. About Osiris Therapeutics Osiris Therapeutics, Inc., having developed the worlds first approved stem cell drug, Prochymal, is the leading stem cell company. The company is focused on developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets. In Biosurgery, Osiris currently markets Grafix for burns and … Continue reading →

Public release date: 27-Sep-2012 [ | E-mail | Share ] Contact: Jennifer Schutz newsbureau@mayo.edu 507-284-5005 Mayo Clinic ROCHESTER, Minn. -- Mayo Clinic researchers have found a way to detect and eliminate potentially troublemaking stem cells to make stem cell therapy safer. Induced Pluripotent Stem cells, also known as iPS cells, are bioengineered from adult tissues to have properties of embryonic stem cells, which have the unlimited capacity to differentiate and grow into any desired types of cells, such as skin, brain, lung and heart cells. However, during the differentiation process, some residual pluripotent or embryonic-like cells may remain and cause them to grow into tumors. "Pluripotent stem cells show great promise in the field of regenerative medicine; however, the risk of uncontrolled cell growth will continue to prevent their use as a therapeutic treatment," says Timothy Nelson, Ph.D., M.D., lead author on the study, which appears in the October issue of STEM CELLS Translational Medicine. Using mouse models, Mayo scientists overcame this drawback by pretreated stem cells with a chemotherapeutic agent that selectively damages the DNA of the stem cells, efficiently killing the tumor-forming cells. The contaminated cells died off, and the chemotherapy didn't affect the healthy cells, Dr. Nelson … Continue reading →

SEOUL, South Korea, Sept. 26, 2012 /PRNewswire/ --In the first study of its kind, researchers at Korea's leading university and the RNL Bio Stem Cell Technology Institute announced this week the results of a study that suggests an astounding possibility: adult stem cells may not only have a positive effect on those suffering from Alzheimer's disease, theycanprevent the disease.Using fat-derived adultstem cells from humans [scientific term:adMSCs, orhuman, adipose-derived mesenchymal stem cells], researchers were able to cause Alzheimer's disease brains in animal models to regenerate. The researchers, for the first time in history, used stem cells toidentify the mechanism that is key to treatment of Alzheimer's disease, and demonstrated how to achieve efficacy as well as prevention of the symptoms of Alzheimer's with adult stem cells, a "holy grail" of biomedical scientists for decades. Alzheimer's disease, the most common form of dementia (loss of brain function), is the 6th leading cause of death, and affects 1 in 8 people -- more than breast cancer. As of 2010, there were 35.6 million people with Alzheimer's disease in the world, but this number is expected to double every 20 years. It is estimated that the total cost of Alzheimer's is US $604 billion … Continue reading →

(SACRAMENTO, Calif.) - Deborah K. Lieu, a stem cell scientist in cardiovascular medicine at UC Davis Health System, has received a $1.3 million research grant from the California Institute for Regenerative Medicine (CIRM) to develop stem cells that could serve as a biological alternative to the electronic pacemakers that people now use to regulate heart rhythm. According to Lieu, each year 350,000 cardiology patients with abnormal heart rhythms receive electronic pacemakers to maintain a normal heart beat. The devices, while effective, have several disadvantages, including limited battery life and poor response to changing heart rates, such as when a person is exercising. Lieu, who is working with colleague Nipavan Chiamvimonvat, the Roger Tatarian Endowed Professor of Cardiovascular Medicine at UC Davis, plans to examine ways to improve the generation of pacemaking cells using human-induced pluripotent stem cells (hiPSCs), potentially creating what she calls a "biopacemaker." "There are more than 3 million patients around the country who are dependent on electronic pacemakers," said Lieu. "Each one costs about $58,000 to implant and requires follow-up surgery about every 5 to 10 years to change batteries. Creating a biopacemaker from stem cells would avoid the burden of battery replacement and provide the physiological … Continue reading →

Public release date: 24-Sep-2012 [ | E-mail | Share ] Contact: David Eve celltransplantation@gmail.com Cell Transplantation Center of Excellence for Aging and Brain Repair Putnam Valley, NY. (Sept. 24, 2012) Two studies in the current issue of Cell Transplantation (21:6), now freely available on-line at http://www.ingentaconnect.com/content/cog/ct/, demonstrate how the use of magnetic particles are a factor that can positively impact on the targeted delivery of transplanted stem cells and to also provide better cell retention. A research team from the University of British Columbia used focused magnetic stem cell targeting to improve the delivery and transport of mensenchymal stem cells to the retinas of test rats while researchers from Cedars-Sinai Heart Institute (Los Angeles) injected magnetically enhanced cardiac stem cells to guide the cells to their target to increase cell retention and therapeutic benefit in rat models of ischemic/reperfusion injury. According to study co-author Dr. Kevin Gregory-Evans, MD, PhD, of the Centre for Macular Degeneration at the University of British Columbia, degeneration of the retina - the cause of macular degeneration as well as other eye diseases - accounts for most cases of blindness in the developed world. To date, the transplantation of mensenchymal stem cells to the damaged retina … Continue reading →

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By Karen Rogers - September 21, 2012 | Tickers: BAX, NBS, OSIR | 0 Comments Karen is a member of The Motley Fool Blog Network -- entries represent the personal opinions of our bloggers and are not formally edited. Stem cell research puts immortality in our hands. By medically treating stem cells to repair damaged organs, one could, in theory, live forever. The following three stem cell research companies are achingly close to perfecting techniques that will repair and strengthen damaged human hearts. Osiris Therapeutics (NASDAQ: OSIR) Prochymal is the only drug thats been granted fast track status and Orphan Drug status by the FDA. Already in Phase III clinical evaluations, Prochymal repairs heart tissue damaged by a heart attack and it is also under evaluation for Chronic Obstructive Pulmonary Disease. Osiris biologic drugs utilize either human mesenchymal stem cells (MSC) or stem cells taken from adult bone marrow to avoid the ethical controversy surrounding embryonic or fetal stem cell research usage. MSC are taken directly from the donors human bone marrow and one single donation can produce up to 10,000 treatments. Osiris has designed their treatment to be universally accepted by all recipients to eliminate rejection problems. This treatment … Continue reading →