Category Archives: Regenerative Medicine

THE WOODLANDS, Texas--(BUSINESS WIRE)--

Opexa Therapeutics, Inc. (OPXA), a biotechnology company developing Tcelna, a novel T-cell therapy for multiple sclerosis (MS), today announced that Neil K. Warma, President and Chief Executive Officer, will present at The Second International Vatican Adult Stem Cell Conference: Regenerative Medicine A Fundamental Shift in Science & Culture, taking place from within The Vatican, April 11-13, 2013.

The conference is part of a five-year collaboration between The Stem for Life Foundation, a not-for-profit organization devoted to raising global awareness of the therapeutic potential of adult stem cells, NeoStem, a leader in the emerging cellular therapy industry and The Vatican's Pontifical Council for Culture and its foundation, called STOQ International (Science, Theology and the Ontological Quest). Among the conference goals are to raise awareness of existing therapies, reduce misperceptions surrounding the field of cellular research and to foster dialogue among researchers, physicians, philanthropists, faith leaders and policy makers to identify unmet medical needs that can benefit from the development of cell therapies.

Opexa is proud to be a part of this international forum designed to highlight the important contributions made by the cell therapy industry to date and to increase awareness of cellular research and the potential of cell therapies to address unmet medical needs, commented Neil K. Warma, President and Chief Executive Officer of Opexa.

Opexa will be included in a special luncheon, Living with Multiple Sclerosis, featuring Meredith Vieira from NBC news and Richard M. Cohen, journalist and husband of Ms. Vieira.

About Tcelna

Tcelna is a personalized therapy that is specifically tailored to each patient's disease profile. Tcelna is manufactured using ImmPath, Opexa's proprietary method for the production of a patient-specific T-cell immunotherapy, which encompasses the collection of blood from the MS patient, isolation of peripheral blood mononuclear cells, generation of an autologous pool of myelin-reactive T-cells (MRTCs) raised against selected peptides from myelin basic protein (MBP), myelin oligodendrocyte glycoprotein (MOG) and proteolipid protein (PLP), and the return of these expanded, attenuated T-cells back to the patient. These attenuated T-cells are reintroduced into the patient via subcutaneous injection to trigger a therapeutic immune system response. Opexa believes the potential combination of efficacy, superior safety, excellent tolerability and administration may position Tcelna as the MS treatment of choice as compared to existing therapeutics.

About Opexa

Opexa is dedicated to the development of patient-specific cellular therapies for the treatment of autoimmune diseases such as MS. The Companys leading therapy candidate, Tcelna, is a personalized cellular immunotherapy that is in Phase IIb clinical development for MS. Tcelna is derived from T-cells isolated from peripheral blood, expanded ex vivo, and reintroduced into the patients via subcutaneous injections. This process triggers a potent immune response against specific subsets of autoreactive T-cells known to attack myelin.

For more information visit the Opexa Therapeutics website at http://www.opexatherapeutics.com.

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Opexa Therapeutics to Present at the Regenerative Medicine - A Fundamental Shift in Science & Culture Conference

THE WOODLANDS, Texas--(BUSINESS WIRE)--

Opexa Therapeutics, Inc. (OPXA), a biotechnology company developing Tcelna, a novel T-cell therapy for multiple sclerosis (MS), today announced that Neil K. Warma, President and Chief Executive Officer, will present at The Second International Vatican Adult Stem Cell Conference: Regenerative Medicine A Fundamental Shift in Science & Culture, taking place from within The Vatican, April 11-13, 2013.

The conference is part of a five-year collaboration between The Stem for Life Foundation, a not-for-profit organization devoted to raising global awareness of the therapeutic potential of adult stem cells, NeoStem, a leader in the emerging cellular therapy industry and The Vatican's Pontifical Council for Culture and its foundation, called STOQ International (Science, Theology and the Ontological Quest). Among the conference goals are to raise awareness of existing therapies, reduce misperceptions surrounding the field of cellular research and to foster dialogue among researchers, physicians, philanthropists, faith leaders and policy makers to identify unmet medical needs that can benefit from the development of cell therapies.

Opexa is proud to be a part of this international forum designed to highlight the important contributions made by the cell therapy industry to date and to increase awareness of cellular research and the potential of cell therapies to address unmet medical needs, commented Neil K. Warma, President and Chief Executive Officer of Opexa.

Opexa will be included in a special luncheon, Living with Multiple Sclerosis, featuring Meredith Vieira from NBC news and Richard M. Cohen, journalist and husband of Ms. Vieira.

About Tcelna

Tcelna is a personalized therapy that is specifically tailored to each patient's disease profile. Tcelna is manufactured using ImmPath, Opexa's proprietary method for the production of a patient-specific T-cell immunotherapy, which encompasses the collection of blood from the MS patient, isolation of peripheral blood mononuclear cells, generation of an autologous pool of myelin-reactive T-cells (MRTCs) raised against selected peptides from myelin basic protein (MBP), myelin oligodendrocyte glycoprotein (MOG) and proteolipid protein (PLP), and the return of these expanded, attenuated T-cells back to the patient. These attenuated T-cells are reintroduced into the patient via subcutaneous injection to trigger a therapeutic immune system response. Opexa believes the potential combination of efficacy, superior safety, excellent tolerability and administration may position Tcelna as the MS treatment of choice as compared to existing therapeutics.

About Opexa

Opexa is dedicated to the development of patient-specific cellular therapies for the treatment of autoimmune diseases such as MS. The Companys leading therapy candidate, Tcelna, is a personalized cellular immunotherapy that is in Phase IIb clinical development for MS. Tcelna is derived from T-cells isolated from peripheral blood, expanded ex vivo, and reintroduced into the patients via subcutaneous injections. This process triggers a potent immune response against specific subsets of autoreactive T-cells known to attack myelin.

For more information visit the Opexa Therapeutics website at http://www.opexatherapeutics.com.

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Opexa Therapeutics to Present at the Regenerative Medicine - A Fundamental Shift in Science & Culture Conference

Image: Bryan Christie

Unique among the human body's larger organs, the liver has a remarkable ability to recover from injury. An individual can lose a big chunk of it in an accident or during surgery, but as long as at least a quarter of the organ remains intact and generally free of scars, it can grow back to its full size and function. Alas, this capacity for self-regeneration does not hold for other body parts. A salamander can regrow its tail, but a person cannot regain an amputated leg or renew sections of the brain lost to Alzheimer's disease. For this feat, humans need helpand that is the promise of an emerging field of research called regenerative medicine.

Stem cellsprogenitor cells that can give rise to a variety of tissuesplay an important role in this endeavor. Scientists are learning how to mix a hodgepodge of sugar molecules, proteins and fibers to create an environment in which the stem cells can develop into replacement tissue. As the following stories show, investigators have made strides in replacing damaged heart tissue and rebuilding muscle. They are also in the early stages of developing new nerve cells. Some of these advances could emerge from the lab as treatments in a few years, or they may take decades, or they may ultimately fail. Here are a few of the most promising ones.

The Future of Medicine Special Report

A Change of Heart: Stem Cells May Transform Treatment for Heart Failure Stem cells may transform the way doctors treat heart failure

Doctors Repair Soldiers' Wounds with Biological Scaffolding Material Regrowing muscles, tendons and even organs may be possible using nature's own adhesive

Use for 3-D Printers: Creating Internal Blood Vessels for Kidneys, Livers, Other Large Organs To build large organs that work properly, researchers need to find a way to lace them with blood vessels

Neural Stem Cell Transplants May One Day Help Parkinson's Patients, Others Neurodegenerative disorders devastate the brain, but doctors hope one day to replace lost cells

This article was originally published with the title The Future of Medicine.

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Future of Medicine : Advances in Regenerative Medicine Teach Body How to Rebuild Damaged Muscles, Tissues and Organs

Public release date: 29-Mar-2013 [ | E-mail | Share ]

Contact: Vicki Cohn vcohn@liebertpub.com 914-740-2100 x2156 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, Mar 28, 2013Explosive growth in the field of tissue engineering and regenerative medicine has led to innovative and promising applications and techniques, many of which are now being tested in human clinical trials. Hot topics, research advances, and transformative publications that are driving the field forward are highlighted in a comprehensive overview of the field presented in Tissue Engineering, Part B, Reviews, a peer-reviewed journal from Mary Ann Liebert, Inc. publishers (http://www.liebertpub.com). The article is available on the Tissue Engineering website (http://www.liebertpub.com/ten).

Matthew Fisher, PhD and Robert Mauck, PhD, Perelman School of Medicine, University of Pennsylvania, and Philadelphia Veterans Administration Medical Center, Philadelphia, PA, identify four key areas in which the field is progressing. The first main theme, in the area of tissue engineering, focuses on advances in grafts and materials, including human or animal tissue from which the cells are removed and the remaining scaffold is used to regenerate new tissues, as well as scaffolds made of new types of biomaterials. Second, in the field of regenerative medicine, the authors highlight the role of novel scaffolds and various growth and control factors in promoting tissue formation and, for example, bone healing.

In the article "Tissue Engineering and Regenerative Medicine: Recent Innovations and the Transition to Translation," (http://online.liebertpub.com/doi/full/10.1089/ten.teb.2012.0723) the authors identify two additional areas that signal progress in the field: the increasing number of applications advancing into clinical trials; and the growing use of novel types of cells, such as induced pluripotent stem cells.

"Considering the rapid pace of growth and development in regenerative medicine, it is imperative that we fully consider recent advances," says Reviews Co-Editor-in-Chief John P. Fisher, PhD, Professor and Associate Chair, Fischell Department of Bioengineering, University of Maryland, College Park, MD. "Dr. Matthew Fisher and Dr. Robert Mauck have wonderfully reviewed the efforts in the tissue engineering field over the past few years, highlighting advances in biomaterials, cell-based constructs, and translational endeavors."

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About the Journal

Tissue Engineering is an authoritative peer-reviewed journal published monthly in print and online in three parts: Part A--the flagship journal; Part BReviews; and Part CMethods. Led by Co-Editors-In-Chief Antonios Mikos, PhD, Louis Calder Professor at Rice University, Houston, TX, and Peter C. Johnson, MD, Vice President, Research and Development, Avery Dennison Medical Solutions of Chicago, IL and President and CEO, Scintellix, LLC, Raleigh, NC, the Journal brings together scientific and medical experts in the fields of biomedical engineering, material science, molecular and cellular biology, and genetic engineering. Tissue Engineering is the Official Journal of the Tissue Engineering & Regenerative Medicine International Society (TERMIS). Complete tables of content and a sample issue may be viewed on the Tissue Engineering website (http://www.liebertpub.com/ten).

About the Publisher

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What advances are driving clinical applications of tissue engineering and regenerative medicine ?

By: PNA/Bernama March 22, 2013 8:52 AM

Reuters file photo of a breast cancer survivor

InterAksyon.com The online news portal of TV5

TOKYO -- Japanese researchers have achieved a major breakthrough in regenerative medicine for breast cancer patients, Japanese news agency Jiji Press reported.

The researchers succeeded in having breast cancer patients recover what was lost after breast-conserving surgery, an operation to remove breast cancer and not breast itself by transplanting fat mixed with their own stem cells.

The achievement was made by a team of researchers led by Bin Nakayama, associate professor at Tottori University during clinical testing conducted between September and January on five women aged between 30 and 60 who underwent breast-conserving surgery.

Durng the tests, fat taken out of the patients' abdomen or hips and mixed with their stem cells was transplanted into where tumours and surrounding tissues were removed.

The researchers said that if only fat is transplanted, most of it is absorbed into the body and about 30 per cent of it remains as it does not have blood vessels.

Between 70 to 90 per cent of transplanted fat remained after blood vessels were newly formed in the fat.

Stem cells are apparently capable of helping bring blood vessels into fat from surrounding tissues, the researchers added.

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Japanese researchers reach breakthrough in breast cancer regenerative medicine

SAN BRUNO,Calif., March 19, 2013 /PRNewswire/ --Cord Blood Registry (CBR), the world's largest newborn stem cell bank, is fueling innovation in newborn stem cell research. As CBR prepares to release its 250th cord blood unit for medical use this month, the newborn stem cell bank announces that 71% of all its units released for use have been for emerging applications in regenerative medicine, such as brain injury, autism and type 1 diabetes. The other 29% have been for traditional transplant use, such as leukemia and sickle cell disease. This rapid increase in the use of family banked units for regenerative medicine applications is a complete reversal from the figures just six years ago, where 25% of the units released were for regenerative medicine applications and 75% for traditional transplant use. More than 50% of all cord blood units released for use in emerging regenerative therapies by family banks have been processed and stored at CBR. CBR is the only family newborn stem cell bank to have established FDA-regulated trials and is connecting client families to more potential treatments. As the industry leader in this initiative, Cord Blood Registry continues to focus on advancing the clinical applications of newborn stem cells.

(Photo: http://photos.prnewswire.com/prnh/20130319/SF78273-INFO)

(Logo: http://photos.prnewswire.com/prnh/20120216/AQ54476LOGO)

Over the past 20 years, cord blood stem cells have been used to treat more than 80 life-threatening diseases and disorders including certain cancers, blood disorders, immune diseases, and metabolic disorders. Today, promising treatments are paving the way for further research. Current FDA-regulated clinical trials are exploring the use of a child's own cord blood stem cells in regenerative medicine for conditions that have no cure today. Most of these groundbreaking trials only use cord blood stem cells processed and stored by Cord Blood Registry for consistency and because of their commitment to quality.

"At an increased pace, CBR is providing families exclusive access to promising new potential treatment options through our focus on clinical trials," said Geoffrey Crouse, CEO of Cord Blood Registry. "We are proud to partner with researchers at the forefront of stem cell medicine."

Clinical Trials Break New Ground in Regenerative Medicine

Cord blood stem cells are currently being evaluated in a series of clinical trials exclusive to CBR clients as potential treatment for autism, cerebral palsy, traumatic brain injury and pediatric stroke. Results will be published upon the completion of the trials.

Dr. Michael Chez, director of pediatric neurology at Sutter Medical Center, is leading a landmark FDA-regulated clinical trial to test the use of a child's own cord blood stem cells as a potential therapy to improve language and behavior in children with autism who have no obvious cause for the condition such as a known genetic syndrome or brain injury.

Dr. James Carroll at Georgia Regents University is conducting the first FDA-regulated clinical trial evaluating the use of cord blood stem cell infusions to treat children with cerebral palsy. Drake Haynes, who suffered a stroke after birth and was later diagnosed with cerebral palsy, was infused with his own CBR processed stem cells. Drake's progress is constantly being monitored and he continues to see multiple physical therapists. His family reports anecdotal evidence of steady progress in Drake's speech and mobility. Drake's mother, Nikki Haynes, describes it as the "blinds being lifted." A second FDA-regulated trial for cerebral palsy is underway at Duke University. A number of CBR families are currently participating in this key research as well.

Dr. Charles Cox, professor of pediatric surgery at The University of Texas Health Science Center in Houston (UT Health), is leading an FDA-regulated trial studying the use of a child's own cord blood stem cells in the treatment of traumatic brain injury (TBI).

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Cord Blood Registry is Advancing Regenerative Medicine Research at Exciting Pace

NEW YORK, NY--(Marketwire - Mar 11, 2013) - TriMarkPublications.com cites in its newly published "Regenerative Medicine Markets" report that the regenerative medicine market will catapult to over $35 billion by 2019. For more information, visit: http://www.trimarkpublications.com/regenerative-medicine-markets/.

Regenerative medicine (RM) can be categorized into three main modalities: tissue engineering, biomaterials and biomolecules, e.g., scaffolds, growth factors and stem cell therapy. Tissue-engineered bone products in the orthopedic segment will see steady growth, from $7.5 billion in 2012 to $3.29 billion in 2019. The up-and-coming cardiology and vascular products segment will also see substantial growth, reaching a market value of $3.29 over the forecast period.

The "Regenerative Medicine Markets" report covers:

The "Regenerative Medicine Markets" report examines companies manufacturing regenerative medicine equipment and supplies in the world. Companies covered include: Amorcyte, Ars Arthro, Axiogenesis, AxoGen, Bellicum, BetaStem, Bioheart, Biomet, BioMimetic, BioTissue, Biovest, BrainStorm Cell, California Stem Cell, Cardio3, Cellartis, CellSeed, Cellular, Chromocell, Cognate, Cook, Cytomedix, Cytonet, Cytori, DanDrit, Fibrocell, Forticell, Gamida, Harvest, Histogenics, Humacyte, Integra, Intercytex, iPierian, Japan Tissue Engineering, Kensey Nash, Kiadis, Life Cell, Living Cell, MaxCyte, MediStem, Mesoblast, MolMed, NanoCor, Neuralstem, NeuroNova, NewLink Genetics, Olympus Terumo, OncoMed, Opexa, Organogenesis, Orthovita, Osiris, Osteotech, Pervasis, Pluristem, Proneuronnologies, RegeneRx, ReNeuron, Revivicor, SanBio, Saneron, Sangamo, Stem Cell Authority, StemCells, Stemline, Stratetech, Synthecon, Tengion, Thermogenesis, TiGenics, Tissue Genesis, ViaCyte, Vistagen and Zen-Bio.

Detailed charts with sales forecasts and marketshare data are included. For more information, visit: http://www.trimarkpublications.com/regenerative-medicine-markets/.

About TriMarkPublications.com

TriMarkPublications.com is a global leader in the biotechnology, healthcare and life sciences market research publishing. For more information, please visit http://www.trimarkpublications.com.

Important Notice

The statements contained in this news release that are forward-looking are based on current expectations that are subject to a number of uncertainties and risks, and actual results may differ materially.

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Regenerative Medicine Market to Catapult to Over $35 Billion by 2019

New Study at the Center for Regenerative Medicine - Mayo Clinic
The Center for Regenerative Medicine at Mayo Clinic investigates what advances of stem cell biology would be useful to apply in the treatment of patients with end stage diseases. Jorge Rakela, MD, associate director for the Center, provides an overview of the Center which is also involved in a tissue engineering program with Arizona State University. Jeffery Cornella, MD, a gynecological surgeon at Mayo Clinic, and Johnny Yi, MD, a surgical fellow at Mayo Clinic, talk about a study underway to develop new tissue to aid in the treatment of vaginal prolapse and other conditions.

By: mayoclinic

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New Study at the Center for Regenerative Medicine - Mayo Clinic - Video

NEW YORK, Feb. 19, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Regenerative medicine and Stem cells Partnering Terms and Agreements http://www.reportlinker.com/p01098514/Regenerative-medicine-and-Stem-cells-Partnering-Terms-and-Agreements.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Biological_Therapy

The Regenerative Medicine and Stem Cells Partnering Terms and Agreements report provides comprehensive understanding and unprecedented access to the Regenerative medicine and Stem cells partnering deals and agreements entered into by the worlds leading healthcare companies.

Trends in regenerative medicine and stem cells deals Deal terms analysis Partnering agreement structure Partnering contract documents Top deals by value Most active dealmakers Average deal terms for regenerative medicine and stem cells

The report provides a detailed understanding and analysis of how and why companies enter regenerative medicine and stem cells partnering deals. The majority of deals are development stage whereby the licensee obtains a right or an option right to license the licensors regenerative medicine and stem cells technology. These deals tend to be multicomponent, starting with collaborative R&D, and commercialization of outcomes.

This report provides details of the latest regenerative medicine and stem cells agreements including cell therapy agreements announced in the healthcare sector.

Understanding the flexibility of a prospective partner's negotiated deals terms provides critical insight into the negotiation process in terms of what you can expect to achieve during the negotiation of terms. Whilst many smaller companies will be seeking details of the payments clauses, the devil is in the detail in terms of how payments are triggered contract documents provide this insight where press releases and databases do not.

This report contains a comprehensive listing of all regenerative medicine and stem cells partnering deals announced since 2008 including financial terms where available including over 550 links to online deal records as disclosed by the deal parties. In addition, where available, records include contract documents as submitted to the Securities Exchange Commission by companies and their partners.

Contract documents provide the answers to numerous questions about a prospective partner's flexibility on a wide range of important issues, many of which will have a significant impact on each party's ability to derive value from the deal.

For example, analyzing actual company deals and agreements allows assessment of the following:

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Regenerative medicine and Stem cells Partnering Terms and Agreements