Category Archives: Regenerative Medicine

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The meeting “Commercialization of Your Regenerative Medicine Research: Lessons from Spin Out Successes” was hosted by the Oxbridge Biotech Roundtable (OBR) (Oxford, UK) at the University of Oxford in February, 2013, and attracted a multi-stakeholder audience spanning academia and industry. 


The event featured case studies from Gregg Sando, CEO, Cell Medica (London, UK), John Sinden, CSO, Reneuron (Guilford, UK), and Paul Kemp, CEO and CSO, Intercytex (Manchester, UK). 


OBR is a student-led initiative with over 7000 members across eight different UK and US locations with a mission to foster a conversation about the healthcare and life sciences industry. 


Anna French and David A. Brindley, along with some of my assistance, captured and have now published the main themes of the meeting and the major questions facing the regenerative medicine industry and its rapidly emerging subsets of cellular and gene therapies. 


Notably, we discuss the compatibility of regenerative therapies to the existing healthcare infrastructure, biomanufacturing challenges (including scalability and comparability), and the amenability of regenerative therapies to existing reimbursement and investment models. Furthermore, we reiterate key words of advice from seasoned industry leaders intended to accelerate the translation path from lab bench to the marketplace.


To read the review see: Commercialization of Regenerative Medicine: Learning from Spin-Outs


Anna French, R. Lee Buckler, and David A. Brindley. Rejuvenation Research. April 2013, 16(2): 164-170. doi:10.1089/rej.2013.1423.

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http://feedproxy.google.com/~r/CellTherapyBlog/~3/4Uv2o54_hWQ/commercialization-of-regenerative.html

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The Alliance for Regenerative Medicine announced today the release of the 2013 annual regenerative medicine industry report.  Here is the announcement in the Wall Street Journal online.

I'm proud to have been a part of putting it together and hope people find it useful.  It is available for download on the ARM website here.  


In addition to the complete download, ARM will make many of the figures, charts,  tables and sections available for members to download and use in their own publications and presentations. Watch for these resources to be announced soon.

Source:
http://feedproxy.google.com/~r/CellTherapyBlog/~3/yFBYKblnudk/2013-annual-regenerative-medicine.html

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The Alliance for Regenerative Medicine announced today the release of the 2013 annual regenerative medicine industry report.  Here is the announcement in the Wall Street Journal online.

I'm proud to have been a part of putting it together and hope people find it useful.  It is available for download on the ARM website here.  


In addition to the complete download, ARM will make many of the figures, charts,  tables and sections available for members to download and use in their own publications and presentations. Watch for these resources to be announced soon.

Source:
http://feedproxy.google.com/~r/CellTherapyBlog/~3/yFBYKblnudk/2013-annual-regenerative-medicine.html

NEWARK, Calif., April 11, 2013 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced that it has entered into an agreement with the California Institute for Regenerative Medicine (CIRM) under which CIRM will provide approximately $19.3 million to help fund preclinical development and IND-enabling activities of the Company's proprietary HuCNS-SC(R) product candidate (purified human neural stem cells) for Alzheimer's disease. The funding, which will be in the form of a forgivable loan, was awarded under CIRM's Disease Team Therapy Development Award program (RFA 10-05) in September 2012. The goal of the research will be to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration within four years.

"With CIRM's support, we are now able to lay the groundwork that could result in the world's first neural stem cell trial in Alzheimer's patients," commented Martin McGlynn, President and CEO of StemCells, Inc. "Currently, there are no good treatment options for Alzheimer's patients, and there aren't any on the horizon, so it is clear that the field could benefit from creative approaches to this devastating and challenging disease. Our collaborators at UC Irvine have provided a compelling preclinical rationale to test the utility of our cells to restore memory in patients afflicted with this deadly condition."

StemCells, Inc. will evaluate its HuCNS-SC cells as a potential therapeutic in Alzheimer's disease in collaboration with researchers at the University of California, Irvine (UCI) led by Frank LaFerla, Ph.D., a world-renowned researcher in the field, and Matthew Blurton-Jones, Ph.D. Dr. LaFerla is Director of the Institute for Memory Impairments and Neurological Disorders (UCI MIND), and Chancellor's Professor, Neurobiology and Behavior. Dr. Blurton-Jones is Assistant Professor, Neurobiology and Behavior, at UCI.

In July 2012, Dr. Blurton-Jones presented data at the Alzheimer's Association Annual Meeting demonstrating that the Company's neural stem cells restored memory and significantly enhanced synaptic function in two animal models relevant to Alzheimer's disease. Importantly, these results did not require reduction in beta amyloid or tau that accumulates in the brains of patients with Alzheimer's disease and account for the pathological hallmarks of the disease.

Terms and Conditions of the Loan

Loan funds are expected to be disbursed periodically over the four-year project period, with disbursements subject to a number of preconditions, including the achievement of certain progress milestones and compliance with certain financial covenants. The term of the loan is ten years, but may be extended under certain circumstances. The loan is unsecured and will bear interest at the one year LIBOR rate plus two percent; however, the interest rate will increase by one percent each year after year five. The loan is forgivable, such that the Company's obligation to repay the loan will be contingent upon the success of HuCNS-SC cells in Alzheimer's disease. No warrants will be issued in connection with the loan, but the Company will owe various success milestone payments in the event of the product's commercial success.

About Alzheimer's Disease

Alzheimer's disease is a progressive, fatal neurodegenerative disorder that results in loss of memory and cognitive function. Today there is no cure or effective treatment option for patients afflicted by Alzheimer's disease. According to the Alzheimer's Association, approximately 5.4 million Americans have Alzheimer's disease, including nearly half of people aged 85 and older. The prevalence of Alzheimer's disease is expected to increase rapidly as a result of the country's aging population.

About CIRM

CIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research opportunities. A list of grants and loans awarded to date may be seen here: http://www.cirm.ca.gov/for-researchers/researchfunding.

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StemCells, Inc. Enters Agreement to Receive $19.3 Million From California Institute for Regenerative Medicine to Help ...

Mahendra Rao, director of the Center for Regenerative Medicine at the National Institutes of Health in Bethesda, Md. Image: Richard Clark, NIH

Researchers are now experimenting with stem cellsprogenitor cells that can develop into many different types of tissueto coax the bodies of a few individuals to heal themselves. Some of the most advanced clinical trials so far involve treating congestive heart disease and regrowing muscles in soldiers who were wounded in an explosion. But new developments are happening so quickly that investigators have come up with a new nameregenerative medicineto describe the emerging field.

Many of the stem cells being studied are referred to as pluripotent, meaning they can give rise to any of the cell types in the body but they cannot give rise on their own to an entirely new body. (Only the earliest embryonic cells, which occur just after fertilization, can give rise to a whole other organism by themselves.) Other stem cells, such as the ones found in the adult body, are multipotent, meaning they can develop into a limited number of different tissue types.

One of the most common stem cell treatments being studied is a procedure that extracts a few stem cells from a person's body and grows them in large quantities in the laboratorywhat scientists refer to as expanding the number of stem cells. Once a sufficient number have been produced in this manner, the investigators inject them back into the patient.

The bone marrow is a rich source of adult stem cells, containing both the hematopoietic stem cells that give rise to the various types of blood and the so-called mesenchymal cells, which can develop into bone, cartilage and fat. Mesenchymal cells are found in the bone marrow and various other places in the body, although whether all mesenchymal stem cells are truly interchangeable irrespective of origin is unclear.

Scientific American spoke with Mahendra Rao, director of the Center for Regenerative Medicine at the National Institutes of Health in Bethesda, Md., to get a sense of the sorts of new developments that might occur in regenerative medicine in the next five years or so.

[An edited transcript of the interview follows.]

Why is there so much excitement about regenerative medicine? You could say that medicine up until now has been all about replacements. If your heart valve isn't working, you replace it with another valve, say from a pig. With regenerative medicine, you're treating the cause and using your own cells to perform the replacement. The hope is that by regenerating the tissue, you're causing the repairs to grow so that it's like normal.

And research into regenerative medicine has been going at a pretty fast pace. Yes, there have been a lot of novel breakthroughs in the past few years. It seems that things are moving relatively rapidly to true translation and clinical practice. When you think about it, it usually takes 10 to 14 years to bring a drug to market. Well, the entire field of pluripotent stem cells is 14 or 15 years old. And yet, in those 15 years there are already clinical trials in place.

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What's Next for Stem Cells and 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