Stem-cell research leaders to meet in NUIG

The Irish Times - Monday, July 2, 2012

LORNA SIGGINS

WORLD leaders in stem-cell technology are due to exchange knowledge of potential treatments at a conference opening in NUI Galway today.

Researchers from NUIG, University College Cork and NUI Maynooth will participate in the event, which has been billed as the first major conference on stem-cell therapy in Ireland.

Prof Anthony Hollander of the University of Bristol, England who was one of a team which successful created and then transplanted the first tissue-engineered trachea or windpipe is among a number of international speakers presenting findings.

The gathering will focus on the realities of stem-cell treatment, Prof Frank Barry, director of NUIGs National Centre for Biomedical Engineering Science has said.

The therapy is complex and controversial, and sometimes exaggerated claims are made, he said.

The researchers are specialists in Mesenchymal, or adult, stem cells, and will be concentrating on what is likely in the future, he added.

The list of conditions which could be treated successfully by stem cells is small, but growing, Prof Barry said.

Leukaemia and other diseases of the blood appear to respond best.

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Former Auburn coach getting stem cell treatments for Lou Gehrig's disease

MOBILE, Alabama -- The Baldwin County doctor that treated former Alabama football players with adult stem cells also has treated at least two people diagnosed with amyotrophic lateral sclerosis, also known as Lou Gehrigs disease.

One of the ALS patients, former NFL football player and college coach Frank Orgel, recently underwent a new stem cell reprogramming technique performed by Dr. Jason R. Williams at Precision StemCell in Gulf Shores.

Before the injections, Orgels health had declined. He could not move his left arm or leg. He couldnt walk or stand on his own, he said.

Within a few days of having the stem cell treatment, Orgels constant muscle twitching diminished, said Bob Hubbard, director of stem cell therapy at the practice. Within weeks, he was able to walk in a pool of water and stand unassisted.

I think its helped me, said Orgel, who was a defensive coordinator at Auburn under former head coach Pat Dye. Im walking in the pool and I used to drag my feet. Now my left leg is picking up.

ALS is a progressive neuro-degenerative disease that affects nerve cells in the brain and the spinal cord. The progressive degeneration of the motor neurons in ALS eventually leads to death, according to the ALS Association.

Stem cells, sometimes called the bodys master cells, are precursor cells that develop into blood, bones and organs, according to the U.S. Food and Drug Administration, which regulates their use. Their promise in medicine, according to many scientists and doctors, is that the cells have the potential to help and regenerate other cells.

While Williams treatments are considered investigational, he has said, they meet FDA guidelines because the stem cells are collected from a patients fat tissue and administered back to that patient during the same procedure.

Orgel, 74, said Williams told him it would take between eight months to a year for his nerves to regrow. He is traveling to Gulf Shores from his home in Albany, Ga., this weekend for another stem cell treatment, Orgel said: I need to get to where I can walk.

In recent years, Orgel has gone to Mexico at least three times for different types of treatments, not sanctioned in the U.S. At least once, he said, he had placenta cells injected into his body. That didnt work, Orgel said. I didnt feel any better.

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Former Auburn coach getting stem cell treatments for Lou Gehrig's disease

Medistem Receives Notice of Patent Allowance Covering Fat Stem Cell Therapy of Autoimmune Diseases

SAN DIEGO CA--(Marketwire -06/29/12)- Medistem Inc. (MEDS) announced today notice of allowance from the United States Patent and Trademark Office (USPTO) for a patent covering the use of fat stem cells, and cells associated with fat stem cells for treatment of diseases related to a dysfunctional immune system. Such diseases include multiple sclerosis, Type 1 diabetes, rheumatoid arthritis and lupus. The allowed patent, entitled "Stem Cell Mediated Treg Activation/Expansion for Therapeutic Immune Modulation" has the earliest priority date of December 2006.

"We have previously published that giving multiple sclerosis patients cells extracted from their own fat tissue, which contains stem cells, appears to confer clinical benefit in a pilot study," said Thomas Ichim, CEO of Medistem. "The current patent that has been allowed, in the broadest interpretation of the claims, gives us exclusive rights to the use of specific types of fat stem cell therapy for autoimmune diseases such as multiple sclerosis."

Subsequent to the filing of the patent application, Medistem together with collaborators at the Lawson Health Sciences Research Institute, Canada, reported data that fat tissue contains high numbers of T regulatory cells, a type of immune cell that is capable of controlling autoimmunity.

This finding was independently confirmed by Dr. Diane Mathis' laboratory at Harvard University, who published a paper in the prestigious journal, Nature Medicine, in which detailed experimental evidence was provided supporting the initial finding that adipose tissue contains high numbers of T regulatory cells. A video describing the paper can be accessed at http://www.youtube.com/watch?v=rEJfGu29Rg8.

The current patent discloses the use of T regulatory cells from fat, combinations with stem cells, and use of fat-derived mononuclear cells. Given that there are currently several groups utilizing this technology in the USA in treating patients, Medistem believes revenue can be generated through enforcement of patent rights.

"Our corporate philosophy has been to remain highly focused on our ongoing clinical stage programs using Medistem's universal donor stem cell, the Endometrial Regenerative Cell (ERC), in the treatment of critical limb ischemia and congestive heart failure," said Dr. Vladimir Bogin, Chairman and President of Medistem. "However, due to the ease of implementation of our fat stem cell technology, combined with the major burden that autoimmune diseases have on our health care system, we are highly incentivized to explore partnering, co-development and licensing opportunities."

Autoimmune conditions occur as a result of the body's immune system "turning on itself" and attacking its own organs or cells. Current treatments for autoimmune conditions are based on "globally" suppressing the immune system by administration of immunosuppressive drugs. This is associated with an increased predisposition to infections and significant side effects. The utilization of stem cells and T regulatory cells offers the potential to selectively suppress pathological immunity while preserving the ability of the body to fight bacteria and viruses. According to the NIH there are approximately 23 million victims of autoimmune conditions.

Links to Documents:

Link to peer-reviewed publication: http://www.translational-medicine.com/content/pdf/1479-5876-7-29.pdf

Link: http://www.marketwire.com/press-release/medistem-files-patent-application-on-therapeutic-cell-population-found-in-fat-tissue-frankfurt-s2u-812298.htm

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Medistem Receives Notice of Patent Allowance Covering Fat Stem Cell Therapy of Autoimmune Diseases

Osiris Bolsters its Stem Cell Intellectual Property Estate

COLUMBIA, Md.--(BUSINESS WIRE)--

Osiris Therapeutics, Inc. (OSIR), announced today the expansion of its intellectual property protection around Prochymal (remestemcel-L). The United States Patent and Trademark Office recently granted Osiris two patents that cover multiple mechanisms of action related to cardiac tissue repair. Additionally, Osiris has enhanced its mesenchymal stem cell (MSC) patent estate with the issuance of patents across Europe and Australia covering stem cells expressing all therapeutically useful levels of cell surface receptors for TNF-alpha, a receptor essential to the cell's ability to counteract inflammation. These patents further support Osiris' considerable intellectual property position, which includes 48 issued U.S. patents around the production, composition, testing and use of the mesenchymal stem cell from both allogeneic and autologous sources.

"These recent additions to Osiris patent estate, combined with the existing broad coverage of our pioneering MSC platform technology, reinforce our industry leading IP portfolio and bolster our dominant position regarding the manufacture and use of mesenchymal stem cells for the treatment of a broad range of diseases, said Chris Alder, Chief Intellectual Property Counsel of Osiris. We have invested significant time and resources building our intellectual property estate, and with the commercialization of Prochymal, we are preparing to take the necessary action to enforce our considerable rights.

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. With Prochymal (remestemcel-L) entering commerce, Osiris has initiated the process of identifying entities that may be infringing upon its intellectual property rights and will take appropriate action as necessary.

About Prochymal (remestemcel-L)

Prochymal is the worlds first approved drug with a stem cell as its active ingredient. Developed by Osiris Therapeutics, Prochymal is an intravenous formulation of MSCs, which are derived from the bone marrow of healthy adult donors between the ages of 18 and 30 years. The MSCs are selected from the bone marrow and grown in culture so that up to 10,000 doses of Prochymal can be produced from a single donor. Prochymal is truly an off-the-shelf stem cell product that is stored frozen at the point-of-care and infused through a simple intravenous line without the need to type or immunosuppress the recipient. Prochymal is approved in Canada and New Zealand for the management of acute graft-versus-host disease (GvHD) in children and is available for adults and children in eight countries including the United States, under an Expanded Access Program. Prochymal is currently in a Phase 3 trial for refractory Crohns disease and is also being evaluated in clinical trials for the treatment of myocardial infarction (heart attack) and type 1 diabetes.

About Osiris Therapeutics

Osiris Therapeutics, Inc. is the leading stem cell company, having developed the worlds first approved stem cell drug, Prochymal. 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 chronic wounds, and Ovation for orthopedic applications. Osiris is a fully integrated company with capabilities in research, development, manufacturing and distribution of stem cell products. Osiris has developed an extensive intellectual property portfolio to protect the company's technology, including 48 U.S. and 144 foreign patents.

Osiris, Prochymal, Grafix and Ovation are registered trademarks of Osiris Therapeutics, Inc. More information can be found on the company's website, http://www.Osiris.com. (OSIRG)

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Gazette.Net: Rockville biotech tests stem cells for depression

Neuralstem, the Rockville company thats developing a stem cell treatment for patients with amyotrophic lateral sclerosis, has begun testing the safety of its treatment for major depressive disorder.

The compound, NSI-189, stimulates new neuron growth in the brain's hippocampus region, which scientists think is involved in depression and other conditions, including Alzheimer's disease, anxiety and post-traumatic stress disorder, according to a company statement. The phase 1b study involves 24 depressed patients and is expected to run six months.

"We believe it could help patients who suffer from depression via a new mechanism that does not seek to modulate brain chemistry, but rather stimulates new neuron growth in the hippocampus and increases hippocampal volume, thereby potentially addressing the problem at the source," Karl Johe, Neuralstem's chief scientific officer, said in the statement.

The company has researched hippocampal stem cell lines since 2000 and in 2009 won U.S. patents for four chemical entities that generate new neurons. In studies, NSI-189 stimulated such growth in mice.

In other Maryland bioscience industry news:

Supernus Pharmaceuticals has received tentative marketing approval from the Food and Drug Administration for its once-daily, extended release version of an epilepsy treatment.

The FDA said it has completed its review of Trokendi XR and no more clinical trials are required. Final approval hinges on resolving a marketing exclusivity issue that involves a specific pediatric population, according to the FDA's letter to Supernus.

Trokendi XR is an extended-release version of topimarate, which is marketed as Topamax by Janssen Pharmaceuticals of Titusville, N.J., to treat seizures and migraine headaches.

"We will continue to work closely with the FDA to further understand the outstanding issue and move forward towards final approval," CEO Jack Khattar said in the statement.

Supernus, which went public this year, also said the FDA denied a petition filed in 2011 by Upsher Smith Laboratories related to its Trokendi XR application.

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Diabetes breakthrough: UBC scientists reverse disease in mice using stem-cell transplants

VANCOUVER -- For the first time ever, University of B.C. scientists have used human embryonic stem cell transplants to reverse Type 1 diabetes in mice with the disease, giving hope to about 300 million people around the world who suffer from the chronic disease.

A 13-member team, whose milestone work is published in the journal Diabetes, shows that after transplantation, the stem cells matured into insulin-secreting, pancreatic beta-cells. The cells automatically sensed blood sugar levels to release the right amount of insulin and a few dozen diabetic mice were gradually weaned off insulin given to them over a period of months.

Insulin is produced by beta-cells to to help the body absorb sugar and use it for energy.

Essentially, the mice were cured of their diabetes by placing the body back in charge of regulated insulin production as it is in healthy, non-diabetics, said lead author Timothy Kieffer.

It took about four to five months for the [stem] cells to become functional in our experiments and the mice were able to maintain good blood glucose levels even when fed a high-glucose diet, said Kieffer, a UBC professor in the department of cellular and physiological sciences.

Type 1 diabetes otherwise known as juvenile diabetes is an autoimmune disease in which a patients immune system kills off insulin-producing cells in the pancreas. About 10 per cent of diabetics are Type 1 and typically, they must inject themselves with insulin or use pumps to control their blood glucose levels.

While pancreatic islet cell transplantation pioneered at the University of Alberta several years ago has been shown to be an effective way of reducing dependence on insulin injections, the treatment is costly and cumbersome as it requires donor cells from cadavers, which are always in short supply. As well, islet cell transplant patients must forever take anti-rejection drugs that can cause organ damage.

In the study methodology, mice were anesthetized and then injected with millions of cells derived from stem cells which were placed under the left kidney area.

Although the research showed that stem cells may one day provide a cure for diabetes, it also revealed hurdles to overcome before agencies like the Food and Drug Administration in the United States or Health Canada can approve the therapy.

For example, some mice developed bone or cartilage in areas where the cells were inserted, an unacceptable side-effect that future experiments must resolve.

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Diabetes breakthrough: UBC scientists reverse disease in mice using stem-cell transplants

Human model of Huntington's disease created from skin's stem cells

Public release date: 28-Jun-2012 [ | E-mail | Share ]

Contact: Tom Vasich tmvasich@uci.edu 949-824-6455 University of California - Irvine

Irvine, Calif., June 28, 2012 An international consortium of Huntington's disease experts, including several from the Sue & Bill Gross Stem Cell Research Center at UC Irvine, has generated a human model of the deadly inherited disorder directly from the skin cells of affected patients.

The re-created neurons, which live in a petri dish, will help researchers better understand what disables and kills brain cells in people with HD and let them gauge the effects of potential drug therapies on cells that are otherwise locked deep in the brain.

UCI scientists were part of a consortium that in 1993 identified the autosomal dominant gene mutation responsible for HD, but there is still no cure, and no treatments are available to even slow its onset or progression. The research, published online today in the journal Cell Stem Cell, is the work of the Huntington's Disease iPSC Consortium. Participants examined several other cell lines and control cell lines to ensure that their results were consistent and reproducible in different labs.

"Our discovery will enable us for the first time to test therapies on human Huntington's disease neurons," said Leslie Thompson, UCI professor of psychiatry & human behavior and neurobiology & behavior, one of the world's leading HD experts and a senior author of the study. "This has been a remarkable time in HD research, with the advent of stem cell technologies that have allowed these scientific advancements. Also, having a team of scientists working together as a consortium has benefited the research tremendously and accelerated its pace."

Leslie Lock, a UCI assistant professor of developmental & cell biology and biological chemistry whose lab helped develop the induced pluripotent stem cells (iPSC), added: "It's exciting to be carrying out work that provides hope for HD patients and their families."

Thompson said that UCI scientists will use the new model to study the specific gene expression changes in human brain cells that trigger the onset of HD, helping them understand how these changes happen and how to correct them.

Huntington's disease afflicts about 30,000 people in the U.S. typically striking in midlife and another 75,000 carry the gene that will eventually lead to it. Caused by a mutation in the gene for a protein called huntingtin, the disease damages brain cells so that individuals with HD progressively lose their ability to walk, talk and reason. It invariably culminates in death. While rare, HD is the most common inherited neurodegenerative disease.

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Human model of Huntington's disease created from skin's stem cells

International Stem Cell Corporation Reports Reaching Milestone in Its Cornea Program

CARLSBAD, CA--(Marketwire -06/28/12)- International Stem Cell Corporation (ISCO) http://www.internationalstemcell.com today announced that its Research and Development team has advanced its program to create a functional and transplantable human cornea by developing a new method to derive corneal endothelium-like cells from human pluripotent stem cells.

This work represents a significant step towards the creation of complete cornea tissue that can be used for transplantation and supports prior data showing indications of corneal endothelium generated by ISCO's collaborators at Sankara Nethralaya Eye Hospital, India. Such cells by themselves may potentially promote wound healing and regeneration of the cornea and therefore could be used as a standalone medical treatment.

Development and commercialization of ISCO's stem cell-derived cornea tissue along with manufacturing of Lifeline Cell Technology's media and cellular products are the foundation for our expansion to the Asian markets and for clinical collaboration with Indian biomedical organizations including Sankara Nethralaya Eye Hospital and All-India Institute for Medical Sciences.

Asia represents a huge potential growth market for ISCO's Cornea program. For example, in India alone there are more than 4 million people suffering from corneal vision impairment with limited access to corneal tissue. ISCO's intention is to work with our clinical affiliate in India to meet this healthcare demand.

Dr. Ruslan Semechkin, Vice President of Research & Development, commented: "This new method not only brings our cornea program closer to clinical use, but it also gives us additional licensing opportunities. We have made good progress towards our goal of creating usable corneas, however the additional work, necessary to prove that these endothelium-like cells can be fully functional, will be done in conjunction with our collaborators."

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at http://www.internationalstemcell.com or follow us on Twitter @intlstemcell.

To receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0

Forward-Looking StatementsStatements pertaining to anticipated developments, the potential benefits of research programs and products, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

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Diabetes reversed in mice using stem cells

ScienceDaily (June 27, 2012) University of British Columbia scientists, in collaboration with an industry partner, have successfully reversed diabetes in mice using stem cells, paving the way for a breakthrough treatment for a disease that affects nearly one in four Canadians.

The research by Timothy Kieffer, a professor in the Department of Cellular and Physiological Sciences, and scientists from the New Jersey-based BetaLogics, a division of Janssen Research & Development, LLC, is the first to show that human stem cell transplants can successfully restore insulin production and reverse diabetes in mice. Crucially, they re-created the "feedback loop" that enables insulin levels to automatically rise or fall based on blood glucose levels. The study is published online June 27 in the journal Diabetes.

After the stem cell transplant, the diabetic mice were weaned off insulin, a procedure designed to mimic human clinical conditions. Three to four months later, the mice were able to maintain healthy blood sugar levels even when being fed large quantities of sugar. Transplanted cells removed from the mice after several months had all the markings of normal insulin-producing pancreatic cells.

"We are very excited by these findings, but additional research is needed before this approach can be tested clinically in humans," says Kieffer, a member of UBC's Life Sciences Institute. "The studies were performed in diabetic mice that lacked a properly functioning immune system that would otherwise have rejected the cells. We now need to identify a suitable way of protecting the cells from immune attack so that the transplant can ultimately be performed in the absence of any immunosuppression."

The research was supported by the Canadian Institutes of Health Research, the Stem Cell Network of Canada, Stem Cell Technologies of Vancouver, the JDRF and the Michael Smith Foundation for Health Research.

Diabetes results from insufficient production of insulin by the pancreas. Insulin enables glucose to be stored by the body's muscle, fat and liver and used as fuel; a shortage of insulin leads to high blood sugar that raises the risk of blindness, heart attack, stroke, nerve damage and kidney failure.

Regular injections of insulin are the most common treatment for the type 1 form of this disease, which often strikes young children. Although experimental transplants of healthy pancreatic cells from human donors have shown to be effective, that treatment is severely limited by the availability of donors.

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Maine game warden finds stem cell match

AUGUSTA, Maine (NEWS CENTER) --InMay,we introduced you to Maine Game Warden Major Gregg Sanborn - when the UMaine football team held a stem cell drive in his honor. Major Sanborn was diagnosed with t-cell lymphoma last September and needed to find a match as soon as possible in order to live.

Last week, Major Sanborn found out that he did find a match - a 26 year old man. He isn't allowed to know anything else about his donor due to privacy laws.

Major Sanborn is already undergoing chemotherapy and will head to Boston on July 9th and will stay there for about six weeks - to begin more aggressive treatments, which will include rebuilding his immune system.

He feels he owes it to all the people who have helped him thus far to fight as hard as he can. "An awful lot of people have done an awful lot of work to make this possible. Their efforts haven't gone in vain, they haven't gone unnoticed," he says,"It's very impressive. I've got a lot of people rooting for me, and I'm going to give it my best so that it's a positive outcome."

Wednesday was Major Sanborn's last day of work at the Maine Department of Inland Fisheries and Wildlife. He actually had to take a few tests in order to keep his license when he comes back to work after the treatments. After the six weeks of treatment, he'll be in isolation for one year.

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Maine game warden finds stem cell match