Baxter Initiates Phase III Adult Stem Cell Clinical Trial for Chronic Cardiac Condition

DEERFIELD, Ill.--(BUSINESS WIRE)--

Baxter International Inc. (NYSE:BAX - News) announced today that it has initiated a phase III pivotal clinical trial to evaluate the efficacy and safety of adult autologous (an individual’s own) CD34+ stem cells to increase exercise capacity in patients with chronic myocardial ischemia (CMI).

Chronic myocardial ischemia (CMI) is one of the most severe forms of coronary artery disease, causing significant long-term damage to the heart muscle and disability to the patient. It is often diagnosed based on symptoms of severe, refractory angina, which is severe chest discomfort that does not respond to conventional medical management or surgical interventions.

“The prospect of using a person’s own adult stem cells to restore and repair blood flow in CMI is a very exciting concept based on a biological regenerative approach,” said Norbert Riedel, Ph.D., Baxter’s chief science and innovation officer. “The goals of this phase III trial are aligned with Baxter’s overall mission to develop life-saving and life-sustaining therapies and it will help us determine if the therapy can make a meaningful difference for CMI patients.”

The trial will enroll approximately 450 patients across 50 clinical sites in the United States, who will be randomized to one of three arms: treatment with their own autologous CD34+ stem cells, treatment with placebo (control), or unblinded standard of care. The primary objective is to evaluate the efficacy of treatment with CD34+ stem cells to improve the functional capacity of patients with CMI, as measured by a change in total exercise capacity at 12 months following treatment. Secondary objectives include reduced frequency of angina episodes at 12 months after treatment and the safety of targeted delivery of the cells.

After stem cell mobilization, apheresis (collecting the cells from the body) and cell processing, participants will receive CD34+ stem cells or placebo in a single treatment via 10 intramyocardial injections into targeted areas of the heart tissue. Efficacy will be measured by a change in total exercise capacity during the first year following treatment and safety data will be collected for two years. Stem cell processing will be conducted in GMP facilities in the United States by Progenitor Cell Therapy (PCT), a subsidiary of NeoStem, Inc. To learn more or enroll, visit http://www.renewstudy.com or http://www.clinicaltrials.gov.

This trial is being initiated based on the phase II data, which indicated that injections of patients’ own CD34+ stem cells may improve exercise capacity and reduce reports of angina episodes in patients with chronic, severe refractory angina.

“The phase II trial provided evidence that this strategy, leveraging the body’s own natural repair mechanisms, can improve exercise capacity and reduce chest pain, the first time these endpoints have been achieved in a population of patients who have exhausted conventional treatment options,” said Douglas Losordo, MD, vice president of new therapeutic development at Baxter.

CD34+ cells, which are blood-forming stem cells derived from bone marrow, are comprised of endothelial progenitor cells (EPCs), which develop into new blood vessels. Previous preclinical studies investigating these cells have shown an increase in capillary density and improved cardiac function in models of myocardial ischemia.

About Baxter

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

This release includes forward-looking statements concerning the use of adult autologous stem cells to treat CMI, including expectations with respect to the related phase III clinical trial. These statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: clinical results demonstrating the safety and effectiveness of the use of autologous stem cells to treat CMI; timely submission of regulatory filings; satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; the enrollment of a sufficient number of qualified participants in the phase III clinical trial; the successful provision of stem cell processing by PCT, a third party; and other risks identified in Baxter’s most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter’s website. Baxter does not undertake to update its forward-looking statements.

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Baxter Initiates Phase III Adult Stem Cell Clinical Trial for Chronic Cardiac Condition

Stem Cell Pioneers Converge in Portland to Discuss and Celebrate a Revolutionary New Stem Cell Entering Human Clinical …

SAN DIEGO, CA and PORTLAND, OR--(Marketwire -02/28/12)- Medistem Inc. (Pinksheets: MEDS.PK - News) announced today its Annual "Evening with Medistem" Event will take place in Portland, Oregon on March 7th, 2012. The event is being hosted by Vladimir Zaharchook, Vice Chairman at Medistem, Inc., and will feature stem cell luminaries and pioneers working with Medistem including Dr. Amit Patel, Director of Regenerative Medicine at University of Utah and the first person to administer stem cells into patients with heart failure, Dr. Michael Murphy, Vascular Surgeon at Indiana University and Principal Investigator for Medistem's FDA clinical trial in patients with risk of amputation, and Dr. Alan Lewis, former CEO of the Juvenile Diabetes Research Foundation, advisory board member of Medistem.

In 2007 Medistem discovered an entirely new type of stem cell, the Endometrial Regenerative Cell (ERC). This cell has proven it is a "universal donor" and can be used to treat many more conditions compared to other types of stem cells. The company received FDA clearance to begin clinical trials in September of 2011 for critical limb ischemia, a condition that is associated with amputation. Medistem is also running a Phase II clinical trial for heart failure using the new stem cell. The ERC stem cell does not involve the highly controversial use of fetal tissue, can be produced very economically and administered to the patient in a very simple manner. Medistem is exploring ways to expand clinical trials of its stem cell into other diseases.

"Stem cells and regenerative medicine offer hope in clinical conditions in which hope previously did not exist," said Dr. Stanley Cohan, Head of Neurology at the St Vincent's Hospital, the largest center for treatment of multiple sclerosis in the Pacific Northwest, who will be attending the event. "We are honored in the Portland community to have this distinguished team of accomplished researchers and medical doctors convene here and discuss with us possible collaborations."

"As a long-time member of the Portland academic community, it is exciting to have companies such as Medistem to visit us and share their experiences 'from the trenches' of what it takes to push a cellular drug through the FDA," said Dr. Shoukrat Milipotiv, Associate Scientist in the Division of Reproductive & Developmental Sciences of ONPRC, Oregon Stem Cell Center and Departments of Obstetrics & Gynecology and Molecular & Medical Genetics, and co-director of the ART/ESC core at the Center. He is an internationally recognized researcher in the area of stem cells.

"The Event is an annual celebration to honor our team and collaborators for the successes of the previous year, while at the same time educate the local business and medical community on the latest research on stem cells not just at Medistem but internationally," said Thomas Ichim, Ph.D Chief Executive Officer of Medistem Inc. "2012 is particularly exciting for us due to approvals for two clinical trials, and the initiation of patient treatments within this context."

About Medistem Inc.

Medistem Inc. is a biotechnology company developing technologies related to adult stem cell extraction, manipulation, and use for treating inflammatory and degenerative diseases. The company's lead product, the endometrial regenerative cell (ERC), is a "universal donor" stem cell being developed for critical limb ischemia and heart failure.

Cautionary Statement

This press release does not constitute an offer to sell or a solicitation of an offer to buy any of our securities. This press release may contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking information. Factors which may cause actual results to differ from our forward-looking statements are discussed in our Form 10-K for the year ended December 31, 2007 as filed with the Securities and Exchange Commission.

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Stem Cell Pioneers Converge in Portland to Discuss and Celebrate a Revolutionary New Stem Cell Entering Human Clinical ...

Stem cell fertility treatments could be risky for older women

Harvard scientists are challenging traditional medical logic that dictates that women are born with a finite amount of eggs.  The scientists said they have discovered the ovaries of young women harbor rare stem cells that are in fact capable of producing new eggs.

If properly harnessed, those stem cells may someday lead to new treatments for women suffering from infertility due to cancer or other diseases – or for those who are simply getting older, according to the researchers.  Lead researcher Jonathan Tilly of Harvard's Massachusetts General Hospital has co-founded a company, OvaScience Inc., to try to develop the findings into fertility treatments.

The idea that women are born with all the egg cells – called oocytes – they’ll ever have has been called into question by past research, which found egg-producing stem cells in adult mice.

In this latest study, Harvard researchers, in collaboration with Japanese scientists, used donated frozen ovaries from 20 year olds and ‘fished out’ the purported stem cells.  

The researchers inserted a gene into the stem cells, which caused them to glow green.  If the cells produced eggs, those would glow green, too.

The researchers first watched through a microscope as new eggs grew in a lab dish.  They then implanted the human tissue under the skin of mice to provide a nourishing blood supply.  Within two weeks, they observed green-tinged cells forming.

While the work of the Harvard scientists does show potential, there are still questions as to whether the cells are capable of growing into mature, usable eggs.

If so, researchers said, it might be possible one day to use the stem cells in order to grow eggs in lab dishes to help preserve cancer patients’ fertility, which can be harmed by chemotherapy.

Now, I just want to say, while this would be a remarkable discovery – if it pans out – I do have a few concerns. 

I think for specific patients in prime, childbearing ages, who are at risk of losing their fertility for one reason or another, this could be a fruitful discovery for them.

Be that as it may, I am totally against commercializing this technology to the point where women going through menopause look at this as another way of getting pregnant.  For many, this could create incredibly high-risk pregnancies, among other medical problems.

While science is capable of great discovery and innovation – particularly in the field of stem cells – I believe that with reproductive medicine, we should move forward with great caution to minimize any risk to mother and baby.

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Stem cell fertility treatments could be risky for older women

Study Could Result In Egg Cell Production For Fertility Treatments

February 27, 2012

Researchers from Massachusetts General Hospital (MGH) have for the first time isolated stem cells that are capable of producing what appear to be normal egg cells or oocytes from the ovaries of reproductive age women.

According to BBC News Health and Science Reporter James Gallagher, the research demonstrates that it could be possible to someday create a virtually unlimited supply of human eggs to assist with fertility treatments and help women hoping to have a child.

Gallagher also said that the MGH researchers have shown that it is possible to find stem cells that spontaneously produce new eggs in laboratory conditions, and that additional research involving mice showed that these oocytes could be fertilized.

The AFP said that the discovery, which is detailed in the March issue of the journal Nature Medicine, suggests that women do not have a limited stock of eggs, and instead replaces it with the theory that the supply of these reproductive cells is “continuously replenished from precursor cells in the ovary.”

An MGH press release said that the study, which was spearheaded by Dr. Jonathan Tilly, director of the hospital’s Vincent Center for Reproductive Biology, is a follow up to earlier research, published eight years ago, which suggested that female mammals continued producing egg cells into adulthood.

“The 2004 report from Tilly’s team challenged the fundamental belief, held since the 1950s, that female mammals are born with a finite supply of eggs that is depleted throughout life and exhausted at menopause,” the MGH press release said.

“That paper and a 2005 follow-up published in Cell showing that bone marrow or blood cell transplants could restore oocyte production in adult female mice after fertility-destroying chemotherapy were controversial; but in the intervening years, several studies from the MGH-Vincent group and other researchers around the world have supported Tilly’s work and conclusions,” it added.

Tilly and his colleagues told Gallagher that they were able to find and isolate these egg-producing stem cells by searching for the protein DDX4, which is only found on the surface of this specific type of stem cell.

“When grown in the lab, the stem cells ‘spontaneously generated’ immature eggs – or oocytes, which looked and acted like oocytes in the body,” the BBC News reporter said. “The cells were ‘matured’ when surrounded by living human ovarian tissue, which had been grafted inside mice.”

“The primary objective of the current study was to prove that oocyte-producing stem cells do in fact exist in the ovaries of women during reproductive life, which we feel this study demonstrates very clearly,” Tilly added. “The discovery of oocyte precursor cells in adult human ovaries, coupled with the fact that these cells share the same characteristic features of their mouse counterparts that produce fully functional eggs, opens the door for development of unprecedented technologies to overcome infertility in women and perhaps even delay the timing of ovarian failure.”

In addition to Tilly, co-author Dr. Yasushi Takai, formerly a research fellow at MGH and currently a faculty member at Saitama Medical University in Japan; Dr. Yvonne White and Dr. Dori Woods of the MGH Vincent Center for Reproductive Biology; and Dr. Osamu Ishihara and Hiroyuki Seki of Saitama Medical University.

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Study Could Result In Egg Cell Production For Fertility Treatments

Cell breakthrough may boost fertility treatment

Scientists say they have found a way to produce human eggs from stem cells. Photo: Paul Harris

AMERICAN scientists say they have found a way to produce human eggs from stem cells, raising hope of an advance in treating infertility in women.

The researchers say their discovery has swept away the belief women have a limited stock of eggs, and replaces it with the theory that supply is continuously replenished from precursor cells in ovaries.

''The prevailing dogma in our field for the better part of the last 50 or 60 years was that young girls at birth were given a bank account of eggs at birth that's not renewable,'' said Jonathan Tilly, director of the Vincent Centre for Reproductive Biology at Massachusetts General Hospital, who led the research.

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Dr Tilly said that as a result of the findings, published in the journal Nature Medicine, ''we might get to the point of having an unlimited source of human eggs''.

In 2004 Dr Tilly discovered that ovarian stem cells in mice could create new eggs, similar to how stem cells in testes produce sperm throughout a man's life.

The latest study proved the same was true in human ovaries, and may point to new ways to overcome infertility or preserve fertility by delaying the time when a woman's ovaries stop functioning, Dr Tilly said.

In the study, healthy ovaries were obtained from consenting patients undergoing sex reassignment surgery.

The stem cells from the ovaries were injected into human ovarian tissue that was then grafted under the skin of mice, which provided the blood supply that enabled the cells to grow. Within two weeks, early stage human follicles with oocytes, as eggs are called, had begun to form.

Dr Tilly said his research was opening other therapeutic avenues in fertility treatment.

''The problem we face with IVF is we don't have many eggs to work with,'' he said. ''These cells are renewable. If we are successful - and it's a big if - in generating functioning eggs from these cells, we can generate as many eggs as we need to.''

Academics said there was still a long way to go before showing the process was viable in humans.

BLOOMBERG, AGENCIES

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‘Scope for innovation in genetic medicine’

There is a tremendous opportunity in genetic medicine for innovation and for new players to make significant contributions, because it is still experimental, noted biologist and Nobel Laureate Dr David Baltimore said yesterday.
“Today, it is mainly the province of biotechnology companies and universities, not big pharmaceutical companies,” he observed in a keynote presentation at the Qatar International Conference on Stem Cell Science and Policy 2012.
There are new genetic tools available – though they are still experimental - to treat diseases which involve adding, subtracting or modifying genes in the cells of the body.
“However, they are powerful tools and I am confident they will be an important part of the medicine of the future,” he said.
Speaking on ‘The hematopoietic stem cell (HSC) as a target for therapy against cancer and Aids,’ Dr Baltimore explained that HSCs are one of the few cell types routinely used for bone marrow transplant.
The HSCs are easily accessible, retroviruses can be used to carry genes into these stem cells, the genes are then expressed in all of cells that derive from the HSC and can correct inherited defects and bring genes that perform therapy under a programme called engineering immunity.
“Though the human immune system is a wondrous creation of evolution yet it is not without certain limitations. One, in particular, is its poor ability to stop the growth of cancer cells– another is its hosting of HIV.
“In the case of cancer, the machinery of immunity can attack cancers but it rarely attacks with the necessary power. For HIV, the ability of the virus to use the CD4 and CCR5 proteins as receptors means that CD4 cells are the major cell type in which the virus grows.
“We have been trying to supply genes to the immune system by gene transfer methods that would improve its ability to block cancer and block infection of CD4 cells by HIV.
“For cancer, we have focused on T cell receptor genes. For HIV, we have used a small interfering ribonucleic acid (siRNA) targeted to CCR5. We have been quite successful in mice with both strategies and are now moving to humans.
“In both cases, our experiments with mice have focused on putting genes into HSCs as, once these cells are altered, they provide modified blood cells to the body for life.
“In our human cancer trials we first used peripheral T cells for modification with dramatic effect but it has been transient.
“We are now moving to stem cells. For the siRNA against CCR5, we plan to initiate trials within six months using autologous, gene-modified stem cells,” he added.
The ensuing panel discussion on ‘Opportunities and challenges for stem cell research,’ saw Prof Irving Weissman (Stanford Institute for Stem Cell Biology and Regenerative Medicine) cautioning against ‘phoney organisations engaged in stem cell therapy.’
Prof Juan Carlos Izpisua Belmonte (Salk Institute for Biological Studies, US) stated that stem cells derived from umbilical cord blood should be considered as one of the key cells for use in regenerative medicine.
The session also featured Dr Alan Trounson (California Institute of Regenerative Medicine), Prof Roger Pedersen (The Anne McLaren Laboratory for Regenerative Medicine, University of Cambridge), Dr Lawrence Corey (University of Washington) and with Dr Richard Klausner (managing partner of biotechnology venture capital firm The Column Group) as moderator.
Earlier, Ambassador Edward P Djerejian (founding director, James A Baker III Institute for Public Policy, Rice University, Houston, Texas, US) spoke about the collaboration with Qatar Foundation on stem cell research.

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‘Scope for innovation in genetic medicine’

Stem cells give Barbaro's half-brother a chance to run again

by WHAS editors

WHAS11.com

Posted on February 27, 2012 at 1:22 PM

TUSCON, Ariz. (WHAS11) -- A famous horse has a new lease on life thanks to a cutting-edge stem cell treatment.

He's the half-brother to Kentucky Derby winner Barbaro and he’s known around the world as Dynaking, but the people who rescued him in Tucson, Ariz. call him "Gifted."

He was born to run, but now he can barely walk. "Gifted" suffers from a condition that affects horses feet, an inflammation of the hoof that kills if left untreated.

Veterinarian Dr. Vernon Dryden flew to Arizona from Kentucky to help.

“What he has is a very difficult thing to overcome and really truly we're not going to cure him but we're going to try to prolong his life,” Dryden said.

Now the recovery is up to "Gifted."

“He's got the will to live like no horse I’ve ever seen before. He is a fighter,” Judy Glore, Heart of Tucson president, said.  
 

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Stem cells give Barbaro's half-brother a chance to run again

StemCells, Inc. to Participate in Qatar International Conference on Stem Cell Science and Policy 2012

NEWARK, Calif., Feb. 27, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM - News) today announced that it will participate in the Qatar International Conference on Stem Cell Science and Policy, which is being held in Qatar from February 27 to March 1, 2012. The Company, which is the leader in development of cell-based therapeutics for central nervous system disorders, was specifically invited by the conference's sponsors, the State of Qatar and Amir of Qatar His Highness Sheikh Hamad bin Khalifa Al-Thani, as well as the James A. Baker III Institute for Public Policy of Rice University, and is the only company to be invited.

Ann Tsukamoto, Ph.D., StemCells' Executive Vice President, Research and Development, will make a presentation on the clinical translation of human neural stem cells. StemCells was the first company to receive authorization from the US Food and Drug Administration to conduct a clinical trial of purified human neural stem cells, and the Company is currently conducting two clinical trials with a third anticipated to start later this year. Dr. Tsukamoto will also be the moderator of the panel session on neurological disorders, which is scheduled to be held on March 1 from 9:30 a.m. to 11:00 a.m. Arabian Standard Time (AST).

In addition, Irving Weissman, M.D., Chairman of StemCells' Scientific Advisory Board, will make a keynote presentation to the conference on Tuesday, February 28 at 9:00 a.m. AST. Dr. Weissman, who is Virginia and Daniel K. Ludwig Professor of Cancer Research, Professor of Pathology and Professor of Developmental Biology at the Stanford School of Medicine, and Director of the Stanford Institute of Stem Cell Biology and Regenerative Medicine, will speak on normal and neoplastic stem cells. Dr. Weissman will also participate in a panel discussion on the opportunities and challenges for stem cell research, and will moderate a panel discussion on pluripotent stem cells.

The Qatar International Conference on Stem Cell Science and Policy will bring together more than 400 international participants from industry, academia and public policy, including leading experts from each of these sectors. The conference's objectives are to showcase the latest stem cell research from around the world, while promoting discussion and awareness of scientific, ethical and regulatory issues related to this innovative and dynamic field.

About StemCells, Inc.

StemCells, Inc. is engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery. The Company's lead therapeutic product candidate, HuCNS-SC(R) cells (purified human neural stem cells), is currently in development as a potential treatment for a broad range of central nervous system disorders. The Company recently completed a clinical trial in Pelizaeus-Merzbacher disease (PMD), a fatal myelination disorder in children, and expects to report the trial results soon. The Company is also conducting a Phase I/II clinical trial in chronic spinal cord injury, and expects to initiate a Phase I/II clinical trial in dry age- related macular degeneration in the near future. In addition, the Company is pursuing preclinical studies of its HuCNS-SC cells in Alzheimer's disease. StemCells also markets stem cell research products, including media and reagents, under the SC Proven(R) brand, and is developing stem cell-based assay platforms for use in pharmaceutical research, drug discovery and drug development. Further information about StemCells is available at http://www.stemcellsinc.com.

The StemCells, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7014

Apart from statements of historical fact, the text of this press release constitutes forward-looking statements within the meaning of the U.S. securities laws, and is subject to the safe harbors created therein. These statements include, but are not limited to, statements regarding the clinical development of its HuCNS-SC cells; the Company's ability to commercialize drug discovery and drug development tools; and the future business operations of the Company. These forward-looking statements speak only as of the date of this news release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect management's current views and are based on certain assumptions that may or may not ultimately prove valid. The Company's actual results may vary materially from those contemplated in such forward-looking statements due to risks and uncertainties to which the Company is subject, including those described under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2010 and in its subsequent reports on Form 10-Q and Form 8-K.

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StemCells, Inc. to Participate in Qatar International Conference on Stem Cell Science and Policy 2012

Nature: BrainStorm's NurOwn™ Stem Cell Technology Offers Hope for Treating Huntington Disease

NEW YORK & PETACH TIKVAH--(BUSINESS WIRE)--

BrainStorm Cell Therapeutics Inc. (OTCBB: BCLI.OB - News), a leading developer of adult stem cell technologies and therapeutics, announced today that the prestigious Nature Reviews Neurology, a Nature Publishing Group Journal, highlighted recently published preclinical research results indicating that stem cells, generated with Brainstorm’s NurOwn™ technology, provide hope for Huntington disease's patients.

In the preclinical studies conducted by leading scientists including Professors Melamed and Offen of Tel Aviv University and originally reported in Experimental Neurology, patients' bone marrow derived mesenchymal stem cells secreting neurotrophic factors (MSC-NTF) that were transplanted into an animal model of Huntington disease showed therapeutic benefits.

Addressing the role of these MSC-NTF cells in Huntington disease, Professor Daniel Offen explains, "the premise is that such cells can be transplanted safely into affected areas of the brain, and thereby serve as vehicles for delivering neurotrophic factors." Offen expressed his hope that this cell-based therapy may eventually progress to the clinic.

BrainStorm is currently conducting a Phase I/II Human Clinical Trial for Amyotrophic Lateral Sclerosis (ALS) also known as Lou Gehrig’s disease at the Hadassah Medical center. Initial results have shown that Brainstorm’s NurOwn™ therapy is safe, does not show any significant treatment-related adverse events, and have also shown certain signs of beneficial clinical effects.

Follow this link for the Research Highlights page in Nature Reviews Neurology (starts Feb. 28th ): http://www.nature.com/nrneurol/journal/vaop/ncurrent/index.html

To read the Original Article entitled ‘Mesenchymal stem cells induced to secrete neurotrophic factors attenuate quinolinic acid toxicity: A potential therapy for Huntington's disease’ by Sadan et al. follow this link: http://www.sciencedirect.com/science/article/pii/S0014488612000295

About BrainStorm Cell Therapeutics, Inc.

BrainStorm Cell Therapeutics Inc. is a biotech company developing adult stem cell therapeutic products, derived from autologous (self) bone marrow cells, for the treatment of neurodegenerative diseases. The company, through its wholly owned subsidiary Brainstorm Cell Therapeutics Ltd., holds rights to develop and commercialize the technology through an exclusive, worldwide licensing agreement with Ramot (www.ramot.org) at Tel Aviv University Ltd., the technology transfer company of Tel-Aviv University. The technology is currently in a Phase I/II clinical trials for ALS in Israel.

Safe Harbor Statement

Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements, including, inter alia, regarding safety and efficacy in its human clinical trials and thereafter; the Company's ability to progress any product candidates in pre-clinical or clinical trials; the scope, rate and progress of its pre-clinical trials and other research and development activities; the scope, rate and progress of clinical trials we commence; clinical trial results; safety and efficacy of the product even if the data from pre-clinical or clinical trials is positive; uncertainties relating to clinical trials; risks relating to the commercialization, if any, of our proposed product candidates; dependence on the efforts of third parties; failure by us to secure and maintain relationships with collaborators; dependence on intellectual property; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility, and risks that we may lack the financial resources and access to capital to fund our operations. The potential risks and uncertainties include risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect its technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. The Company does not undertake any obligation to update forward-looking statements made by us.

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Nature: BrainStorm's NurOwn™ Stem Cell Technology Offers Hope for Treating Huntington Disease

Stem cell find offers hope for infertility

Stem cell find offers hope for infertility

Monday, February 27, 2012

An experiment that produced human eggs from stem cells could one day be a boon for women who are desperate to have a baby, according to a study published yesterday.

The work sweeps away the belief that a woman has only a limited stock of eggs and replaces it with the theory that the supply is continuously replenished from precursor cells in the ovary, its authors said.

If the report is confirmed, harnessing those stem cells might one day lead to better treatments for women left infertile because of disease — or simply because they’re getting older.

"Our current views of ovarian aging are incomplete. There’s much more to the story than simply the trickling away of a fixed pool of eggs," said lead researcher Jonathan Tilly of Harvard’s Massachusetts General Hospital, who had long hunted these cells in a series of studies.

His previous work drew fierce scepticism. Independent experts urged caution about the latest findings.

A key next step is to see whether other laboratories can verify the work. If so, then it would take years of additional research to learn how to use the cells, said Teresa Woodruff, fertility preservation chief at Northwestern University’s Feinberg School of Medicine.

Still, even a leading critic said such research may help dispel some of the enduring mystery surrounding how human eggs were born and matured.

"This is going to spark renewed interest, and more than anything else it’s giving us some new directions to work in," David Albertini, director of the University of Kansas’ Center for Reproductive Sciences said.

Scientists have long taught that all female mammals are born with a finite supply of egg cells, called ooctyes, that runs out in middle age.

Tilly first challenged that notion in 2004, reporting the ovaries of adult mice harbour some egg-producing stem cells.

He collaborated with scientists in Japan, who were freezing ovaries donated by healthy 20-somethings. Tilly also had to address a criticism: How to tell if he was finding true stem cells or just very immature eggs.

His team latched onto a protein believed to sit on the surface of only those purported stem cells and fished them out. To track what happened next, they inserted a gene that makes some jellyfish glow green into those cells. If the cells made eggs, those would glow, too. "Bang, it worked — cells popped right out," said Tilly.

a d v e r t i s e m e n t

 

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Stem cell find offers hope for infertility