DoH vs imported stem cells

Manila, Philippines The Department of Health (DOH) will soon ban the importation of imported stem cell preparations that were gathered from animals and even from fetal embryo.

The Philippine Society for Stem Cell Medicine (PSSCM) said these stem cell preparations are usually shipped from Germany and were gathered from sheep, rabbits and other animals but are sold as human stem cells. Dr. Rey Melchor Santos, PSSCM said the draft on the guidelines for the use of stem cell medicine in the country will soon be nalized by the DoH and this will include a ban on the use of imported stem cells including stem cells taken from aborted fetuses.

There are some preparations from other countries derived from fetal embryo which is unethical and is totally not allowed in the country, Melchor told reporters in a forum in Quezon City yesterday.

According to Melchor, administering stem cell treatment is a delicate matter as complications also occur. He said there are reports of stem cells causing cancer to patients who received it.

We have to be really careful where the stem cell is coming from because we dont know its complications. Incompatibility or rejections can kill the patient, the doctor warned.

The DoH allows the use of adult autologous stem cells or those that were sourced from the patient himself. Stem cells can be harvested from the bone marrow or from the adipose tissues (body fat). Incoming President of the Philippine Medical Association (PMA) Dr. Leo Olarte said the guidelines would also limit the use of stem cell treatment among licensed facilities and trained medical personnel. (Jenny F. Manongdo)

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DoH vs imported stem cells

Pre-clinical research shows promising treatment for diabetic wounds using stem cells

Mar. 12, 2013 Pre-clinical research has generated some very promising findings using adult stem cells for the treatment of diabetic wounds. The research carried out by scientists at the National University of Ireland Galway, is published in Diabetes, the official journal of the American Diabetes Association.

The work showed that a particular type of stem cell, known as the mesenchymal stem cell (MSC), could increase wound healing when applied together with a biomaterial made from collagen. Diabetic patients have an impaired ability to heal wounds and there is a critical need to develop new treatments to improve healing particularly in patients with foot ulcers. In fact, foot ulceration will affect up to 25% of people suffering from diabetes during their lives and may result in amputation.

For the past number of years, lead-author on the research paper Dr Aonghus OLoughlin has been funded by Molecular Medicine Ireland to work in the Regenerative Medicine Institute (REMEDI) at National University of Ireland Galway and Galway University Hospitals. He collaborates with Professor Timothy OBrien, Director of REMEDI, to develop new ways to increase healing of diabetic wounds.

Professor OBrien, principal investigator on the research project, said: This data will now allow us proceed to apply for approval to carry out first in human studies of this therapeutic approach. We are currently preparing the regulatory submission to undertake a human clinical trial. Meanwhile, part of the funding needed to pursue the human clinical trial has been received from Diabetes Ireland.

MSCs have many attractive therapeutic properties, Professor OBrien added. They can be isolated from adults and are easy to grow in the laboratory. It has been shown in Galway and by other scientists that they release special factors that can help new blood vessels to grow. Increasing blood flow is a key step in wound healing.

REMEDI is a Science Foundation Ireland-funded research centre, led byNational University of Ireland Galway, with partners in University College Cork and NUI Maynooth. The research centre is a partnership between scientists, clinicians and industry and is the leading centre in the area of stem cell and regenerative medicine in Ireland. REMEDI is a part of the National University of Ireland Galways translational and clinical research programme with the objective of translating research discoveries into improved patient care.

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The above story is reprinted from materials provided by National University of Ireland, Galway, via AlphaGalileo.

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Pre-clinical research shows promising treatment for diabetic wounds using stem cells

World’s First Three-Parent Monkeys Created

The finding could fundamentally change how we look at human stem cell tech: If chimeric monkeys require totipotent cells before they can come into being, it stands to reason that human embryonic stem cell therapy might also require totipotent stem cells to render cures. Indeed, the find suggests that testing human therapies on mice and other mammalian species may have sent us down the garden path.

The Chimeric Advantage

The ability to create chimera from stem cells not only in mice but in other animals, including primates, could prove to be a major advance in biomedical science. In a 2009 study, University of Georgia at Athens cloning expert Steve Stice created 29 chimeric piglets by injecting pluripotent stem cells into pig embryos before implanting them into a surrogate womb.

Although it wasnt the first time chimeric pigs were created, it was the first time they came about using cloned pluripotent cells. And because pigs are genetically closer to humans than mice are, success in creating chimeric pigs from stem cells offered renewed hope that the technology could lead to better pharmaceutical testing or stem cell therapies.

Mitalipov couldnt agree more. Stem cell therapies hold great promise, he says, from possible treatments for brain disease to heart disease and age-related disorders. No drug could restore functional tissue the way that stem cells could. But given the difficulty of achieving monkey chimeras from pluripotent cells, Mitalipov thinks we might need to derive an entirely new stem cell class for regenerative medicine in humans: the all-powerful totipotent cells.

Meanwhile, the monkeys will be weaned and raised to adulthood. We will see if these three monkeys can have normal offspring. We will want to see if these chimeras persist through the generations, Mitalipov says.

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World's First Three-Parent Monkeys Created

State judge: Bonita stem cell doctor Grekos should lose medical license

BONITA SPRINGS A state judge has recommended Bonita Springs cardiologist Zannos Grekos lose his medical license, saying he committed medical malpractice when he performed an unproven stem cell treatment on a patient that had no chance of success, records showed Monday.

In issuing a 25-page recommended order Monday that now goes to the state Board of Medicine, administrative law judge J. Lawrence Johnston said the case finding supports the imposition of a penalty at the top of the ranges, namely revocation and a $20,000 fine.

The case involves Grekos unorthodox stem-cell therapy in 2010 on 69-year-old Domenica Fitzgerald, who suffered a stroke and was taken off life support. She died April 4, 2010.

She had gone to Grekos for what she believed was going to be a stem cell treatment using her own stem cells to repair tingling in her legs that was a side-effect from chemotherapy for breast cancer treatment several years earlier.

Grekos had developed a following in Southwest Florida when he arranged for people to have their cultivated stem cells injected into their body at the site of damaged heart or lung tissue.

He would extract a sample of their blood and send it to a laboratory in Israel for spinning to cultivate the stem cells. From there, the blood would be sent to the Dominican Republic. Several patients who benefited from this treatment stand by Grekos and attended the hearing last fall in Naples.

But with Fitzgerald, Grekos treated her in his own Bonita Springs practice and when he aspirated bone marrow from her, it wasnt processed. He instead injected unconcentrated and grossly filtered bone marrow aspirate into her carotid artery.

The judge said what Grekos did had virtually no hope of success and had a very high probability that it would cause the patient to have a serious stroke.

He said Grekos should have known his treatment carried grave risks.

Instead he denies the gravity of the risk, the judge said. He (stated) that he did not know what would happen as a result of this procedure.

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State judge: Bonita stem cell doctor Grekos should lose medical license

BrainStorm Cell Therapeutics Presents Breakthrough Phase I/II ALS Clinical Data at the American Academy of Neurology …

NEW YORK, NY and PETACH TIKVAH, ISRAEL--(Marketwire - Mar 13, 2013) - BrainStorm Cell Therapeutics ( OTCQB : BCLI ), a leading developer of adult stem cell technologies for neurodegenerative diseases, will be presenting the initial results of its Phase I/II ALS trial at the 65th Annual Meeting of the American Academy of Neurology (AAN) in San Diego, California, from March 16-23.BrainStorm's groundbreaking clinical trial data were selected for one of only twelve oral presentations in the Emerging Science Session on Wednesday, March 20th.

The presentation, to be made by Principal Investigator Professor Dimitrios Karussis of the Hadassah Medical Center in Jerusalem, will be the first to make public the outstanding Phase I/II clinical trial safety data and promising initial indications of clinical efficacy observed after treatment with NurOwn, BrainStorm's stem cell therapy candidate for ALS.

"We are honored to present these important clinical data at the most prestigious world neurology meeting," commented Professor Karussis. "We are confident that the results observed so far will be indicative of the potential therapeutic benefit of NurOwn cells for treatment of ALS," he added.

The American Academy of Neurology Annual Meeting is one of the world's most important annual events for neurologists and neuroscience professionals and the largest such international meeting of its kind with more than 12,000 attendees at last year's meeting. For more information about the AAN annual meeting and for a complete list of abstracts, please refer to the conference Web site at http://www.aan.com/go/am13.

The following is the key NurOwn-related abstract being presented at the AAN meeting:

About NurOwnNurOwn is an autologous, adult stem cell therapy technology that differentiates bone marrow-derived mesenchymal stem cells (MSC) into specialized, neuron-supporting cells.These neuron-supporting cells (known as "MSC-NTF" cells) secrete neurotrophic, or nerve-growth, factors for PROTECTION of existing motor neurons, PROMOTION of motor neuron growth, and RE-ESTABLISHMENT of nerve-muscle interaction.The ability to differentiate mesenchymal stem cells into MSC-NTF cells, and confirmation of their activity and potency before transplantation, makes NurOwn a first-of-its-kind approach for treating neurodegenerative diseases.More information about NurOwn can be found at http://brainstorm-cell.com/index.php/science-a-technology/-nurown.

About BrainStorm Cell Therapeutics, Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. For more information, visit the company's website at http://www.brainstorm-cell.com.

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. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements.The potential risks and uncertainties include, without limitation, 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 the 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.These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements.The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

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BrainStorm Cell Therapeutics Presents Breakthrough Phase I/II ALS Clinical Data at the American Academy of Neurology ...

Stem Cell Orthopedic Applauds New Studies Supporting Plasma Therapy Treatments

Stem Cell Orthopedic applauds new studies finding Platelet-Rich Plasma (PRP) therapy helpful in treating osteoarthritis.

(PRWEB) March 13, 2013

PRP stem cell therapy is a promising and exciting treatment that takes a concentration of a persons own plasma from their blood, and injects them into areas of their body in need of new growth and tissue repair. This process applied to many sufferers of osteoarthritis has shown to not only relieve their pain and improve their joint function, but studies prove that PRP injections appear to even delay the progression of osteoarthritis in general. As experts in PRP arthritis therapy, Stem Cell Orthopedic has lead the way in improving this groundbreaking treatment option and its applications to treat people around the world in need of its regenerative properties.

The Institute of Regenerative and Molecular Orthopaedics is headed by the world-renowned stem cell treatment pioneer, Dr. Joseph Purita. The IRMO are of the few orthopedic practices on earth that utilizes stem cell therapy and PRP therapy with orthopedic surgery. As more and more studies around the world sing the praises of platelet rich plasma therapy, Stem Cell Orthopedic will continue offering this trailblazing treatment to help maximize the recovery of their patients across the United States and beyond.

About Stem Cell Orthopedic

The Institute of Regenerative and Molecular Orthopaedics (IRMO) is a world-class orthopedic practice and stem cell facility staffed with seasoned board certified orthopedic surgeons. They differ from most orthopedic practices because they offer stem cells and platelet rich plasma (PRP) therapy in conjunction with surgery or as alternative to surgical procedures. They utilize state-of-the-art technology and the latest in stem cell research to best treat their patients. IRMO uses hematopoietic stem cells (HSC), which are found circulating in blood, fat, and bone marrow, to help repair the body. They are headed by Medical Director, Dr. Joseph Purita, a world-renowned pioneer in laser orthopedic surgery and graduate of the esteemed Georgetown University Medical School. For more information, visit http://www.stemcellorthopedic.com/ or follow them on Facebook or Twitter.

Contact Us Stem Cell Orthopedic 561-300-1840 Email Information

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Nuvilex, Inc. Cell -in-a-Box Technology Could Revitalize the Stem Cell Phenomenon

NEW YORK, NY--(Marketwire - Mar 12, 2013) - Nuvilex, Inc. ( OTCQB : NVLX ), an international biotech company, could dramatically shift the stem cell conversation with its Cell-in-a-Box technology.

Remember not so long ago when every science related conversation seemed to weave its way into a conversation about stem cells? Back around 2007, there was a real phenomenon going on among biotechnology companies that had anything at all to do with stem cells, and now six years later with more research in the books, that enthusiasm has waned a bit.

Still, stem cell treatments are being developed for many ailments including heart damage, arthritis, "joint" injuries, neurologic diseases such as Parkinson's, Alzheimer's, ALS, dementia, and even wound repair, among a host of others. However, progress with the development of stem cell-based therapies has been tempered somewhat, largely because of the characteristics of the stem cells themselves.

The way the process is supposed to work is that stem cells or other therapeutic cells are implanted or injected into a patient's body to enable the cells' therapeutic action. This therapeutic action can be achieved by the cells producing a "beneficial" healing factor, or by "signaling" to other cells and stimulating healing.

Clear the Hurdles - Reignite the Phenomenon

However, industry leaders have consistently found a number of hurdles limiting the success of stem cell treatments including; immune system attacks on the transplanted cells, migration of the cells after transplantation, formation of abnormal growths (including tumors) after such migration, problems with long-term storage of the cells for later use, and problems with the use of the cells inside bioreactors.

With recent estimates predicting the global market for stem cells and stem cell products reaching almost $6.6-billion by 2016, the research continues. Companies like StemCells, Inc., Aastrom Biosciences, Inc., BioTime, Inc., International Stem Cell Corp. and Advanced Cell Technology among many others are hard at work in the sector trying to solve the roadblocks that keep the FDA from approving any stem cell treatment to date.

Meanwhile, Nuvilex, a biotech headquartered in Silver Spring, Maryland, is currently in negotiations with biotechnology and pharmaceutical entities that wish to examine the employment of Nuvilex's living cell encapsulation technology, or Cell-in-a-Box, in the development of treatments for various diseases that would utilize stem cells.

What is Cell-in-a-Box?Could this living cell encapsulation technology be the silver bullet to get many stem cell companies through some of the roadblocks that have plagued their success?

Read the full Feature News Article at http://www.stockhousegroup.com/features

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Nuvilex, Inc. Cell -in-a-Box Technology Could Revitalize the Stem Cell Phenomenon

VistaGen Therapeutics to Present CardioSafe 3D(TM) Developments at Society of Toxicology’s 52nd Annual Meeting

SOUTH SAN FRANCISCO, CA--(Marketwire - Mar 11, 2013) - VistaGen Therapeutics, Inc. ( OTCQB : VSTA ), a biotechnology company applying stem cell technology for drug rescue, predictive toxicology and drug metabolism assays, today announces it will feature key developments involving CardioSafe 3D, its pluripotent stem cell-based bioassay system for heart toxicity, in a poster presentation at the Society of Toxicology's 52nd Annual Meeting, the world's premier toxicology conference, in San Antonio, Texas, on March 11, 2013, at 7:30 am PDT.

Dr. Hai-Qing Xian, Senior Scientist, will present VistaGen's poster titled "Development of Improved hESC-Based High-Throughput Screening Assays for Cardiotoxicity Assessment," which will detail the following expanded functional and electrophysiological results:

H. Ralph Snodgrass, PhD, VistaGen's President and Chief Scientific Officer, stated, "I am very pleased with these results, because they confirm that our stem cell-based human cardiomyocyte screening systems will provide improved capabilities and resolution for our cardiac drug rescue programs, which we believe will contribute to the efficient and rapid identification of safer and highly effective new drug therapies."

About VistaGen Therapeutics

VistaGen is a biotechnology company applying human pluripotent stem cell technology for drug rescue, predictive toxicology and drug metabolism screening. VistaGen's drug rescue activities combine its human pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube, with modern medicinal chemistry to generate novel, safer chemical variants (Drug Rescue Variants) of once-promising small molecule drug candidates. These are drug candidates discontinued by pharmaceutical companies, the U.S. National Institutes of Health (NIH) or university laboratories, after substantial investment in discovery and development, due to heart or liver toxicity or metabolism issues. VistaGen uses its pluripotent stem cell technology to generate early indications, or predictions, of how humans will ultimately respond to new drug candidates before they are ever tested in humans, bringing human biology to the front end of the drug development process.

VistaGen's small molecule prodrug candidate, AV-101, has completed Phase 1 development for treatment of neuropathic pain. Neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system, affects millions of people worldwide.

Visit VistaGen at http://www.VistaGen.com, follow VistaGen at http://www.twitter.com/VistaGen or view VistaGen's Facebook page at http://www.facebook.com/VistaGen.

Cautionary Statement Regarding Forward Looking Statements

The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to the success of VistaGen's stem cell technology-based drug rescue, predictive toxicology and metabolism screening activities, further development of stem cell-based bioassay systems, and potentially improved cell therapies, for human blood system disorders or other diseases or conditions, clinical development and commercialization of AV-101 for neuropathic pain or any other disease or condition, its ability to enter into strategic predictive toxicology, metabolism screening, drug rescue and/or drug discovery, development and commercialization collaborations and/or licensing arrangements with respect to one or more drug rescue variants, cell therapies or AV-101, risks and uncertainties relating to the availability of substantial additional capital to support its research, drug rescue, development and commercialization activities, and the success of its research and development plans and strategies, including those plans and strategies related to any drug rescue variant or cell therapy identified and developed by VistaGen, or AV-101. These and other risks and uncertainties are identified and described in more detail in VistaGen's filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC's website at http://www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.

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VistaGen Therapeutics to Present CardioSafe 3D(TM) Developments at Society of Toxicology's 52nd Annual Meeting

Recombinant spider silk matrices for neural stem cell cultures

Neural stem cells (NSCs) have the capacity to differentiate into neurons, astrocytes, and oligodendrocytes. Accordingly, NSCs hold great promise in drug screening and treatment of several common diseases. However, a major obstacle in applied stem cell research is the limitation of synthetic matrices for culturing stem cells. The objective of this study was to evaluate the suitability of recombinant spider silk (4RepCT) matrices for growth of NSCs. NSCs isolated from the cerebral cortices of mid-gestation rat embryos were cultured on either 4RepCT matrices or conventional poly-L-ornithine and fibronectin (P + F) coated polystyrene plates. From 48 h of culture, no significant differences in cell proliferation or viability were detected in NSC cultures on 4RepCT compared to control matrices (polystyrene plates coated with P + F). The NSCs retained an undifferentiated state, displaying low or no staining for markers of differentiated cells. Upon stimulation NSCs grown on 4RepCT differentiated efficiently into neuronal and astrocytic cells to virtually the same degree as control cultures, but a slightly less efficient oligodendrocyte differentiation was noted. We suggest that recombinant spider silk matrices provide a functional microenvironment and represent a useful tool for the development of new strategies in neural stem cell research.

This paper was originally published in Biomaterials (2012) 31, 7712-7717.

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Recombinant spider silk matrices for neural stem cell cultures

ReNeuron Group wins grants for stem cell therapy development

LONDON (SHARECAST) - ReNeuron Group has won two grants worth 1.2m pounds to develop its stem cell therapy.

The grants were awarded by the UK Biomedical Catalyst, a programme of public funding jointly managed by the Technology Strategy Board and the Medical Research Council.

The first award of 0.4m will be used for ReNeurons ReN009 stem cell therapy candidate for critical limb ischaemia, a severe blockage in the arteries which markedly reduces blood-flow to the extremities including hands, feet and legs.

The second award of 0.8m relates to the company's ReN003 stem cell candidate for the treatment of retinitis pigmentosa, an eye disease in which there is damage to the retina.

Michael Hunt, the Chief Executive Officer of ReNeuron, said: "We are delighted to have been successful in winning the two grants we applied for in the current round of the Biomedical Catalyst funding competition.

"This highly competitive scheme involves a rigorous peer review of applicants' technologies and commercial development plans.

"In common with other awardees, we therefore regard the grants as representing a strong independent endorsement of ReNeuron's world-class stem cell development capabilities which we hope will eventually lead to the wide-scale treatment of disease conditions where there is currently a very large unmet medical need."

Shares rose 0.86% to 2.94p at 08:52 Monday.

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ReNeuron Group wins grants for stem cell therapy development