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Husband testifies wife 'was looking for a cure' and found Bonita stem-cell doctor

The Grekos hearing is scheduled to resume today. The location is the Collier County Courthouse in room 4-D, according to a case filing Monday.

The hearing before J. Lawrence Johnson, an administrative law judge from Tallahassee, is scheduled to last four days. The Collier County Courthouse is located at 3315 U.S. 41 E.

Photo by Allie Garza

Zannos Grekos

EAST NAPLES The patient was friends with the mother of Dr. Zannos Grekos, a Bonita Springs cardiologist who performed stem cell therapy on people with debilitating illnesses.

Chemotherapy for breast cancer several years earlier had left the 69-year-old patient, Domenica Fitzgerald, with numbness in her legs. She was unable to walk for more than 10 minutes. She hoped Grekos and his stem cell treatment could help.

"She was looking for a cure. She wanted to get well," her husband, John "Jack" Fitzgerald, testified Tuesday.

A four-day administrative hearing started Tuesday in a Collier County courtroom for a state Department of Health complaint against Grekos. The state says he committed medical malpractice and violated other standards of care when he performed a stem cell treatment on the patient on March 24, 2010. The patient suffered brain damage.

The state is only identifying the patient in its complaint by her initials, D.F. The Daily News learned of her identity by a public records request to the Collier County Medical Examiner's Office of all people who died on April 4, 2010, in the county. That was the day that Fitzgerald died after being taken off life support.

The state last year restricted Grekos' license after her death and ordered him not to do anything with stem cells with other patients. His license was fully suspended earlier this year when the state said he violated the order by treating another patient who also died.

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Husband testifies wife 'was looking for a cure' and found Bonita stem-cell doctor

ReNeuron progresses stroke clinical trial

LONDON (ShareCast) - ReNeuron has reported further progress in the clinical trial of its ReN001 stem cell therapy for disabled stroke patients, known as the PISCES study.

The third and penultimate batch of three patients have all been successfully treated with ReN001 and discharged from hospital with no acute safety issues arising. This follows approval last month by the independent Data Safety Monitoring Board (DSMB) for the study to proceed to completion of dosing of this batch of patients.

The PISCES study continues to run to plan, with no cell-related serious adverse events reported in any of the patients treated to date, the clinical-stage stem cell specialist reported. The remaining three, high-dose cohort patients to be treated in the PISCES study have been identified and evaluated as potentially eligible for treatment, with patient enquiries continuing to come into the Glasgow clinical site and a number of patients consequently identified as reserve candidates for the study. Subject to DSMB approval, these final three patients are scheduled to be treated in January and March 2013.

In June of this year, interim data from the PISCES study from the first five patients treated was presented by the Glasgow clinical team at the 10th Annual Meeting of the International Society for Stem Cell Research (ISSCR) in Yokohama, Japan (EUREX: FMJP.EX - news) . Reductions in neurological impairment and spasticity were observed in all five patients compared with their stable pre-treatment baseline performance and these improvements were sustained in longer term follow-up.

Based on the above progress, the company announced last month that, ahead of plan, it had submitted an application to the UK regulatory authority to commence a multi-site Phase II clinical trial to examine the efficacy of ReN001 in patients disabled by an ischaemic stroke.

This trial is designed to recruit from a well-defined population of patients between two and four months after their stroke, which the company and its clinical collaborators currently believe will be the optimum treatment window for the therapy. Subject to continuing positive progress with the PISCES study, and subject to regulatory and ethical approvals, the company hopes to be able to commence the Phase II stroke study in mid-2013. The proposed study is expected to take up to 18 months to complete.

ReNeuron's ReN001 stem cell therapy is being administered in ascending doses to a total of 12 stroke patients who have been left disabled by an ischaemic stroke, the most common form of the condition.

This news should also have positive read-across for Aim-listed Angel Biotechnology (Berlin: A3G.BE - news) , which supplies the stem cells used in the study.

CM

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Research firm reaped stem cell funds despite panel's advice

StemCells Inc. has a history not much different from those of dozens, even hundreds, of biotech companies all around California.

Co-founded by an eminent Stanford research scientist, the Newark, Calif., firm has struggled financially while trying to push its stem cell products through the research-and-development pipeline. It collects about $1 million a year from licensing patents and selling cell cultures but spends well more than $20 million annually on R&D, so it runs deeply in the red.

On the plus side, StemCells Inc. has had rather a charmed relationship with the California stem cell program, that $3-billion taxpayer-backed research fund known formally as the California Institute for Regenerative Medicine.

The firm ranks first among all corporate recipients of approved funding from CIRM, with some $40 million in awards approved this year. That's more than has gone to such established California nonprofit research centers as Cedars-Sinai Medical Center, the Salk Institute for Biological Studies, and the Sanford-Burnham Medical Research Institute.

The record of StemCells is particularly impressive given that one of the two proposals for which the firm received a $20-million funding award, covering a possible Alzheimer's treatment, was actually rejected by CIRM's scientific review panel twice. Nevertheless, the stem cell agency's governing board went ahead and approved it last month.

What was the company's secret? StemCells says it's addressing "a serious unmet medical need" in Alzheimer's research. But it doesn't hurt that the company also had powerful friends going to bat for it, including two guys who were instrumental in getting CIRM off the ground in the first place.

There's nothing improper about the state stem cell agency funding private enterprise; that's part of its statutory duties, and potentially valuable in advancing the goals of research. In part that's because CIRM is in a good position to help biotech firms leapfrog the "valley of death" the territory between basic research and the much more expensive and speculative process of moving a technology to clinical testing and, hopefully, the marketplace. Unfortunately, that's also the point where outside investment often dries up.

But private enterprise is new territory for CIRM, which has steered almost all its grants thus far to nonprofit institutions. Those efforts haven't been trouble-free: With some 90% of the agency's grants having gone to institutions with representatives on its board, the agency has long been vulnerable to charges of conflicts of interest. The last thing it needed was to show a similar flaw in its dealings with private companies too.

That brings us back to StemCells Inc. First, consider the firm's pedigree. Its co-founder was Irving Weissman, director of Stanford's Institute for Stem Cell Biology and Regenerative Medicine and a stem cell research pioneer. Weissman was one of the most prominent and outspoken supporters of Proposition 71, the 2004 ballot initiative that established the stem cell agency.

He's also been a leading beneficiary of CIRM funding, listed as the principal researcher on three grants worth a total of $24.5 million. The agency also contributed $43.6 million toward the construction of his institute's glittering $200-million research building on the Stanford campus. As of mid-April Weissman was still listed as a shareholder of StemCells, where his wife, Ann Tsukamoto, is an executive. Weissman, who is traveling in Africa, could not get back to me by deadline to talk about his relationship with the company.

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VistaGen Therapeutics Completes $3.25 Million Financing and $3.0 Million Debt Restructuring

SOUTH SAN FRANCISCO, CA--(Marketwire - Oct 16, 2012) - VistaGen Therapeutics, Inc. ( OTCBB : VSTA ) ( OTCQB : VSTA ), a biotechnology company applying stem cell technology for drug rescue and novel pharmaceutical assays for predictive heart and liver toxicology and drug metabolism screening, today announced the completion of the previously announced $3.25 million financing commitment with Platinum Long Term Growth VII, LLC (Platinum) and approximately $3.0 million strategic debt restructuring. The combined transactions involve the Company's three largest institutional shareholders and its patent counsel.

"Today marks a significant turning point for VistaGen. These transactions represent a tremendous vote of confidence by four of our major stakeholders and position us to realize the full measure of our commercial opportunities involving our stem cell technology platform and AV-101 clinical program," said Shawn K. Singh, VistaGen's Chief Executive Officer.

"Our expectations are set very high. Over the next 12 months, we plan to achieve multiple transformative milestones, both in the lab and in the clinic. This funding provided by Platinum, combined with our strategic equity-based restructuring transactions with Cato Research, Morrison & Foerster and University Health Network, will be instrumental in our success," concluded Mr. Singh.

Allen Cato, M.D., Ph.D., co-founder and Chief Executive Officer of Cato Research, stated, "By more closely approximating human biology, VistaGen's stem cell-based bioassay systems can improve the predictability of the drug development cycle and lower the cost of new drug research and development. We are pleased to support VistaGen's efforts to transform the drug development process and to bring safer, more effective therapies to market."

Michael Goldberg, M.D., Portfolio Manager of Platinum Long Term Growth VII, commented, "VistaGen has been, and continues to represent, an excellent investment opportunity for Platinum. Our continued commitment toward supporting VistaGen underscores our confidence in the Company's novel stem cell technologies and AV-101."

Further information regarding the Company's recent financing transaction with Platinum Long Term Growth Fund, and its strategic debt restructuring transactions with Cato Research, Morrison & Foerster and University Health Network, is set forth in the Company's Current Reports on Form 8-K filed with the U.S. Securities and Exchange Commission (SEC) and available on both the SEC's website at http://www.sec.gov and the Company's website at http://www.VistaGen.com.

About VistaGen Therapeutics

VistaGen is a biotechnology company applying human pluripotent stem cell technology for drug rescue and novel pharmaceutical assays for predictive heart and liver toxicology and drug metabolism screening. VistaGen's drug rescue activities are focused on combining its human pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube, with modern medicinal chemistry to generate new chemical variants (Drug Rescue Variants) of once-promising small-molecule drug candidates. These are drug candidates discontinued due to heart or liver toxicity after substantial investment and development by large pharmaceutical companies, the U.S. National Institutes of Health (NIH) or university laboratories. 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.

Additionally, VistaGen's orally-available, small molecule drug candidate, AV-101, is completing 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. To date, VistaGen has been awarded over $8.5 million from the NIH for development of AV-101.

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.

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VistaGen Therapeutics Completes $3.25 Million Financing and $3.0 Million Debt Restructuring

University of Maryland School of Medicine scientists develop stem cell model for hereditary disease

Public release date: 15-Oct-2012 [ | E-mail | Share ]

Contact: Karen Robinson karobinson@som.umaryland.edu 410-706-7590 University of Maryland Medical Center

A new method of using adult stem cells as a model for the hereditary condition Gaucher disease could help accelerate the discovery of new, more effective therapies for this and other conditions such as Parkinson's, according to new research from the University of Maryland School of Medicine.

Scientists at the University of Maryland School of Medicine reprogrammed stem cells to develop into cells that are genetically similar to and react to drugs in a similar way as cells from patients with Gaucher disease. The stem cells will allow the scientists to test potential new therapies in a dish, accelerating the process toward drug discovery, according to the paper published online in the journal the Proceedings of the National Academy of Sciences (PNAS) on Oct. 15 (Panicker et.al.).

The study was funded with $1.7 million in grants from the Maryland Stem Cell Research Fund; researchers received a start-up grant for $200,000 in 2007 and a larger, five-year grant for $1.5 million in 2009.

"We have created a model for all three types of Gaucher disease, and used stem cell-based tests to evaluate the effectiveness of therapies," says senior author Ricardo Feldman, Ph.D., associate professor of microbiology and immunology at the University of Maryland School of Medicine, and a research scientist at the University of Maryland Center for Stem Cell Biology and Regenerative Medicine. "We are confident that this will allow us to test more drugs faster, more accurately and more safely, bringing us closer to new treatments for patients suffering from Gaucher disease. Our findings have potential to help patients with other neurodegenerative diseases as well. For example, about 10 percent of Parkinson's disease patients carry mutations in the recessive gene for Gaucher disease, making our research possibly significant for Parkinson's disease as well."

Gaucher disease is the most frequent lipid-storage disease. It affects 1 in 50,000 people in the general population. It is most common in Ashkenazi Jews, affecting 1 in 1,000 among that specific population. The disease occurs in three subtypes Type 1 is the mildest and most common form of the disease, causing symptoms such as enlarged livers and spleens, anemia and bone disease. Type 2 causes very serious brain abnormalities and is usually fatal before the age of two, while Type 3 affects children and adolescents.

The condition is a recessive genetic disorder, meaning that both parents must be carriers for a child to suffer from Gaucher. However, said Dr. Feldman, studies have found that people with only one copy of a mutated Gaucher gene those known as carriers are at an increased risk of developing Parkinson's disease.

"This science is a reflection of the mission of the University of Maryland School of Medicine to take new treatments from bench to bedside, from the laboratory to patients, as quickly as possible," says E. Albert Reece, M.D., Ph.D., M.B.A., vice president for medical affairs at the University of Maryland and John Z. and Akiko K. Bowers Distinguished Professor and dean of the University of Maryland School of Medicine. "We are excited to see where this research goes next, bringing new hope to Gaucher patients and their families."

Dr. Feldman and his colleagues used the new reprogramming technology developed by Shinja Yamanaka in Japan, who was recognized with this year's Nobel Prize for Medicine or Physiology. Scientists engineered cells taken from the skin of Gaucher patients, creating human induced pluripotent stem cells, known as hiPSC stem cells that are theoretically capable of forming any type of cell in the body. Scientists differentiated the cells to form white blood cells known as macrophages and neuronal cells.

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RBCC: Could Stem Cells Be Key to Promising Autism Therapy?

NOKOMIS, Fla.--(BUSINESS WIRE)--

Rainbow Coral Corp. (RBCC) subsidiary Rainbow BioSciences will keep a close eye on a new study that could potentially lead to stem cell therapies for children with autism.

Researchers have been given the go-ahead by the FDA to launch a small study evaluating the effectiveness of autism treatments using patients own umbilical cord blood. Thirty children, aged two to seven, will receive injections of their own stem cells from the cord blood banked by their parents at birth.

Scientists will evaluate whether the stem cell therapy helps improve language and behavior in the children. Although the cause of autism is unknown and there is no cure for the disorder, one theory suggests that autism occurs because cell in the brain, known as neurons, are not connecting normally. Its possible that stem cells may address this problem.

RBCC is working to capitalize on the rising demand for effective new stem cell treatments by bringing a potentially game-changing stem cell technology to market. The company is close to a deal with Regenetech to acquire a license to perform cell expansion using that companys Rotary Cell Culture SystemTM, a rotating-wall bioreactor originally developed by NASA.

The rotating-wall bioreactor is capable of multiplying functional, 3-D stem cells for use in a variety of research projects, said RBCC CEO Patrick Brown. Stem cells carry tremendous potential to help researchers develop new treatments and cures for devastating diseases from Parkinsons to Alzheimers and even autism, but much research must be done first. Consequently, were very optimistic about the market potential for this revolutionary bioreactor technology.

RBCC plans to offer the new technology to help kickstart billions of dollars worth of research in an industry currently dominated by Amgen, Inc. (AMGN), Celgene Corporation (CELG), Genzyme Corp. (NASDAQ:GENZ) and Gilead Sciences Inc. (GILD).

For more information on Rainbow BioSciences, please visit http://www.rainbowbiosciences.com/investors.html.

About Rainbow BioSciences

Rainbow BioSciences, LLC, is a wholly owned subsidiary of Rainbow Coral Corp. (OTCBB:RBCC). The company continually seeks out new partnerships with biotechnology developers to deliver profitable new medical technologies and innovations. For more information on our growth-oriented business initiatives, please visit our website at [http://www.RainbowBioSciences.com]. For investment information and performance data on the company, please visit http://www.RainbowBioSciences.com/investors.html.

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RBCC: Could Stem Cells Be Key to Promising Autism Therapy?

Realizing the potential of stem cell therapy

Public release date: 15-Oct-2012 [ | E-mail | Share ]

Contact: Kat Snodgrass 202-962-4090 Society for Neuroscience

NEW ORLEANS New animal studies provide additional support for investigating stem cell treatments for Parkinson's disease, head trauma, and dangerous heart problems that accompany spinal cord injury, according to research findings released today. The work, presented at Neuroscience 2012, the annual meeting of the Society for Neuroscience and the world's largest source of emerging news about brain science and health, shows scientists making progress toward using stem cell therapies to repair neurological damage.

The studies focused on using stem cells to produce neurons essential, message-carrying cells in the brain and spinal cord. The loss of neurons and the connections they make for controlling critical bodily functions are the chief hallmarks of brain and spinal cord injuries and of neurodegenerative afflictions such as Parkinson's disease and ALS (amyotrophic lateral sclerosis), also known as Lou Gehrig's disease.

Today's new findings show that:

Other recent findings discussed show that:

"As the fields of developmental and regenerative neuroscience mature, important progress is being made to begin to translate the promise of stem cell therapy into meaningful treatments for a range of well-defined neurological problems," said press conference moderator Jeffrey Macklis, MD, of Harvard University and the Harvard Stem Cell Institute, an expert on development and regeneration of the mammalian central nervous system. "Solid, rigorous, and well-defined pre-clinical work in animals can set the stage toward human clinical trials and effective future therapies."

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This research was supported by national funding agencies such as the National Institutes of Health, as well as private and philanthropic organizations.

Todd Bentsen, (202) 962-4086

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Realizing the potential of stem cell therapy

Beauty salon ‘offers’ stem cell therapy

With all the publicity about the miraculous effects of stem cell therapy, the Department of Health (DOH) should prepare itself for the possibility that the new procedure would be performed by unqualified, and completely clueless, people.

I passed a beauty parlor recently and saw a huge poster on its door announcing the arrival of stem cell therapy. I was instantly reminded of botched breast enhancement and nose jobs performed by salon personnel who seemed to think it was as easy to learn complicated surgical procedures as it was to train to cut hair or do manicures and pedicures.

The DOH should start warning the public not to fall for these special offers just because they are available at giveaway rates.

Modern lifestyle problem

Experts have repeatedly talked about problems brought about by modern lifestyles. Changing diets and stress are two of the best known. Dr. Jaime G. Ignacio, section chief of gastroenterology at Veterans Hospital and head of the Digestive Malignancy Council of the Philippine Society of Gastroenterology, said constipation could be one of the consequences of the combination of these two factors.

Speaking at an event hosted by Boehringer Ingelheim, maker of Dulcolax (generic name Bisacodyl), a formulation for constipation relief, Ignacio, who, as a gastroenterologist is a specialist in digestive system disorders, defined the problem as having fewer than three bowel movements in a week (normal ranges from three times a week to three times a day).

He said constipation itself was not a disease but it could sometimes be a symptom of something serious, like colorectal cancer. But he said about 95 percent of cases were acuteoccurring suddenly and lasting for only a short periodresulting from some sudden lifestyle or hormonal changes, the taking of medication, lack of exercise, etc.

Ignacio said acute was easy to treat, with products like Dulcolax to solve the problem. But, if left unattended, acute constipation could lead to a chronic or long-term condition, which was the more worrisome, and would need medical attention.

He said constipation should be treated as soon as the problem had lasted for four or more days.

Constipation is part of modern living. [Like other diseases] prevention is the key. Safe and effective treatment is available [if needed], Ignacio stressed.

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Beauty salon ‘offers’ stem cell therapy

Chinese bid to save girl's sight

Chloe Wilson, from Forrester, Edinburgh, was born with septo-optic dysplasia a rare condition which means her pituitary gland has not developed properly.

As a result, the 19-month-old's optic nerve is underdeveloped, leaving her with hormone deficiencies and very little vision.

Her parents, Kayleigh and Scott Wilson, both 22, started a campaign in April to raise 15,000 to take her to the Chinese city of Guangzhou to undergo a controversial stem-cell treatment not available in the UK.

But thanks to the efforts of many other fundraisers and donors, some of whom have never even met the family, the total raised now stands at nearly 25,000.

The total means the young family can afford far more stem- cells, vastly increasing the chance of success.

Mrs Wilson, a nursery assistant, said: "I thought we were looking at a year-and-a-half before we hit our target. Now we've gone nearly ten grand over it in less than half that time.

"We just want to thank everyone who has helped give us this chance. People have been amazing,. Their generosity will stay with us forever, and we'll make sure Chloe knows all about it when she is older."

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Chinese bid to save girl's sight