Significant Recovery Of Motor And Neurological Functions In Ischemic Stroke Rats With Neuralstem NSI-566 Cells

ROCKVILLE, Md., Oct. 15, 2012 /PRNewswire/ --Neuralstem, Inc. (NYSE MKT: CUR) announced that data on Neuralstem's NSI-566 spinal cord-derived neural stem cell line in a rat model of ischemic stroke was presented in a poster, "Histopathological Assessment of Adult Ischemic Rat Brains after 4 Weeks of Intracerebral Transplantation of NSI-566RSC Cell Line," at The Society for Neurosciences Annual Meeting (http://www.sfn.org/AM2012/). This study was conducted independently in the laboratory of Dr. Cesar Borlongan, who is the director at the Center of Excellence for Aging and Brain Repair at the University of South Florida College of Medicine. Post-mortem histology was conducted in collaboration with Neuralstem. Rats that suffered ischemic stroke by middle cerebral artery occlusion, were transplanted 7 days post-stroke with increasing doses of NSI-566 into the stroke area. The animals were followed for safety and behavioral response for 56 days post-transplantation. Researchers reported Saturday that there was significant improvement in both motor and neurological tests in the stem cell-treated rats. There were significant dose-dependent differences in the behavioral improvement across treatment groups at post-transplantation periods, with the highest dose showing the most significant improvement in both motor and neurological tests. Similarly, there were significant differences in the behavioral performance among treatment groups at post-transplantation periods, with the most significant improvement in both motor and neurological tests seen at day 56 post-transplantation.

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"This study was designed to evaluate the potential therapeutic value of intracerbral dosing of human neural stem cells (NSI-566, supplied by Neuralstem) in an animal model of adult ischemic stroke," said Cesar V. Borlongan, Ph.D., University of South Florida College of Medicine, and the lead study author. "The results are very clear. The recovery of motor and neurological tests demonstrated by high-dose transplanted stroke animals was significantly better throughout the 56-day study period compared to vehicle-infused stroke animals, or low-dosed animals. In addition, there was stable improvement in the high-dose animals, and they showed a trend of better improvement over time."

A separate poster, "Survival and Differentiation of Human Neural Stem Cells (NSI-566RSC) After Grafting into Ischemia-Injured Porcine Brain," was also presented on Saturday. This study was independently carried out by Dr. Martin Marsala and his colleagues. Dr. Marsala is a professor and the head of the Neuroregeneration Laboratory at University of California San Diego and also a member of the Sanford Consortium for Regenerative Medicine. In this study, the same stem cells were transplanted into the brains of pigs that received an ischemic stroke on one side of the brain. 8-9 weeks after the ischemic event, which models chronic stroke in humans, feasibility and safety of escalating cell doses and injections were assessed. Body temperature, behavior, muscle tone and coordination, sensory function, food consumption, defecation, and micturition were monitored at least twice daily for the first 7 days, and once weekly thereafter, until termination. Up to 12 million cells in 25 cell injection deposits via 5 cannula penetrations were shown to be safe, which closely mimics the intended clinical route and method of delivery in future human clinical trials. At 6 weeks post-transplantation, there were no complications from the cell transplantation method or the cells. All animals recovered and showed progressive improvement with no distinction. All treated animals showed effective engraftment and neuronal maturation with extensive axonal projections. These data support the application of NSI-566RSC cell line to be transplanted into a chronic stage of previously ischemia-injured brain for treatment of motor deficits resulting from stroke.

"Our study was designed to evaluate the potential value of Neuralstem's cells in a chronic model of ischemic stroke and in a species that allowed for the use of human scale transplantation tools and dosing," said Martin Marsala, MD, at the University of California at San Diego Medical School, and the lead study author of the porcine study. "We have demonstrated clearly that both the route of administration and the cells are safe and well tolerated and that the cells survived and differentiated into mature neurons in the host brain tissue."

"We have demonstrated safety and efficacy of NSI-566RSC in a subacute model of ischemic stroke in rats and feasibility and safety in a chronic model of ischemic stroke in mini-pigs," said Karl Johe, PhD, Chairman of Neuralstem's Board of Directors and Chief Scientific Officer. "Together, these two studies demonstrate strong proof of principle data that our NSI-566 cells are ready to go into humans to treat paralysis in stroke patients."

Neuralstem has recently completed a Phase I trial testing the safety of NSI-566 in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) and has been approved to initiate a human clinical trial in ischemic stroke in China, through its subsidiary, Suzhou Neuralstem.

About Neuralstem

Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem has recently treated the last patient in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, and has been awarded orphan status designation by the FDA.

In addition to ALS, the company is also targeting major central nervous system conditions with its NSI-566 cell therapy platform, including spinal cord injury, ischemic stroke and glioblastoma (brain cancer). The company has submitted an IND (Investigational New Drug) application to the FDA for a Phase I safety trial in spinal cord injury.

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Significant Recovery Of Motor And Neurological Functions In Ischemic Stroke Rats With Neuralstem NSI-566 Cells

State licensing hearing for Bonita Springs stem cell doctor to begin Tuesday

The Grekos hearing is scheduled to begin at 9 a.m. Tuesday in the Martin Luther King, Jr. Administration Building, room 1-140A, 5775 Osceola Trail, Naples. It is scheduled for four days.

Photo by Allie Garza

Zannos Grekos

BONITA SPRINGS Bonita Springs physician Zannos Grekos, whose license is in jeopardy for controversial stem cell therapy, is getting his day before a judge.

Barring a last-minute delay or settlement, an administrative hearing is scheduled to begin Tuesday in Naples for the 47-year-old. He is fighting to get his license back in good standing from a suspension order, while the state Department of Health is pursuing more discipline and potentially revocation of his license.

Trained as a cardiologist, he's been licensed in Florida since 1996.

The trial-like proceeding, without a jury, is scheduled for four days before an administrative law judge. The proceeding is open to the public. The case against Grekos has garnered considerable media attention, including CNN and inquiries from European media.

A Texas father, Jimmy Bell, will be tracking what happens. Last year, he paid $57,000 upfront for his 5-year-old son, Jason, to undergo stem cell therapy to fight pulmonary hypertension. Despite pleas that his boy was weakening by the day, the treatment was never scheduled and Jason died. Bell received a $10,000 refund.

"He's taking advantage of people and it's more for personal gain," Bell said. "I'd like to see that stopped."

The hearing has been rescheduled numerous times since the state issued an emergency restriction against Grekos in February 2011. Authorities restricted his license and told him not to do any treatment with patients which involve bone marrow or stem cells.

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State licensing hearing for Bonita Springs stem cell doctor to begin Tuesday

Moriguchi admits to lying about stem cell trial

Monday, Oct. 15, 2012

NEW YORK/BOSTON Hisashi Moriguchi, a Japanese researcher who had said he implemented the world's first clinical trial using a trailblazing stem cell technology, admitted Saturday most of what he claimed in an academic conference presentation about the procedure was false.

At a news conference in New York, Moriguchi said, "While the treatment was implemented, it was only one procedure. At the end of the day, I lied."

He earlier said treatment using induced pluripotent stem cells was conducted on a total of six people, including the first case on a man with a failing heart in February this year. He also corrected the timing of the trial to June last year.

He said he was present during the procedure allegedly undertaken in the United States and showed his passport record to reporters.

Massachusetts General Hospital in Boston, where he claimed that the trial was conducted, said Friday there are no records of him having undertaken the procedure or of applying for approval to carry it out.

Moriguchi has been staying in New York after a presentation of his alleged treatment at a two-day stem cell research conference that ran from Wednesday at Rockefeller University.

On the timing of the surgery procedure, Moriguchi said, "It wasn't February 12. Let me correct it. It was in the first half of June last year. I don't remember (the exact date) until I check it later. Six people were present there."

During the news conference, he also said the procedure was in fact conducted at another hospital in Boston, rather than MGH, affiliated with Harvard University.

"iPS cells were successfully cultured in a large volume and surgery was conducted," he said. "Since it can't be done alone, I needed help from many people concerned."

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Moriguchi admits to lying about stem cell trial

Teva-Clal Biotech Stem Cell Venture in European Regulator Talks

Gamida Cell Ltd., whose shareholders include Clal Biotechnology Industries Ltd. (CBI) and Teva Pharmaceutical Industries Ltd. (TEVA), is in talks with European regulators to define a review process for its flagship product.

The stem cells developer said the European Medicines Agency accepted a units stance that positive results from the Phase III trial of its StemEx product would constitute the basis for approval, according to a statement to the Tel Aviv Stock Exchange. The unit, Gamida Cell-Teva Joint Venture, expects to release results of a 100-patient trial this year.

Efforts to advance the treatment in Europe come after a setback in talks with the U.S. Food and Drug Administration. The FDA told Gamida to update its control group in its Phase III study and that the regulator is no longer obligated to a Special Protocol Assessment, according to a Tel Aviv Stock Exchange announcement dated Aug. 20. Clal Biotechnology said Gamida will apply for StemEx approval in the U.S. in the beginning of 2013.

The route with the FDA is not going as smoothly as they had hoped so they are seeking to advance the product with another regulator as well, said Steven Tepper, an analyst at Harel Finance Ltd. in Tel Aviv. They are trying a different strategy.

Clal Biotech jumped as much as 8.1 percent, the biggest intraday increase since Sept. 24, to 12.18 shekels, before closing at 12.10 shekels. Teva fell 0.8 percent to 152.20 shekels.

The StemEx technology expands umbilical stem cells, enabling them to be used in cord blood transplants to leukemia and lymphoma patients who are unable to find bone-marrow donors. Jerusalem-based Gamida says that as many as 35,000 such patients are candidates for its technology with a market as much as $1 billion.

To contact the reporter on this story: David Wainer in Tel Aviv at dwainer3@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

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Teva-Clal Biotech Stem Cell Venture in European Regulator Talks

U.S. hospital: No record of researcher's iPS trial

Sunday, Oct. 14, 2012

BOSTON The U.S. hospital where researcher Hisashi Moriguchi claimed to have conducted a cutting-edge stem-cell treatment said Friday there are no records of him having undertaken the procedure or applying for approval to carry it out.

Moriguchi earlier said he had conducted the procedure on six patients at Massachusetts General Hospital, affiliated with Harvard University, where induced pluripotent stem (iPS) cells produced from the livers of the patients, who were suffering from heart disease, were transplanted after growing them into heart muscle cells.

When confronted by reporters Friday in New York, however, Moriguchi was evasive about whether he actually performed the clinical procedure. "I would like to tell you the truth" on another occasion, he said.

Citing a hearing from a doctor who has coauthored reports with Moriguchi, the Massachusetts hospital said that "Dr. (Raymond) Chung has no knowledge of the clinical procedure that Dr. Moriguchi reported" recently at a stem-cell confab in New York.

"We cannot find any evidence of that procedure taking place at Massachusetts General Hospital," the hospital said in a statement. "No request to conduct that sort of clinical trial was ever submitted or approved" by the hospital's institutional review board, which reviews and approves all studies involving human patients.

"There is no evidence in the records of the Harvard University Institutional Review Board or the Institutional Review Board of Harvard Medical School of Moriguchi applying for permission to carry out any experiment of any kind," the hospital added.

A public relations official at the hospital said it believes a 34-year-old man with heart disease that Moriguchi claimed was the first of the six patients to receive a transplant does not exist.

The official said the hospital could not find any records indicating that the procedure claimed to have been taken by Moriguchi was applied to a patient at the hospital during the time when the man allegedly received the transplant.

Moriguchi identified himself as a visiting lecturer at Harvard, but the university has since said he currently has no affiliation with either it or the Massachusetts hospital.

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U.S. hospital: No record of researcher's iPS trial

Stem-cell transplant claims debunked

Hisashi Moriguchi presented his work at the New York Stem Cell Foundation meeting this week.

AP/Press Association

From the beginning, it seemed too good to be true. Days after Kyoto University biologist Shinya Yamanaka won a Nobel prize for his 2006 discovery of induced pluripotent stem (iPS) cells (see 'Cell rewind wins medicine Nobel'), Hisashi Moriguchi a visiting researcher at the University of Tokyo claimed to have modified that technology to treat a person with terminal heart failure. Eight months after surgical treatment in February, said a front-page splash in the Japanese newspaper Yomiuri Shimbun yesterday, the patient was healthy.

But after being alerted to the story by Nature, Harvard Medical School and Massachusetts General Hospital (MGH), where Moriguchi claimed to have done the work, denied that the procedure had taken place. No clinical trials related to Dr Moriguchi's work have been approved by institutional review boards at either Harvard University or MGH, wrote David Cameron, a spokesman for Harvard Medical School in Boston, Massachusetts. The work he is reporting was not done at MGH, says Ryan Donovan, a public-affairs official at MGH, also in Boston.

A video clip posted online by the Nippon News Network and subsequently removed showed Moriguchi presenting his research at the New York Stem Cell Foundation meeting this week.

If true, Moriguchis feat would have catapulted iPS cells into use in a wide range of clinical situations, years ahead of most specialists' predictions. I hope this therapy is realized in Japan as soon as possible, the head of a Tokyo-based organization devoted to helping children with heart problems told Yomiuri Shimbun.

But there were reasons to be suspicious. Moriguchi said he had invented a method to reprogram cells using just two chemicals: microRNA-145 inhibitor and TGF- ligand1. But Hiromitsu Nakauchi, a stem-cell researcher at the University of Tokyo, says that he has never heard of success with that method. He adds that he had also never heard of Moriguchi before this week.

Moriguchi also said that the cells could be differentiated into cardiac cells using a 'supercooling' method that he had invented. Thats another weird thing, says Nakauchi.

The article in which Moriguchi presented his two-chemical method, published in a book1 describing advances in stem-cell research, includes paragraphs copied almost verbatim from other papers. The section headed 2.3 Western blotting, for example, is identical to a passage from a 2007 paper by Yamanaka2. Section 2.1.1, in which Moriguchi describes human liver biopsies, matches the number of patients and timing of specimen extractions described in an earlier article3, although the name of the institution has been changed.

When contacted by Nature, Moriguchi stood by his publication. We are all doing similar things so it makes sense that wed use similar words, he says. He did admit to using other papers as reference.

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Stem-cell transplant claims debunked

Bay Area stem cell researchers see encouraging results

SAN FRANCISCO (KGO) -- Bay Area stem cell researchers are reporting early, encouraging results from two clinical trials. The first, involves patients, paralyzed with spinal cord injuries and a treatment that could offer new hope for their future.

Nearly 20 years after the football injury that left him paralyzed, Roman Reed still holds onto the hope that he will someday walk again.

"One hundred percent, without a doubt. I've been wrong about the date, but not the fact I will walk again," said Reed.

Reed now runs a foundation to promote stem cell research and has been closely watching a clinical trial being conducted by Bay Area based Stem Cells Inc. Its goal is to use stem cell therapy to restore motor function in patients with spinal cord injuries.

"We're on the road on to being able to cure paralysis, it's so important, and stem cells are the way to do it," said Reed.

Stephen Huhn, M.D., Ph.D., from Stem Cells Inc., says the test procedure began a two hour surgery to clear a path to the spinal cord. Researchers then injected the cells directly into the damaged area.

"So the first three patients in the trial were designed to enroll patients who had the worst of the worst injuries. In other words, complete loss of sensory function and complete loss of motor function below the level of injury," said Huhn.

The phase one trials are all about establishing safety, but six months out, the researchers began measuring some intriguing improvements in two of those three patients. Both reported feeling in areas below the areas of their injuries.

The company cautions that the data is very preliminary, but they say researchers were able to measure the improved sensory response using several testing methods, including electrical stimulation, and response to heat -- which are considered more accurate than the patient's own self-reporting.

"You can't fake that. When we saw that data, that's when we became very excited," said Martin McGlynn, the CEO of Stems Cells Inc.

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Bay Area stem cell researchers see encouraging results

Doubt cast on clinical stem cell tests

Friday, Oct. 12, 2012

Harvard University said neither it nor Massachusetts General Hospital have ever authorized any iPS-related clinical studies by Hisashi Moriguchi, who claims to have achieved the first clinical application using the revolutionary stem cell technology.

"No clinical trials related to Moriguchi's work have been approved by institutional review boards at either Harvard University or Massachusetts General Hospital," a statement issued by Harvard and related institutes said Thursday.

The statement confirmed that Moriguchi "was a visiting fellow at Massachusetts General Hospital from 1999-2000," but added that he "has not been associated with (the institution) or Harvard since that time."

Moriguchi, a researcher at University of Tokyo Hospital, claimed to be a visiting lecturer at Harvard and to have conducted clinical trials at Massachusetts General Hospital with other researchers to transplant artificial cardiac muscle cells developed from iPS cells into six patients with heart disease.

The claim came just after Shinya Yamanaka of Kyoto University and a British scholar were jointly awarded this year's Nobel Prize in physiology or medicine for their research on iPS cells. Yamanaka and John Gurdon were credited with the discovery that mature human cells can be reprogrammed as immature cells capable of developing into all types of body parts.

"Research has been conducted after going through due procedures, such as consultations with a university ethics committee," Moriguchi claimed. "I have been told my method of creating iPS cells is different from the one used by Yamanaka (and Gurdon), but I have been doing it my way and no problems have been identified after transplants."

Moriguchi, who is thought to have asked a heart surgeon to carry out cell transplants, unveiled details about the treatment at a meeting of annual stem-cell research conference at Rockefeller University in New York held Wednesday and Thursday.

But the event's organizer, the nonprofit New York Stem Cell Foundation, subsequently said it "has received information from Harvard University that raises legitimate questions concerning a poster presentation" by Moriguchi, and has withdrawn it from the conference.

Moriguchi graduated from Tokyo Medical and Dental University with a degree in nursing science and does not have a license to practice medicine, according to a professor who taught him as an undergraduate.

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Doubt cast on clinical stem cell tests

Regenevéda Opens Flagship Stem Cell Therapy Clinic in Beverly Hills

Beverly Hills, CA (PRWEB) October 12, 2012

Regenevda (http://www.regeneveda.com) recently opened its brand new flagship facility in Beverly Hills. Founded by world renowned surgeon Dr. Thom Lobe, Regenevda specializes in cutting edge anti-aging treatments such as Stem Cell Therapy, IV Vitamin Therapy, and HGH Therapy.

Dr. Thom Lobe is an internationally respected surgeon and has been in practice for over 30 years. Consistently pioneering advances in medicine, Dr. Lobe was one of the first doctors to ever separate conjoined twins. Consistently working to help make advances in medicine, Dr. Lobe also has over 200 publications to his credit.

Overseeing the business aspect of Regenevda is Lindsey Combs. She is responsible for sales, staff, accounting, facility management, and business development. A graduate of the University of California, Los Angeles, Ms. Combs has been working in the anti-aging field for over 10 years and has been a California Licensed Esthetician since 2003.

Being one of the very few physicians in the country to hold the most advanced board certification (FAARM), Dr. Lobe is able to offer Stem Cell Therapy at the Regenevda clinic. Inside each persons own body, there are special cells in nearly every organ and tissue that have the ability to help heal damage. These special cells are called Stem Cells and this therapy works by harvesting these cells from a persons own blood, bone marrow, or fat and can help with different conditions. Some examples of procedures that use Stem Cell Therapy are: Stem Cell Facelifts, Stem Cell Breast Augmentation, and Stem Cell Joint Therapy. Stem Cell treatments are safe, non-invasive, and are done under local anesthesia.

Intravenous Nutrition Therapy (or IV Vitamin Therapy) is another anti-aging and rejuvenation treatment that can also help patients prevent migraines, lose weight, fight chronic infections like hepatitis, candida, lyme disease, as well as fight acute infections like the flu and mono. IV Therapy works by using intravenous solutions to deliver vitamins and minerals directly to the body cells. This bypasses the digestive system and provides a more direct method of delivery, which ensures that all of the nutrients required are delivered, allowing the patient to feel an improvement in condition almost immediately.

Human Growth Hormone (HGH) Therapy is another advanced treatment offered at Regenevda. HGH is secreted by the Pituitary gland and fuels cell growth and reproduction. This production peaks at adolescence. Over time, due to the effect of aging, the production of HGH slows down dramatically. As production declines, it makes it more difficult for the body to recover from physical and mental exertion. HGH Therapy acts as a supplement for HGH deficient adults to lessen body fat, boost lipid lineament, improve memory, promote bone density, as well as decrease risk factors that involve cardio-vascular conditions. If used at the onset of the decrease in HGH production, HGH Therapy can help curtail early aging and even be used as preventive measure against osteoporosis. A complete analysis of the patients sex hormones, evaluation of glucose regulation and functions of the adrenal gland, thyroid gland, and pancreas are performed before the treatment is administered for optimal results.

Combining decades of medical experience with the most cutting edge advances in medical technology, the Regenevda clinic looks to pave the way for the future of anti-aging treatments. The Regenevda Beverly Hills Institute of Cellular Therapy is located at 50 North La Cienega Boulevard. For any inquiries, they can be reached at 855-734-3638, or visit http://www.regeneveda.com.

About Regenevda :

Regeneveda, home of The Beverly Hills Institute of Cellular Therapy, provides state-of-the-art Stem Cell Therapy. Stem Cell Therapy is an effective treatment for chronic conditions such as Arthritis, Diabetes, Chronic Sports Injuries, and Chronic Pain, but is also revolutionizing anti-aging treatments such as Breast Enhancement, Erectile Dysfunction, and Facial Aging.

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Regenevéda Opens Flagship Stem Cell Therapy Clinic in Beverly Hills

Stem Cell Transplants May Show Promise for Multiple Sclerosis

By Denise Mann WebMD Health News

Reviewed by Louise Chang, MD

Oct. 10, 2012 -- New research suggests that stem cell transplants to treat certain brain and nervous system diseases such as multiple sclerosis may be moving closer to reality.

One study found that experimental stem cell transplants are safe and possibly effective in children with a rare genetic brain disease. Another study in mice showed that these cells are capable of transforming into, and functioning as, the healthy cell type. The stem cells used in the two studies were developed by study sponsor StemCells, Inc.

Both papers appear online in Science Translational Research.

The work, while still in its infancy, may have far-reaching implications for the treatment of many more common diseases that affect the brain and nervous system.

Researchers out of the University of California, San Francisco (UCSF), looked at the how neural stem cells behaved when transplanted into the brains of four young children with an early-onset, fatal form of Pelizaeus-Merzbacher disease (PMD).

PMD is a very rare genetic disorder in which brain cells called oligodendrocytes can't make myelin. Myelin is a fatty substance that insulates the nerve fibers of the brain, spinal cord, and optic nerves (central nervous system), and is essential for transmission of nerve signals so that the nervous system can function properly.

In multiple sclerosis, the myelin surrounding the nerve is targeted and damaged by the body's immune system.

The new study found that the neural stem cell transplants were safe. What's more, brain scans showed that the implanted cells seem to be doing what is expected of them -- i.e. making myelin.

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Stem Cell Transplants May Show Promise for Multiple Sclerosis