Stem Cell Clinic

Japanese researcher Moriguchi admits lying about stem cell clinical trial

Washington, Oct. 15 (ANI): Japanese researcher Hisashi Moriguchi, who said that he had implemented the world's first clinical trial using a trailblazing stem cell technology, has admitted that most of what he claimed in an academic conference presentation about the procedure was false.

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

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.

According to the Japan Times, 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 that 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, adding: "Since it can't be done alone, I needed help from many people concerned."

According to the report, the procedure required extracting immature cells from the patient's liver to create chemically induced pluripotent cells, which can turn into any type of body parts, according to Moriguchi. They were then turned into heart muscle cells for injections into the man's heart. (ANI)

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Japanese researcher Moriguchi admits lying about stem cell clinical trial

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