Stem Cell Clinic

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