Perry brings his stem-cell cause to Houston

By adminOctober 31, 2012Stem Cell Treatment

Gov. Rick Perry pushed Friday for Texas to become the center of adult stem-cell therapy, disregarding the federal government's increasing crackdown on clinics marketing the experimental medicine.

Perry told a crowd of stem-cell researchers, industry leaders and patients gathered in Houston that the young science "holds the promise of miracles" desperately needed by people across the world and suggested Texas' "wildcat spirit" and "conducive climate" can make it happen here.

"I'm not shy about asking people to relocate or start up their companies in Texas," said Perry, likening stem-cell treatment to previous innovations in space and heart care. "All of you outside the state of Texas - come on in. The water's fine. We've got an amazing environment here."

Perry, who famously got the unlicensed treatment for an ailing back in 2011, said the state has made sure that innovators won't be "hindered by exorbitant taxes, wrapped up by bureaucratic red tape or at the mercy of predatory attorneys, seeking to make steady money off extensive, drawn-out court cases."

Perry's remarks, made at the first of a planned annual Houston conference, came as the state appears headed toward a collision with the Food and Drug Administration, which has begun stepping up action against businesses that treat patients with their own stem cells. Last month, it issued a warning letter to Celltex Therapeutics Corp., the largest facilitator of the therapy in the Houston area, saying the process it puts the cells through alters them and makes them a biologic drug. The letter said the therapy was thus under FDA jurisdiction.

Perry's position

The letter was delivered just a few months after the Texas Medical Board began implementing a policy allowing doctors to use stem cells banked at facilities such as Celltex as long as it's part of research overseen by a panel that reviews clinical trials for patient safety. The TMB said it was allowing stem-cell use because it couldn't wait on the FDA.

As a result of the FDA letter, Celltex is in the process of closing down its 2012 trials.

Perry told the media after his keynote address that he disagrees with the FDA's decision on Celltex. He said that therapy involving one's own stem cells should no more be regulated by the FDA than bone marrow transplants or in-vitro fertilization.

Stem cells are cells in the body that multiply to replenish dying cells. The basis of what's known as regenerative medicine because of their ability to grow new tissue and repair diseased or injured body parts, they are touted by some as the future of medicine.

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Perry brings his stem-cell cause to Houston

Stem cell therapy a cure-all? Not so fast

By adminOctober 31, 2012Stem Cell Treatment

MANILA, Philippines Its supposed to cure various illnesses such as cancer, spinal cord injury and Parkinsons disease. Is stem cell therapy the cure-all that it is touted to be?

Health Undersecretary Teodoro Herbosa said it is important to note that stem cell treatments are still at the experimental stage.

"The advisory is very clear. This is still an investigative form of therapy. Anecdotal reports are not enough evidence to say there is treatment, he said in an interview on ANC's Talkback with Tina Palma.

He said there are only two standard stem cell therapies considered effective and acceptable to the medical community.

"To date, I can only name two cases that are considered standard therapy. That is bone marrow transplantation--one for severe cancer, blood cancer and the other one is bone marrow transplantation after chemotherapy for any type of cancer, he said.

Herbosa said the Department of Health cannot confirm yet if stem cell treatment is indeed effective against certain diseases.

Dr. Tranquilino Elicao Jr., an oncologist who availed of the treatment in April in Frankfurt, Germany, said stem cell therapy cured his high blood pressure, sugar, cholesterol and uric acid.

He had 12 injections of cells, which came from lambs.

After a month, I had my blood tests. Everything went down to normal, Elicao said.

Elicao also said he is not taking medication anymore because he has regained his health.

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Stem cell therapy a cure-all? Not so fast

FDA issues warning letter to local stem cell company

By adminOctober 18, 2012Stem Cell Treatment

The Food and Drug Administration has informed the Sugar Land company involved in Gov. Rick Perry's adult stem-cell procedure that it is illegally marketing an unlicensed drug.

In a warning letter, the FDA gave Celltex Therapeutics Corp. 15 business days to submit a plan to address the agency's concerns, including correcting previously cited manufacturing problems. The letter said that failure to respond promptly could result in seizure or injunction by the FDA.

"Based on (our) information, your product violates the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act," says the letter, sent on Sept. 24 and publicly posted Tuesday.

The letter comes about six months after the FDA made a 10-day inspection of the facilities where Celltex banks and grows stem cells taken from prospective patients. The agency subsequently filed a report, obtained by the Chronicle in June, detailing dozens of manufacturing deficiencies, from incorrectly labeled products to failed sterility tests.

The new warning letter reiterates those problems and asks for more information about them.

David Eller, Celltex's CEO, was unavailable Tuesday, but a public relations official said the company on Wednesday would make available a redacted copy of its letter to the FDA.

In a previous news release, Eller said Celltex "respectfully but firmly" disagreed with the FDA's position that its process causes the cells to be considered biological drugs and thus subject to the federal agency's regulations. Biological drugs involve living human cells, as opposed to chemically synthesized drugs.

"We are considering all options as we work with the agency toward a resolution," Eller said in the release.

Adult stem cells multiply to replenish dying cells. Long used to treat leukemia and other cancers, they have recently shown promise for tissue repair in other diseases, though most scientists in the field consider them not ready for mainstream use.

Treatment, at a price

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FDA issues warning letter to local stem cell company

FDA issues warning to local stem cell company

By adminOctober 18, 2012Stem Cell Treatment

The Food and Drug Administration has informed the Sugar Land company involved in Gov. Rick Perry's adult stem-cell procedure that it is illegally marketing an unlicensed drug.

In a warning letter, the FDA gave Celltex Therapeutics Corp. 15 business days to submit a plan to address the agency's concerns, including correcting previously cited manufacturing problems. The letter said that failure to respond promptly could result in seizure or injunction by the FDA.

"Based on (our) information, your product violates the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act," says the letter, sent on Sept. 24 and publicly posted Tuesday.

The letter comes about six months after the FDA made a 10-day inspection of the facilities where Celltex banks and grows stem cells taken from prospective patients. The agency subsequently filed a report, obtained by the Chronicle in June, detailing dozens of manufacturing deficiencies, from incorrectly labeled products to failed sterility tests.

The new warning letter reiterates those problems and asks for more information about them.

David Eller, Celltex's CEO, was unavailable Tuesday, but a public relations official said the company on Wednesday would make available a redacted copy of its letter to the FDA.

In a previous news release, Eller said Celltex "respectfully but firmly" disagreed with the FDA's position that its process causes the cells to be considered biological drugs and thus subject to the federal agency's regulations. Biological drugs involve living human cells, as opposed to chemically synthesized drugs.

"We are considering all options as we work with the agency toward a resolution," Eller said in the release.

Adult stem cells multiply to replenish dying cells. Long used to treat leukemia and other cancers, they have recently shown promise for tissue repair in other diseases, though most scientists in the field consider them not ready for mainstream use.

Treatment, at a price

The rest is here:
FDA issues warning to local stem cell company

FDA issues warning to Sugar Land stem cell company

By adminOctober 18, 2012Stem Cell Treatment

The Food and Drug Administration has informed the Sugar Land company involved in Gov. Rick Perry's adult stem-cell procedure that it is illegally marketing an unlicensed drug.

In a warning letter, the FDA gave Celltex Therapeutics Corp. 15 business days to submit a plan to address the agency's concerns, including correcting previously cited manufacturing problems. The letter said that failure to respond promptly could result in seizure or injunction by the FDA.

"Based on (our) information, your product violates the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act," says the letter, sent on Sept. 24 and publicly posted Tuesday.

The letter comes about six months after the FDA made a 10-day inspection of the facilities where Celltex banks and grows stem cells taken from prospective patients. The agency subsequently filed a report, obtained by the Chronicle in June, detailing dozens of manufacturing deficiencies, from incorrectly labeled products to failed sterility tests.

The new warning letter reiterates those problems and asks for more information about them.

David Eller, Celltex's CEO, was unavailable Tuesday, but a public relations official said the company on Wednesday would make available a redacted copy of its letter to the FDA.

In a previous news release, Eller said Celltex "respectfully but firmly" disagreed with the FDA's position that its process causes the cells to be considered biological drugs and thus subject to the federal agency's regulations. Biological drugs involve living human cells, as opposed to chemically synthesized drugs.

"We are considering all options as we work with the agency toward a resolution," Eller said in the release.

Adult stem cells multiply to replenish dying cells. Long used to treat leukemia and other cancers, they have recently shown promise for tissue repair in other diseases, though most scientists in the field consider them not ready for mainstream use.

Treatment, at a price

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FDA issues warning to Sugar Land stem cell company

Stem cell doctor in court: Day 2

By adminOctober 18, 2012Stem Cell Treatment

COLLIER COUNTY -

A Southwest Florida doctor spent another day in court fighting for his right to practice medicine.

Bonita Springs cardiologist Zannos Grekos' license is currently suspended because two of his patients died after undergoing a controversial stem cell procedure.

Wednesday was day two of what's scheduled to be a four day trial. The courtroom was again filled with patients supporting Grekos and his stem cell treatment.

This hearing focuses only on the first patient that died after getting that treatment. Her family was also in attendance and wants Grekos' medical license revoked.

Dr. Richard Roland spoke about a call he got from Grekos in 2010. He had just performed a stem cell procedure on his patient Domenica Fitgzerald and something went wrong.

Roland was Fitzgerald's ICU doctor.

"I was quite shocked. My first comment was, 'You did what?' His response was, 'Yes. We've been having good luck with these procedures,'" Dr. Roland said. "I had concerns that this was criminal."

Fitzgerald's family says the breast cancer survivor was looking for a cure for nerve damage caused by chemotherapy.

They say Grekos gave her false hope.

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Stem cell doctor in court: Day 2

Patient's husband testifies in stem cell doctor's hearing

By adminOctober 17, 2012Stem Cell Treatment

COLLIER COUNTY, Fla - A controversial stem cell doctor is fighting for his medical license in Collier County court.

Two of Dr. Zannos Grekos' patient who underwent experimental stem cell procedures died and as part of his defense, his attorney's say, family members of those patients could have done more to save their lives.

This week long hearing focuses on a 69 year old patient of Dr. Grekos who died in 2010. For the first time Tuesday that woman's husband talked about her experimental procedure, but he also describes her untimely death hours after receiving a stem cell treatment.

In March of 2010, Dr. Zannos Grekos preformed a cerebral angiogram and experimental stem cell procedure on a 69 year old woman, but as soon as she got home, her husband Jack says things go scary as his wife's condition took a turn for the worst.

"I thought she had a stroke, but I didn't know, I'm not a doctor," says Jack while testifying Tuesday. "But, there was nothing there, she was just blank."

Jack told the courtroom his wife went to Dr. Grekos' practice Regenocyte in Bonita Springs to cure a walking disability that occurred from breast cancer treatments. They were told by Dr. Grekos, worst case, it wouldn't work, but Tuesday he described the moments leading up to his wife's death.

"They told me she would be fine by the morning. I just kept an eye on her. Then, after she vomited and it was real bad. Then I called 911."

In cross examination Dr. Grekos' attorney, Richard Ozelie, referred to a deposition that describes how Jack's wife hit her head on the floor. According to a state report the patient suffered a severe brain stem injury. But, today in court Jack said his wife didn't fall, but slid out of a reclining chair.

Ozelie asks Jack, "Is it your testimony that your wife did not fall?"

"That's right, she did not fall, she couldn't even get up," says Jack.

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Patient's husband testifies in stem cell doctor's hearing

Stem-cell fraud hits febrile field

By adminOctober 17, 2012Stem Cell Treatment

Hisashi Moriguchi was besieged by reporters after giving a press conference retracting his claims.

J. Sato/Getty

Rarely has such a spectacular scientific claim been debunked so rapidly. For a few brief hours last week, Hisashi Moriguchi, a project researcher at the University of Tokyo, was riding high, lauded by his nations press for pioneering work on induced pluripotent stem (iPS) cells. His feat was said to be the first successful use in humans of a technology that days earlier had won his countryman, Kyoto Universitys Shinya Yamanaka, a share of the Nobel Prize in Physiology or Medicine1.

Yet a swift investigation by Nature and several stem-cell researchers found that Moriguchis claim to have cured six heart-failure patients with cells derived from iPS cells was untrue; that he had lied about his university affiliations; and that he had plagiarized key parts of his research papers2. At a hastily convened press conference on 13 October, Moriguchi recanted. I admit that I lied, he told reporters, adding that his career as a researcher is probably over.

The sad episode could be written off as one researchers runaway fantasy. But it highlights the febrile nature of the iPS-cell field, particularly in Japan. Many researchers fear that the therapeutic promise of these cellswhich could open the way to creating replacement tissues to treat diseasewill spur a premature rush to clinical applications before their safety and efficacy can be proven.

The story kicked off when Moriguchis claims were splashed over the front page of Yomiuri Shimbunthe highest-circulation newspaper in the worldon 11October. He described how he had reprogrammed patients liver cells into an embryonic state, with the potential to develop into many different cell types. After converting these iPS cells into heart-muscle cells, he supposedly injected them into six patients in the United States to successfully repair their damaged heart tissue.

But inconsistencies in the account quickly became apparent. Alerted by Nature, Harvard Medical School and the Massachusetts General Hospital, both in Boston, denied that the procedures had taken place there, or that Moriguchi was affiliated with them, as he had claimed. In an interview with Nature, Moriguchi could not provide details of the ethics review board that had approved the procedures; the source of the clinical-grade cells; or the names of collaborators. He claimed to have carried out an incredible range of activities almost single-handedly and described unconventional and unlikely methods for producing the cells. Yet he trained as a nurse, lacks a medical degree, and his most recent research was in medical economics. Nature also discovered that the publications that Moriguchi had used to support his claims3, 4 contained technical images copied from other sources, as well as plagiarized passages from other articles5, 6. We are all doing similar things, so it makes sense that wed use similar words, Moriguchi told Nature.

On 13 October, the day after Nature ran its expos2, Moriguchi held a press conference in New York, where he had been attending a meeting of the New York Stem Cell Foundation. He admitted that most of his claims were untrue, but maintained that he had injected iPS-cell-derived heart cells into one patient, and that he could produce notes to prove it. The University of Tokyo and the Tokyo Dental and Medical University, where Moriguchi claimed to have carried out collaborative studies, have subsequently launched investigations into the affair. Nature Publishing Group, which has published papers by Moriguchi in its journal Scientific Reports, says that it is aware of the issues surrounding these publications and is investigating.

Researchers trying to understand why Moriguchi would engage in such reckless fabrication have noted a climate that allows such claims to gain prominence with little challenge. Since Yamanakas discovery of iPS cells in 2006, some Japanese media and government officials have taken a highly competitive tone about the technology. In its original article about Moriguchis claims, Yomiuri Shimbun noted that a burdensome regulatory system was holding back Japans clinical research relative to the United States, and, in a 2009 correspondence published in Nature7, Moriguchi argued that Japan is in danger of being overtaken in the field of human iPS-cell research.

Scientists, journalists and regulators here need to be especially careful not to let their pride in Yamanakas achievement affect their critical faculties, or overwhelm them in national fervour, says Douglas Sipp, who researches stem-cell ethics and regulation at the RIKEN Center for Developmental Biology in Kobe, Japan.

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Stem-cell fraud hits febrile field

Hearing starts for doctor accused of using stem cell procedure

By adminOctober 17, 2012Stem Cell Treatment

An administrative hearing got underway Tuesday between state health care regulators and Dr. Zannos Grekos, a Bonita Springs cardiologist, regarding his controversial stem cell practice and whether he committed medical malpractice.

More than a dozen observers are present in the Collier County courtroom, many of them supporters of Grekos who have said previously that he changed his life when he injected them with their own stem cells to treat damaged heart muscle, lung tissue or for spinal injuries.

The state Department of Health in 2011 issued an emergency restriction on Grekos medical license, ordering him not to do anything with patients and their own stem cells.

The order came after an investigation found he had had performed stem cell procedure in 2010 on a 69-year-old woman, using her own blood, in hopes it would provide relief against nerve damage in her legs that occurred from earlier breast cancer treatment. After the treatment with Grekos, she suffered brain damage and later was taken off life support.

Three family members of the patient, Domenica Fitzgerald, are present and her husband, John Fitzgerald, will be a witness for the state. The start of the hearing is bittersweet for him and his family.

We need closure, he said.

Grekos is fighting the state's complaint and is seeking to have his license reinstated. Before the start of the hearing and during breaks, Grekos greeted his supporters and hugged several of them.

The hearing is before administrative law judge J. Lawrence Johnson, and is scheduled to last four days. The judge has ordered witnesses not to be present in the courtroom except during their testimony.

In opening statements, the prosecutor for the state health department, Robert Milne, said that the treatment Grekos performed had no scientific backing in research, and a neurosurgeon with the University of South Florida will testify about that.

In addition, Milne said that chemotherapy destroys stem cells and so Grekos' extraction of bone marrow aspirate in the patient, to use her stem cells, had no therapeutic value.

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Hearing starts for doctor accused of using stem cell procedure

Harvard Ophthalmologist Dr. Ula Jurkunas Introduces Stem Cell Transplant for Eyes

By adminOctober 17, 2012Stem Cell Treatment

Grants Pass, OR (PRWEB) October 16, 2012

Harvard Ophthalmologist and Corneal Stem Cell Researcher Ula Jurkunas, MD, has announced an important new stem cell transplant procedure for the eyes.

Speaking on the Sharon Kleyne Hour Power of Water radio show, Dr. Jurkunas, predicted that the procedure will offer a significant benefit to patients with certain corneal diseases, and corneal injuries such as chemical and thermal burns (The cornea is the eyes clear portion).

Stem cell research has been in the news because the 2012 Nobel Prize for Medicine was awarded for stem cell research.

Dr. Jurkunas explained to host Sharon Kleyne that the human eye produces its own adult (non-embryonic) stem cells. These are found between the limbus (where the clear cornea meets the white of the eye) and the conjunctiva (the red meaty tissue in the eyes inner corner). Their function is to replenish corneal cells to keep the cornea clear and healthy.

Production of corneal stem cells, according to Dr. Jurkunas, can become impaired due to a disease entity such as an infection, severe allergy, severe dry eye, immunological disorder or chronic inflammation; or due to injury such as a chemical or thermal burn. These traumas can cause the cornea to become cloudy and ulcerated. Prior to the present corneal stem cell research, there had been no reliable, non-invasive treatment for these conditions.

Corneal stem cell transplantation, Dr. Jurkunas explains, has the advantage of utilizing the patients own tissue as donor cells. Stem cells may be taken either from healthy tissue elsewhere in the diseased eye, from the patients other eye, or from the patients inner cheek (which has many similarities to eye tissue and also produces adult stem cells). Donor stem cells are then isolated and grown in culture. The final step is to transfer them to the affected cornea using a stem cell bandage.

The procedure, says Dr. Jurkunas, has resulted in dramatic corneal clearing and sight restoration. Although research is ongoing and the procedure remains experimental, corneal stem cell therapy is available in clinical trials. Widespread applications of the procedure, including routine testing for corneal stem cell deficiency, are anticipated. Stem cell therapy, according to Dr. Jurkunas, could eventually be used for macular degeneration, glaucoma and other eye diseases.

Dr. Jurkunas stressed the importance of water and hydration in maintaining a healthy tear film and cornea. The tear film covering the cornea is 99% water and is essential to the light refraction that enables vision. Dry eye and related eye infections, according to Dr. Jurkunas, can damage both the cornea and adjacent stem cell producing tissues that enable the cornea to repair itself. Water in the tear film stimulates the healthy production of stem cells. Water is also critical to keeping stem cells viable during transplantation.

Mrs. Kleyne and Dr. Jurkunas agree that non-invasive therapies using the bodys own tissues, such as corneal stem cell transplantation, could eventually prove indispensable in combating the worldwide health effects of global drying and dehydration.

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Harvard Ophthalmologist Dr. Ula Jurkunas Introduces Stem Cell Transplant for Eyes