FDA issues warning to Sugar Land stem cell company

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

See more here:
FDA issues warning to Sugar Land stem cell company

Stem cell doctor in court: Day 2

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.

See the article here:
Stem cell doctor in court: Day 2

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

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.

View post:
Patient's husband testifies in stem cell doctor's hearing

Stem-cell fraud hits febrile field

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.

View original post here:
Stem-cell fraud hits febrile field

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

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.

Go here to read the rest:
Harvard Ophthalmologist Dr. Ula Jurkunas Introduces Stem Cell Transplant for Eyes

Hearing starts for doctor accused of using stem cell procedure

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.

See the rest here:
Hearing starts for doctor accused of using stem cell procedure

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.

Link:
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

See the rest here:
ReNeuron progresses stroke clinical trial

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.

Here is the original post:
Research firm reaped stem cell funds despite panel's advice

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.

See the rest here:
VistaGen Therapeutics Completes $3.25 Million Financing and $3.0 Million Debt Restructuring