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FDA issues warning to Sugar Land stem cell company

Posted: Published on October 23rd, 2012

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 … Continue reading

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PropThink: Stem Cell Divestiture May Benefit Geron Shareholders More than the Company

Posted: Published on October 23rd, 2012

By Jake King Geron Corp (GERN) may have finally found a buyer for its suspended stem cell program. The company has been searching since November of 2011 when Geron halted the projects to focus on the development of Imetelstat and GRN-1005, both cancer treatments. BioTime (BTX) has offered to combine some of its own stem cell assets with those of Geron - plus stock in two BTX subsidiaries - in a new, publicly traded company, BioTime Acquisition Corp (BAC). Through the transaction, GERN shareholders will be given a 21.4% stake in the new company (aggregate); subscription rights to purchase additional stock in BAC, potentially increasing aggregate ownership to 45%; $13M (current value) in BTX warrants; and additional BAC warrants as part of the subscription rights. Already the market likes the looks of the deal, and GERN is up 7% in the early afternoon. Through the transaction, GERN shareholders have the opportunity to continue investing in GERN`s human embryonic stem cell treatments, which many are calling the future of biotech. Divesting of the stem cell program has been a high priority for GERN, and management expected it to generate capital for the company; the all-stock transaction offered by BioTime, however, will … Continue reading

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Stem cell bodyguards

Posted: Published on October 23rd, 2012

Public release date: 22-Oct-2012 [ | E-mail | Share ] Contact: Yivsam Azgad news@weizmann.ac.il 972-893-43856 Weizmann Institute of Science Hiding deep inside the bone marrow are special cells. They wait patiently for the hour of need, at which point these blood forming stem cells can proliferate and differentiate into billions of mature blood immune cells to help the body cope with infection, for example, or extra red blood cells for low oxygen levels at high altitudes. Even in emergencies, however, the body keeps to a long-term plan: It maintains a reserve of undifferentiated stem cells for future needs and crises. A research team headed by Prof. Tsvee Lapidot of the Institute's immunology Department recently discovered a new type of bodyguard that protects stem cells from over-differentiation. In a paper that appeared in Nature Immunology, they revealed how this rare, previously unknown sub-group of activated immune cells keeps the stem cells in the bone marrow "forever young." Blood forming stem cells live in comfort in the bone marrow, surrounded by an entourage of support cells that cater to their needs and direct their development the mesenchymal cells. But the research team, which included postdoctoral fellow Dr. Aya Ludin, Prof. Steffen Jung … Continue reading

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Stem cell bodyguards: Rare immune cells keep blood stem cells youthful

Posted: Published on October 23rd, 2012

ScienceDaily (Oct. 22, 2012) Hiding deep inside the bone marrow are special cells. They wait patiently for the hour of need, at which point these blood-forming stem cells can proliferate and differentiate into billions of mature blood immune cells to help the body cope with infection, for example, or extra red blood cells for low oxygen levels at high altitudes. Even in emergencies, however, the body keeps to a long-term plan: It maintains a reserve of undifferentiated stem cells for future needs and crises. A research team headed by Prof. Tsvee Lapidot of the Institute's immunology Department recently discovered a new type of bodyguard that protects stem cells from over-differentiation. In a paper that appeared in Nature Immunology, they revealed how this rare, previously unknown sub-group of activated immune cells keeps the stem cells in the bone marrow "forever young." Blood-forming stem cells live in comfort in the bone marrow, surrounded by an entourage of support cells that cater to their needs and direct their development -- the mesenchymal cells. But the research team, which included postdoctoral fellow Dr. Aya Ludin, Prof. Steffen Jung of the Immunology Department and his group, and Ziv Porat of the Biological Services Unit, discovered … Continue reading

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ACT’s European Clinical Trial Advances to First Patient Treatment with Higher Dosage of Embryonic Stem Cell-Derived …

Posted: Published on October 23rd, 2012

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, today announced treatment of the fourth patient, the first in the second patient cohort, in its European clinical trial for Stargardts Macular Dystrophy (SMD). The patient was injected with 100,000 human embryonic stem cell-derived retinal pigment epithelial (RPE) cells, as compared with 50,000 cells in the three patients comprising the first cohort. The outpatient transplantation surgery was performed successfully and the patient is recovering uneventfully. Our progress continues in our European clinical trial and both our trials in the U.S., as seen most recently with last weeks announcement of treatment of the second patient in the second patient cohort of our U.S. trial for SMD, said Gary Rabin, chairman and CEO of ACT. As I mentioned last week, we have mapped out the series of patients to complete the second cohort of both our trials for SMD, as well as for our trial for dry age-related macular degeneration (dry AMD), pending DSMB review, and we anticipate generating patient data at a faster pace. Initiated in January of this year, the Phase I/II trial is designed to determine the safety and tolerability of … Continue reading

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Stars And Their Stem Cell Sessions

Posted: Published on October 23rd, 2012

By JOJO P. PANALIGAN Ricky Reyes swears that two injections of fresh stem cell were all it took to bid his athritis adieu (Photo courtesy of rickyreyes.ph) MANILA, PhilippinesYouve been eating the right food, getting complete sleep, taking vitamins, avoiding stress and exercising regularly but you still dont have the glow of Madonna, Angelina Jolie and Sandra Bullock. To quote the title of a song from Miss Saigon, you ask, Why, God? But you dont have to wait for the clouds to part and for a booming voice from heaven to know the answer, just read on: Youve not had stem cell therapy. Bulletin Entertainment found out about this at the recent press conference tendered by Villa Medica. The doctors, experts and patients flown in by the leading provider of fresh cell therapy, revealed that while many stars say its this diet or that fitness craze that has got them looking much, much younger, these celebs have actually undergone the therapy many times to fantastic results. Asked why they dont get these big stars to endorse them, Villa Medica simply said that theyd rather use the money for research and helping the less fortunate. Anyway, the results speak for itself … Continue reading

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Houston company ceases supplying stem cells

Posted: Published on October 23rd, 2012

Under fire from the Food and Drug Administration, the Houston-area company that facilitated Gov. Rick Perry's controversial 2011 stem-cell treatment has stopped providing doctors with the cells patients banked at its facility for the procedure. In a response to an FDA warning that it is acting illegally by marketing the unlicensed therapy, Celltex Therapeutics Corp. wrote the federal agency this week that it has ceased enrolling patients in the clinical trials the state requires of stem-cell providers. Celltex was the Houston area's primary sponsor of such for-profit trials. "We're telling potential patients that we will still bank their stem cells but that we can't sponsor the required trials until we're in compliance with the FDA," said Andrea Ferrenz, Celltex's executive vice president and legal counsel. "We hope that will be in a matter of months." Ferrenz called the FDA warning letter, publicly posted Tuesday, "a disappointment" but said it actually just moves up Celltex's plan to move into agency-approved trials targeting specific disease conditions. The Sugar Land company had been operating for nearly 18 months facilitating adult stem-cell procedures with little regulation. The Texas Medical Board in July began requiring that any stem-cell procedure be reviewed for patient safety by … Continue reading

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Thai medical council approves 11 stem-cell studies

Posted: Published on October 23rd, 2012

Bangkok (The Nation/ANN) - The Thai Medical Council has given the green light for medical schools to conduct 11 types of stem-cell research with the aim of finding clues for regenerative medication. Since the council issued a regulation to tighten control over controversial stem-cell research in 2010, approval has been sought for some 17 studies. But the council has approved only 11 studies, which will include research into the most common diseases such as diabetes, arthritis, retina irregularities and the spinal chord, Dr Somsak Lohlekha, who chairs the council's stem-cell research regulatory panel, said. Separately, the council has been asked to certify two other studies related to heart disease as standard treatment, but it has put them on hold due to opposition from Thailand's Royal College of Physicians and Royal College of Surgeons. "These two medical colleges found that patients with heart disease did not feel any better after getting stem-cell injections," Somsak said. Moreover, stem-cell treatment for heart disease had yet to be accepted by the international medical community as standard treatment. "We found that many patients spent more than a million baht for this treatment and their condition did not improve," he said. Of the 11 stem-cell studies … Continue reading

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Medical Council okays 11 stem-cell studies

Posted: Published on October 23rd, 2012

Home national Medical Council okays 11 stem-cell studies Health Chularat Saengpassa, Pongphon Sarnsamak The Nation October 23, 2012 7:38 pm But the council has approved only 11 studies, which will include research into the most common diseases such as diabetes, arthritis, retina irregularities and the spinal chord, Dr Somsak Lohlekha, who chairs the council's stem-cell research regulatory panel, said. Separately, the council has been asked to certify two other studies related to heart disease as standard treatment, but it has put them on hold due to opposition from Thailand's Royal College of Physicians and Royal College of Surgeons. "These two medical colleges found that patients with heart disease did not feel any better after getting stem-cell injections," Somsak said. Moreover, stem-cell treatment for heart disease had yet to be accepted by the international medical community as standard treatment. "We found that many patients spent more than a million baht for this treatment and their condition did not improve," he said. Of the 11 stem-cell studies approved by the council, one is being conducted at the Police General Hospital. The research team, led by Pol.Mai.Gen Dr Thana Turajane, has succeeded in developing adult stem cells derived from blood that can develop … Continue reading

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Research firm reaped stem cell funds despite panel's advice

Posted: Published on October 18th, 2012

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 … Continue reading

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