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HemoGenix® FDA Master File to Measure Blood Stem Cell Potency for Cellular Therapy Products:

Posted: Published on June 26th, 2012

COLORADO SPRINGS, Colo.--(BUSINESS WIRE)-- HemoGenix announced today that FDA CBER has given HemoGenix its first Master File Number for an in vitro blood stem cell potency, quality and release assay (HALO-96 PQR) (1)for cellular therapy products(2)used for stem cell transplantation purposes. HALO-96 PQR is the first commercially available stem cell potency assay for cellular therapy products. It incorporates the most sensitive readout available to measure changes in the cells energy source (ATP) as a function of the potential for stem cells to proliferate. Potency and quality of stem cell therapeutic products are required to be measured prior to use to help predict the engraftment of the cells in the patient. At the present time, tests such as cell number, viability and a stem cell marker called CD34 are routinely used. However, none of these tests specifically measure stem cells and none determine the stem cell biological activity required for a potency assay. The only cell functionality test presently used in this field, especially for umbilical cord blood transplantation, is the colony-forming unit (CFU) assay, which is subjective, non-validated and has been used since the early 1970s. HALO-96 PQR changes this paradigm. It is particularly needed in the umbilical cord blood … Continue reading

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FDA Criticizes Perry’s Stem Cell Lab

Posted: Published on June 26th, 2012

HOUSTON (AP) - The U.S. Food and Drug Administration has issued a new report criticizing the Texas company that stored adult stem cells from Texas Gov. Rick Perry for use in an experimental procedure for his back pain, according to a newspaper report Monday. An FDA report obtained by the Houston Chronicle said CellTex Therapeutics cannot guarantee the stem cells it takes from patients remain sterile and alive. The nine-page report dated April 27 says the lab, located in the Houston suburb of Sugar Land, does not have procedures to prevent contamination of products that are supposed to be sterile. The report also says the lab didnt have written records of investigations into the failure of a batch of cells. It also says the lab has not marked some lab products properly. The deficiencies identified reflect significant problems, serious issues, said Paul Knoepfler, an associate professor at the University of California-Davis School of Medicine, in an interview with the newspaper. If I were a patient, they would scare me off big time. CellTex was thrust into the news last year when Perry, then running for the Republican nomination for president, revealed that he had stem cells taken from fat in … Continue reading

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Danish 'penis-doctor' plans Swedish clinic

Posted: Published on June 26th, 2012

Danish plastic surgeon Jrn Ege Siana, or the penis-doctor as he is known in Denmark, has been given the go ahead to start practicing medicine in Sweden, despite several convictions and a slew of medical complaints in Denmark. After the clinic went bankrupt in 2004 following some unhappy customers reporting their grievances to authorities, Siana was subsequently convicted of aggravated fraud and of weapons crimes a year later. To escape the law, Siana fled to Greece, but returned in 2009 and was sentenced to two years in prison. While behind bars, he was also convicted of planning an art theft and lost his medical licence in Sweden and Denmark due to a forgery conviction. However, at the end of May Siana got his Danish licence back and two weeks later Swedish authorities also gave him the green light to practice medicine in Sweden. In his letter to the Medical Responsibility Board (Hlso- och sjukvrdens ansvarsnmnd - HSAN) Siana claimed to have a long list of would-be patients, waiting for him to start practicing again where he is currently living in Malm, in the south of Sweden. It would be in the interest of my patients if I were able to … Continue reading

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Reproductive Medicine Associates of New Jersey and Auxogyn Launch Fertility Study To Advance Goals of ‘One Embryo, One …

Posted: Published on June 26th, 2012

MORRISTOWN, N.J., June 26, 2012 /PRNewswire/ --Fertility experts at Reproductive Medicine Associates of New Jersey (RMANJ) announced that they will partner with Auxogyn, Inc., to conduct a groundbreaking IVF study that aims to advance the goals of single embryo transfer (SET), and reduce the financial and health implications of multiple pregnancies. (Logo: http://photos.prnewswire.com/prnh/20120402/NY80340LOGO) "Our objectives at RMANJ are two-fold: To increase the healthy live birth rate for those undergoing assisted reproductive procedures, and to decrease the multiple embryo transfer rate, thereby reducing multiple pregnancies," commented Richard T. Scott, Jr., M.D., F.A.C.O.G., H.C.L.D., founding partner of RMANJ. "Through this collaborative research study with Auxogyn, we will explore new, previously unidentified factors that cause one chromosomally normal embryo to implant where another seemingly healthy embryo does not. These discoveries could directly impact clinical practice in the future, moving us closer to the ultimate goal of the IVF field one embryo, one healthy baby." For patients enrolled in the study, researchers will evaluate the use of both RMANJ's proprietary Comprehensive Chromosome Screening (CCS) and Auxogyn's Eeva (Early Embryo Viability Assessment) Test to detect healthy embryos prior to implantation. CCS is a rapid-method 24-chromosome screening technique that accurately identifies whether embryos are euploid (have … Continue reading

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Reproductive Medicine Associates of New Jersey and Auxogyn Launch Fertility Study To Advance Goals of 'One Embryo, One …

Posted: Published on June 26th, 2012

MORRISTOWN, N.J., June 26, 2012 /PRNewswire/ --Fertility experts at Reproductive Medicine Associates of New Jersey (RMANJ) announced that they will partner with Auxogyn, Inc., to conduct a groundbreaking IVF study that aims to advance the goals of single embryo transfer (SET), and reduce the financial and health implications of multiple pregnancies. (Logo: http://photos.prnewswire.com/prnh/20120402/NY80340LOGO) "Our objectives at RMANJ are two-fold: To increase the healthy live birth rate for those undergoing assisted reproductive procedures, and to decrease the multiple embryo transfer rate, thereby reducing multiple pregnancies," commented Richard T. Scott, Jr., M.D., F.A.C.O.G., H.C.L.D., founding partner of RMANJ. "Through this collaborative research study with Auxogyn, we will explore new, previously unidentified factors that cause one chromosomally normal embryo to implant where another seemingly healthy embryo does not. These discoveries could directly impact clinical practice in the future, moving us closer to the ultimate goal of the IVF field one embryo, one healthy baby." For patients enrolled in the study, researchers will evaluate the use of both RMANJ's proprietary Comprehensive Chromosome Screening (CCS) and Auxogyn's Eeva (Early Embryo Viability Assessment) Test to detect healthy embryos prior to implantation. CCS is a rapid-method 24-chromosome screening technique that accurately identifies whether embryos are euploid (have … Continue reading

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Glucose deprivation activates feedback loop that kills cancer cells, study shows

Posted: Published on June 26th, 2012

ScienceDaily (June 26, 2012) Compared to normal cells, cancer cells have a prodigious appetite for glucose, the result of a shift in cell metabolism known as aerobic glycolysis or the "Warburg effect." Researchers focusing on this effect as a possible target for cancer therapies have examined how biochemical signals present in cancer cells regulate the altered metabolic state. Now, in a unique study, a UCLA research team led by Thomas Graeber, a professor of molecular and medical pharmacology, has investigated the reverse aspect: how the metabolism of glucose affects the biochemical signals present in cancer cells. In research published June 26 in the journal Molecular Systems Biology, Graeber and his colleagues demonstrate that glucose starvation -- that is, depriving cancer cells of glucose -- activates a metabolic and signaling amplification loop that leads to cancer cell death as a result of the toxic accumulation of reactive oxygen species, the cell-damaging molecules and ions targeted by antioxidants like vitamin C. The research, which involved UCLA scientists from the Crump Institute for Molecular Imaging, the Institute for Molecular Medicine, the California NanoSystems Institute, the Jonsson Comprehensive Cancer Center, the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research, and … Continue reading

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FDA report faults Houston-area stem-cell company

Posted: Published on June 26th, 2012

The Sugar Land company involved in Gov. Rick Perry's unlicensed adult stem-cell procedure is rife with basic manufacturing problems, according to the U.S. Food and Drug Administration. In a report one expert called a blow to the entire adult stem-cell industry, the FDA found that Celltex Therapeutics Corp. cannot guarantee the sterility, uniformity and integrity of stem cells it takes from people and then stores and grows for eventual therapeutic reinjection. "You have not performed a validation of your banking and thawing process to assure viability" of the stem cells, reads the April 27 report, meaning that the company cannot verify the cells are alive. The FDA report, which followed an April 16-27 inspection of Celltex, was released under the Freedom of Information Act Monday to the Houston Chronicle and a University of Minnesota bioethicist who complained in February that Celltex is a potential danger to patients and not in compliance with federal law. The report, partially redacted, was not accompanied by a warning letter. A former FDA official who asked not to be identified, however, said the deficiencies - 79 in all, from incorrectly labeled products to failed sterility tests - are so serious that Celltex risks being shut … Continue reading

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HemoGenix® FDA Master File to Measure Blood Stem Cell Potency for Cellular Therapy Products:

Posted: Published on June 26th, 2012

COLORADO SPRINGS, Colo.--(BUSINESS WIRE)-- HemoGenix announced today that FDA CBER has given HemoGenix its first Master File Number for an in vitro blood stem cell potency, quality and release assay (HALO-96 PQR) (1)for cellular therapy products(2)used for stem cell transplantation purposes. HALO-96 PQR is the first commercially available stem cell potency assay for cellular therapy products. It incorporates the most sensitive readout available to measure changes in the cells energy source (ATP) as a function of the potential for stem cells to proliferate. Potency and quality of stem cell therapeutic products are required to be measured prior to use to help predict the engraftment of the cells in the patient. At the present time, tests such as cell number, viability and a stem cell marker called CD34 are routinely used. However, none of these tests specifically measure stem cells and none determine the stem cell biological activity required for a potency assay. The only cell functionality test presently used in this field, especially for umbilical cord blood transplantation, is the colony-forming unit (CFU) assay, which is subjective, non-validated and has been used since the early 1970s. HALO-96 PQR changes this paradigm. It is particularly needed in the umbilical cord blood … Continue reading

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Effects of High Blood Pressure Drug May Mimic Celiac Disease

Posted: Published on June 26th, 2012

FRIDAY, June 22 (HealthDay News) -- A new report suggests that the common blood pressure drug olmesartan (Benicar) can cause symptoms that mimic celiac disease, leading to misdiagnosis and unnecessary treatment. It's not clear how often people who take the blood pressure-lowering drug will develop the gastrointestinal problems that are similar to those caused by celiac disease. For the moment, though, the side effects appear to be unusual, said Dr. Peter Green, director of the Celiac Disease Center at Columbia University Medical School, who was not involved with the study. Still, Green noted, his center has seen patients who developed celiac disease-like symptoms while taking olmesartan and some have been quite ill. "One went into kidney failure and needed dialysis," he said. According to the new study from the Mayo Clinic in Rochester, Minn., 22 patients -- aged 47 to 81, average age 70 -- had symptoms of chronic diarrhea and weight loss of an average of 40 pounds. Fourteen of the patients needed to be hospitalized. Tests showed that these patients didn't have celiac disease, a condition that causes gastrointestinal problems due to an allergy to gluten, which is found in products such as wheat and rye. However, all … Continue reading

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Agents raid drug treatment center

Posted: Published on June 26th, 2012

11:11 a.m. PDT, June 26, 2012 SAN DIEGO -- State and federal officers raided the offices of a private drug treatment clinic Tuesday in connection with allegations that drugs were being overprescribed to patients, sources close to the investigation said. About a dozen agents from the Drug Enforcement Agency, the California Medical Board and the California Department of Alcohol and Drug Programs executed two search warrants at the offices of Bay Recovery Center at 4241 Jutland Drive in Bay Park. The agents arrived at about 9 a.m. and interviewed employees and gather documents. Bay Recovery Center is an inpatient treatment center for chronic pain and drug dependency, according to Dr. Jerry Rand, the program's director. It has 24 beds in three homes overlooking Mission Bay. Agents executed additional search warrants Tuesday at each of the three treatment homes and at Rand's residence, officials said. In June, an amended complaint was filed against Rand with the California Medical Board alleging that he overprescribed drugs to himself and his patients, according to the board's website. The complaint alleges that a woman under Rand's care killed herself at one of the homes in 2008 on her 29th birthday. Rand's brother and an employee … Continue reading

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