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Gov. Perry's stem-cell firm draws FDA scrutiny

Posted: Published on March 16th, 2012

The U.S. Food and Drug Administration has received a complaint alleging the Houston company involved in Gov. Rick Perry's unregulated adult stem-cell operation is a potential danger to patients and not in compliance with federal law. In an eight-page letter sent last month, University of Minnesota bioethicist Leigh Turner called on the FDA to investigate Celltex Therapeutics Corp., which banks people's stem cells for future reinjection in the event of disease or injury. Perry was the company's first customer last year. "It appears their business plan involves injecting or infusing on a for-profit, commercial basis non-FDA-approved adult stem cells into paying customers," Turner wrote in the Feb. 21 letter. "This plan conflicts with FDA regulations governing human stem cells." An FDA spokeswoman declined comment, but Turner said an agency official told him the matter has been assigned to an investigator and is being taken seriously. Celltex co-founder David Eller said Tuesday night he is confident the company will "meet all FDA specifications." He emphasized that Celltex doesn't administer stem cells, but stores and processes them at the behest of doctors who later reinject them into patients. Dr. Stanley Jones, a Houston orthopedic surgeon, injected Perry's stem cells during his back … Continue reading

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Cell phone use in pregnancy may be linked to behavior trouble in children

Posted: Published on March 16th, 2012

By JIM SHELTON Journal Register News Service news@morningjournal.com Twitter: @morningjournal Hugh Taylor (Photo courtesy of Yale University) NEW HAVEN, Conn. -- Yale University researchers say they may have found a link between cell phone use during pregnancy and behavioral problems in children such as hyperactivity. We cant extrapolate from this what level of exposure is bad, but it lays the groundwork for saying cell phone exposure can cause harm, says Hugh S. Taylor, a professor at the Yale School of Medicine and chief of the division of reproductive endocrinology and infertility in the schools department of obstetrics, gynecology and reproductive sciences. If youre pregnant, it makes sense to move your cell phone away from your abdomen when youre not on an active call. Putting it on a desk or a table might be better, Taylor says. The Yale study was conducted on pregnant mice, exposing them to radiation from a cell phone placed over their cage. Taylor says the findings, published in the March 15 issue of Scientific Reports, mirror those of previous epidemiological studies conducted with people. Those studies, Taylor explains, were sometimes dismissed by critics as being inconclusive, because other environmental factors in the pregnant womens lives might … Continue reading

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Cell phone use in pregnancy may cause behavioral disorders in offspring, mouse study suggests

Posted: Published on March 16th, 2012

ScienceDaily (Mar. 15, 2012) Exposure to radiation from cell phones during pregnancy affects the brain development of offspring, potentially leading to hyperactivity, Yale School of Medicine researchers have determined. The results, based on studies in mice, are published in the March 15 issue of Scientific Reports, a Nature publication. "This is the first experimental evidence that fetal exposure to radiofrequency radiation from cellular telephones does in fact affect adult behavior," said senior author Dr. Hugh S. Taylor, professor and chief of the Division of Reproductive Endocrinology and Infertility in the Department of Obstetrics, Gynecology & Reproductive Sciences. Taylor and co-authors exposed pregnant mice to radiation from a muted and silenced cell phone positioned above the cage and placed on an active phone call for the duration of the trial. A control group of mice was kept under the same conditions but with the phone deactivated. The team measured the brain electrical activity of adult mice that were exposed to radiation as fetuses, and conducted a battery of psychological and behavioral tests. They found that the mice that were exposed to radiation tended to be more hyperactive and had reduced memory capacity. Taylor attributed the behavioral changes to an effect during … Continue reading

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Cell phone use in pregnancy may cause behavioral disorders in offspring

Posted: Published on March 16th, 2012

Public release date: 15-Mar-2012 [ | E-mail | Share ] Contact: Karen N. Peart karen.peart@yale.edu 203-432-1326 Yale University New Haven, Conn. Exposure to radiation from cell phones during pregnancy affects the brain development of offspring, potentially leading to hyperactivity, Yale School of Medicine researchers have determined. The results, based on studies in mice, are published in the March 15 issue of Scientific Reports, a Nature publication. This is the first experimental evidence that fetal exposure to radiofrequency radiation from cellular telephones does in fact affect adult behavior, said senior author Hugh S. Taylor, M.D., professor and chief of the Division of Reproductive Endocrinology and Infertility in the Department of Obstetrics, Gynecology & Reproductive Sciences. Taylor and co-authors exposed pregnant mice to radiation from a muted and silenced cell phone positioned above the cage and placed on an active phone call for the duration of the trial. A control group of mice was kept under the same conditions but with the phone deactivated. The team measured the brain electrical activity of adult mice that were exposed to radiation as fetuses, and conducted a battery of psychological and behavioral tests. They found that the mice that were exposed to radiation tended to … Continue reading

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Bioheart and Ageless Partner to Advance Stem Cell Field With Laboratory Training Programs

Posted: Published on March 16th, 2012

SUNRISE, Fla., March 15, 2012 (GLOBE NEWSWIRE) -- Bioheart, Inc. (BHRT.OB) announced today that it has successfully conducted a laboratory training course in partnership with the Ageless Regenerative Institute, an organization dedicated to the standardization of cell regenerative medicine. The attendees participated in hands on, in depth training in laboratory practices in stem cell science. "We had students from all over the world attend this first course including physicians, laboratory technicians and students," said Mike Tomas, Bioheart's President and CEO. "Bioheart is pleased to be able to share our 13 years of experience in stem cell research and help expand this growing life science field." The course included cell culture techniques and quality control testing such as flow cytometry and gram stain. In addition, participants learned how to work in a cleanroom operating according to FDA cGMP standards, regulations used in the manufacture of pharmaceuticals, food and medical devices. Aseptic techniques were also taught as well as cleanroom gowning, environmental monitoring and maintenance. Future courses are open to physicians, laboratory technicians and students. After graduating the course, attendees are prepared to pursue research and careers in the field of stem cells and regenerative medicine. For more information about the course, … Continue reading

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Cell Phone Radiation Leads to Hyperactive Offspring in Mice

Posted: Published on March 16th, 2012

Researchers at the Yale School of Medicine have presented the first experimental evidence showing that exposure to cell phone radiation in the womb affects fetal brain development and could lead to hyperactivity. The study was done on mice and the results cant be directly applied to humans: gestation periods, fetal brain development, and relevant exposure levels are all very different. Nonetheless, Hugh Taylor, director of the Yale Center for Reproductive Biology, says that limiting cell phone use during pregnancy is warranted. Taylor and his colleagues published their findings today in the journal Scientific Reports. The researchers positioned a cell phone making a muted, but active, phone call above the cage of a group of pregnant mice. The control groups cage was kept under a deactivated phone. The researchers performed various behavioral and psychological tests on the mice born to both groups, and also measured brain electrical activity. They found that adult mice that were exposed to radiation as fetuses tended to be more hyperactive and anxious, and had less memory capacity. The behavioral changes could be attributed to the effect of RF radiation on neuron development in the brains prefrontal cortex, the same region thats associated with Attention Deficit Hyperactive … Continue reading

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Cell Radiation Tied to Behavior Problems?

Posted: Published on March 16th, 2012

A new study could re-ignite the debate over the potentially dangerous effects of cell phone radiation on children's behavior. Researchers from the Yale School of Medicine found that exposing pregnant mice to radiation from a cell phone affected the behavior of their offspring later. They found that the mice exposed to radiation as fetuses were more hyperactive, had more anxiety and poorer memory -- symptoms associated with attention deficit hyperactivity disorder (ADHD) -- than mice who were not exposed to radiation. Neurological tests revealed that the radiation exposure led to abnormal development of neurons in the part of the brain linked to ADHD, leading the authors to suggest that cell phone radiation exposure may play a role in the disorder. "During critical windows in neurogenesis, the brain is susceptible to numerous environmental insults; common medically relevant exposures include ionizing radiation, alcohol, tobacco, drugs and stress," wrote the authors, led by Dr. Hugh Taylor, professor and chief of the Division of Reproductive Endocrinology and Infertility. They added that while their study provides "the first experimental evidence of neuropathology due to in-utero cellular telephone radiation," the data are not conclusive, and more research is needed to determine the effects of radiation on … Continue reading

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TiGenix Reports Full Year 2011 Financial Results

Posted: Published on March 16th, 2012

LEUVEN, BELGIUM--(Marketwire -03/15/12)- TiGenix NV (EURONEXT: TIG) today gave a business update and announced financial results for the full year 2011. Business highlights Financial highlights "TiGenix has created a new and strong basis in 2011 on which we can build going forward and we have strengthened our position as the European leader in cell therapy," says Eduardo Bravo, CEO of TiGenix. "We have delivered on our promises: we have obtained national reimbursement for ChondroCelect in Belgium and made progress in other European markets. We advanced all clinical stem cell programs on plan, and raised substantial funds from specialized healthcare investors and through non-dilutive financing. Today, TiGenix is well-positioned to reach the next value-enhancing inflection points." Business Update Successful integration of Cellerix reinforces leadership position in cell therapyIn May 2011, TiGenix closed the business combination with the stem cell therapy company Cellerix, creating the European leader in cell therapy. During 2011 the Company succeeded in rapidly integrating both entities. The Company now combines top line revenues with an advanced pipeline of clinical stage regenerative and immuno-modulatory products. TiGenix's operations are supported by a strong commercial and manufacturing infrastructure for advanced cell therapies, an experienced international management team and a solid cash … Continue reading

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Washington Center for Pain Management Begins Enrollment in United States Stem Cell Therapy Study in Subjects With …

Posted: Published on March 16th, 2012

EDMONDS, Wash., March 14, 2012 /PRNewswire/ --Washington Center for Pain Management is participating in a nationwide FDA-cleared adult stem cell study testing novel treatment for chronic low back pain and has enrolled its first patient. The study will test the use of Mesenchymal Precursor Cells (MPCs) adult stem cells derived from bone marrow that will be directly injected into the lumbar disc. The minimally invasive procedure may offer an alternative to back surgery for eligible patients with chronic pain from degenerative discs. An estimated 30 million people in the United States suffer from back pain. Degenerative disc disease is the most common cause of low-back pain, which develops with the gradual loss of a material called proteoglycan, which cushions the bones of the spine and enables normal motion. Most patients with low-back pain respond to physical therapy and medications, but in advanced cases, artificial disc replacement or spinal fusion -- removal of the degenerated discs and the fusion of the bones of the spine -- is necessary. However, these surgeries often are not entirely effective. "Millions of Americans are debilitated by chronic low back pain," says Dr Hyun Joong Hong MD, the lead investigator at The Washington Center for Pain … Continue reading

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Ottawa researchers to lead world-first clinical trial of stem cell therapy for septic shock

Posted: Published on March 16th, 2012

Public release date: 15-Mar-2012 [ | E-mail | Share ] Contact: Jennifer Ganton jganton@ohri.ca 613-798-5555 x73325 Ottawa Hospital Research Institute A team of researchers from the Ottawa Hospital Research Institute (OHRI) and the University of Ottawa (uOttawa) has been awarded $367,000 from the Canadian Institutes of Health Research (CIHR) and $75,000 from the Stem Cell Network to lead the first clinical trial in the world of a stem cell therapy for septic shock. This deadly condition occurs when an infection spreads throughout the body and over-activates the immune system, resulting in severe organ damage and death in 30 to 40 per cent of cases. Septic shock accounts for 20 per cent of all Intensive Care Unit (ICU) admissions in Canada and costs $4 billion annually. Under the leadership of Dr. Lauralyn McIntyre, this new "Phase I" trial will test the experimental therapy in up to 15 patients with septic shock at The Ottawa Hospital's ICU. The treatment involves mesenchymal stem cells, also called mesenchymal stromal cells or MSCs. Like other stem cells, they can give rise to a variety of more specialized cells and tissues and can help repair and regenerate damaged organs. They also have a unique ability to … Continue reading

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