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Stem cell therapy: FDA regulatory science aims to …

Posted: Published on August 21st, 2014

By: Steve Bauer, Ph.D. One of FDAs primary missions is to make sure that the products we approve are safe and effective. There is tremendous interest in the development of regenerative medicine, including numerous proposed products that rely on stem cells. Stem cells have the ability to generate more stem cells or to turn into more mature cell types such as nerve- or bone-producing cells. These properties make stem cells potentially well suited for use in regenerative medicine. They might be used in repairing heart, nerve, and brain damage or in treating diabetes and other diseases by repairing or replacing cells and tissues. Steve Bauer, Ph.D., chief of the Cellular and Tissues Therapy Branch, Division of Cellular and Gene Therapies, in the Office of Cellular, Tissue and Gene Therapy at CBER. Because stem cells can change based on their surroundings, whether during growth outside of the body or following injection into the body, ensuring the safety of effective regenerative medicine products can be challenging. One type of adult stem cell, the multipotent marrow stromal cell (MSC) more popularly called the mesenchymal stem cell is the subject of a great deal of research in regenerative medicine. These cells can divide repeatedly, … Continue reading

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US FDA outlines manufacturing-focused stem cell research …

Posted: Published on August 21st, 2014

US FDA researchers are developing tools to help cell therapy developers improve how they manufacture stem cells in a new lab consortium unveiled by the agency this week. In a blog post this week Food and Drug Administration (FDA) cellular and tissue therapy chief, Steve Bauer, outlined the potential of mesenchymal stem cell, the scientific hurdles the developers and regulators face and the agencys efforts to address them. Stem cells have the ability to generate more stem cells or to turn into more mature cell types such as nerve- or bone-producing cells. These properties make stem cells potentially well suited for use in regenerative medicine. But there are still scientific questions to answer about MSCs. A particularly important set of questions is how the manufacturing of these cells outside of the body could affect their potential healing properties and their safety. Research focus To address these scientific questions the CBER has formed a seven-strong laboratory consortium to create tests and techniques to help developers improve their stem cell manufacturing processes, using cells from eight different donors. Work ranges from the identification of 84 cell surface proteins that manufacturers can use to track the growth and differentiation of stem cells in … Continue reading

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Health bosss conflict on IVF

Posted: Published on August 21st, 2014

A YORK health boss has explained why he did not vote in a crucial decision over IVF - and has said he will oppose such a postcode lottery if elected as MP. Dr Mark Hayes, chief clinical officer of the Vale of York Clinical Commissioning Group (CCG), has publicly said he wishes to end a situation in which York is the only area in the country not to offer IVF. But he did not cast a vote in favour of providing IVF treatment after governing members of the CCG suggested the Labour candidate for Selby and Ainsty may be seen to be playing for votes. A narrow 5-4 vote then saw commissioners backtrack on a decision to allow a cycle of IVF because it cannot afford the service. Dr Hayes yesterday dismissed calls from Conservative MP Julian Smith for his resignation due to a conflict of interest, saying he did not anticipate that another situation would arise where he would have to abstain from a vote or decision-making process. But he did add that he will campaign against the injustice of a postcode lottery should he become an MP. Dr Hayes said: We have a National Health Service and its … Continue reading

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Genetics used to improve plants for bioenergy

Posted: Published on August 21st, 2014

Jeon Hong and Maria Harrison This image shows an arbuscular mycorrhizal fungus (green) inside Brachypodium distachyon root cells (red). The fungi invade root cells and naturally deliver essential nutrients phosphate and nitrogen - which are necessary for plant growth, development and yield - from the soil to the plants. Jeon Hong and Maria Harrison Brachypodium distachyon, a model grass species. An upcoming genetics investigation into the symbiotic association between soil fungi and feedstock plants for bioenergy production could lead to more efficient uptake of nutrients, which would help limit the need for expensive and polluting fertilizers. The study is part of a three-year, $864,400 U.S. Department of Energy (DOE) grant to researchers at the Boyce Thompson Institute for Plant Research (BTI) at Cornell. It is one of eight awards nationwide by the DOE last month aimed at accelerating genetic breeding programs to improve plant feedstocks for the production of biofuels, biopower and bio-based products. The U.S. Department of Agriculture also funded two additional projects as part of this program. Maria Harrison, a professor at BTI, is the grants principal investigator. Co-PI Zhangjun Fei, an associate professor at BTI, will provide bioinformatics expertise for the project. They are Cornell adjuncts in … Continue reading

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Gene therapy protects mice from lethal heart condition, MU researchers find

Posted: Published on August 21st, 2014

PUBLIC RELEASE DATE: 19-Aug-2014 Contact: Derek Thompson thompsonder@health.missouri.edu 573-882-3323 University of Missouri-Columbia COLUMBIA, Mo. A new gene therapy developed by researchers at the University of Missouri School of Medicine has been shown to protect mice from a life-threatening heart condition caused by muscular dystrophy. "This is a new therapeutic avenue," said Yi Lai, Ph.D., the leading author of the study and assistant research professor in the MU School of Medicine's Department of Molecular Microbiology and Immunology. "This is just a first step, but we hope this could lead to a treatment for people with this devastating heart condition, which is a leading cause of death for people with Duchenne muscular dystrophy." About one in 3,500 children, mostly boys, are born with Duchenne muscular dystrophy (DMD). They experience a progressive wasting away of muscles, starting in the legs and pelvis. Children with DMD have difficulty walking, and most need wheelchairs by age 12. As DMD depletes the skeletal muscles, it also causes the heart to decay. A weakened heart kills up to 40 percent of people with DMD, usually by their 20s or early 30s. DMD originates with mutations in a single gene. For more than two decades, researchers have explored … Continue reading

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Hemet man convicted after DNA links him to two unsolved rapes

Posted: Published on August 21st, 2014

A Hemet man was found guilty Wednesday after DNA evidence taken during a theft conviction linked him to two unsolved rapes committed roughly 10 years ago. Kevin Lawrence Saint John, 45, faces 40 years to life in state prison after a jury convicted him of two felony counts of forcible rape, which carried sentence enhancement allegations, according to the Orange County district attorney's office. In 2012, Saint John's DNA was entered into a state database after he was convicted of receiving stolen property. His DNA matched with evidence collected during an investigation into two rapes committed in 2004, the district attorney's office said in a statement. He was ultimately arrested at his home in Rancho Cucamonga. Prosecutors said Saint John entered a 7-Eleven on Aug. 10, 2004, forced a 21-year-old store employee into a freezer and raped her. He used empty boxes to shield his face from surveillance cameras as he exited the store. Nearly a month later, he approached another 21-year-old woman, who was using a payphone in a Walmart parking lot, and offered to help her find a ride home. After she agreed to the ride, he drove her to an isolated construction area in Highland and raped … Continue reading

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DNA shows Japanese fathered 15 surrogate babies: Thai police

Posted: Published on August 21st, 2014

BANGKOK: A DNA test of a Japanese man embroiled in a surrogacy scandal in Thailand shows that he is the biological father of at least 15 babies, police said Wednesday (Aug 20). But his motives remained a mystery two weeks after the discovery of nine babies in a Bangkok apartment triggered a human trafficking probe. The alleged father, who is reported by Japanese media to be the son of an IT millionaire, has left Thailand but voluntarily sent the DNA sample to try to clear his name. "It is confirmed that he is the father of all the babies - the 15 babies that we checked," Thai police doctor Lieutenant General Jongjate Aojanepong told AFP after the preliminary result. The authorities still hope that the man will return to Thailand to help with the investigation, police Lieutenant General Kokiat Wongvorachart told reporters. "If he comes, we will get clear information from him," he added. Asked about the content of a written explanation submitted by the Japanese through his lawyer, Kokiat said: "He said he can take care of them. He wants to have children." "From our checks of the living conditions of the babies, so far there has not been … Continue reading

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Judge allows new DNA testing in 1996 Putnam rape case

Posted: Published on August 21st, 2014

WINFIELD A judge will allow new DNA testing that could exonerate a Hurricane man whos spent more than 15 years in prison after being convicted of raping his 5-year-old daughter. Putnam Circuit Judge Joseph Reeder denied a request Wednesday made by Joseph Lavigne Jr. for a new trial, but granted his request to allow testing of various evidence that has either never been DNA tested before or hasnt been tested with current methods. Lavigne is serving a jail sentence of 22 to 60 years. The evidence includes hairs collected during his daughters examination at a hospital following the February 1996 rape and at a subsequent evaluation at the hospital the following month. It also includes towels and washcloths gathered from Lavignes home and swabs taken as part of a rape kit. Lavignes daughter, Katie Haught Kelly, has publicly said she doesnt believe he raped her, and the request for DNA testing referenced an affidavit in which she states shes absolutely certain he didnt do it. Joe has never disputed that someone abducted his daughter while she was sleeping at home and brutally assaulted her, Lavignes request to allow the testing states. He adamantly denies, however, that he was the perpetrator. … Continue reading

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A professors view on chemistry, muscles, bones and injury

Posted: Published on August 21st, 2014

NEW YORK A professor emeritus of chemistry who taught for more than 50 years at Long Island University in New York believes that when it comes to sports injuries, the differences in the chemistry of ligaments and tendons compared to muscle and bone may be overlooked. Its a big unknown, but a lot of ball players are getting hurt today, and I got a feeling their muscles are getting too strong for tendons and ligaments and too strong for each other, Lawrence Rocks said. Rocks is a baseball outsider, although son Burton Rocks is a baseball player agent and author. The elder Rocks said that NASA has done the most research on the physical makeup and atrophying of different elements of the body: i.e., how fast bones lose calcium. The ligaments and tendons are proteins which are also carbohydrates, Rocks said. The meniscus between the bones, thats carbohydrate chemistry. That material is the same type of material in your eyeball. Theres a large carbohydrate component complex carbohydrates, theres dozens of them, in the meniscus between bones, in the cartilage and in some of the tendons. The tendons are not pure muscle. Ultimately, Rocks echoed those directly entrenched in the athletic … Continue reading

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Boston, Worcester Officials Support Medical Marijuana Dispensary Despite State Rejection

Posted: Published on August 21st, 2014

Good Chemistry of Massachusetts was declared out of the running for one of the states medical marijuana dispensary licenses after state officials said it lacked support. But in the wake of that rejection, city officials in Boston and Worcester are going to bat for the company, The Boston Globe reports. According to the report, Good Chemistry is including letters of support from Worcesters mayor, a city councilor, six state legislators, and Boston City Council President Bill Linehan in a lawsuit seeking a temporary restraining order against the state. Advertisement - Continue Reading Below In letters urging the state to reverse its denial of Good Chemistry of Massachusetts dispensary in Worcester, the mayor, a city councilor, and six state legislators wrote that the company has broad support in the city and is being unfairly penalized. In Boston, City Council President Bill Linehan also wrote a letter to the state in June supporting Good Chemistrys plans for a dispensary in the city. On Tuesday, he said he stands by that support even though state health officials have announced that the company was eliminated. You can read the full Boston Globe report here. Go here to read the rest: Boston, Worcester Officials Support … Continue reading

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