Gene therapy part 3 in vitro gene therapy
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Gene therapy part 4 applications and future prospects
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Human gene therapy, types of gene therapy part 1
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Human gene therapy, types of gene therapy part 2
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Human gene therapy, types of gene therapy part 3
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Human gene therapy, types of gene therapy part 4
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Several gene therapies are or will soon be in late-stage human trials. One of them could be the first to get FDA approval for sale in the U.S.

Though many gene therapies have been tested in patients around the world in hopes of curing hereditary diseases, few governments have approved their sale, and none has been approved in the United States. That could change in coming years as several therapies enter advanced trials.

A big step forward already came in November 2012, when the European Medicines Agency gave the Dutch biotech startup UniQure permission to sell its treatment. That approval came as a relief to many in the field, who had been waiting for a break in the clouds hanging over the technology since failed and fatal trials in the 1990s. You see a resurgence in terms of investors, and in truth, a number of problems have been solved, says Katherine High, a medical researcher at Childrens Hospital of Philadelphia, who is overseeing a late-stage clinical trial for a different gene therapy.

Still, experts say it is likely to be a few years before a treatment is approved in the U.S. With its European approval in hand, UniQure may have good chance of also getting the first U.S. approval, but the company says it has not yet submitted an application to the FDA.

Like most gene therapies, UniQures treatment uses a modified virus to deliver a working copy of a gene to patients who lack a healthy version. In this case, the gene is needed for the body to break down fats; without it, patients can develop painful and even fatal inflammation of the pancreas. UniQure uses a modified version of a virus that most of us already carry. The choice of virus used to deliver a gene therapy depends in part on where the treatment needs to go in the body and whether the viruses are intended to replicate themselves. Some viruses, for instance, are designed to spread throughout the body to kill cancer cells.

There are several groups that could be the first to develop a U.S.-approved gene therapy (see table). Highs team is one; they are enrolling patients in a late-stage trial of a treatment for a disorder that causes blindness at an early age. The patients in this trial have previously been given the gene therapy in one eye, and now the other will be tested.

In the experimental treatment, doctors inject a virus-based particle just behind a patients retina. The treatment improved some patients vision to the point that they were no longer legally blind. Some patients have been stable for nearly six years. The trial is scheduled to end in April 2015.

Another possibility comes from Massachusetts-based Bluebird Bio, which has published results from patients who have seemingly been cured of a genetic blood disease (see Gene Therapy Combats Hereditary Blood Disease). The company is about to start testing its approach in a hereditary neurological disorder that is often fatal in young boys.

In a different form, gene therapy could also become an option for cancer treatment. At a meeting this summer, Amgen announced that it had met its goals for an advanced test of a gene therapy for melanoma that has spread from the skin to other parts of the body. The Amgen treatment, which was engineered from a virus that normally causes cold sores, takes a two-pronged approach to fighting cancer. The virus selectively infects cancer cells, where it replicates until the cell bursts. While growing inside the cell, the virus also produces a protein that rouses the immune system. When the cell explodes, immune cells are attracted to the tumor site to fight the disease.

In a test in patients with late-stage melanoma, 26 percent of patients whose cancer had spread saw a partial or complete tumor response for at least six months. In 11 percent of patients, the cancer completely disappeared, which suggests that the therapy spreads throughout the body, targeting tumors that werent initially injected. Overall survival rates for cancer patients in the trials are expected to be reported in the first half of 2014.

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Grant to Rice, UTHealth will push regenerative medicine
A $75 million Department of Defense grant to improve technologies to treat soldiers injured on the battlefield and advance care for the public will involve b...

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Strata Rx 2013: August Calhoun, "Healthcare Analytics in the Age of Personalized Medicine"
Strata Rx 2013: August Calhoun, "Healthcare Analytics in the Age of Personalized Medicine"

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Strata Rx 2013: Amit Sinha, "Addressing Big Data challenges for Real time Personalized Medicine"
Strata Rx 2013: Amit Sinha, "Addressing Big Data challenges for Real time Personalized Medicine"

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Bladder Cancer and Personalized Medicine
Carl Morrison, MD, DVM, of Roswell Park Cancer Institute #39;s Center for Personalized Medicine, discusses a gene found to be common to both Alzheimers Disease a...

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Spinal Cord Injury patient demonstrates progress after treatment at Stem Cell Institute Panama
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Healing Breakthrough For Spinal Cord Injury
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Canadian Association For Research in Regenerative Medicine Promotional Video
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Kilian Receives Stemlogix Stem Cell Therapy

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Ben Moody of Evanescence talks HGH Stem Cell Therapy MetroMD Los Angeles

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CALGARY, ALBERTA--(Marketwired - Sep 27, 2013) - Researchers from the universities of Calgary and Cambridge, UK, have discovered that a mutation in a gene necessary for the metabolism of folic acid not only impacts immediate offspring but can also have detrimental health effects, such as spina bifida and heart abnormalities, on subsequent generations. The animal study, published this week in the journal Cell, also sheds light on the molecular mechanism of folic acid (also known as folate) during development.

About one in 1,200 children are born with spina bifida. The detrimental effects of folic acid deficiency during pregnancy on development are well known. As a result Canada, and many other countries, have implemented folate fortification programs which require folic acid to be added to cereal products. The aim has been to reduce the incidence of developmental problems, including spina bifida. However, until now, very little was known about how folic acid deficiency caused the diverse range of health problems in offspring.

"Fortification programs have reduced the risk of health effects but not eliminated them completely," says Dr. Jay Cross, with the faculties of medicine and veterinary medicine. "Based on our research, we now believe that it may take more than one generation to eliminate the health problems caused by folate deficiency. In addition, we need to be thinking not just about our own genes and how they impact our health and development, but also those of our descendents."

Cross, also a member of the Alberta Children's Hospital Research Institute, co-authored the study with Dr. Erica Watson from the University of Cambridge. Watson is a University of Calgary alumna and started the work during her PhD studies with Cross before moving to Cambridge.

Researchers from the university used mice for the study because their folic acid metabolism is very similar to humans. This enabled the researchers to explore how the molecular mechanism of folic acid deficiency impacted development, thereby causing developmental problems.

Dr. Roy Gravel, also a co-author of the study and member of the Alberta Childrens' Hospital Research Institute says this study provides a tremendous opportunity to look at the prevention of diseases like spina bifida. "The work began as a study of a gene called Mtrr in mice. The goal was to shed light on how a mutation in Mtrr would affect folate metabolism. The multigeneral effect we observed was completely unexpected," says Gravel.

The Mtrr gene encodes an enzyme that is key to the metabolism of folic acid and, when mutated, causes similar effects to dietary folic acid deficiency. The researchers found that when either the maternal grandmother or the maternal grandfather had this Mtrr mutation, their genetically normal grandchildren were at risk of a wide spectrum of developmental abnormalities, even if the mutated gene was not inherited through to the next generations. These developmental abnormalities were also seen in the fourth and fifth generations of mice.

Through a series of experiments, researchers discovered that the developmental abnormalities were not passed down genetically. Instead, the defects were the result of "epigenetic" changes, which had been inherited. Epigenetics is a process which turns genes on and off through chemical modifications to DNA without changing the genetic code itself. Epigenetic inheritance refers to the passing along of these epigenetic marks as cells divide during development. It had been previously thought that epigenetic modifications were, for the most part, 'wiped clean' after each generation.

The researchers hypothesize that, for a yet unknown reason, some of these abnormal epigenetic marks caused by the Mtrr mutation escape this normal erasure and are inherited by the next generation. If the abnormal epigenetic marks that regulate genes important for development are inherited, then these generations may develop abnormalities as a result of the wrong genes being turned on or off.

"There have been several recent studies implicating folate in different types of human diseases, not just developmental abnormalities, and so our work provides insights into potential biochemical mechanism but also adds a layer of complexity in thinking about transgenerational effects of folate," says Cross.

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Prof. Chris Shaw at MND Scotland 2013 Open Day/AGM: "Update on the Genetics of MND"
Our 2013 Open Day/AGM Keynote Speaker, Professor Chris Shaw, Professor of Neurology and Neurogenetics at the Institute of Psychiatry, King #39;s College London. ...

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Genetics Plays Genesis: "More Fool Me" Teatro Coliseo. Bs.As.- 21-09-2013.
Genetics Plays Genesis: 40° aniversario de "Selling England By The Pound". Canción: "More Fool Me". Teatro Coliseo. 21-09-2013. Bs.As.- GENETICS: Daniel Raws...

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Genetics plays Genesis: "Dancing with the Moonlit Knight". Coliseo. 21-09-13.
Genetics Plays Genesis: 40° aniversario de "Selling England By The Pound". Canción: ""Dancing with the Moonlit Knight". Teatro Coliseo. 21-09-2013. Bs.As.- G...

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Genetics - The Musical Box (Parte 2) @ Teatro Coliseo, Bs As, 21/09/13.
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In a step that brings stem cells closer to the clinic, researchers in Japan have found that transplanting reprogrammed stem cells into the brains of primates elicits little rejection by their immune systems.

Induced pluripotent stem cells (iPSCs) are created when skin cells, for example, are genetically reprogrammed to an embryonic-like state. This kind of stem cells holds great potential for the treatment of disease, since the cells are genetically identical to the patient they are taken from.

However, studies in rodents have suggested that the immune system may still recognize cells derived from iPSCs as foreign, and mount an attack on them. This has cast doubt on the feasibility of similar cell therapy for humans.

To test this in an animal more closely related to humans, researchers studied macaques. Using cells taken from the monkeys mouths or from their bloodstream, the researchers created iPSCs which they then, in turn, transformed into neurons. These neurons were of a specific kind: dopamine-producing neurons, the type depleted by Parkinsons disease.

Each monkey got six injections of these neurons into its brainsome which had been made from their own cells and others which were from another individual and therefore mismatched. The team could then see what kind of immune response each type produced.

Over subsequent months of observation, the monkeys showed very little immune response to transplants of their own cells. Their immune response was much higher in response to cells from another monkey.

The team also tracked how well the neurons survived after transplantation. They found that even when there was an immune response from the primate, the dopamine-producing neurons survived. The study is published today in Stem Cell Reports.

Trials using iPSCs to treat people with Parkinsons disease could therefore be on the horizon. These findings give a rationale to start autologous transplantationat least of neural cellsin clinical situations, says senior author Jun Takahashi of Kyoto University.

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Paul Greenberg for Discovery News 2013-09-25 18:20:43 UTC

The war veteran who recoils at the sound of a car backfiring and the recovering drug addict who feels a sudden need for their drug of choice when visiting old haunts have one thing in common: Both are victims of their own memories. New research indicates those memories could actually be extinguished.

A new study from the Massachusetts Institute of Technology found a gene called Tet1 can facilitate the process of memory extinction. In the study, mice were put in a cage that delivered an electric shock. Once they learned to fear that cage, they were then put in the same cage but not shocked. Mice with the normal Tet1 levels no longer feared the cage once new memories were formed without the shock. Mice with the Tet1 gene eliminated continued to fear the cage even when there was no shock delivered.

We learned from this that the animals defective in the Tet1 gene are not capable of weakening the fear memory, Le-Huei Tsai, director of MIT's Picower Institute for Learning and Memory, told Discovery News. For more than a half century it has been documented that gene expression and protein synthesis are essential for learning and forming new memories. In this study we speculated that the Tet1 gene regulates chemical modifications to DNA.

SEE ALSO: Sleep Helps Reinforce Memory

The MIT researchers found that Tet1 changes levels of DNA methylation, the process of causing a chemical reaction. When methylation is prominent, the process of learning new memories is more efficient. When methylation is weaker, the opposite is true.

The results support the notion that once a fear memory is formed, to extinguish that memory a new memory has to form, Tsai said. The new memory competes with the old memory and eventually supersedes the old memory.

Experts in the study of memory and anxiety agree.

This is highly significant research in that it presents a completely new mechanism of memory regulation and behavior regulation, said Jelena Radulovic, a professor of bipolar disease at Northwestern University. The mechanism of manipulating DNA is likely to affect many other things. Now the question will be whether there will be patterns that emerge, whether there will be side effects on moods and emotions and other aspects. But the findings have real relevance.

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No More Bad Flashbacks: Scientists Find Gene That Erases Memories

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Javascript is currently disabled in your web browser. For full site functionality, it is necessary to enable Javascript. In order to enable it, please see these instructions. 22 hours ago When rare "words" (codons) are present near the start of bacterial genes, working copies of the gene don't as readily into structures that block protein production. To find out the rare words themselves or lack of roadblocks increased protein production, Wyss Institute researchers synthesized 14,000 snippets of DNA with rare codons, roadblocks, both, or neither (individual pixels in this diagram), inserted them into genes, and measured how much protein they produced. Those with rare codons and roadblocks no longer made more protein (green pixels). That showed that rare codons work by removing roadblocks. Credit: Wyss Institute

Scientists routinely seek to reprogram bacteria to produce proteins for drugs, biofuels and more, but they have struggled to get those bugs to follow orders. But a hidden feature of the genetic code, it turns out, could get bugs with the program. The feature controls how much of the desired protein bacteria produce, a team from the Wyss Institute for Biologically Inspired Engineering at Harvard University reported in the September 26 online issue of Science.

The findings could be a boon for biotechnologists, and they could help synthetic biologists reprogram bacteria to make new drugs and biological devices.

By combining high-speed "next-generation" DNA sequencing and DNA synthesis technologies, Sri Kosuri, Ph.D., a Wyss Institute staff scientist, George Church, Ph.D., a core faculty member at the Wyss Institute and professor of genetics at Harvard Medical School, and Daniel Goodman, a Wyss Institute graduate research fellow, found that using more rare words, or codons, near the start of a gene removes roadblocks to protein production.

"Now that we understand how rare codons control gene expression, we can better predict how to synthesize genes that make enzymes, drugs, or whatever you want to make in a cell," Kosuri said.

To produce a protein, a cell must first make working copies of the gene encoding it. These copies, called messenger RNA (mRNA), consist of a specific string of words, or codons. Each codon represents one of the 20 different amino acids that cells use to assemble proteins. But since the cell uses 61 codons to represent 20 amino acids, many codons have synonyms that represent the same amino acid.

In bacteria, as in books, some words are used more often than others, and molecular biologists have noticed over the last few years that rare codons appear more frequently near the start of a gene. What's more, genes whose opening sequences have more rare codons produce more protein than genes whose opening sequences do not.

No one knew for sure why rare codons had these effects, but many biologists suspected that they function as a highway on-ramp for ribosomes, the molecular machines that build proteins. According to this idea, called the codon ramp hypothesis, ribosomes wait on the on-ramp, then accelerate slowly along the mRNA highway, allowing the cell to make proteins with all deliberate speed. But without the on-ramp, the ribosomes gun it down the mRNA highway, then collide like bumper cars, causing traffic accidents that slow protein production. Other biologists suspected rare codons acted via different mechanisms. These include mRNA folding, which could create roadblocks for ribosomes that block the highway and slow protein production.

To see which ideas were correct, the three researchers used a high-speed, multiplexed method that they'd reported in August in The Proceedings of the National Academy of Sciences.

First, they tested how well rare codons activated genes by mass-producing 14,000 snippets of DNA with either common or rare codons; splicing them near the start of a gene that makes cells glow green, and inserting each of those hybrid genes into different bacteria. Then they grew those bugs, sorted them into bins based on how intensely they glowed, and sequenced the snippets to look for rare codons.

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A hidden genetic code for better designer genes

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EWING, N.J.--(BUSINESS WIRE)--

Proterro, Inc., the only biofeedstock company that actually makes sucrose instead of extracting it from crops or deconstructing cellulosic materials, has named Timothy Cooper, Ph.D., vice president of engineering.

Dr. Cooper joins Proterros executive team with more than two decades of deep experience in bioprocessing. Prior to joining Proterro, he was responsible for Eastman Chemical Companys biotechnology effort, managing genetic engineering and fermentation development programs, and driving generation of intellectual property.

Before Eastman Chemical, Dr. Cooper was fermentation research leader at Dow AgroSciences LLC, where he was responsible for development and scale-up of new fermentation processes and managing the fermentation development efforts of three laboratories.

At Wyeth Pharmaceuticals, Inc., Dr. Cooper directed the companys fermentation and recovery development effort that solved key manufacturing obstacles of a complicated, multicomponent vaccine, successfully scaling the process to commercial volumes.

Dr. Coopers experience also includes:

A member of the American Chemical Society and the Society of Industrial Microbiology, Dr. Cooper earned a Bachelor of Science in chemical engineering from Tennessee Technological University and a Ph.D. in chemical engineering at the University of Wisconsin.

Other Proterro News

In a separate announcement today Proterro said it has reached new milestones in development. (See Proterro Meets Key Milestones)

About Proterro, Inc.

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Biofeedstock Company Proterro Names Bioprocessing Expert Engineering VP

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