Santa Monica biotech company Kite Pharma Inc. is being acquired by industry giant Gilead Sciences Inc. in an $11.9-billion deal that demonstrates the promise of using a persons own immune system to fight cancer.

Foster City-based Gilead said Monday that it would maintain and even expand Kite Pharmas Los Angeles area operations, which include a 100,000-square-foot manufacturing facility in El Segundo.

Dr. Arie Belldegrun, Kite Pharmas founder and chief executive, will help during the merger transition, a Gilead spokeswoman said, but she offered no details on leadership plans beyond that.

The purchase of Kite, which is on the verge of gaining approval for an innovative treatment, expands the cancer-fighting portfolio of Gilead.

The acquisition of Kite establishes Gilead as a leader in cellular therapy and provides a foundation from which to drive continued innovation for people with advanced cancers, Gilead Chief Executive John F. Milligan said in a statement.

Kite Pharma has a cell therapy treatment for non-Hodgkins lymphoma under review by the Food and Drug Administration that uses a patients immune cells to fight cancerous cells. Swiss drugmaker Novartis Corp. also is developing a similar cell therapy treatment for a rare form of leukemia, which is poised to become the first gene therapy to receive FDA approval.

Cell therapy, like many cancer treatments, is expected to be expensive. The costs to patients and providers could cause problems for Gilead, which has come under fire for the high price of its drugs.

Kevin Young, Gileads chief operating officer, would not say Monday what the treatment would cost. But he told analysts on a conference call that I certainly think this innovation will support very healthy reimbursement.

Gilead is to pay $180 in cash for each share of Kite Pharma, a 29% premium over the Friday closing price. Kite Pharma stock leaped 28% to $178.05 on Monday. Gilead shares rose about 1% to $74.69.

Since the start of the year, Kite Pharmas stock price has nearly quadrupled. The shares got a significant boost after a study of the companys gene therapy reported positive results.

The boards of both companies have approved the deal, and its expected to close by the end of the year.

Gilead has developed top-selling treatments for HIV and the liver-destroying hepatitis C virus, but leaders of the biotechnology company told analysts Monday that its push into oncology has been largely nascent so far.

Kite Pharmas research and development, as well as commercialization operations, are to remain in Santa Monica. Manufacturing of Kite Pharmas treatment is to continue at the facility in El Segundo. Kite Pharma has about 600 employees at the two facilities combined, company spokeswoman Christine Cassiano said.

Gilead was impressed with Kite Pharmas team and plans to keep investing in its operations, said Gilead spokeswoman Amy Flood.

The transaction is not about financial synergies or cost savings, she said. This is a growth area, and we anticipate we will increase the number of employees at Kite.

Analysts said it made sense for Gilead to keep and even expand Kite Pharmas Los Angeles-area operations.

That manufacturing in L.A., that marketing team, I think is really, really critical in the process, especially when theyre about to launch in this area, said Tony Butler, an analyst at Guggenheim Securities.

Its important that they keep that together, he said.

Biren Amin, an equity analyst at Jefferies, said Gilead was unlikely to make a change to Kite Pharmas operations with FDA approval of its treatment right around the corner.

If one even thought about transferring it out of El Segundo, I think it would be next to impossible because youd have to have that site up and running for product launch later this year, Amin said.

Kite Pharma was founded in 2009 by Belldegrun, an Israeli-born cancer doctor with decades of experience in immunotherapy. It went public in 2014.

Its cancer treatment, called CAR T, involves reprogramming a patient's disease-fighting T-cells to seek and destroy only abnormal, cancerous lymph cells. Healthy cells are not harmed.

The process involves drawing blood from a patient, refrigerating it and flying it to Kites facilities, where the cells are modified, frozen and then flown back to doctors who reinject them into patients.

In a 2015 interview with the Los Angeles Times, Belldegrun likened the cancer-fighting treatment to the navigation system in an automobile.

"The GPS will lead you to the cancer cell, and not the normal cell, and selectively kill only the cancer cell," Belldegrun said.

In February, Kite Pharma reported that a major study of the gene therapy process found that more than a third of very sick lymphoma patients showed no signs of the disease six months after a single treatment. And 82% of patients had their cancer shrink at least by half at some point after the treatment, the study found.

CAR T has the potential to become one of the most powerful anti-cancer agents for hematologic cancers, Belldegrun said in a statement Monday. With Gileads expertise and support, we hope to fulfill that potential by rapidly accelerating our robust pipeline and next-generation research and manufacturing technologies.

Gilead was criticized two years ago for high prices for its hepatitis C drugs, including one that began at $1,000 per pill. The drugs were developed by biotech firm Pharmasset Inc., which Gilead acquired in 2011.

A bipartisan Senate Finance Committee report in 2015 said that Gilead put profits before patients in pricing the drug. Also, AIDS activists have complained about the prices of Gileads HIV medications.

The CAR T treatment could be expensive as well because of the complexities of the therapy. Novartis treatment very likely will hit the market first so Gilead will have that price to work from, said Alan Carr, an analyst at Needham & Co.

There are a lot of oncology drugs right now that are expensive. Theres a lot of controversy around that, he said. Im not sure that Gilead is particularly susceptible to that.

The Associated Press was used in compiling this report.

Twitter: @JimPuzzanghera

jim.puzzanghera@latimes.com

UPDATES:

3:15 p.m.: This article was updated with information about Kite Pharma founder Dr. Arie Belldegrun.

1:25 p.m.: This article was updated with the closing stock prices for Kite Pharma and Gilead Sciences.

1:05 p.m.: This article was updated with analyst comment and additional details about drug pricing.

8:30 a.m.: This article was updated with details about Kite Pharmas workforce and current stock prices.

7 a.m.: This article was updated with additional detail and the opening stock prices of Kite Pharma and Gilead.

6:45 a.m.: This article was updated throughout with staff reporting.

This article was originally published at 5:25 a.m.

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Gilead is buying Kite Pharma, a cancer-fighting Santa Monica biotech firm, for $11.9 billion - Los Angeles Times

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Early embryos two days after co-injection with a gene-correcting enzyme. (OHSU)

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A few weeks ago, two stories crossed paths. In MIT Technology Review, we learned that, for the first time in the United States, researchers had used the gene-editing technique known as CRISPR to modify a human embryo. Severaldays later, CBS Newsreleased a report that through nearly universal prenatal testing followed by selective abortion, Iceland has virtually eliminated Down syndrome. Ad Policy

The CRISPR story shows that we are on the cusp of an enormous leap of capability when it comes to shaping the genetic potential of our offspring. Meanwhile, Ive contended that the past decades of testing, genetic consultation, and decision-making about abortion related to prenatal diagnoses of Down syndrome have served as a kind of test run for the future of human procreation. Can we make informed choices? Can we understand that probability doesnt equate to outcome when were talking genetic makeup? Can we use science to build a more just, happier humanity?

If whats happening in Iceland is, indeed, a test run, its a test were failing. Prospective parents are making decisions based on fear and stigma, helped along by the medical profession. As our tools to make such decisions get even more powerful, we have to shift how we talk about genetic diversity.

Cards on the table: Im the father of a boy with Down syndrome. I am pro-choice, anti-eugenics, and pro-information. In preparation for the age of CRISPR, well need to develop new ways to talk about whats normal and whats good, because we face decisions that are nearly unprecedented in human history. I say nearly, because with Down syndrome prenatal testing, we have a body of evidence for what happens when we expand our power to determine who gets born without building systems to ensure that we make informed decisions.Related Article

CRISPR (short for Clustered Regularly Interspaced Short Palindromic Repeats) is wickedly powerful. It makes reasonably precise changes to a targeted cells DNA by means of a technique adapted from naturally occurring DNA-editing defense mechanisms in bacteria. Chinese scientists first modified human embryos two years ago. The researchers in Oregon used it to change the DNA of a large number of one-celled embryos with the goal of demonstrating both that the technique could be used at scale and that the genes causing disease could be effectively identified and eliminated.

Each new development, as previously covered in The Nation, sparks rounds of debates between those optimistic about fighting diseases and those concerned about implications. For example, sickle-cell patients hope for a cure, while the intelligence community worries that terror groups could weaponize CRISPR. Earlier this year, the National Academy of Sciences, Engineering, and Medicineagreedthat genome editing could be used to modify embryos, but should be allowed only for treating or preventing diseases or disabilities at this time. Ethicists demand more robust engagement of the questions we are about to face, as techniques move from the research to the practical stage. Still, most of the debates remain locked in abstract thought experiments.Most Popular

Prenatal testing followed by selective abortion is not genetic engineering. It is, however, a space in which we have real-world data about how people make choices about procreation when granted additional information about the genetic makeup of their potential offspring. It turns out, perhaps unsurprisingly, that fear, misinformation, and bias shape our decision-making.Current Issue

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Take Iceland. In the small island country, all pregnant women are informed of the availability of genetic screening. Between 80 and 85 percent take the test, and nearly 100 percent of all positive tests for Down syndrome result in termination. What are we to make of such an outcome? Each person hearing the words Down syndrome applied to their fetus does so as a consumer of a culture that, broadly speaking, denigrates life with developmental disabilities. Geneticist Kari Stefansson characterized the counseling as heavy-handed in favor of termination, and so thats where the momentum is. If Icelandic doctors, nurses, and genetic counselors dont find ways to mitigate that, the disability largely disappears.

This is typically the moment in essays about prenatal testing in which I assure you that my son is happy. He is. Hes 10. He likes Hamilton and Harry Potter, and is a wonderfully inventive communicator. We are privileged to live in a good community with good schools, and when we encountered obstacles to his long-term supports in one state, we could move. Weve never denied that there are challenges, but the greatest ones are constructed by an ableist society, not inherent to his disability. Society can be changed. His genes dont need to be.

But the decision whether or not to terminate is not about my sons outcomes, but accepting two general principles. First, with good social supports, theres no reason that people with Down syndrome cant lead good lives included within communities. For a doctor to assert the probability that Down syndrome leads to despair is simply not true. Second, in general, probabilities never guarantee outcomes. Our genes encode an array of probabilities into our bodies.

In recent years, rather than focusing on the abortion itself (or decision to carry to term), North American activists in Down-syndrome advocacy communities have tried to look at the communication in the period between the positive test and the decision about whether or not to terminate. The goal is to provide materials to better inform the tens of thousands of doctors, nurses, and counselors who encounter women in the context of prenatal testing. These efforts have coalesced around the nonpartisan rubric: pro-information.

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I e-mailed Stephanie Meredith,Lettercase program director at the University of Kentuckys Human Development Institute, where she has helped develop resources for distribution to people who talk to women about prenatal testing. She told me that many genetic counselors and obstetricians offer compassionate, sensitive, and balanced support following prenatal testing, but some clinicians may provide insufficient, outdated, or unintentionally biased counseling. Outcomes for people with Down syndrome and related conditions have changed remarkably over the past 50 years. But too many people involved in prenatal care lack up-to-date information, and theres no easy way for institutes like Merediths to reach every clinician in the country. Meanwhile, companies selling prenatal tests want to increase their market share. Meredith said that clinicians are constantly inundated by marketing from testing labs with very little educational support regarding the conditions included in the test.

Ive spent years talking to parents who received prenatal tests (we did not). Some were told flatly untrue statements about Down syndrome, breaking up marriages and leaving families overwhelmed by stress. In fact, theres evidence that families like mine divorce at lower ratesthan other families. Others were presented with outdated statistics about early death as a likely outcome. Its not (although the premature death rates of African Americans with the condition remainfar too high). Its true that people with Down syndrome once tended to die young and learn little, but thats a fact linked to the era of mass institutionalization. Inclusion has radically changed the probabilities. My son has as good a chance to live as long, happy, productive life as anyone of our socioeconomic status. But expectant parents hearing the words Down syndrome for the first time will only know this if theyre told.

Unfortunately, politics is making it hard to hold the pro-information coalition together, thanks to Americananti-choice efforts. Around the country, the GOP is proposing and passing lawsbanning abortion if a woman tells her doctor shes doing it because of a prenatal diagnosis. We cant be pro-information if we criminalize such conversations. Such a bill ispending right now in Ohio.

What does all this have to do with CRISPR? Right now, were still in a liminal state when it comes to predicting genetic outcomes for fetuses. Our tools, from amniocentesis (developed in the 1950s and 60s) to contemporary screenings that locate fetal blood cells in the mothers bloodstream, are reactive and postconception. Soon, theyll shift to preconception and proactive. What will the tens of thousands of clinicians tell would-be parents as they get flooded with messaging from companies eager to sell their high-tech CRISPR product lines?

Preventing this potentially dystopian future where altered genes separates the haves from the have-nots starts by shifting discourse. A pro-information approach demands that everyone involved in genetic counseling have access to the best data and presents it in a value-neutral way. We must build systems now that grow as our tools evolve. If we do not, genetic diversity will gradually become code for poverty, and new stigmas will run all the way to the DNA.

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We're Failing Our Test Run for the Age of CRISPR | The Nation - The Nation.

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In the new Eterna challenge, called OpenCRISPR, players will design a guide RNA molecule that leads CRISPR to the right sequence of DNA for editing or binding. The RNA is the part that confers gene specificity. Its the thing that says, Go after gene A, not gene B, said Chang.

The difficulty for Eterna players is to come up with an RNA molecule that does several things, said Greenleaf. The guide RNA has to be recognized by the CRISPR-associated enzyme. The CRISPR-enzyme system has to be able to recruit biochemical activity to the targeted gene. And lastly, the activity of the CRISPR-enzyme system has to be controlled by a small-molecule drug, so there needs to be a binding pocket for that small molecule. The RNA molecule has to function so that the CRISPR system is active when the small-molecule drug is present and inactive when its not. So far, experts have not been able to create such a drug-activated CRISPR, which is why Chang and Greenleaf are calling on the community of Eterna gamers for help.

The new puzzle will be quite different from the recent challenge in which Eterna players had to design a molecule that could do a mathematical calculation for a tuberculosis diagnostic test. The CRISPR puzzle actually should be pretty easy to solve in silico, even for new players who get to the switch design levels, said Rhiju Das, PhD, associate professor of biochemistry and principal investigator for Eterna.

How those Eterna-designed switches will behave in living cells is a big question. Das said the team will be asking players for different possible solutions to the same problem. Were not sure yet if there will be unforeseen problems with the Cas9 protein experimentally. Thats partially why we want as many diverse solutions as possible for the Greenleaf and Chang labs to test, even in this pilot round, Das said.

It will be an iterative process, said Greenleaf. His Stanford lab will test the first round of solutions and then return these data to the players with refinements that will guide their design work.

Were hoping for 10,000 to 100,000 players to contribute 10 solutions each. If we get that many, well indeed work to get that many synthesized and tested, Das said.

One of the goals of Stanfords Center for Personal Dynamic Regulomes is to get people interested in science, said Chang. The Eterna game is a powerful way to engage lots and lots of people, he said. Theyre not just passive users of information but actually involved in the process.

Like other computer games, Eterna allows players to accumulate points, build expertise and advance to higher levels. The best players have a chance of having their designs implemented in the lab.

One thing that makes the project exciting, said Chang, is that it is an experiment in the sociology of science. There is a misconception of science as something that happens in an ivory tower by someone in a white coat with a long beard. And they are saying things and drawing things that nobody understands. But its not like that! Its really like a puzzle that anybody can get engaged with, he said.

Anyone interested in playing Eterna can sign up here.

In addition to the funding from NIGMS and Stanfords Center for Personal Dynamic Regulomes, the new Eterna challenge is being launched with collaborative support from the Innovative Genomics Institute at the University of California-Berkeley. Stanfords departments of Biochemistry and of Genetics also supported the work.

Continue reading here:
Online game challenges players to design on/off switch for CRISPR ... - Stanford Medical Center Report

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Treatment for adults

Treatment for male hypogonadism depends on the cause and whether you're concerned about fertility.

Hormone replacement. For hypogonadism caused by testicular failure, doctors use male hormone replacement therapy (testosterone replacement therapy, or TRT). TRT can restore muscle strength and prevent bone loss. In addition, men receiving TRT may experience an increase in energy, sex drive, erectile function and sense of well-being.

If a pituitary problem is the cause, pituitary hormones may stimulate sperm production and restore fertility. Testosterone replacement therapy can be used if fertility isn't an issue. A pituitary tumor may require surgical removal, medication, radiation or the replacement of other hormones.

In boys, testosterone replacement therapy (TRT) can stimulate puberty and the development of secondary sex characteristics, such as increased muscle mass, beard and pubic hair growth, and growth of the penis. Pituitary hormones may be used to stimulate testicle growth. An initial low dose of testosterone with gradual increases may help to avoid adverse effects and more closely mimic the slow increase in testosterone that occurs during puberty.

Several testosterone delivery methods exist. Choosing a specific therapy depends on your preference of a particular delivery system, the side effects and the cost. Methods include:

Injection. Testosterone injections (testosterone cypionate, testosterone enanthate) are safe and effective. Injections are given in a muscle. Your symptoms might fluctuate between doses depending on the frequency of injections.

You or a family member can learn to give TRT injections at home. If you're uncomfortable giving yourself injections, a nurse or doctor can give the injections.

Testosterone undecanoate (Aveed), an injection recently approved by the Food and Drug Administration, is injected less frequently but must be administered by a health care provider and can have serious side effects.

Gel. There are several gel preparations available with different ways of applying them. Depending on the brand, you either rub testosterone gel into your skin on your upper arm or shoulder (AndroGel, Testim, Vogelxo), apply with an applicator under each armpit (Axiron) or pump on your front and inner thigh (Fortesta).

As the gel dries, your body absorbs testosterone through your skin. Gel application of testosterone replacement therapy appears to cause fewer skin reactions than patches do. Don't shower or bathe for several hours after a gel application, to be sure it gets absorbed.

A potential side effect of the gel is the possibility of transferring the medication to another person. Avoid skin-to-skin contact until the gel is completely dry or cover the area after an application.

Oral testosterone isn't recommended for long-term hormone replacement because it might cause liver problems.

Testosterone therapy carries various risks, including contributing to sleep apnea, stimulating noncancerous growth of the prostate, enlarging breasts, limiting sperm production, stimulating growth of existing prostate cancer and blood clots forming in the veins. Recent research also suggests testosterone therapy might increase your risk of a heart attack.

Sept. 29, 2016

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Male hypogonadism - Treatment - Mayo Clinic

Recommendation and review posted by Bethany Smith

What Makes Ehormones Different?

Each person is biologically unique, therefore, EHormones s Physicians design a comprehensive Hormone Replacement Therapy (or HRT) protocol to match each persons individual needs. At EHormones, individuals undergo comprehensive lab work as well as a physical examination. Additionally, each individual receives a thorough consultation with his or her physician to discuss and interpret the comprehensive lab results. Thereafter, every EHormones managed physician will use your medical history, symptoms, and labs to develop an individualized and comprehensive Hormone Replacement Therapy protocol.

Testosterone Replacement Therapy (or TRT) is typically administered in the form of once weekly Testosterone injections. There may be ancillary medications which allow the testes to continue its natural production of testosterone while on therapy, and an Aromatase Inhibitor, an estrogen suppressing pill typically taken once to several times weekly.

HGH Therapy prescribed by an EHormones managed physician is also administered by injection, typically in the form of Sermorelin and/or Growth Hormone Releasing Peptides.

Female Bio-identical Hormone Replacement Therapy is generally administered in the form of transdermal creams, typically applied daily to the skin.

We offer comprehensive Hormone Programs for nearly all budgets.

Our affiliates have offices in many US cities and we continue to grow. Getting started is as easy as setting you up for lab work.

With 100% confidentiality, our doctors and staff are available by phone for any questions you may have while you are under our care.

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EHormonesMD Hormone Doctors - Ehormones

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When an experiment turns into a tradition in Laughlin, it means there was a show worth taking a chance on at one timethen consistently that same show proved itself time after time to be one audiences didnt want to miss. The Memorial Day Comedy Festival at the Riverside Resort was that show. Experiencing comedy served up as a variety show with veteran comedian Gabe Lopez as the shows producer, performer and emcee was like discovering a hidden gem on the entertainment landscapemore along the lines of one of those underground clubs in Vegas, known only to a lucky few. But now the word is out and the Comedy Festival is coming back to the Riverside Resort over the Labor Day weekend this time.

If you are a local, or a regular visitor to Laughlinespecially if your visits are on holiday weekendsyou are aware that the Avi Resort & Casino doesnt simply wait for the Fourth of July to set off a major fireworks display. Nope. Beginning in 1996, and continuing every year since, they have been filling the skies above the Colorado River with the amped-up creations of Zambelli Internationale Fireworks on Memorial Day weekend, the Fourth of July and Labor Day weekend.

The Colorado Belle is home to a multitude of outdoor festivals that embrace particular themes and for the Labor Day Riverwalk Festival, its a celebration of the end of summer and the cooler temperatures just starting to take hold of the Colorado River regionthink of it as one big neighborhood block party.

Theres a lot to be said for being in the right place at the right time, but could Air Supplys long-time success be the result or a chance meeting or was the cosmos working overtime on a little something called destiny? Maybe, but one thing is for surenone of it would have been possible at all without their hard work and tenacity to make it happen.The two Russells, Graham Russell and Russell Hitchcock, happened to be cast in the same Sydney, Australian production of Jesus Christ Superstar in 1975, and everything changed after that.

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Husband on clomid for low sperm count - The doctors who pioneered the ivf procedure in australia - Laughlin Entertainer

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30 August 2017

By sex and relationship expert Tracey Cox

Tracey Cox

Men watch porn mostmen watch porn. But most men enjoy porn without binging on itandenjoy sex with their partners. Most dont replace one with the other.

Watching porn doesnt mean hes more likely to cheat either. In fact, if he has a higher sex drive than you and hes watching porn, chances are hes probably NOT cheating.

There are certain bits on human bodies that feel good sexually if theyre touched in the right way. Were hot-wired that way.

If you couldnt see and didnt know who was touching you, you could be turned on by anyone.

And I mean anyone.

While our brains most certainly contribute to what turns us on, theres a hell of a lot of anatomy at play also.

The term erogenous zone refers to places in our body that are packed with nerve endings so have heightened sensitivity.

The anus is one of them. Stimulate it effectively and he will feel pleasure - simple as that.

If he enjoys anal simulation, its because it feels good and hes comfortable enough in his sexuality NOT to be hung up on the this must mean Im gay myth.

Anal stimulation alone does not make him gay. Continually wanting to and having sex with other men is what makes him gay (or bi).

Some men do. Some women do as well. Some men also want to watch sport all the time. Some dont. Some men want to sleep all the time. Some dont. I think you get my drift.

There is continual and constant research on male versus female sex drives that turns up interesting and complex results. The implications are there are many factors at play, when predicting someones sex drive, not just gender.

The standard sex myth that says men want sex, women want love is pass and hopelessly out of date. In fact, research by online sex toy retailer Lovehoney found that sex with love was more important to men than women.

Plenty of things stop him getting hard too much alcohol, not feeling well, stress, performance anxiety, some medication, the need for more or different stimulation and the list goes on.

Contrary to popular belief, his penis isnt operated by a mechanical lever that moves to up whenever he sees a hot woman.

OK, well there might be something in that theory for the average 17-year-old but once grown-up life steps in, with all its pressures and stress, that soon disappears.

No doubt Donald Trump believes it but most (sane) men gave up on the Sorry I cheated honey but Im programmed to do it argument eons ago.

Women are still more socialized to restrict themselves to one partner but figures for the number of women having affairs continues to rise.

Were not animals we have brains and the ability to reason. Cheating is a choice not a biological need.

Psychologically, most men would probably prefer to have an erection during any sort of sexual activity even if penetrative sex isnt on the agenda.

Why? Because both sexes have been brainwashed to think desire equals a hard penis. It doesnt. (See above)

Arousal happens in the brain: he could be massively turned on giving you oral but still not be hard by time youve had an orgasm.

Turning you on is a huge erotic kick: your reaction is about to star in his next masturbatory session.

While there are a lot of things that can help me hold off orgasm and ejaculation, its also down to genetics. The size of his penis, how long his dad lasted (and his dad) all this is completely out of his control.

By all means try out all the tried-and-tested methods but after that, let it go and work around it if he doesnt last long.

Tracey has her own range of sex toys with Lovehoney, Britain's biggest online sex toy retailer.

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7 Things Most Women Believe About Men And Sex (That Simply Aren't True!) - FemaleFirst.co.uk

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Clamp (glowing green) is found all over these fly chromosomes, but it's particularly concentrated at the histone locus (red) at the bottom center. Credit: Rieder, et. al.

An essential fruit fly protein called CLAMP may help biologists answer the key question of how the same protein can manage to coordinate two completely different processes on distinct chromosomes in the same cell.

New research on a crucial protein in fruit flies provides a clear model for a fundamental question in biology that's significant for drug development in particular: What influences the exact same protein to coordinate a vital molecular process on one chromosome but an entirely different one on another chromosome?

The new study concerns the recently discovered protein CLAMP. Previously, scientists at Brown University had identified CLAMP as the linchpin in the process by which cells in males doubly express their single X chromosome to achieve genetic parity with females, a process necessary for male existence and survival. Now, in a study published in the journal Genes and Development, the researchers have identified another role for CLAMP that is equally essential to males and females alikethe protein is responsible for coordinating the process by which the DNA in newly replicating cells of an embryo becomes properly wound up and structured.

"It's really exciting because now we have these two separate chromosomes on which CLAMP does vital jobs," said senior author Erica Larschan. "That sets us up for a compare-and-contrast strategy where we can understand how one protein can function differently in context-specific ways."

That matters, added co-lead author Leila Rieder, a postdoctoral researcher at Brown, because in order for clinical interventions that target key proteins to do more good than harm, they need to be tailored to a specific context. It may be tempting to block or amplify a gene or protein to treat a disease, but without confining the intervention to that one process, it could upset the entirely healthy actions of the same gene or protein in an unrelated process. That could produce potentially devastating side effects.

"One of the biggest fears about using genetics in people is that there are off-target effects," Rieder said. "You don't know when you manipulate a gene if it's going to have a single effect or if it's going to have many effects. We don't understand all the roles that that one manipulation is going to have."

The confirmation of a second life-giving role for CLAMP, Rieder and Larschan said, provides a perfect example of a protein that is essential in two completely different ways in the convenient research model of the fruit fly.

CLAMP goes GAGA

CLAMP binds to DNA all over the fly genome, but it kicks into consequential action when it finds a long series of repeats of the nucleotides GA. In the new study, the scientists found long GA repeats and CLAMP on chromosome 2L at the "histone locus," where a cluster of genes produce the proteins around which DNA gets wound up to fit inside the nucleus. In many organisms, humans included, cells assemble the same cadre of proteins around which they wrap their DNA. Approximately a yard of DNA is present in every microscopic cell, so it is essential that it be tightly packed but still accessible for regulation immediately in a newly fertilized egg.

In a series of experiments, a team at Brown, the University of North Carolina and Massachusetts General Hospital found that in fruit flies, CLAMP is the protein that launches the process of gene regulation that produces histones by recruiting other known regulators. It is among the very first proteins on the scene of the histone locus in a newly fertilized egg and opens up the histone locus for expression by the cell, they found. Experiments in which the team interfered with CLAMP led almost universally to fly eggs failing to hatch.

Foiling CLAMP proved to be so lethal, in fact, that studying its function at all required an experimental ploy that would allow the scientists to manipulate CLAMP while keeping the flies alive. To understand, for example, how CLAMP lures the other histone-related proteins to the histone locus, the Brown team worked with the University of North Carolina collaborators, including co-lead author Kaitlin Koreski, to generate CLAMP mimics that wouldn't interfere with natural CLAMP's DNA binding, but could still attract the other key regulatory proteins that control histone gene regulation.

Same protein, different functions

Larschan and Rieder's new understanding of CLAMP's function at the histone locus now matches their understanding of its function on the X chromosome. But they said they don't yet know exactly what differs about the context of those two chromosomes such that CLAMP, with the same molecular anatomy and bound to the same GA repeats, manages to recruit two completely different groups of proteins to perform separate gene expression tasks.

That's the next step in their research.

"It sets up a paradigm for the future," Larschan said. "There are very few casesthat's what I'm always surprised about when I read the literaturewhere there are such specific roles at different sites for a single protein. It's a really strong model."

Explore further: GAGA may be the secret of the sexesat least in insects

More information: Leila E. Rieder et al, Histone locus regulation by the Drosophila dosage compensation adaptor protein CLAMP, Genes & Development (2017). DOI: 10.1101/gad.300855.117

More:
Fruit fly protein dual duties may make it model for studies of protein function in context - Phys.Org

Recommendation and review posted by sam

Genetic knowledge may be beneficial related to issues such as selection of optimal supportive care, informed medical decision-making, prognostic considerations, and avoidance of unnecessary testing.

Genetics is the study of heredity or how different characteristics (traits) are passed from a parent to a child. A person inherits these traits from their parents. Each person has several thousand genes that are made up of DNA. Genes are packaged into larger structures called chromosomes. Chromosomes are present in almost every human body cell. Genetics play a part in many types of epilepsy.

Advances in science and technology can help identify molecular defects (for example, deletions or mutations) that contribute to the genetics of some types of epilepsy. Genetic testing helps scientists and physicians better understand how various genes may interact to produce a specific epilepsy syndrome. This genetic information may give people with epilepsy and their families more detail about their specific epilepsy syndrome. Several epilepsies have a genetic component and we know that epilepsy can run in families.

Usually, genetic testing requires a blood or salivasample to be taken from the person with epilepsy. The sample is then sent to a laboratory for genetic testing. The test looks at the DNA in the persons blood or saliva. The sample is analyzed for mutations or changes in a subset of genes that have a known association with different types of epilepsy.

There are five types of genetic disorders:

The inheritance of epilepsy is frequently complex. Genetic disorders can cause epilepsy alone or may cause a syndrome that affects various parts of the body as well as epilepsy. Some epilepsy syndromes are known to have a genetic basis, but the gene or genes that cause the syndrome have not yet been identified. Finally, some genetic disorders arise spontaneously through new gene mutations.

More than 20 different syndromes with epilepsy as a main feature have been mapped to specific genes. Many more single gene disorders that cause brain abnormalities or metabolic disorders have epilepsy as a primary symptom. Also, scientists have identified mutations in genes that control sodium, potassium, and calcium channels that can also cause epilepsy.

Its important to note that genetic testing in some epilepsy syndromes has already played a significant role in clinical practice. This has been particularly true for people with epileptic encephalopathies that begin in infancy and early childhood. For example, this may include:

More challenging at this time are the subgroup of genetic generalized epilepsies (GGE) that include childhood absence epilepsy, juvenile absence epilepsy, juvenile myoclonic epilepsy, photosensitive epilepsy, and generalized tonic-clonic seizures. GGE has a complex genetic inheritance pattern. This subset of epilepsies present a challenge, and currently we have little information about the genes that are implicated in GGE.

However, genetic testing still may have a key role to play. Over time, as more information is collected, the cause of these epilepsies will be better understood. Knowing the cause may improve testing, diagnosis, clinical treatment, and family counseling.

Below are listed some of the epilepsy syndromes that may result from genetic disorders. New genes involved in epilepsy are being identified regularly, and the genetics of epilepsy spectrum continues in a period of rapid growth.

Single Gene Epilepsy Syndromes

Other Single Gene Disorders that Can Manifest as Epilepsy

Other Inherited Metabolic Conditions that May Cause Seizures

Multifactorial Disorders

Mitochondrial Disorders

Chromosomal Disorders

Visit link:
Genetic Testing | Epilepsy Foundation

Recommendation and review posted by simmons

One of the UK's largest women's hospitals is to increase its ability to genetically test newborn babies 12-fold.

Liverpool Women's NHS Foundation Trust will be able to screen all infants for inherited conditions or illnesses and plan for early treatment as part of a major new IT project.

It will also contribute to a major population health programme in Liverpool analysing genetic information by location, identifying and enabling work to prevent localised health issues.

IT firm Novosco will introduce the computing system.

Novosco managing director Patrick McAliskey said: "We are delighted to secure this contract which will enable the trust to take genetic testing to the next level and play an important role in the identification and prevention of conditions and illnesses in new-born babies and the wider population."

This role of genetics in healthcare is one of the most rapidly expanding areas of development for Liverpool Women's.

It provides a regional clinical genetics service based at Alder Hey Hospital, covering a population of around 2.8 million people from across Merseyside, Cheshire and the Isle of Man, chief executive Kathryn Thomson posted on the trust's website.

She added: "To discover that you or any child you have or plan to have may be at risk of a genetic disorder which could cause disability or a rare condition is traumatic.

"People are sometimes shocked and anxious and wonder what the future might hold.

"They need as much information and support as possible to help them cope.

"That is why the often unsung work of our clinical genetics team is so important, providing diagnosis and supporting families when they need it most."

Liverpool Women's NHS Foundation Trust specialises in the health of women and their babies - both within the hospital and in the community. It is one of only two such specialist trusts in the UK - and the largest women's hospital of its kind.

Novosco is an IT infrastructure and managed cloud computing company and employs over 150 people. It has its headquarters in Belfast, with offices in Manchester, Dublin, and Cork.

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Hospital to boost genetic testing for newborn babies - ITV News

Recommendation and review posted by sam

By Bryan Sater

The urgent race to cure a rare disease that attacks the muscular system does not happen overnight.

Researchers have made significant progress toward saving 11-year-old Talia Duffs life. Duff suffers from CMT4J, a degenerative genetic disease similar to ALS. But plenty of work remains.

While the Duff family pushes the science of gene therapy to save Talia, fundraising efforts in the community continue and local teens have a plan to help Talia with the challenges of her daily life.

Working toward a cure

The potential cure for Talia exists in the form of gene therapy, where a healthy gene replaces the mutated gene (FIG4), which causes CMT4J.

Scientists at Jackson Laboratory, in Bar Harbor, Maine, have harvested a benign virus, like the common cold, stripped some of its DNA, and attached it to a healthy copy of the FIG4 gene.

Called a vector, this manipulated virus delivers the healthy FIG4 gene into the body by infecting cells in a targeted location, such as motor neurons in the spinal cord.

Theoretically, gene therapy not only stops the disease, but could allow peripheral nerves to heal and give Talia back some of her lost strength.

The gene therapy that could save Talias life could also have a wide-reaching effect on how rare disease are treated throughout the world. Potentially, others who suffer from a one-gene mutation defect could benefit by replicating the same sort of find and replace method that gene therapy proscribes.

Currently, research on mice genetically-altered to have CMT4J is being conducted at Jackson Labs. The mice have received the viral vector and are being studied for their response. Results of the experiment have not yet been published, but the Duffs scientific team expects to make an announcement in the coming weeks regarding the status of the test-subject mice.

Fundraising

While gene therapy has been identified as the potential cure for CMT4J, paying for the process is still a major obstacle. The money raised so far covered the cost of the viral vector creation, but as CMT4J advances its assault on Talias respiratory system, the Duffs continue to face increasing urgency in their fundraising efforts.

Pharmaceutical companies are not inclined to pipeline drugs for a disease that affects less than two dozen people worldwide. And normal scientific channels could take more than a decade, time which Talia does not have.

The Duffs did get some help from Jackson Labs, as the facility allocated money it received from a National Institute of Health grant toward some of the pre-clinical trial expenses.

However, the Duffs still need to raise between $1 million and $2 million in the coming year in order to fund a clinical trial in humans. They have raised nearly $300,000 so far and fundraising efforts are ongoing.

On Oct. 20, the Dare to Be Rare Gala will be Cure CMT4Js biggest fundraiser yet. Between sponsorship, ticket sales and live and silent auctions, the organization hopes to raise nearly $100,000.

Local fundraisers continue to chip away as well, including last weeks Tidbits for Talia at the Mayflower restaurant, flower sales at Ipswich Flowers, ongoing sales of brightly-colored shoelaces in the community, and outreach to major donors for significant gifts.

The amazing Ipswich community has contributed so much to our cause both financially and emotionally, said Talias mother, Jocelyn. Their support means so much to our family. It also lends tremendous credibility as we continue to pursue corporate and private donors beyond Ipswich. We hope they will feel compelled to give once they learn of Ipswich's generosity and the incredible work being done by our scientists in the lab."

Robotic arm

A group of high school students is doing what they can to help improve Talias quality of life. As CMT4J has progressed, Talia has lost most use of her extremities, including her arms and legs, compromising her ability to do simple things, such as lift a fork to her mouth or hold a book to read.

Enter the Ipswich High School Robotics Team. The students have established a four-phase plan to develop a robotic arm to help Talia with some of these regular tasks. They have secured a $10,000 Payne Grant to fund the project and have put together an initial prototype for the robotic arm that Talia will be able to use.

The team intends to accomplish two things with this project, said Rick Gadbois, team mentor, who met Jocelyn Duff at a rare disease conference last fall. Students will invent a device that helps Talia with daily activities, and will also publicize the effort to bring attention to CMT4J, to get funding for clinical research, for treatment and for a cure.

Talias health

While CMT4J weakened her limbs to the point where she depends entirely on a wheelchair, it has now begun to attack Talias respiratory system as well. The involuntary muscles that precipitate breathing are weakening, preventing her from coughing or taking deep breaths.

Three times per day, Talia must submit to a cough-assist machine, which, said Jocelyn Duff, forces air down her lungs and then vacuums it right back out in order to clear out any secretions in the lungs.

In addition, Talia now sleeps with a BIPAP machine, which delivers focused pressure to her lungs while she sleeps. The purpose is to maintain the oxygen saturation in her body at night, thus helping her sleep better and providing her more energy during the day.

Throughout it all, Talia continues to fight, and according to her mother, She is still her amazing, resilient, brave self.

Talias summer

Despite her condition, Talia was still able to enjoy summer as much as any 11-year-old. Her family vacationed in Maine, where she got to kayak, one of her favorite activities.

She took in a Red Sox game with a fellow CMT4J patient who visited from Seattle. The pair went onto the field at Fenway for batting practice and met Sox first baseman Mitch Moreland, who chatted with them.

Talia also began preparing for the start of sixth grade next week by going to locker night at the middle school and gathering her back-to-school supplies.

I think she is excited about school starting again this year, seeing her old friends and making some new ones, said Jocelyn Duff.

Visit link:
Ipswich resident Talia Duff's fight for life continues, family hopes to raise funds for research - Wicked Local Ipswich

Recommendation and review posted by Bethany Smith

CSL Behring, a Montgomery County-based global developer of biotherapeutic products, has entered into a deal to buy Calimmune Inc. for $91 million.

The deal also includes the potential for Calimmune to earn additional performance based milestone payments of up to $325 million over a period currently anticipated to be around eight years or more following the closing of the transaction. The transaction is expected to close within the next two weeks.

Calimmune, a biotechnology company specializing in hematopoietic stem cell gene therapy, has research and development facilities in Pasadena, Calif., and Sydney, Australia. [Hematopoietic stem cells are responsible for the production of all cellular blood components.]

The acquisition provides CSL Behring of King of Prussia, Pa., with Calimmunes pre-clinical asset, CAL-H, an experimental gene therapy for the treatment of sickle cell disease and beta-thalassemia. Officials at CSL Behring, a division of CSL Ltd. of Australia, said CAL-H complements CSL Behrings current product portfolio and its "deep expertise" in hematology.

To read the full story, click here.

For more business news, visit Philadelphia Business Journal.

Published at 9:28 PM EDT on Aug 28, 2017

Link:
$91M Deal: CSL Acquires California Stem Cell Gene Therapy Developer - NBC 10 Philadelphia

Recommendation and review posted by Bethany Smith

DUBLIN--(BUSINESS WIRE)--The "Global Cartilage Repair Market 2017-2021" report has been added to Research and Markets' offering.

The global cartilage repair market to grow at a CAGR of 11.59 % during the period 2017-2021.

The treatment of articular cartilage has evolved tremendously in the past decade. Reparative and restorative methods have been developed to address the significant source of morbidity in the young and active patients. Articular cartilage injury can be focal, which is localized or systemic. Procedures are being developed not only to alleviate the symptoms associated with articular cartilage defects but also to limit the progression of cartilage damages into degenerative diseases.

According to the report, one of the major drivers for this market is Rising incidence of accidental injuries. Globally, the road traffic injuries are increasing, with post complicated symptoms such as weakening of tendons, cartilage tear, and orthopedic issues.

The latest trend gaining momentum in the market is Gene therapy and stem cell therapy. Gene therapy is one of the promising fields in the cartilage repair. Many clinical studies have been performed for cartilage repair. The researchers are trying to develop gene therapy for cartilage repair and currently been investigated for clinical application.

Further, the report states that one of the major factors hindering the growth of this market is Product side effects. Surgeons use cartilage repair products such as tissue scaffold to improve the recovery. These products once grafted in the body may cause serious complications, resulting in their increased scrutiny for safety and efficacy. In many autologous chondrocyte implantation, there were common complications such as graft rejection, symptomatic hypertrophy, disturbed fusion and delamination.

Key vendors

Other prominent vendors

Key Topics Covered:

For more information about this report visit https://www.researchandmarkets.com/research/rjx284/global_cartilage

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Global Cartilage Repair Market 2017-2021 - Gene Therapy and Stem Cell Therapy is the latest Market Trend Making ... - Business Wire (press release)

Recommendation and review posted by simmons

(Reuters) - The U.S. Food and Drug Administration (FDA) is stepping up efforts to better regulate an emerging field of medicine that holds significant promise for curing some of the most troubling diseases by using the body's own cells.

A small number of "unscrupulous actors" have seized on the promise of regenerative medicine and stem cell therapies to mislead patients based on unproven, and in some cases, dangerously dubious products, the FDA said on Monday. (bit.ly/2iB4Xls)

Regenerative medicine makes use of human cells or tissues that are engineered or taken from donors. Health regulators have approved some types of stem cell transplants that mainly use blood and skin stem cells after clinical trials found they could treat certain types of cancer and grow skin grafts for burn victims.

But many potential therapies are still in the earliest stages of development. These therapies are sometimes advertised with the promise of a cure, but they often have scant evidence backing their efficacy or safety.

The FDA said it had taken steps to tackle the problem of some "troubling products" being marketed in Florida and California.

Federal officials on Friday seized from San Diego-based StemImmune Inc vials containing hundreds of doses of a vaccine reserved only for people at high risk for smallpox, the FDA said. (bit.ly/2wC1DMU)

The seizure followed recent FDA inspections that confirmed the vaccine was used to create an unapproved stem cell product, which was then given to cancer patients, the agency added.

The FDA also sent a warning letter to a Sunrise, Florida-based clinic for marketing stem cell products without regulatory approval and for major deviations from current good manufacturing practices. (bit.ly/2giGlx9)

The health regulator will present a new policy framework this fall that will more clearly detail the "rules of the road" for regenerative medicine, FDA Commissioner Scott Gottlieb, a cancer survivor, said in a statement.

Reporting by Natalie Grover in Bengaluru; Additional reporting by Tamara Mathias; Editing by Sai Sachin Ravikumar

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FDA steps up scrutiny of stem cell therapies - Reuters

Recommendation and review posted by simmons

Grand Fan Group, a supplier of hair, body wash and care brands, has bought the Cicabel brand from French pharmaceutical producer, Santinov.

The deal

The Chinese distributor held a press conference and officially announced the acquisition on 27th August 2017.

Grand Fan Group acquired both the Cicabel brand and all of the medical products maker'stechnologies. To kickstart its position within the Chinese marketplace, Grand Fan Group will also introduce its first peptide-based Cicabel face mask to consumers in September 2017.

This arrangement is the Chinese distributors first move into the skin care sector and is part of its wider strategic plan to improve its brands for Chinas make up and skin care industries, along with advancing its three existing hair and personal care names.

Stem cell R&D

French medical products manufacturer, Santinov, first brought its Cicabel name to the beauty-loving market 130 years ago with its facial masks. The label conducted extensive research and development and used stem cells to create skin care masks.

In today's market, biotechnology is having a considerable influence over cosmetic product launches. As a result, medical standards are a core component of facial mask production as Cicabel is using biomedical technologies to launch new innovations.

Medical skin care move

In recent years, consumers have sought high-tech skin care therapies with high-achieving performance. To combine both medical and beauty developments, Cicabelssoon-to-be-launched mask concentrates on skin care and rejuvenation using advanced technologies.

The brands facial mask contains purified ingredients that provide energy to the skin stem cells. These selected elements also protect and activate the cells and promote the proliferation of skin epidermal cells and the anagenesis of skin fibrosis, the company stated in a recent press release.

As facial rejuvenation becomes a key interest in skin care, the brand hopes that its proprietary technologies can propel it into high-tech medical skin care.

Made for high-end consumption

As Chinese consumers favour luxury products, the brands first release following the acquisition aims to reach premium product status.

With our strong confidence in high-tech approaches when it comes to improving one's appearance, we decided to take over Cicabel, an executive at Grand Fan Group stated.

Here is the original post:
Chinese hair and personal care distributor acquires Cicabel - CosmeticsDesign-Asia.com

Recommendation and review posted by sam

Cardiac predecessor cells appear to rejuvenate the hearts of older animals, according to a recent study from Cedars-Sinai Heart Institute that may lead to tests in humans.

Signs of rejuvenation in rats included a 20 percent increase in exercise capacity, faster regrowth of hair, and lengthening of the protective caps of chromosomes.

The study used cardiosphere-derived cells, or CDCs, which are like stem cells, but can only develop into heart cells. These cells are already being used in a human clinical trial to repair damage from heart attacks. The trial is being conducted by Beverly Hills-based Capricor in several hospitals, including Scripps La Jolla.

Since these cells have already been found to be safe, it should be fairly straightforward to extend testing from repairing heart damage in people to rejuvenation, said study leader Dr. Eduardo Marbn. Hes director of the Los Angeles Institute, part of Cedars-Sinai Medical Center. Marbn is also a co-founder of Capricor, publicly traded on Nasdaq.

However, a researcher not involved in the study said that while it was well done, the history of stem cell treatments indicates that proving efficacy in people promises to be far more difficult.

The study used cells taken from newborn rats, injected into the hearts of older, senescent rats. It was published Aug. 14 in the European Heart Journal.

The study is exceptional in both its scope and breadth, said Dr. Richard Schatz, a Scripps Clinic cardiologist involved in the Capricor trial at Scripps La Jolla.

It examines an extraordinary number of variables rarely seen in such studies to ask the question of the impact of CDC (specialized stem cells) on cardiac aging in rats, Schatz said by email. Every parameter of how aging might be studied moved in the right direction, meaning there might be a biologic effect of their cells throughout the body.

Schatz cautioned that scientific excellence doesnt equal clinical success.

The technologys muscle-improving effectiveness could also help patients with Duchenne muscular dystrophy, Marbn said. That use is in clinical testing by Capricor. Early results in patients have been promising enough that more studies are planned.

Capricor clinical trial information is available at http://capricor.com/clinical-trials.

Marbn said the study adds to growing evidence that progenitor cells exert their healing power by secreting chemicals that stimulate repair, not by permanently incorporating themselves into the body. The chemicals are enclosed in tiny vesicles called exosomes that the cells shed.

Until fairly recently, exosomes were dismissed as cellular debris, but are now being appreciated for their role in cell signaling, Marbn said.

There's a staggering number, something like 100 billion to a trillion exosomes per drop of blood, per drop of cerebrospinal fluid, Marbn said. They are plentiful in breast milk. The only thing we know right now is that there is a complex signaling system.

These exosomes travel far beyond the heart to reach skeletal muscle, which is weakened in Duchenne muscular dystrophy, he said.

Schatz said the study provides evidence that the cells exert many different effects beyond those in a single target organ, through the exosomes, seen in humans as well.

This is very good news if you are a rat, but the obvious limitation is how will this play out in humans, Schatz said.

Previous clinical trials of stem cells have been successful in Phase 1 and 2, Schatz said, but fail in Phase 3. So the researchers face a daunting road ahead to demonstrate usefulness in people.

This does not take away from the brilliant science behind this exceptional group of investigators, Schatz said. They should be congratulated for a very thoughtful and expansive look at a fascinating subject, the clinical relevance of which remains to be seen.

The rejuvenation effects to some degree resemble cells created when adult cells are reprogrammed back to being stem cells, Marbn said.

Certain factors are turned on that regress the cells to act like embryonic stem cells. These are called induced pluripotent stem cells, because they can become nearly any cell in the body, a property called pluripotency.

Something like this might be happening through exosome-mediated reprogramming.

We have a suspicion that even though we didn't go about trying to activate those factors, some of them may in fact be turned on by the therapy, Marbn said.

Understanding precisely what is going on will take much more work to sort out, he said. For example, lengthening the protective caps of chromosomes, or telomeres, is presumably caused by production of telomerase, an enzyme that makes them longer. But how?

Knowing the exosomes are involved doesnt narrow it down very much, he said.

We think that there's thousands and thousands of different bioactive molecules within exosomes. And so I can't right now point to, let's say, these five RNAs and say, they're the ones that we think are doing the trick, Marbn said. But somewhere in the genetic instructions in the exosomes are signals that cause telomerase to be activated and elongation of the telomeres.

Even without understanding the precise mechanism, the demonstrated results have been promising enough for Capricor to continue clinical testing in Duchenne muscular dystrophy, Marbn said, even though its outside the companys initial focus on heart disease.

The heart attack research gave mixed messages, he said. Capricor isnt abandoning it, but has given priority to the muscular dystrophy program.

Duchenne muscular dystrophy patients and their parents are more interested in increasing skeletal muscle function than heart function, he said. The disease virtually exclusively affects males, and they often die when quite young.

Go here to read the rest:
Young cardiac cells rejuvenate hearts, in animal study - The San Diego Union-Tribune

Recommendation and review posted by simmons

SPECIAL ADVERTISING REPORT

HOWEVER, THERE ARE OTHER components of KentuckyOne Health Heart and Vascular Care that make it the critical statewide resource it is today. Research, community outreach and support of advocacy organizations are all important aspects of our mission to be the states leader in cardiovascular care.

Innovative Care

KentuckyOne provides patients with a full spectrum of cardiovascular care, with treatments for common problems as well as complex cardiovascular conditions. Our surgeons, nursing staff and other health care professionals utilize the latest diagnostic and therapeutic techniques to treat any type of patient with any type of condition.

Whether youre in need of heart attack care; heart rhythm care for cardiac arrhythmia; transplant (Louisville only) or mechanical device care for advanced heart failure; minimally invasive treatment for a disease like aortic stenosis or mitral regurgitation; vascular care for an aneurysm or artery disease; cardiac rehabilitation at one of our Healthy Lifestyle Centers; or some other type of heart and vascular service, KentuckyOne Health is the place to go.

Having access to the best equipment and newest treatments is only part of the equation, said Nezar Falluji, MD, MPH, interventional cardiologist with KentuckyOne Health Cardiology Associates and director of cardiovascular services for the KentuckyOne Health Lexington market at Saint Joseph Hospital. The teamwork and collaboration between cardiologists, cardiovascular surgeons, anesthesiologists, nurses and other staff and physicians is what sets us apart.

Groundbreaking Research

Through a partnership with the University of Louisville and its physicians, KentuckyOne Health, and specifically Jewish Hospital and University of Louisville Hospital, is the site for groundbreaking research across many disciplines. Jewish Hospital is the primary site in Louisville for cardiovascular research.

The University of Louisville offers access to academic research and innovation that may be effectively applied in clinical settings, said Mark Slaughter, MD, professor and chair of the Department of Cardiovascular and Thoracic Surgery at the University of Louisville and executive director of cardiovascular services for the KentuckyOne Health Louisville market. Through this research component, Jewish Hospital, the University of Louisville and KentuckyOne Health are leading the way in developing next-generation cardiovascular therapies.

Roberto Bolli, MD, chief of the Division of Cardiovascular Medicine at the University of Louisville, is a renowned researcher whose stem cell therapy work has garnered worldwide attention.

Dr. Bolli has become a world leader in using patients own stem cells, growing them in tissue culture and then infusing them back into the injured heart, as a way to repopulate the heart with cardiac cells that will grow and heal. He is doing truly leading-edge cardiac stem cell work right here in Kentucky.

Many of the vascular diseases are silent and often go unnoticed until they eventually lead to major problems, said Stephen Self, MD, vascular surgeon at KentuckyOne Health Vascular Surgery Associates. Its crucial that people are aware of the risk factors and become proactive about their health.

Knowing the Risk Factors

Despite the sly nature of many vascular diseases, there are some controllable and uncontrollable risk factors you should know about, including:

Age People 50 and older are at greatest risk.

Smoking Smoke inhalation increases vascular damage.

Lack of exercise Contributes to fat storage, muscle loss and low energy.

Obesity A common sign of poor vascular health

Unhealthy diet Poor diets can increase bad cholesterol levels and high blood pressure.

Genetics Your family medical history can help define your risk.

Protecting Yourself

I recommend people with increased risk of vascular disease, such as those who smoke or have high blood pressure or high cholesterol, and anyone over the age of 50, get vascular screenings, said Steve Lin, MD, who specializes in vein care at KentuckyOne Health Cardiology Associates. They are completely painless, inexpensive and can ultimately save your life.

See original here:
Providing Leading-edge Cardiovascular Care - The Lane Report

Recommendation and review posted by Bethany Smith

The U.S. Food and Drug Administration on Monday announced a crackdown on deceptive and dangerous stem cell clinics, starting with actions against a California company accused of giving smallpox vaccine to cancer patients, and a Florida company that ruined the eyesight of three women.

Our actions today should also be a warning to others who may be doing similar harm, FDA Commissioner Scott Gottlieb said in a statement, urging consumers and health-care providers to report rogue clinics and injuries.

FDA Commissioner Scott Gottlieb

The California company, San Diego-based StemImmune Inc., was combining the vaccine with stem cells derived from fat, then giving it intravenously or injecting it into tumors of cancer patients at clinics in Rancho Mirage and Beverly Hills, Calif., the FDA said.

U.S. marshals on Friday seized five vials of smallpox vaccine, including one that was partially used. The agency is investigating how the company obtained the vaccine, which has been stockpiled by the government in case of a bioterrorist attack.

The vaccine is made with live vaccinia virus, a poxvirus similar to but less harmful than smallpox. The vaccine could cause life-threatening problems in immune-compromised cancer patients, and alsoin certain unvaccinated people who might be accidentally infected by the patients, the FDA explained.

Speaking as a cancer survivor, Gottlieb said in a statement, I know all too well the fear and anxiety the diagnosis of cancer can have and how tempting it can be to believe the hollow claims made by these kinds of unscrupulous clinics. The FDA will not allow deceitful actors to take advantage of vulnerable patients.

In a separate enforcement action, the FDA sent a warning letter last week to U.S. Stem Cell Clinic of Sunrise, Fla., saying it could face product seizure or an injunction. Agency inspectors found that the clinic was processing fat-derived stem cells and claiming to treat a raft of conditions, including Parkinsons disease, amyotrophic lateral sclerosis (ALS), rheumatoid arthritis, diabetes, and heart failure.

In March, U.S. Stem Cell made headlines when an article in the New England Journal of Medicine reported that three women with age-related macular degeneration suffered severe and permanent vision damage one was blinded after stem cells were injected into their eyeballs at the clinic. The article was written by doctors unconnected with the clinic who treated the women for the disastrous results.

Critics of unapproved stem cell treatments have called for tougher oversight by the FDA, as well as by the Federal Trade Commission, which regulates advertising, and by state medical boards, which oversee the practice of medicine.

The regulatory moves come as so-called regenerative medicine is exploding, spawning an industry built on unproven treatments using stem cells from bone marrow or fat. In recent months, networks of chiropractors have run big-budget ads for such treatments in newspaper across the country, including the Inquirer. Those ads, however, focus on addressing orthopedic problems such as degenerative discs and arthriticknees.

The only FDA-approved stem cell therapies involve using cells from bone marrow or umbilical cord blood to treat blood cancers and certain immune disorders. In general, biologic tissues that are processed and marketed as therapies are supposed to go through the FDAs drug approval process, which involves years of costly clinical testing in humans.

However, the FDA has tried to find a middle ground, recognizing the potential promise of stem cells in tissue repair and regeneration. The FDA has published, but has not finalized, draft guidance for stem cell products, saying they can be exempted from the drug approval process under certain scenarios. Among other criteria, the cells must be minimally manipulated and used in a homologous way, meaning for the same function they perform naturally in the body.

In a policy statement issued Monday, Gottlieb promised that this fall, the agency will advance a comprehensive policy framework that will more clearly describe the rules of the road for this new field. It will enable responsible product developers to gain FDAapproval with minimal burdens and costs.

We want to facilitate innovation, he wrote.

Published: August 28, 2017 4:42 PM EDT

We recently asked you to support our journalism. The response, in a word, is heartening. You have encouraged us in our mission to provide quality news and watchdog journalism. Some of you have even followed through with subscriptions, which is especially gratifying. Our role as an independent, fact-based news organization has never been clearer. And our promise to you is that we will always strive to provide indispensable journalism to our community. Subscriptions are available for home delivery of the print edition and for a digital replica viewable on your mobile device or computer. Subscriptions start as low as 25 per day.We're thankful for your support in every way.

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FDA moves to curb dangerous stem cell clinics - Philly.com

Recommendation and review posted by sam

RENTON Turns out, Doug Baldwin started this current Seahawks fad of traveling outside the teams normal medical coverage to get far-flung treatment using body cells.

The Seahawks No. 1 wide receiver told me Monday he went overseas before this season -- to England, to be exact -- for pre-emptive, preventative treatment to maintain healthy knees.

I had mine in the offseason. I did stem-cell, Baldwin said, drenched in sweat in the hallway outside the teams locker room just after completing Mondays practice.

I mean, I dont have any ailments. Im trying to find every edge I can get.

Baldwin, Seattles $46 million receiver, tied Bobby Engrams 2007 franchise record with 94 receptions last season. He earned his first Pro Bowl selection. In 2015, the season that led to his contract extension, he co-led the NFL with 14 touchdown catches.

He said hed been looking into stem-cell therapy for years.

Transplanting or using bone marrow is the most widely used stem-cell therapy to treat or prevent a condition or disease. The U.S. Food and Drug Administration further explains stem cells may also help repair the body by dividing to replenish cells that are damaged by disease, injury, or normal wear.

So why London for Baldwin?

The FDA, as stated on its website, has not approved any stem cell-based products for use in this country other than using human umbilical cord blood forming stem cells for certain diseases.

There was a company wed be speaking to, Baldwin said of the London place he got treatment, without wanting to disclose many details. Did my research. Took my two years to finally decide.

In the last two weeks, seven Seahawks have gone away and outside the teams regular medical treatment to get a debated blood-re-injection process called regenokine to treat aching joints and/or aid in recovery from surgery. The treatment was founded in Germany, where its known as orthokine.

K.J. Wright returned last week from regenokine treatment, the re-injection of ones blood after it is heated and spun in a centrifuge to enhance its anti-inflammatory properties. The Pro Bowl outside linebacker played in Seattles exhibition last Friday against Kansas City.

D.J. Alexander the Pro Bowl special-teams player the Seahawks acquired this summer in a trade with Kansas City, went for regenokine treatment last week.

On Monday, coach Pete Carroll said wide receiver and kick returner Tyler Lockett, Pro Bowl defensive ends Michael Bennett and Cliff Avril, starting left guard Luke Joeckel and starting outside linebacker Michael Wilhoite are away from the team getting the same treatment Wright and Alexander had. Carroll said the team expects all those players to be ready for the opening game Sept. 10 at Green Bay.

That process reportedly costs $10,000. That doesnt count the travel and hotel costs of flying to get the therapy, of course. The FDA has yet to approve regenokine for use in the U.S., largely because its still unproven and reportedly because the agency has issues with the heating of the blood.

That is probably why Carroll said this on Thursday: Ive never had the OK that I can talk about it; I dont even know if I can talk about it. I was always afraid I wouldnt pronounce it right. But what I know its called is regenokine.

Dr. Peter Wehling in Germany, the man who founded the procedure known there as orthokine, was said in 2013 to have treated 30 to 40 NFL players with it. At that time the treatment process took four days, which could explain why Wright and his Seahawks successor have been missing a week of practices and games this month for it.

LifeSpan Medicine, clinic in Santa Monica, California, with offices also in New York and Dallas, lists regenokine as one the regenerative therapies it practices -- again, without FDA approval for use in this country.

Carroll said this on Monday:

Baldwin turns 29 next month. The opening at the Packers will begin the second season of the four-year, $46 million extension he signed in the summer of 2016. He looked ready for the 2017 season in Seattles most recent preseason game, Friday against Kansas City. He had two catches for 45 yards in 2 1/2 quarters, racing across the field and away from Chiefs defenders.

Hes only missed two games in his six-year career. Those absences were in his second season, 2012, after Seattle signed him as one of the leagues most successful undrafted free agents of the last decade.

Now, hes one of the trend-setters among eight Seahawks whove received alternative therapy.

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Why Doug Baldwin went to England for stem-cell therapy - The News Tribune (blog)

Recommendation and review posted by Bethany Smith

Dr. Khan from Wasatch Pain Solutions gave us insight to Regenexx, the world's most advanced stem cell and blood platelet procedures.

On what makesRegenexx treatments better than any other, Dr. Khan explained that a network of doctors and researchers have performed more stem cell related procedures than any other group in the United States; over 51,000 procedures. Which he says has lead them to producing over 50% of all available orthopedic stem cell research in the world.

Dr. Khan explained they only use a persons own living stem cells from their bone marrow along with their own blood platelets during their patented 3-step process. Studies show that bone marrow stem cells are vastly superior for orthopedic applications like helping to regenerate cartilage and heal tissue damage. The outcome that their process produces can help patients avoid surgery and maintain a very active lifestyle without severe pain.

For more information visit wasatchpainsolutions.com or call (801) 302-2690.

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How your own stem cells could relieve your chronic pain - Good4Utah

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Multiple sclerosis sufferer Roy Palmer is about to embark on the next phase of his pioneering treatment.

But it comes with risks he is prepared to take in the hope it will cure the debilitating condition.

The 43-year-old father of two from Quedgeley is determined it will work. He was diagnosed with relapsing remitting MS but now has the secondary progressive form of the disease, which means it gets steadily worse.

He said: I fought for a year to get hematopoietic stem cell transplantation and many people told me I didnt fit the criteria but I didnt let that stop me.

Mr Palmer had a week of injections to draw the stem cells from his bone marrow.

He and his wife Helen travelled to Hammersmith Hospital in London where he was given a day of chemotherapy.

Mr Palmer lost his hair as a result and was left feeling sick and tired.

The stem cells have been frozen and will be reintroduced to his body after another aggressive course of chemotherapy.

It will be fed directly into a main artery in his chest before Mr Palmer spends the next four weeks in isolation.

He will start the treatment on September 18 his 24th wedding anniversary.

Mr Palmer said: Im not someone to sit around and feel sorry for myself.

If the treatment works then, oh my God, I couldnt begin to describe what it would mean to me.

He added: To be able to walk out of my front door would mean the world.

I know Im lucky to be able to get the treatment. Im worried, my immune system will be obliterated, but I have to give this everything. Im a fighter and determined to make this work.

Mr Palmers family back his decision to undergo HSCT treatment, although they worry about the effect it will have.

His 45-year-old wife said: When they give the chemotherapy it brings the body back down to zero.

It will stop any immune system and take some time for the body to start getting back to normal.

When Roys levels are up they will start to reintroduce the stem cells.

The MS Society website says HSCT aims to reset the immune system to stop it attacking the central nervous system.

It uses chemotherapy to remove the harmful immune cells and then rebuilds the immune system using haematopoietic stem cells found in bone marrow.

They can produce all the different cells in the blood.

Mrs Palmer said: Im happy for Roy to take that risk and to support him but it is a lethal dose of chemo.

The treatment can be done abroad and costs around 60,000. In the past we were considering that option but there is no aftercare.

The couples daughter Abi, 12, said: I feel a little scared for dad but okay. I cant remember him walking.

And 20-year-old son Jack said: Dad has been in a chair for about 10 years and to see him walk again would mean everything.

Just standing next to each other would mean the world.

Once the stem cells are back in Mr Palmers body the hope is he will make a full recovery and be free of MS,

He said: It will be great to not have to ask people to do things for me.

I do what I can but I dont like to hang around waiting.

I want people to know there is treatment and it can be a fight but Ive got to do this now.

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MS sufferer gets pioneering stem cell treatment - Gloucestershire Live

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When an experiment turns into a tradition in Laughlin, it means there was a show worth taking a chance on at one timethen consistently that same show proved itself time after time to be one audiences didnt want to miss. The Memorial Day Comedy Festival at the Riverside Resort was that show. Experiencing comedy served up as a variety show with veteran comedian Gabe Lopez as the shows producer, performer and emcee was like discovering a hidden gem on the entertainment landscapemore along the lines of one of those underground clubs in Vegas, known only to a lucky few. But now the word is out and the Comedy Festival is coming back to the Riverside Resort over the Labor Day weekend this time.

If you are a local, or a regular visitor to Laughlinespecially if your visits are on holiday weekendsyou are aware that the Avi Resort & Casino doesnt simply wait for the Fourth of July to set off a major fireworks display. Nope. Beginning in 1996, and continuing every year since, they have been filling the skies above the Colorado River with the amped-up creations of Zambelli Internationale Fireworks on Memorial Day weekend, the Fourth of July and Labor Day weekend.

The Colorado Belle is home to a multitude of outdoor festivals that embrace particular themes and for the Labor Day Riverwalk Festival, its a celebration of the end of summer and the cooler temperatures just starting to take hold of the Colorado River regionthink of it as one big neighborhood block party.

Theres a lot to be said for being in the right place at the right time, but could Air Supplys long-time success be the result or a chance meeting or was the cosmos working overtime on a little something called destiny? Maybe, but one thing is for surenone of it would have been possible at all without their hard work and tenacity to make it happen.The two Russells, Graham Russell and Russell Hitchcock, happened to be cast in the same Sydney, Australian production of Jesus Christ Superstar in 1975, and everything changed after that.

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Kamagra gold 100mg review - Laughlin Entertainer

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I dont remember the exact moment I found out my dad had Huntingtons disease, or how I found out it was genetic. What I do remember is showing off, in high school biology, that I knew the Huntington's gene was dominant in males. My reasoning was that my dad, his dad, and his granddad all had Huntingtons. I knew my two sisters and I still had a chance at getting it, but it wasnt as likely. This, of course, is not true.

Looking back, I clearly wanted to believe it was more common in men. I used that explanation as a coping mechanism to deal with the fact that, as a 14-year-old, not only was my dad dying, but he was dying from something my sisters and I might die from, too.

For those of you who dont know what Huntingtons disease is, its a fatal genetic disorder that causes the progressive breakdown of nerve cells in the brain," according to the Huntingtons Disease Society of America (HDSA). "It deteriorates a person's physical and mental abilities during their prime working years and has no cure." The HDSA Web site even notes that many describe the symptoms as a combination of having Parkinsons, Alzheimers and ALS all at once. Those symptoms can include mood swings, depression, and personality changes; slurred speech; the inability to think clearly; involuntary movements called chorea; and eventually the inability to walk, talk, and swallow.

The typical HD patient begins showing symptoms between the ages of 30 to 50, according to the HDSA, which worsen over a 10- to 25-year span. My dad was diagnosed in his forties and passed away two days before his 58th birthday. People with Huntingtons often die from infections, aspiration pneumonia, or even complications from falling. My dads cause of death was cardiorespiratory failure, brought on by all the health issues surrounding his disease.

Although there are only about 30,000 symptomatic Americans currently living with HD, there are more than 200,000 who are at risk. To me, this at-risk reality is like being forced to live in no mans land. The whole 50/50 thing is so definitely not definite. Its unsettling knowing what my exact odds are and that they dont lean one way or another. The odds arent against me, but they arent in my favor either.

The uncertainty can be put to rest by a not-so-simple genetic test. Jill Goldman, genetic counselor at the Taub Institute at Columbia University Medical Center, tells SELF that there is an international protocol which includes a DNA component that can reveal whether an individual will develop the disease. First, the person at risk will call an HD or movement disorder clinic to get information such as what the protocol entails, what the risks are, and what it costs.

Next comes a meeting with a genetic counselor who further educates the individual on the genetics of the disease and provides guidance on the potential impact of dealing with the DNA result. Its having the person think about everything that theyre going to have to deal with after getting the test results, says Goldman. Talking about what they would do with a positive result, could they cope with that? What about a negative result, because for some people that can be just as devastating.

If the person wishes to continue, he or she often moves on to a psychiatrist for an evaluation. Here they will explore different coping mechanisms and ways to handle the diagnosis. Theyre also going to explore if the person is coming in with anxiety or depression," says Goldman. If there are any concerns or a person isn't psychologically prepared for what lies ahead, then therapy will be recommended.

The last step in the protocol is the actual neurological exam and the DNA test. Here, the at-risk person usually has a choice about whether they want to hear what the neurologist finds or not, explains Goldman. It's obviously an extremely personal decision to do this. Less than 20 percent of people at risk come for testing, and many of them will actually stop the process, she says. Even after having their blood drawn, there are people who dont come for their results.

I thought there was no way I could live without knowing. I figured if I tested negative, it would lift this huge weight off my shoulders. If I tested positive, at least I could deal with it head on.

I have since grown out of this mentality and decided its best I dont 100 percent know what my fate with HD is. It wasnt until I was 17 or 18 years old that I realized I didnt actually want to know my results. If Im being honest with myself, its probably because I got scared. The idea of feeling mortal at a time in your life when youre supposed to feel invincible was way too frightening for my mind to grasp at the time. It still is at age 24. I already lost a lot of my youth through a divorce and a sick parent. I didnt need to push myself into another form of maturity over another life issue most people dont have to deal with until theyve lived another 50 years or more.

To me, not knowing seems like my best option if I want to live a normal life. Most people dont know what health issues theyll have to deal with in the future; why would I need to know? If I decide to start a family, Ill probably get tested. But until then, Id rather live with my 50/50 chance.

Even though I dont want to know my results, I still accept and recognize that HD is a part of my life. Huntingtons tends to be one of those diseases that some people choose to ignore or keep a secret, which I get; HD is a daunting reality and people should handle it however they feel is safest and healthiest for them. For me, I have found it best to fully embrace my at-risk status. By acknowledging and owning it, I feel I am able to gain more control in an uncontrollable situation. By sharing my status and having HD in my life now, it wont be as earth-shattering if it comes later. By being up front, I am able to (somewhat) avoid pity. Its hard to pity someone who isnt hiding or ashamed.

Most importantly, sharing my reality helps spread awareness of the disease. Whether Im writing about it to a wide audience like this or sharing my story with friends who share it with more friends, I truly believe that its through awareness that we will bring an end to this disease.

Theres no one clear way I can describe how it feels to have a 50/50 chance of Huntingtons. Honesty, it depends on if Im having a glass-half-full or glass-half-empty kind of a day. Sometimes I feel jealous that other people dont have to deal with a life-changing decision, other times I feel grateful for how its motivated and shaped me as a person. My feelings are full of these types of contradictories thanks to the uncertainty a 50/50 chance like mine leaves you with.

Overall, though, I feel sad. Even though Ive come to terms with my 50/50 reality, I still feel sad picturing my life coming to end because of HD. I dont mean a dying end eitherwere all going to die. I mean the life that I know as a loving friend, partner, daughter, and writer ending. Because inevitably, if I do have HD, thats the reality I face. And since this reality is the only experience Ive had with HD, its hard for me to imagine living on the right half of 50 percent.

Related:

You May Also Like: I Have a Pre-Existing Condition: Real People Share Their Health Conditions

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I Have a 50/50 Chance of Developing Huntington's Disease - SELF

Recommendation and review posted by sam

The dead bodies of cryogenically frozen people and pets, DNA samples, and even organs, such as brains, might soon be sent to space. Russia's first and only cryonics company,KrioRus, announced an agreement with Space Technologies, a new science and tech consortium.

Satellites with cryo-capsules will be launched into orbit by Russian rockets, said Yulia Arkhipova, general director ofSpace Technologies.

Cryogenics facilities exist only in the U.S. and Russia. Since 2005,KrioRushas frozen the bodies and brains of 54 people, eight dogs, nine cats,three birds, and even one pet chinchilla. According to the company, many frozen individuals once had the aspiration to go to space.

Arkhipova didnt provide details on whether her company has partnerships with established Russian space organizations. Space Technologies was registered in 2016 and it doesnt have its own rocket fleet or launch vehicles. The company hasnt yet implemented a single space project but already announced ambitious plans, such as the creation ofRussia'sfirst private cosmodrome and a new orbital station,MIR-2.

The cryo-capsules wont be just hanging about in orbit, Arkipova promised. The company is planning to develop satellites for in-orbit repairs but, once again, Arkhipova didnt provide any details. The leading Russian space companies are developing these satellites, the technologies are unique and its classified information, Arkipova said.

The names of these leading space companies are classified, as well as the names of the organization's founders. Space Technologies declined to respond to these questions.

Freezing bodies and cryogenic experiments might be necessary for the future development of space travel to distant planets or galaxies.

Cryogenic freezing is the process of preserving a dead body with liquid nitrogen. Currently, it can only happen at the moment when someone has just been declared dead. The freezing process must begin as soon as the patient dies in order to preventbraindamage.

First, the body is cooled in an ice bath to gradually reduce its temperature, and then doctors drain the blood and replace it with an anti-freeze fluid to stop harmful ice crystals forming.

People who make the decision to freeze their bodies believe scientists will one day in the future figure out how to warm up the body and bring them back to life. Hopefully by that time doctors will be able to cure cancer and other illness.

According to KrioRus, the cost of preserving a body in space starts from $250,000. Space Technologies didnt clarify the costs of launching a body into orbit.

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Blast off into eternity: Russian company to send the dead into space - Russia Beyond the Headlines

Recommendation and review posted by simmons

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Life Extension Archives - NutraPlanet

Recommendation and review posted by simmons