Mitalipov successfully repairs genes in human embryos

A ground breaking discovery by Shoukhrat Mitalipov, Ph.D.,was reported in Nature the successful removal of a lethal geneticdefect in human embryos. The breakthrough is the initial confirmation that adangerous genetic defect can in theory be erased.

Scientific success in embryo editing re-opens reg debate. BioWorld

Study in Nature demonstrates method for repairing genes in human embryos that prevents inherited diseases. OHSU News

Gene Editing Breakthrough. Charlie Rose Show

A Promising And Still Uncertain Future For Human Gene Editing. Science Friday

In Breakthrough, Scientists Edit a Dangerous Mutation From Genes in Human Embryos. NY Times

First human embryo editing experiment in U.S.'corrects' gene for heart condition. The Washington Post.

Scientists Precisely Edit DNA In Human Embryos To Fix A Disease Gene. NPR

Human embryos edited to stop disease. BBC

A Gene Editing Breakthrough. On Point with Tom Ashbrook.

First U.S.-based group to edit human embryos brings practice closer to clinic. Science

In breakthrough, OHSU corrects defective gene in embryo. Oregonlive.

First Safe Repair of Gene in Human Embryos. Associated Press.

A new discovery may unlock the answer to a vexing scientificquestion: How to conduct mitochondrial replacement therapy, a new gene-therapytechnique, in such a way that safely prevents the transmission of harmful mitochondrialgene mutations from mothers to their children.

For women with mitochondrial diseases, a step closer to preventing transmission. STAT

Human embryo experiment shows progress toward 'three-parent' babies. The Washington Post

Families struggling with infertility or a genetic predisposition for debilitating mitochondrial diseases may someday benefit from a new breakthrough led by scientists at OHSU and the Salk Institute for Biological Studies.

Egg 'nobbles' can be used to create embryos, say scientists in fertility breakthrough

Fertility success may get boost from new research

First he pioneered a new way of making life. Now he wants to try it in people

Shoukhrat Mitalipov: The cloning chief.

Researchers announced they had derived stem cells fromcloned human embryos, a long-awaited research coup that Science's editors choseas a runner-up for Breakthrough of the Year.Read the article on Science

#4. Finally, We're Just Like Dolly

#5. Functioning Organs Made From Stem Cells

#2. Human embryonic stem cells cloned

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Center for Embryonic Cell and Gene Therapy | Center for ...

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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.

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Young cardiac cells rejuvenate heart in animal study - The San Diego Union-Tribune

The U.S. Food and Drug Administration announced a crackdown on stem-cell clinics marketing and selling unapproved and potentially harmful therapies for cancer and other diseases.

The agency took action against two large clinics in Florida and California, which have started selling treatments that the agency says use stem cells but have not been approved as safe and effective by the FDA.

"A small number unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products," FDA Commissioner Scott Gottlieb, M.D., said in a statement.

The FDA issued a warning letterto US Stem Cell Clinic of Sunrise, Florida, after an inspection in which the agency found that the clinic was processing body fat into stem cells and administering the product both intravenously or directly into the spinal cord of patients with Parkinson's disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease and pulmonary fibrosis.

"The FDA has not reviewed or approved any biological products manufactured by US Stem Cell Clinic for any use," the agency said in a statement.

During the inspection, investigators also reported the clinic deviated from guidelines put in place to prevent microbiological contamination, which puts patients at risk for infections, the agency said.

Also this week, the FDA seized five vials of a smallpox vaccinefrom StemImmune Inc. in San Diego, California, which the agency said was used to create an unapproved treatment of stem cells and excess amounts of the vaccine, which was then administered to cancer patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California.

The FDA says this treatment put patients at risk for potential harms including inflammation and swelling of the heart and surrounding tissues.

The agency said it will investigate how StemImmune Inc. obtained the vials of the vaccine, which each contained 100 doses. The vaccine is not commercially available and is reserved only for people considered at high risk for smallpox, such as some members of the military. One vial was partially used, while four of the vials were still intact, the FDA reports.

"I've directed the agency to vigorously investigate these kinds of unscrupulous clinics using the full range of our tools, be it regulatory enforcement or criminal investigations. Our actions today should also be a warning to others who may be doing similar harm, we will take action to ensure Americans are not put at unnecessary risk," Gottlieb said.

In response, Dr. Mark Berman, co-founder of the California Stem Cell Treatment Centers, told the Los Angeles Times that the comments from the FDA are "disparaging and misrepresentative," and said they showed "a lack of understanding" of surgical procedures in which patients' own stem cells are used to promote regeneration.

Berman, who is also director of stem cell implantation at StemImmune, called the clinic's products "cutting edge cancer therapy" for Stage 4 cancer patients, the Times reports.

US Stem Cell Clinicposted a response to its website, saying, "The safety and health of our patients are our number one priority and the strict standards that we have in place follow the laws of the Food and Drug Administration."

"The FDA has stated that they will have specific stem cell guidelines by the 21st Century Cures Act deadline of December 13, 2017 and we intend to follow those standards as well," the statement continues. "We have helped thousands of patients harness their own healing potential. It would be a mistake to limit these therapies from patients who need them when we are adhering to top industry standards."

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FDA cracks down on clinics selling unapproved stem cell therapies - CBS News

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

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

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.

This story includes sponsored content.

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

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

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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.

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Providing Leading-edge Cardiovascular Care - The Lane Report

Bone marrow contains hematopoetic stem cells, the precursors to every blood cell type. These cells spring into action following bone marrow transplants, bone marrow injury and during systemic infection, creating new blood cells, including immune cells, in a process known as hematopoiesis.

A new study led by University of Pennsylvania and Technical University of Dresden scientists has identified an important regulator of this process, a protein called Del-1. Targeting it, the researchers noted, could be an effective way to improve stem cell transplants for both donors and recipients. There may also be ways to modulate levels of Del-1 in patients with certain blood cancers to enhance immune cell production. The findings are reported this week in The Journal of Clinical Investigation.

Because the hematopoetic stem cell niche is so important for the creation of bone marrow and blood cells and because Del-1 is a soluble protein and is easily manipulated, one can see that it could be a target in many potential applications, said George Hajishengallis, the Thomas W. Evans Centennial Professor in the Department of Microbiology in Penns School of Dental Medicine and a senior author on the work.

I think that Del-1 represents a major regulator of the hematopoetic stem cell niche, said Triantafyllos Chavakis, co-senior author on the study and a professor at the Technical University of Dresden. It will be worthwhile to study its expression in the context of hematopoetic malignancy.

For Hajishengallis, the route to studying Del-1 in the bone marrow began in his field of dental medicine. Working with Chavakis, he had identified Del-1 as a potential drug target for gum disease after finding that it prevents inflammatory cells from moving into the gums.

Both scientists and their labs had discovered that Del-1 was also expressed in the bone marrow and began following up to see what its function was there.

In the beginning, I thought it would have a simple function, like regulating the exit of mature leukocytes [white blood cells] from the marrow into the periphery, Hajishengallis said, something analogous to what it was doing in the gingiva. But it turned out it had a much more important and global role than what I had imagined.

The researchers investigations revealed that Del-1 was expressed by at least three cell types in the bone marrow that support hematopoetic stem cells: endothelial cells, CAR cells and osteoblasts. Using mice deficient in Del-1, they found that the protein promotes proliferation and differentiation of hematopoetic stem cells, sending more of these progenitor cells down a path toward becoming myeloid cells, such as macrophages and neutrophils, rather than lymphocytes, such as T cells and B cells.

In bone marrow transplant experiments, the team discovered that the presence of Del-1 in recipient bone marrow is required for the transplanted stem cells to engraft in the recipient and to facilitate the process of myelopoesis, the production of myeloid cells.

When the researchers mimicked a systemic infection in mice, animals deficient in Del-1 were slower to begin making myeloid cells again compared to those with normal Del-1 levels.

We saw roles for Del-1 in both steady state and emergency conditions, Hajishengallis said.

Hajishengallis, Chavakis and their colleagues identified the protein on hematopoetic stem cells with which Del-1 interacts, the 3 integrin, perhaps pointing to a target for therapeutic interventions down the line.

The scientists see potential applications in bone marrow and stem cell transplants, for both donors and recipients. In donors, blocking the interaction between Del-1 and hematopoetic stem cells could enhance the mobilization of those progenitors into the bloodstream. This could be helpful for increasing donor cell numbers for transplantation. Transplant recipients, on the other hand, may need enhanced Del-1 interaction to ensure the transplanted cells engraft and begin making new blood cells more rapidly.

In addition, people undergoing chemotherapy who develop febrile neutropenia, associated with low levels of white blood cells, might benefit from the role of Del-1 in supporting the production of immune-related blood cells such as neutrophils.

Its easy to think of practical applications for these findings, said Hajishengallis. Now we need to find out whether it works in practice, so our studies continue.

Ioannis Mitroulis, Lan-Sun Chen and Rashim Pal Singh of TU-Dresden were co-lead authors on the study, and Ben Wielockx of TU-Dresden was a co-senior author along with Hajishengallis and Chavakis. They were joined by coauthors Tetsuhiro Kajikawa, Kavita Hosur, Tomoki Maekawa and Baomei Wang of Penn Dental Medicine; Ioannis Kourtzelis, Matina Economopoulou, Maria Troullinaki, Athanasios Ziogas, Klara Ruppova, Pallavi Subramanian, Panayotis Verginis, Malte Wobus, Martin Bornhuser and Tatyana Grinenko of TU-Dresden; Torsten Tonn of the German Red Cross Blood Donation Service in Dresden; and Marianna Di Scala and Andrs Hidalgo of the Spanish National Center for Cardiovascular Research.

The study was supported by the Deutsche Forschungsgemeinschaft, European Commission, European Research Council and National Institutes of Health (grants AI068730, DE024153, DE024716, DE0152 54 and DE026152).

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Bone Marrow Protein May Be Target for Improving Stem Cell Transplants - Penn: Office of University Communications

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

Researchers are looking for ways eliminate the need for bone marrow donors altogether and instead use different types of cells derived from the patient in need of a transplant, says Dr Vladislav Sandler.

At the moment, people who develop leukaemia, lymphoma and otherblood diseases often need to undergo a hematopoietic stem cell transplantation (HSCT). This is because initial treatment of the disease (front-line therapy) often fails and the disease comes back.

Hematopoietic stem cells (HSC) are vital because they constantly regenerate the blood system giving rise (differentiating) into all types of blood cells such as red blood cells, white blood cells and platelets. Sometimes,patients get cells for the HSCT from close relatives (related allogeneic transplantation), who happen to be a match or by using donor data bases that can match them with strangers (unrelated allogeneic transplantation). The patients own HSC are wiped out with chemotherapy and replaced with donated blood-forming steam cells which create healthy new blood cells free from disease.

The patients own HSC are wiped out with chemotherapy and replaced with the donated blood-forming stem cells which createhealthy new blood cellsfree from disease.

Often, there is not a perfect match between a donor and a patient but physicians try and find the closest one possible. When a match is not perfect, a risk of rejection of the newly transplanted cells significantly grows. There are several teams of researchers trying to find a way to eliminate the need for bone marrow donors altogether and instead use different types of cells derived from the patient in need of a transplant.

This work, to directly reprogram the patients own cells to create hematopoietic stem cells, (from which all cellular blood components are derived) has been going on for some time and has had some success[1][2][3]. However, it is a very long and cumbersome process to produce HSC cells from a patients own cells and it looks like this may never be a practicable solution to the problem. We simply cant seem to be able to get the newly formed HSC cells to replicate into the sufficient number of cells needed to form a viable HSCT.

What I discovered when I was at Cornell University was that there is a small subset of postnatal hemogenic endothelial cells (Hu-PHEC) which survive in the liver and blood vessels of the umbilical cord and placenta into adulthood. It has been known for quite a while that in the fetus, similar cells produce first definitive HSC. It was accepted as a dogma that they either lose their ability to do this after birth or simply disappear. However, as it often happens in science, this was not entirely correct. Hu-PHEC can be isolated from postnatal tissues and made to generate HSCde-novo.

In animal experiments, we took purified and stimulated Hu-PHEC and transplanted them into immunocompromised mice.

What we found was that the transplanted cells did engraft and created a healthy new human blood system in the recipient mice. What seemed to happen was that by putting them back into circulation within the body reactivated their ability to produce HSC cells as they doin utero.

We dont yet understand the mechanism but we are working on this and we need to work out a way to get enough cells for human transplantation.

Development of Hu-PHEC technology would create an opportunity to get rid of bone marrow/HSC donations. We would no longer have to go to a donor or a family member, but simply harvest some of these special post-natal hemogenic endothelial cells from the patients own body.

Another area of our research has been to develop a conditioning product which helps eliminate the patients diseased HSC with minimal collateral damage to the rest of the body. At the moment, patients undergo a rather terrible process of preparation for a HSCT. It involves chemotherapy and radiation and can seriously harm various unrelated healthy cells. In some cases, patients do not survive the conditioning process. We have developed a type of immune therapy which is a bi-specific antibody that redirects patients own immune cells to only attack and kill HSC. It leaves other cells alone, so does not damage reproductive system. This should mean that men and women undergoing conditioning in advance of a bone marrow transplantion would not need to undergo fertility saving treatment (no need to freeze sperm or eggs). This bi-specific antibody, which is filed for a world-wide patent, is much less dangerous and detrimental to health than current treatment options. We have proved its effectiveness in animal trials, but we are now hoping to move on to Phase 1 clinical trials within the next two years.

[1]Sandler, V. M. et al. Reprogramming human endothelial cells to hematopoietic cells requires vascular induction. Nature 511, 312-318, doi:10.1038/nature13547 (2014).Validated in: Lis, R. et.al. Conversion of adult endothelium to immunocompetent hematopoietic stem cells. Nature Published online 17 May 2017, doi:10.1038/nature22326 (2017).

[2]Sandler V.M et al.Reprogramming of Embryonic Human Fibroblasts into Fetal Hematopoietic Progenitors by Fusion with Human Fetal Liver CD34+ Cells. PLoS ONE 6(4) 2011.

[3] Pereira C.F. et al. Induction of a hemogenic program in mouse fibroblasts. Cell Stem Cell. 2013 Aug 1;13(2):205-18.

Vladislav Sandler is the co-founder of HemoGenyx LLC, a US preclinical stage biotechnology company launching innovative new treatments for blood diseases using blood-forming (hematopoietic) stem cell transplantation (HSCT) techniques.

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Eliminating the need for bone marrow donors - The Hippocratic Post (blog)

For anyone diagnosed with cancer, Alzheimers or AIDS, perhaps the best hope for finding cures lies in their own bodies more specifically, in the cells traveling through their blood.

Scientists at major universities and pharmaceutical companies need more of those cells to do their cutting-edge medical research, and Folsoms StemExpress is leading the way nationwide. Company CEO Cate Dyer is trying to get out the word to potential donors that their blood is essential to this work.

StemExpress collects blood, bone marrow, plasma or cord blood at its centers and compensates donors for their time and discomfort. Then it processes their samples into a range of products, including many of the cells on your bodys healing team: white blood cells, stem cells, T cells and others that answer the call when the body confronts a disease or disability.

We really want to get out to people in Sacramento and the region that we need diseased donors at our sites, and thats everyone people who have an early-diagnosed cancer, people in treatment, theyre having radiation post-treatment and remission, from everything like AML, leukemia, lymphoma, all of the major cancer space, said Cate Dyer, the companys founder and CEO. But also, we have AIDS projects going on right now where we need AIDS-positive samples.

Its not just cancer or AIDS, though. Some researchers also use cells from the samples to study chronic diseases such as diabetes and high blood pressure or to study illnesses that have no cures such as Alzheimers or Parkinsons.

Researchers can take many paths when studying cells from different people, at different stages of a disease, said Dr. Michael Chez, a pediatric neurologist with Sutter in the Sacramento region. For example, researchers could develop screenings for early detection of a disease or genetic defect, or duplicate defective tissues to see how to repair what went wrong. Their findings might help to develop drugs or chemicals that will help to reverse or change the course of a disease. Already, scientists have begun harvesting stem cells, turning them into specific tissues and using them for replacement or repair.

To help potential donors understand the impact they can have on research, Dyer highlighted the work that StemExpress started doing seven years ago with San Diego-based Sequenom, a life-sciences company that was attempting to develop a less-invasive way to check for genetic defects in fetuses. At the time, doctors were using a needle, pushing through the wall of the abdomen and into the uterus to collect and test elements of the amniotic fluid to assess genetic abnormalities.

It was a procedure that frightened women not only because of concerns about their unborn babies but also because they feared that they might be one of the small percentage of women who suffered a major complication as a result of the amniocentesis.

Sequenom envisioned a test that, by contrast, would simply examine blood drawn from the expectant mother. To develop the test, Sequenoms researchers would have to isolate and study DNA strands for both expectant moms and their fetuses. By studying DNA from thousands of donors, the life sciences company was able to identify DNA mutations, deletions and alterations and develop a way to check for them in the blood rather than in amniotic fluid.

At the time, when I met (Sequenoms senior director of clinical operations) they were sourcing about 25 (blood) samples a week, just to give you a ballpark, Dyer said, and I asked him, Well, how long is it going to take you to meet all the (Food and Drug Administration) requirements needed, sourcing 25 samples a week? And, he was like, Five to six years to get all our projects together.

Dyer made it her priority to significantly speed up that development timeline by delivering 300 samples a week, a feat she said the company accomplished within 90 days. Along the way, Stem Express became the largest global supplier of maternal blood for research purposes.

If it takes six years for them to source all the samples and another year and a half to get that through the FDA, youre looking at an eight-year turnaround just to get that ... to a patient, Dyer said. If we can shorten that, which we did, to almost a year and a half and get that then to the FDA and back out to patients, weve just massively impacted patient health care.

Chez talks regularly with patients or the parents of patients who are impatient for better treatments or cures, he said, but the availability of donor blood, cells and DNA already has sped up the pace of development of new drugs, screenings or treatments, and that pace should continue to improve as the bank of samples grows.

What also excites Chez is that multiple researchers can benefit from the millions of cells extracted from a blood draw from a single patient. Think of what this means, he said, for orphan diseases those conditions that affect fewer than 200,000 U.S. residents, such as Lou Gehrigs, cystic fibrosis or muscular dystrophy. A physician might run into a patient with one of these conditions once every 10 years, he said, but a few people living with these illnesses now have the power to provide cells to foster research around the world.

Experts then can study how a disease manifests at the cellular level, design methods of treatment and test them on human tissue in the lab, Chez said. There may not be enough patients in any one place to design treatment studies, he said, so human tissues can expand statistical ways to study the safety and efficacy of treatments.

One patient could help a disease study in multiple places versus just being limited to one researcher at one university, Chez said. If you have multiple people doing the work, it just amplifies how quickly things get done and the statistical power of that type of research. This is exponentially changing the algorithm of how research will be done in disease.

Dyer said she is often asked: Could giving blood pose a health risk for people struggling with cancer or other diseases? Her answer: It depends on the patient. StemExpress puts each donor through health assessments to determine how much blood they can give. Some patients may only be able to give one tablespoon; others, as much as six tablespoons.

Patients receive $25-$50 for blood draws, fees that are set by an independent review board. The company has collection centers at 2210 E. Bidwell St. in Folsom, another in Arlington, Mass., and is working to open another center in San Diego.

Researchers are typically specific about the kinds of diseased blood they need and even the stage or progression, Dyer said, so StemExpress is working to expand its donor database to ensure it has a variety of the cells needed.

Want to support biomedical research?

StemExpress is seeking people willing to give blood, white blood cells and bone marrow. The company accepts donations from patients who are healthy or those struggling with chronic or terminal illnesses.

The company compensates donors, based on the time they spend and the invasiveness of the procedure. People who give blood receive $25-50, for instance, while marrow donors receive $250.

A review board, independent of StemExpress, sets the payments. To learn more or to make an appointment, visit http://www.stemexpressdonors.com or call 1-877-900-7836.

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Struggling with a chronic or life-threatening illness? Your blood can help research cures - Sacramento Bee

PHOENIX, Aug. 28, 2017 /PRNewswire/ -- Creative Medical Technology Holdings Inc. (OTCQB ticker symbol CELZ) announced today completion of enrollment in the Company's clinical trial assessing safety and efficacy of its CaverstemTM procedure to treat erectile dysfunction in patients who do not respond to currently available treatments.Approximately 30% of the 30,000,000 patients suffering from erectile dysfunction do not respond to drugs like Viagra, Cialis and Levitra, in part due to an underlying degeneration of the biological machinery needed to achieve erections.

"The CaverstemTM procedure, which uses the patient's own bone marrow derived stem cells to induce arterial and venous regeneration, is an outpatient procedure able to be conducted by Urologists in their medical facilities. We are using a patient's own cells and we do not manipulate the stem cells through the use of chemicals, growth factors or expansion and have experienced no procedure-related safety issues," said Dr. Thomas Ichim Co-Founder and Chief Scientific Officer of Creative Medical Technology Holdings, Inc.

The clinical trial covering patients ages 18 to 80 received Institutional Review Board (IRB) approval in December 2016. The trial is sponsored by us based on our patented technology and is conducted by Dr. Jacob Rajfer, Principal Investigator and Los Angeles Biomedical Institute at Harbor UCLA Hospital in Torrance, CA.

"I am pleased with the expedience and efficiency at which enrollment was reached. As someone who regularly sees patients suffering from treatment non-responsive erectile dysfunction, I am excited to see the development of a novel approach to treating this condition using the patient's own natural regenerative processes," said Dr. Alexander Gershman, member of the Company's Scientific Advisory Board and Director of Institute of Advanced Urology at the Cedars-Sinai Medical Tower; Director of Urologic Laparoscopy in the Division of Urology, Harbor-UCLA Medical Center."

"We are very fortunate to work with the expert team at Los Angeles Biomedical Institute - UCLA/Harbor Hospital who have done an outstanding job with subject recruitment, screening, treatment and follow-up.We firmly believe that we are on schedule for commercialization of the Caverstem TM procedure through publication and presentation of trial results, marketing, licensing, training and sales in 2018," said Timothy Warbington, President and CEO of Creative Medical Technology Holdings Inc.

About Creative Medical Technology Holdings

Creative Medical Technology Holdings, Inc. is a clinical stage biotechnology company currently trading on the OTCQB under the ticker symbol CELZ. For further information about the company go to http://www.creativemedicaltechnology.com. For more information on our CaverstemTM procedure please go to http://www.caverstem.com.

Forward-Looking Statements

OTC Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission's website at http://www.sec.gov.

View original content:http://www.prnewswire.com/news-releases/creative-medical-technology-holdings-achieves-100-patient-enrollment-in-caverstemtm-clinical-trial-for-stem-cell-treatment-of-erectile-dysfunction-300509805.html

SOURCE Creative Medical Technology Holdings, Inc.

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Creative Medical Technology Holdings Achieves 100% Patient Enrollment in CaverstemTM Clinical Trial for Stem Cell ... - Markets Insider

A human stem cell replicating itself.

Hal X. Nguyen and Aileen J. Anderson

But when it comes to spinal cord injuries, the healing process goes awry.

Immune cells rush in and cause a scar that blocks the ability of neurons to regrow and reconnect. However, recent studies have shown that the immune system can also aid regeneration.

The immune system has both positive and a negative impact what it does is really context specific, says Jan Kaslin, who studies neural regeneration in zebrafish at the Australian Regenerative Institute of Medicine in Melbourne, Australia.

Stem cells provide a great hope for damaged spinal cords and brain injury but it has not been clear on how the immune system may affect the regrowth.

Now a new study has taken a look at how stem cells and the immune system interact in the repair of the spinal cord. Led by Aileen Anderson from the University of California, Riverside and published in the Journal of Neuroscience, the study suggests that whether or not the immune system hinders or helps transplanted stem cells to regrow lost tissue may be influenced by the presence of certain kinds of immune cells.

The study used stem cells derived from human foetal brain tissue and transplanted them into mice with a wound in their spinal cord. They then blocked the invasion of a specific population of immune cells called neutrophils and observed how well the wound was repaired by transplanted the stem cells.

In contrast to earlier research, Andersons team found with that with neutrophils out of the way the wound healed more easily, requiring few stem cells.

This is the first data to show that the immune environment can be altered to allow stem cell populations to perform better in terms of restoring function, according to Anderson.

Can other immune cells be manipulated to increase the effectiveness of stem cell transplantation in spinal cord regeneration?

These findings are an important of piece of the puzzle, says Kaslin, that may significantly improve future stem cell transplantation approaches.

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Immune cells may prevent stem cell growth in spinal cord repair - Cosmos

Jerika Bolen, the 14-year-old who made headlines when she decided to stop treatment for Type 2 Spinal Muscular Atrophy, has died.

Jerika Bolen and her mother, Jen, share a moment on the way to a July 2016 prom in Appleton, Wis. Jerika died in September 2016, after she decided to end treatment for an incurable genetic disease.(Photo: Danny Damiani, The (Appleton, Wis.) Post-Crescent)

APPLETON, Wis. Nearly one year after a Wisconsin teen with an incurable genetic disease announced her intention to go without a life-sustaining ventilator, experts say her case has had surprisingly minimal impact on the right-to-die debate.

"I fully expected it to continue in the dialogue," said Paul J. Ford, director of the NeuroEthics Program at Cleveland Clinic, about Jerika Bolen's story.

Jerika, of Appleton, Wis., died last September after a lifelong battle with spinal muscular atrophy type 2, which destroys nerves cells in the brain stem and spinal cord that control voluntary muscle activity. Her death last year came after a final summer that included a prom in her honor in July.

When I decided, I felt extremely happy and sad at the same time, Jerika told USA TODAY NETWORK-Wisconsin in July 2016. There were a lot of tears, but then I realized Im going to be in a better place, and Im not going to be in this terrible pain."

More: Following 'Last Dance' prom, Wisconsin teen Jerika Bolen dies

Jerika's decision drew national attention, including an overwhelming amount of support from well-wishers worldwide. But her story also drew the ire of disability rights groups who attempted to intervene in Jerika's decision to stop treatment.

For Jerika's case, it really pushes the boundaries between the right to refuse treatment and assisted suicide.

"It was an exceedingly complicated case," said Arthur Caplan, head of the division of bioethics at New York Universitys School of Medicine. "(Jerika) was 14, so not quite old enough to be legally able to make her decisions, but old enough that many (medical experts) would say she was old enough to help determine her care."

Jerika was mostly immobile and in chronic pain from spinal muscular atrophy. She ranked her pain as a seven on a scale of one to 10 on her best days.

Medications had damaged her body. She had more than 30 visits to operating rooms. She had her spine fused in 2013 and the heads of her femurs removed in 2015.

The day of Jerika's death, Jen Bolen, who declined to be interviewed for this story, told USA TODAY NETWORK-Wisconsin that "no one in their right mind would let someone suffer like she was.

"Suffering is a pretty strong, compelling reason to back away," Caplan said.

Not Dead Yet, a national disability rights group, was one of five disability rights groups that asked authorities to conduct an investigation into Jerika's care.

Diane Coleman, Not Dead Yet's president and CEO, said the groups questioned Jerika's decision to die, as well as the public's response.

More: Wisconsin teen's battle to stop treatment isnt unique

More: Is Wisconsin teen's decision to die a turning point?

"We were trying to be gentle and respectful, but also to say that Jerika had a lot to live for, even if she couldn't yet see that herself," Coleman said.

(Jerika) was 14, so not quite old enough to be legally able to make her decisions, but old enough that many (medical experts) would say she was old enough to help determine her care.

A letter Not Dead Yet and other disability rights groups wrote in early August 2016 raised questions about Jerika's care and said the teenager was "clearly suicidal." Disability Rights Wisconsin also wrote a letter to Outagamie County, Wis., child protection authorities.

"For Jerika's case, it really pushes the boundaries between the right to refuse treatment and assisted suicide," Coleman said. "If she had continued using her (ventilator) ... things would be different, and she didn't get to get there.

"Almost all of the coverage supported her death. That's what's wrong."

Ford said it's difficult from the outside to understand a person's life and level of suffering.

"(Jerika) went through a lot," Caplan said. "She knows more about that than many people weighing in on what should happen."

Caplan said Jerika's story didn't take on the dimension of Terry Schiavo, a Florida woman who remained in a "persistent" vegetative state for 15 years, or Brittany Maynard, a 29-year-old with brain cancer who relocated to Oregon so she could legally kill herself with medication.

"(Jerika) was saying, 'I've been through so much. I don't want to do this anymore,' " Caplan said. "Which is an important question, but it isn't quite analogous to what happens either when someone requests help in dying or says, 'I don't want to be maintained because I'm so old and so frail that there's no point.' She was in a different situation."

More: Q&A: What you should know about right to die

More: Child neglect claimed in teen's plan to end her own life

Caplan said Americans are "completely and utterly confused" about right-to-die issues, including how to deal with mental impairment in dying, whether to honor a child's request and even what constitutes death.

"Where views diverge is saying how much suffering is too much to ask someone to bear, and whose responsibility is it to partake in ending a life if it's more suffering than anyone ought to bear," Ford, the Cleveland Clinic ethicist, said.

One of those issues is physician-assisted suicide. Public opinion about the practice remains divided: a 2013 Pew Research Center survey found that 47% of Americans approve of laws to allow the practice for the terminally ill, while 49% disapprove.

Five states California, Colorado, Oregon, Vermont and Washington and Washington, D.C., have legalized the practice, and Montana recognized it following a state Supreme Court ruling.

Ford said there was "a great energy among states" to continue the legislation for terminally ill adults a year ago.

More: Teen's plan to die has disability groups seeking intervention

More: More than a thousand people turn out for prom of Wisconsin teen choosing to die

"Those have sort of taken a backseat, recently," he said.

Earlier this year, Wisconsin State Rep. Sondy Pope introduced legislation, modeled closely after other physician-assisted suicide laws, that would allow terminally ill Wisconsin adults to receive medication to end their lives.

Pope, who conceded that the legislation has no immediate chance of becoming law, said she would support legislation to allow a minor who isn't terminal to die with "very, very thoughtful safeguards that include input from loved ones."

"That's way down the road in a case-by-case individual basis ... It doesn't seem right, morally, to say, 'I'm sorry. You're not 18. You have to suffer.' "

Follow Ethan Safran on Twitter:@EthanSafran

More: Girl, 14, with incurable disease makes heartbreaking decision to die

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Year after Jerika Bolen's death, debate continues on right-to-die issues - USA TODAY

Social security expenditures keep rising endlessly as the aging of Japans population accelerates with the low birthrate. Yet, little is known about the way huge sums of taxpayer money are being poured into wasteful projects tied to vested interests in the name of saving human lives.

The Japan Agency for Medical Research and Development (AMED), which Prime Minister Shinzo Abe created with much fanfare in 2015 as a counterpart to the U.S. National Institute of Health, has an annual budget in excess of 140 billion. But the National Cancer Center (NCC), which is supposed to be a major recipient of the AMED fund, is in trouble because excessive sums have been spent on construction of buildings and facilities in the name of life science research.

A glance at the NCCs financial statements shows that its retained earnings plummeted from 5.6 billion in fiscal 2010 to 762 million in 2015. The steep fall in the retained earnings is not due to cuts in grants from the Health, Labor and Welfare Ministry, as a high-ranking NCC official claims. The NCC earned 31.4 billion from medical services and 4.3 billion from research projects in fiscal 2010, and these earnings rose by 41 percent to 44.4 billion and 14 percent to 9.2 billion, respectively, unequivocally showing that the rise in earnings far exceeded the cut in government grants.

Then why have its retained earnings fallen so rapidly? The answer is that excessive investments in construction of new facilities have eaten into its funds. For example, it cost 5.4 billion to build a new research center on next-generation surgery and endoscopy, which was completed in May, and another 16.7 billion to build a new research laboratory that began operating in July. The question here is not the sheer sum spent on these projects, but their balance with the institutes earnings. During the 2010-16 period, money spent on such construction projects exceeded the NCCs operating income by 44.3 billion. It seems clear that the NCC is investing beyond its means even as construction costs surge ahead of the 2020 Tokyo Olympic Games.

Cases of advanced medicine becoming an arena for big spending like public works projects are also found in the field of heavy particle therapy. Japan has five institutions specializing in this field, the pioneer among them being the National Institute of Radiological Sciences in Chiba Prefecture. The number in Japan represents nearly half of the 11 such facilities now operating worldwide.

The five heavy particle therapy facilities are located in Chiba, Hyogo, Gunma, Saga and Kanagawa prefectures, with one more being planned in Yamagata. And oddly enough, though, the NCC supposedly the control tower of cancer therapy in Japan has no such institute. That is said to be because those institutes were located in facilities with close links to the Education, Culture, Sports, Science and Technology Ministry which took the lead in the development of heavy particle therapy instead of the health ministry.

One reason why Gunma University has one of those institutes is not because the university excelled in cancer treatment but, according to a source familiar with the decision, because of the influence of former education minister Hirofumi Nakasone, an Upper House member elected from the Gunma constituency and a powerful member of the Liberal Democratic Partys education lobby. Gunma Prefecture was eager to have the facility established there because that involved heavy initial investments about 7 billion each for the buildings and radiation equipment providing huge economic benefits to local construction and other related industries.

Haphazard ways in which money is being spent on advanced medical research are also found in the projects for biobanks, institutions that collect and preserve biospecimens of people such as blood, urine and DNA samples. Through followup research on the registered people and linking with their clinical information, their activities are expected to contribute to identifying the causes of illnesses and developing new medicines.

Of a number of biobanks set up in Japan, the Tohoku Medical Megabank Organization at Tohoku University is by far the largest. It started operating in fiscal 2011 as part of a series of government projects for recontruction from the Great East Japan Earthquake and tsunami that hit the regions Pacific coast. In its initial year of operation, more than 10 billion from the government budget was poured into the Tohoku Medical Megabank. A total of 5.1 billion was spent on the construction and design of a seven-story complex and another 7.5 billion on its facilities and equipment in the years through fiscal 2013. While spending was scaled back in subsequent years, 4.5 billion has been set aside for the project in fiscal 2017 a sum equivalent to the funding allocated to Kyoto University for its research on iPS (induced pluripotent stem) cells.

Tohoku Medical Megabank is staffed with 32 professors, 10 associate professors and 25 instructors. However, some of the staff are deemed not necessarily fit for the types of work assigned to the institute, leading some students to comment sarcastically that those who have failed to be promoted to full professorship at Tohoku University have been given new jobs at the biobank. Moreover, the quality of some of the work performed by the institute has been called into question.

The value of biobank is determined by the quality of the data obtained by its research. If the quality is poor, such an institute would not be trusted by researchers in pharmaceutical companies or other institutes. Six years after its creation, Tohoku Medical Megabanks achievement remains poor in terms of significant research that would have lured pharmaceutical firms and others to collaborate with the institute. The head of the biobank is not deterred, however, as he says his institutes research projects take time before tangible results can be produced, and the institute keeps asking for more funding from the AMED.

As funding for Tohoku Medical Megabank gets prioritized, budgetary allocations for the more prestigious BioBank Japan, which has been jointly established by the government-affiliated Riken research institute and the University of Tokyos Institute of Medical Science, has been significantly reduced. The budget cut by AMED is about to deal a fatal blow to the institute that has played a leading role in genome research in Japan.

Given Japans dire fiscal conditions, government funding on scientific research cannot be an exception to budget cuts. Time will come sooner or later for the generous funding for Tohoku Medical Megabank to be curtailed. Today, however, huge sums of taxpayer money are being poured on the institute despite its poor records of significant achievements in the name of the reconstruction of the areas ravaged by the 2011 disasters. Along with the spending of taxpayer money, new positions are being created for post-retirement jobs for government bureaucrats.

The circumstances surrounding those advanced medical research institutes look similar to those involving the governments public works projects: Securing funding from taxpayer money becomes more important than the outcome of projects. Unless the structure is fixed, there will be no hope of medical science becoming a core of the governments growth strategy.

This is an abridged translation of an article from the August issue of Sentaku, a monthly magazine covering political, social and economic scenes. More English articles can be read at http://www.sentaku-en.com

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Wasteful spending on medical public works - The Japan Times

KING OF PRUSSIA, Pa., Aug. 28, 2017 /PRNewswire/ --Global biotherapeutics leader CSL Behring announced today that it has agreed to acquire Calimmune, Inc., a biotechnology company focused on the development of ex vivo hematopoietic stem cell (HSC) gene therapy with R&D facilities in Pasadena, California and Sydney, Australia for an upfront payment of $91 million.

The acquisition will provide CSL Behring with Calimmune's pre-clinical asset, CAL-H, an HSC gene therapy for the treatment of sickle cell disease and -thalassemia, which complements CSL Behring's current product portfolio and deep expertise in hematology.

Additionally, CSL Behring will acquire two unique proprietary platform technologies, Select+ and Cytegrity. These technologies are designed to address some of the major challenges currently associated with the commercialization of stem cell therapy, including the ability to manufacture consistent, high-quality products, and to improve engraftment, efficacy and tolerability. Both technologies have broad applications in ex vivo stem cell gene therapy.

"Calimmune shares in our promise and focus to improve the lives of patients with rare and serious medical conditions," said CSL Limited Chief Executive Officer and Managing Director, Paul Perreault. "The acquisition represents another important step in the execution of our strategy for sustainable growth."

"Calimmune's scientific accomplishments are impressive," Perreault added. "The team has built a robust technology platform, and designed a promising HSC gene therapy candidate - CAL-H, which strongly aligns with our longer-term strategic goals, and complements our core competencies and areas of therapeutic focus. While Calimmune is still in the early stages, we believe that our combined strengths have tremendous potential to change treatment paradigms, and most importantly, significantly improve the lives of our patients."

Calimmune Chief Executive Officer Louis Breton said, "We are excited to become part of CSL Behring. They are an established global industry leader in protein-replacement therapies and have a proven track record of driving innovations through the development pipeline and delivering differentiated products to the global marketplace. Together, we are well positioned to take our achievements to the next level."

CAL-H, Calimmune's HSC gene therapy for sickle cell and -thalassemia, employs both the Select+ system, and the Cytegrity virus production platform. CAL-H has yielded early positive preclinical results and demonstrates the potential to offer a significant advantage to patients suffering from these currently incurable genetic diseases.

Both proprietary technologies have the potential to be used in treatments for a wide range of other rare diseases that would complement CSL Behring's business, including those within the company's current product portfolio.

About Sickle Cell Disease and thalassemiaSickle cell disease and -thalassemia are inherited disorders that affect hemoglobin, the protein in red blood cells that carries oxygen to different parts of the body. They are chronic diseases that dramatically impair the function of many organs and are associated with substantial morbidity, poor quality of life and a shortened life expectancy. The severe forms of both these diseases remain areas of high unmet need with sickle cell disease affecting approximately 150,000 Americans and Europeans and -thalassemia approximately 16,000. Although there are effective treatments available to relieve the symptoms of these diseases, there are no disease modifying treatments and in many cases regular blood transfusions are also required. Bone marrow transplant has been shown to be an effective cure in children, however, is rarely done due to the lack of closely matched donors.

About Select+ Calimmune's Select+TM is a proprietary technology aimed at driving selection of the genetically modified stem cells once they are given back to patients, to decrease toxicity and improve efficacy. One of the historical challenges for gene therapy is achieving a high enough engraftment of stem cells in the bone marrow to reach the relevant therapeutic window. Toxic conditioning regimens used to drive engraftment of gene modified cells can cause a range of adverse events that often require hospitalization and have additional long-term risks.Calimmune has focused on and made significant investments in solving this issue with Select+TM.The combination of Select+TM and lentiviral therapeutic applications aims to reduce the conditioning regimens, increase engraftment and overall efficacy, and improve the patient experience, ultimately making stem cell gene therapy an out-patient modality.

About Cytegrity Calimmune's CytegrityTM is a scalable manufacturing technology for the production of lentiviral vectors, which are used as a delivery mechanism for gene therapy. Lentiviral vectors are traditionally manufactured in small batches through a convoluted process; Cytegrity represents a new system that increases consistency and quality, and significantly lowers costs.

Transaction & Closing CSL Behring will have operational control ofCalimmune following closing of the transaction. In addition to the upfront payment, theagreement between the parties includes the potential for 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, subject to the satisfaction of various closing conditions.

Weil, Gotshal & Manges LLP acted as legal advisor to CSL Behring. Piper Jaffray & Co. acted as exclusive financial advisor and Cooley LLP acted as legal advisor to Calimmune.

About Calimmune Calimmune is a privately owned company committed to accelerating the promise of gene therapy to liberate patients from chronic and currently incurable diseases. To achieve this ambitious goal, Calimmune has built a suite of technologies to advance the delivery, manufacturing, and overall efficiency of these life-changing medicines. Calimmune's lead development programs are novel ex vivo gene therapies for hematologic diseases.

About CSL BehringCSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients' needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company's products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic disease of the newborn.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company,CSL Limited(ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs nearly 20,000 people, and delivers its life-saving therapies to people in more than 60 countries. For more information visitwww.cslbehring.comand follow us on http://www.Twitter.com/CSLBehring.

View original content with multimedia:http://www.prnewswire.com/news-releases/csl-behring-to-acquire-biotech-company-calimmune-and-its-proprietary-stem-cell-gene-therapy-platform-300510086.html

SOURCE CSL Behring

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CSL Behring to Acquire Biotech Company Calimmune and its Proprietary Stem Cell Gene Therapy Platform - Markets Insider

This is not about creating zombies-those so-called living (or walking) dead that are very popular and make a really great theme for TV shows and movies.

Even the Game of Thrones has its version of the living dead with them nasty creatures called White Walkers and Wights.

But then again, thats only science fiction, isnt it? Well, maybe not. In fact, this science-fiction plot could soon play out in real life. Read on.

Researchers from U.S.-based biotech company Bioquark are aimimg to resurrect patients who have been declared brain dead. Yep, you read it right. Resurrect, just like those stories in the Bible. Really bringing back people to life.

It goes without saying that this is really a serious matter. More importantly, Bioquarks small pilot study has been approved and gotten ethical permission by none other than the National Institutes of Health. The study would be an attempt to reawaken the clinically-dead brains of patients who have suffered serious brain injuries.

How will Bioquark do it?

Through stem cell therapy, which has been proven successful already in treating various diseases such as acquired ataxia, Alzheimers disease, Bells Palsy, cerebral atrophy, cirrhosis, optic nerve damage, osteoarthritis, and leukemia.

But, with brain-dead people, its going to be a real challenge since this condition according to medical experts is irreversible.

Brain death is different from a heart thats already stopped beating. A heart can still be revived and sustained by a ventilator or life-support system.

However, in the case of brain death, you cannot revive dead neurons with the help of a life-support machine even though it continues to pump oxygen to the body. The oxygen will get into the other organs like the heart, but it can no longer be utilized by the brain when the neurons are dead.

Neurons are the working units of the brain, specialized cells which are responsible for transmitting information to other nerve cells, gland cells, and muscles.They form networks or connections in the brain which number up to trillions.

A traumatic brain injury, sudden cardiac arrest, or a stroke caused by a ruptured blood vessel in the brain can cause brain tissues to start dying due to oxygen deprivation.

Oxygen-Deprived Brains Timeline:

However, Bioquark is hopeful that stem cell treatment may spur the growth of new neurons to replace the dead ones and pave the way to revive a clinically dead brain. After all, the brain is a fighter and scientists have found out that our gray matter has a small reservoir of stem cells which can produce new neurons.

Researchers are thinking of the possibility of urging these stem cells to generate new neurons which can remedy injured brain tissues. One other option is to inject neural stem cells into the brain of a person who has just died, and these may generate the necessary new neurons to help revive the brain.

Soon, Bioquark will find out the answer or learn some more information from their pilot study which is the first stage of the companys broaderReanima project. The project is exploring the potential of cutting edge biomedical technology for human neuro-regeneration and neuro-reanimation as a way to hopefully give patients and their loved ones a second chance in life.

Bioquark is set to conduct this very first human trial in partnership with the Indian biotech company Revita Life Sciences which specializes in stem cell treatment.

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Brain Dead Patients Could Be Brought 'Back to Life' in Groundbreaking Stem Cell Therapy - Wall Street Pit

Northern New Mexico College started its fall semester last Monday by welcoming several new faculty and staff members to the Northern family, in addition to the incoming freshmen students.

Northern believes that its biggest assets are its people, which is why the College invites the campus and wider community to give a very warm welcome to the Colleges new faculty and staff.

Sushmita Nandy, PhD

Assistant Professor, Biology

Dr. Sushmita Nandy is a stem cell and cancer biologist by training. She earned her PhD from All India Institute of Medical Sciences, New Delhi, India. She then pursued her post-doctoral research work, first at The Jackson Laboratory, in Bar Harbor, Maine, and later at the Paul L. Foster School of Medicine, Texas Tech University Health Sciences Center, in El Paso, Texas. Her PhD research work involved investigating the regenerative potential of human mesenchymal stem cells and developing approaches to coax them towards cardiac and dopaminergic neuronal lineages.

Rhiannon West, PhD

Assistant Professor, Biology

Dr. Rhiannon West received her PhD from the University of New Mexico where she focused on the behavior and ecology of pupfishes. Dr. West then had a post-doctoral position at the University of Lincoln-Nebraska which focused on the behavioral ecology of green swordtails.She studies the behavioral ecology of pupfish (Cyprinodon spp.) where she examines the interaction between behavioral mechanisms, mate choice, morphology, and phenotypic plasticity.

Martina J. Granado, MSN, RN, CNM

Martina joins the associate degree nursing program as an adjunct faculty member. She is a graduate of Northern's associate and baccalaureate degree nursing programs, and recently received her Masters degree in nursing from the University ofNewMexico as a Certified Nurse Midwife. Her area of clinical expertise is maternal/newborn, labor and delivery, and obstetrical care. Martina is employed as a Certified Nurse Midwife at Bridge Care for Women in Los Alamos.

Sarah Graham Edwards, BA, BSN, RN

Sarah joins the associate degree nursing program as an adjunct faculty member. She received her Bachelor of Science in Nursing from State University ofNewYork. Her area of clinical expertise is labor and delivery and she maintains a clinical practice as astaffnurse at Christus St. Vincent Regional Medical Center.

Deborah Kitchen, BSN, RN

Debbie brings over 40 years of experience in nursing to her position as an adjunct faculty member. She will be teaching the nurse aide training program in the College of Nursing and Health Sciences. She is an experienced nurse aide instructor and has worked in a variety long-term care facilities and community health settings.

Gabriel Martinez

Gabriel is thenewAssistant Athletic Director/Associate Head Mens Basketball Coach. Gabriel graduated from NNMC with his Bachelor in Business Administration. He also played on the mens basketball team for four years.

Miquella Espinoza

Miquella is the new Transition Specialist for the High School Equivalency Program. She joined the College as a student and is expected to graduate this fall with a BA in Integrative Studies with an emphasis in Psychology. She received an AAS in Human Services in May 2015 from NNMC. Miquella has tutored and coached kindergarten and elementary students for seven years. She is excited for the opportunity to work with students who are in search of bettering their lives and continuing their education.

JoRonda Abeyta

JoRonda recently joined Northern as an academic advisor after graduating from NNMC with herBachelor's degree in Psychology in May of 2017. She is a Licensed Substance Abuse Associate through the State of New Mexico and is working to become a Licensed Alcohol and Drug Abuse Counselor. JoRonda also plans to pursue her master's degree in August of 2018.

Patrick K. Bendegue

Patrick is a math instructor for the High School Equivalency Program and the College. Born in Cameroon, Patrick graduated from Covenant Ministries Academy in Atlanta, Georgia. He attended Morehouse College for a year under a basketball scholarship while pursuing a degree in computer engineering. He then transferred to Northern as part of the mens basketball team, during which time he received several awards. Patrick graduated with a Bachelor in Engineering Information Technology from Northern.

Joanna Martinez

Joanna is the new Business Office Receptionist. She was previously employed with CNM where she worked as an Assessment Technician for over 2 years. She is married to Gabriel Martinez and has a 9-year-old son, Elijah. Next spring, Joanna will be graduating with her third Associates in Business Administration.

Excerpt from:
NNMC Welcomes Fall Semester; New Faculty & Staff - Los Alamos Daily Post

(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