Stem Cell Clinic

First implants of stem-cell pouches to ‘cure’ type 1 diabetes – New Scientist

Stem cells have been cultured to treat many different of conditions

Lewis Houghton/Science Photo Library

By Andy Coghlan

Last week, two people with type 1 diabetes became the first to receive implants containing cells generated from embryonic stem cells to treat their condition. The hope is that when blood sugar levels rise, the implants will release insulin to restore them to normal.

About 10 per cent of the 422 million people who have diabetes worldwide have type 1 diabetes, which is caused by the bodys immune system mistakenly attacking cells in the pancreas that make insulin. For more than 15 years, researchers have been trying to find a way to use stem cells to replace these, but there have been several hurdles not least, how to get the cells to work in the body.

Viacyte, a company in San Diego, California, is trying a way to get round this. The firms thumbnail-sized implant, called PEC-Direct, contain cells derived from stem cells that can mature inside the body into the specialised islet cells that get destroyed in type 1 diabetes.

The implant sits just below the skin, in the forearm, for example, and is intended to automatically compensate for the missing islet cells, releasing insulin when blood sugar levels get too high.

If it works, we would call it a functional cure, says Paul Laikind, of Viacyte. Its not truly a cure because we wouldnt address the autoimmune cause of the disease, but we would be replacing the missing cells.

The device has already been safety tested in 19 people with diabetes, using smaller numbers of cells. Once implanted, the progenitor cells housed in the device did mature into islet cells, but the trial didnt use enough stem cells to try to treat the condition.

Now Viacyte has implanted PEC-Direct packages containing more cells into two people with type 1 diabetes. A third person will also get the implant in the near future. Once inside the body, pores in the outer fabric of the device allow blood vessels to penetrate inside, nourishing the islet progenitor cells. Once these cells have matured which should take about three months the hope is that they will be able to monitor sugar levels in the blood, and release insulin as required.

If effective, it could free people with type 1 diabetes from having to closely monitor their blood sugar levels and inject insulin, although they would need to take immunosuppressive drugs to stop their bodies from destroying the new cells.

If successful, this strategy could really change the way we treat type 1 diabetes in the future, says Emily Burns of the charity Diabetes UK. A similar way to treat the condition with pancreas cells from organ donors has been in use for nearly 20 years, successfully freeing recipients from insulin injections, but a shortage of donors limits how many people are able to have this treatment.

This isnt a problem with stem cells. The embryonic stem cells used to make the progenitor cells originally came from a spare early stage embryo donated by a woman who was having IVF. Because embryonic stem cells, and the progenitor cells made from them, can be multiplied in limitless amounts, Laikand says that, if the treatment works, the method would be able to treat everyone who has the condition.

A limitless source of human insulin-producing cells would be a major step forward on the journey to a potential cure for diabetes, says James Shapiro at the University of Alberta, Canada, who has collaborated with Viacyte on this project, and who pioneered the donor pancreas method decades ago. For sure, this will in the end prove to be a durable landmark for progress in diabetes care.

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Breakthrough Stem Cell Study Offers New Clues to Reversing Aging – Singularity Hub

What causes the body to age?

The Greek Philosopher Aristotle thought it was the hearta hot, dry organ at the seat of intelligence, motion and sensation.

Fast-forward a few centuries, and the brain has overthrown the heart as master of thought. But its control over bodily agingif anywas unclear. Because each organ has its own pool of stem cells to replenish aged tissue, scientists have long thought that the body has multiple aging clocks running concurrently.

As it turns out, thats not quite right.

This week, a study published in Nature threw a wrench into the classical theory of aging. In a technical tour-de-force, a team led by Dr. Dongsheng Cai from the Albert Einstein College of Medicine pinpointed a critical source of aging to a small group of stem cells within the hypothalamusan ancient brain region that controls bodily functions such as temperature and appetite.

Like fountains of youth, these stem cells release tiny fatty bubbles filled with mixtures of small biological molecules called microRNAs. With age, these cells die out, and the animals muscle, skin and brain function declines.

However, when the team transplanted these stem cells from young animals into a middle-aged one, they slowed aging. The recipient mice were smarter, more sociable and had better muscle function. Andget thisthey also lived 10 to 15 percent longer than mice transplanted with other cell types.

To Dr. David Sinclair, an aging expert at Harvard Medical School, the findings represent a breakthrough in aging research.

The brain controls aging, he says. I can see a day when we are implanted with stem cells or treated with stem cell RNAs that improve our health and extend our lives.

Its incredible to think that a tiny group of cells in one brain region could be the key to aging.

But to Cai, there are plenty of examples throughout evolution that support the theory. Experimentally changing a few of the 302 neurons in the nematode worm C. elegans is often sufficient for changing its lifespan, he says.

Of course, a mammalian brain is much more complicated than a simple worm. To narrow the problem down, Cai decided to zero in on the hypothalamus.

The hypothalamus has a classical function to regulate the whole bodys physiology, he says, so theres a natural logic for us to reason that the hypothalamus might be involved in aging, which was never studied before.

Even so, it was a high-risk bet. The hippocampusbecause of its importance in maintaining memory with ageis the most popular research target. And while the hypothalamus was previously somehow linked to aging, no one knew how.

Cais bet paid off. In a groundbreaking paper published in 2013, he found that a molecule called NF-kappaB increased in the hypothalamus as an animal grew older. Zap out NF-kappaB activity in mice, and they showed much fewer age-related symptoms as they grew older.

But heres the kicker: the effects werent limited to brain function. The animals also better preserved their muscle strength, skin thickness, bone and tendon integrity. In other words, by changing molecules in a single part of the brain, the team slowed down signs of aging in the peripheral body.

But to Cai, he had only solved part of the aging puzzle.

At the cellular level, a cornucopia of factors control aging. There is no the key to aging, no single molecule or pathway that dominates the process. Inflammation, which NF-kappaB regulates, is a big contributor. As is the length of telomeres, the protective end caps of DNA, and of course, stem cells.

Compared to other tissues in the body, stem cells in the brain are extremely rare. So imagine Cais excitement when, just a few years ago, he learned that the hypothalamus contains these nuggets of youth.

Now we can put the two threads together, and ask whether stem cells in the hypothalamus somehow regulate aging, he says.

In the first series of experiments, his team found that these stem cells, which line a V-shaped region of the hypothalamus, disappear as an animal ages.

To see whether declined stem cell function contributes to aging, rather as a result of old age, the researchers used two different types of toxins to wipe out 70 percent of stem cells while keeping mature neurons intact.

The results were striking. Over a period of four months, these mice aged much faster: their muscle endurance, coordination and treadmill performance tanked. Mentally, they had trouble navigating a water maze and showed less interest in socializing with other mice.

All of these physiological changes reflected an acceleration in aging, Cai and team concluded in their article.

And the consequences were dire: the animals died months earlier than similar transgenic animals without the toxin treatment.

If the decline in stem cell function is to blame for aging, then resupplying the aged brain with a fresh source of stem cells should be able to reinvigorate the animal.

To test this idea, the team isolated stem cells from the hippocampus of newborn mice, and tinkered with their genes so that they were more resilient to inflammation.

We know the aged hypothalamus has more inflammation and that hurts stem cells, so this step was necessary, explained the authors.

When transplanted into middle-aged mice, they showed better cognitive and muscular function four months later. Whats more, they lived, on average, 10 percent longer than mice transplanted with other cell types. For a human, that means extending an 85-year life expectancy into 93. Not too shabby.

But the best was yet to come. How can a few cells have such a remarkable effect on aging? In a series of follow-up experiments, the team found that the pool of biological molecules called microRNAs was to thank.

microRNAs are tiny molecules with gigantic influence. They come in various flavors, bearing rather unimaginative names like 106a-5p, 20a-5p and so on. But because they can act on multiple genes at the same time, they pack a big punch. A single type of microRNA can change the way a cell workswhether it activates certain signaling pathways or makes certain proteins, for example.

While most cells make microRNAs, Cai found that the hypothalamus stem cells have a unique, very strong ability to pack these molecules up into blobs of membrane and shoot them out like a bubble gun.

Once outside the cell, the microRNAs go on a fantastic voyage across the brain and body, where they tweak the biology of other tissues.

In fact, when the team injected purified little bubbles of microRNAs into middle-aged mice, they also saw broad rejuvenating effects.

Cai explains: we dont know if the microRNAs are pumped out to directly affect the rest of the body, or if they first act on different areas of the brain, and the brain goes on to regulate aging in the body.

Even so, the aging field is intrigued.

According to Dr. Leonard Guarente, an aging biologist at MIT, the study could lead to new ways to develop anti-aging therapies.

Whats more, its possible the intervention could stack with other known rejuvenating methods, such as metformin, young blood or molecules that clean out malfunctioning cells.

Its possible that stem-cell therapy could boost the hypothalamus ability to regulate aging. However, scientists still need to know how stem cells link with the hypothalamus other main role, that is, releasing hormones.

Of course, injecting cells into the brain isnt a practical treatment. The team is now working hard to identify which of the thousands of types of microRNAs control aging and what exactly they do.

Then the goal is to validate those candidate anti-aging microRNAs in primates, and eventually, humans.

Of course humans are more complex. However, if the mechanism is fundamental, you might expect to see effects when an intervention is based on it, says Cai.

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Surgeons focus on stem cell transplants to help save sight of acid attack victims – Evening Standard

Eye doctors are fast-tracking efforts to improve stem cell transplants to save the sight of people blinded in Londons acid attack epidemic, the Standard can reveal.

Research at The Royal Free Hospital aims to boost success rates, particularly where cells are taken from deceased donors at present, three-quarters of such transplants fail.

Corneal stem cell transplants have been used for some time on acid victims, including model Katie Piper.

But they are difficult and risky to perform, with doctors hampered by a shortage of donated eyes.

They are most successful when one eye is damaged and cells can be transplanted from the healthy eye. This works in about seven out of 10 cases.

The success rate is about 25 per cent when both eyes are damaged and cells are harvested from the eye of a deceased donor.

Consultant ophthalmic surgeon Alex Shortt, who is carrying out the research at the Royal Frees institute of immunity and transplantation in Hampstead, said the aim was a success rate of 95 per cent. The work is being funded by the Wellcome Trust and Moorfields Eye Charity.

A total of 454 acid attacks were reported to the Metropolitan police last year, almost three times the number in 2014. Mr Shortt said: The last six to 12 months has seen demand for these treatments rise hugely.

He said the challenge was to remove scar tissue without creating a new scar as the eye healed. A sample of healthy corneal stem cells are grown in the laboratory to form a sheet, which is attached to the surface of the damaged eye to enable the cornea to regenerate.

The success rate is about 68 per cent. It fails in three out of 10 people. They regrow a scar and they go blind again, Mr Shortt added.

We are trying to move to the point where we can use donor cells and prevent the body from rejecting them. Then we can treat patients more cheaply, and have a bank of cells ready to go as soon as we see a severe injury.

Next week NHS rationing body NICE is due to decide whether to approve an 80,000 Italian stem cell treatment, Holoclar, that works for seven in 10 patients. However, it is only effective where cells can be taken from the patients undamaged eye.

NICE is likely to require patients to undergo a cheaper treatment first.

Medics are also appealing for more people to donate their corneas after death. NHS Blood and Transplant said more than one in 10 donors place restrictions on the use of their eyes, the most for any organ.

About 70 corneas a week are needed but 50 are donated. Hundreds of corneas are imported from the US and Europe.

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Researchers Use Simpler, Safer Method to Obtain Stem Cells for Treating Lung Diseases – Cystic Fibrosis News Today

A new method of isolating lung stem cells could help speed the development of stem-cell based therapies for lung diseases, including cystic fibrosis, according to a University of North Carolina study.

That method is extracting them with a tube from the mouth to the lung rather than surgery. The team has already used the method in their pulmonary fibrosis research work.

The new study, Derivation of therapeutic lung spheroid cells from minimally invasive transbronchial pulmonary biopsies, was published in the journalRespiratory Research.

Doctors can use stem cells to restore injured lungs, but obtaining and maintaining the cells is challenging.

Not only do they need a lot of lung tissue to extract the stem cells, but the way they have obtained the tissue with surgery is highly invasive. This has led to high death rates among patients who have had the biopsy surgery.

Still, isolating the cells for stem cell-based therapies is a good way to treat many lung diseases.

Until recently,University of North Carolina Health Careresearchers used lung tissue biopsies to obtain stem and support cells that they can cultivate for treatments. They discovered thatlung spheroid cells can help regenerate the lungs of mice with pulmonary fibrosis.

The team is now using a relatively non-invasive procedure, called a transbronchial biopsy, to isolate lung spheroid cells while reducing the risks associated with obtaining them by surgery. In this procedure, a lung pneumologist inserts a thin, lighted tube, or bronchoscope, through a patients nose or mouth to collect several pieces of lung tissue.

This is the first time anyone has generated potentially therapeutic lung stem cells from minimally invasive biopsy specimens, Dr. Jason Lobo, an assistant professor of medicine at the university, said in a press release.

We snip tiny, seed-sized samples of airway tissue using a bronchoscope, said Lobo, a co-lead authoer of the study. This method involves far less risk to the patient than does a standard, chest-penetrating surgical biopsy of lung tissue.

They were able to obtain more than 50 million lung spheroid cells from one small piece of isolated tissue. When they injected the cells into mice, they were delighted to find that the cells ended up in the animals lungs.

These cells are from the lung, and so in a sense theyre happiest, so to speak, living and working in the lung, said the other co-lead author, Dr. Ke Cheng. He is an associate professor in the universitys Departments of Molecular Biomedical Sciences and Biomedical Engineering.

In a second study, published in the journalStem Cells Translational Medicine,researchers highlighted lung spheroid cells potential to treat cystic fibrosis. Injecting the cells in rats with cystic fibrosis significantly reduced their lung inflammation and scarring, compared with control animals.

Also, the treatment was safe and effective, whether the lung spheroid cells were derived from the recipients own lungs or from the lungs of an unrelated strain of rats, Lobo said. In other words, even if the donated stem cells were foreign, they did not provoke a harmful immune reaction in the recipient animals, as transplanted tissue normally does.

Scientists have had discussions with theU.S. Food and Drug Administrationabout clinical trials of lung spheroid cells as a pulmonary fibrosis therapy.

Cells isolated from patients own lung tissue would eliminate the risk of the body rejecting the stem cells. Such treatments require a lot cells, however and doctors might opt to harvest some from healthy volunteers and whole lungs obtained from organ donation networks.

Our vision is that we will eventually set up a universal cell donor bank, Cheng said.

The researchers hope that some day their stem cell therapycan be used in other lung diseases, including cystic fibrosis.

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Researchers Use Simpler, Safer Method to Obtain Stem Cells for Treating Lung Diseases - Cystic Fibrosis News Today

University of Minnesota bioethicist takes on clinics touting stem-cell studies – Minneapolis Star Tribune

U of M professor Leigh Turner is taking huge flack from this "stem sell" industry for a paper he wrote analyzing how many of the clinics are using the government website clinicaltrials.gov to advertise their services by disguising them as legitimate clinical trials, which they are not. Photographed at the University...

Renee Jones Schneider, Star Tribune

By Joe Carlson , Star Tribune August 05, 2017 - 6:46 PM

The clinics offer futuristic-sounding treatments for everything from eye problems to osteoarthritis.

Listed on a government website, they present the opportunity to participate in clinical trials to test the potential of one of the most promising tools in medicine the bodys own stem cells. Its an attractive pitch for many patients, even though some of the clinics charge $6,000 and up to participate.

Now, with a national debate raging over the future of one of the hottest frontiers in 21st-century medicine, a University of Minnesota bioethicist has taken center stage in questioning whether many of these services are legitimate.

You have these businesses that dont have meaningful clinical research going on, the Us Leigh Turner said in an interview. There is a risk for fraud, in that people may be charged thousands of dollars to get an intervention that has no chance of working.

Turner has emerged as a major critic of the clinics, some of which he says have flawed procedures that allow bias to distort the results of treatment studies. He also says allowing clinics to list studies can imply government approval, lending false legitimacy to marketing pitches.

My concern is that you basically take clinicaltrials.gov and transform it into a marketing platform, Turner said.

In the past, Turner has moved beyond academic criticism, reporting several clinics he considered questionable to regulators at the U.S. Food and Drug Administration.

One of them, Celltex Therapeutics Corp., received a warning letter from the FDA for its practices in 2012. The company eventually moved its stem-cell infusion operations to Mexico, but it pushed back against Turner in a complaint lodged with U President Eric Kaler.

Clinics have also fired back at Turners latest critical article, which appeared last month in the medical journal Regenerative Medicine.

Research scientist Duncan Ross of Florida-based Kimera Labs, which was identified in Turners July 19 article as advertising an undisclosed pay-for-participation stem-cell study on clinicaltrials.gov, has threatened legal action.

I encourage you to amend your publication or I am going to bring suit against the institution for defamation or slander, Ross wrote to Turner. I am going to lobby the journal for the retraction of this publication. I followed the letter of the FDA as it exists at this time and I am not going to have my name disparaged because of your lack of interest in due diligence.

Turner said no litigation has materialized, and an editor at Regenerative Medicine said no request for a retraction has been made.

Beverly Hills cosmetic surgeon Dr. Mark Berman who is co-medical director of the national Cell Surgical Network, another clinic group named in Turners article said academic researchers like Turner are misguided and out of touch with real-world medical needs.

We are not taking public funding and using it to our benefit while pursuing scientific excellence were actually trying to help our patients while learning about the treatments and the disease they have, Berman said in an e-mail to the Star Tribune. Frankly, I think this is much more ethical than a major university with billions of endowment dollars taking millions of dollars of taxpayer money so they can build new offices and laboratories to further the study of stem cells.

Stem cells are the undifferentiated raw cells in the body that have the ability to quickly produce copies of themselves and also change into other kinds of cells like bone, muscle and blood cells.

Hospitals have safely used stem-cell transplant procedures to treat cancers for decades, but the FDA has approved just one commercial stem-cell product to date, which is made from infant cord blood and can only be used to produce more blood cells.

One of the most common sources of stem cells in pay-to-participate studies is body fat, often obtained via liposuction and known as adipose-derived stem cells. The fact that a byproduct of liposuction can be turned into a potentially therapeutic substance helps explain why smaller clinics are often affiliated with or run by plastic surgeons and cosmetic surgery centers.

Some critics have called for more oversight by the FDA. FDA officials, for their part, have said they share the excitement over the theoretical promise of stem cells to treat or cure disease by converting into cell types needed by the patient. But the agency has sounded a cautionary tone over the profusion of stem-cell clinics and studies popping up around the country.

Studies so far have not reliably demonstrated the effectiveness of stem-cell treatments, even in some of the most systematically studied conditions, FDA officials wrote in the New England Journal of Medicine in March. This lack of evidence is worrisome.

Turner said that many of the studies advertised on clinicaltrials.gov dont seem geared to produce high-quality data that will be medically useful, especially when they involve open-label study designs, where doctors and patients know what treatments are given, and patients are paying out of their own pockets.

In most clinical trials, study subjects are not charged fees to participate. In contrast, individuals enrolled in what are often called pay-to-participate studies are charged thousands or tens of thousands of dollars, Turners report says. Pay-to-participate studies also risk amplifying placebo effects as a result of the sizable fees companies often charge research participants and the hyperbole used to promote such studies.

Allowing participants to know what treatments are given departs from a typical randomized, blind study in which the intervention is kept secret for a period of time. That practice reduces the risk of a placebo effect, which can run high in medical studies.

A 2010 analysis of studies of irritable bowel syndrome treatments found that nearly 40 percent of 8,400 patients experienced an improvement in their symptoms even though they didnt receive the drug being studied.

Tennessee resident Doug Oliver, a nationally known advocate for stem-cell research who says he was legally blind before his eyes were treated with stem cells, agreed that placebo-controlled trials are the best way to ensure that patients are really being helped by a treatment.

But he argues that the coming age of cellular medicine will also require a wider understanding of how medical evidence is generated.

Oliver said most stem-cell clinics are trying to do the right thing, and many people feel that it wasnt even possible to get true FDA oversight of a stem-cell clinical trial before the signing of the 21st Century Cures Act last December. But even Oliver acknowledges that some clinics have exploited clinicaltrials.gov and disregarded any form of regulation thus far.

You have a group of clinics, which I think is a minority, maybe 20 percent, who are ill-intended, unqualified, or there is a personal and cultural aversion to doing anything that even smacks of following a regulation, he said. There are a number of clinics out there like that, and they are hurting people and they should be shut down.

Joe Carlson 612-673-4779

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