New Texas Law on Stem Cell Treatments: Showdown With FDA Coming? – Regulatory Focus

Posted 28 June 2017 By Zachary Brennan

With a new Texas law now in the books to allow companies to sell unproven stem cell treatments without US Food and Drug Administration (FDA) approval, some experts wonder when FDA will step in to shut down companies and clinics exposing people to unapproved medical products.

Similar to the Right to Try laws spreading across the US and attempting to undercut FDAs regulation of investigational products, the Texas law, which had been brewing in some form since 2012, applies to certain investigational stem cell treatments for patients with certain severe chronic diseases or terminal illnesses.

And though the Texas law says that it applies to stem cell treatments currently under investigation in clinical trials, it also blocks the Texas Medical Board from revoking, failing to renew or suspending a physicians license based solely on the physicians recommendations to an eligible patient regarding access to or use of an investigational stem cell treatment.

An investigation by Nature in 2012 uncovered unproven and costly stem cell treatments being sold in Texas.

Leigh Turner, anassociate professorat the University of Minnesotas Center for Bioethics and School of Public Health and co-author of a paper in Cell on the selling of stem cell therapies directly to US consumers, explained to Focus the unpredictable nature of Texas law, as the state already has one of the highest concentrations of unregulated stem cell clinics (California and Florida also have high concentrations of such clinics, he said, noting his investigation found more than 500 such clinics in the US).

There are lots of credible stem cell researchers in Texas, but theyre not the ones pushing for this bill, Turner said, noting that the greatest concern should be focused on clinics offering unproven stem cell treatments for a range of diseases with few or no treatment options, like ALS, autism, spinal cord injuries and others.

And though there are provisions in the bill that, according to Turner, could knock some businesses out of the marketplace in Texas, he said its hard to know which way itll break, though it seems clearly based on the fantasy that Texans have to go elsewhere to receive these investigational stem cell therapies.

FDA has so far let these direct-to-consumer stem cell clinics flourish and has only issued a limited number of warning letters to companies like Cell Vitals in 2014, Irvine Stem Cell Treatment Center in 2015 and Lavian in 2016.

Former FDA Commissioner Robert Califf, Center for Biologics Evaluation and Research Director Peter Marks and CBER Deputy Director Celia Witten in December 2016 made the case in the New England Journal of Medicine that the hype over such treatments outpaces the evidence that they are safe and effective, though the agency has not cracked down on the direct-to-consumer stem cell market.

FDA couldve done something since 2009, this is a marketplace thats been around a while, Turner said.

And because many of the clinics engage in interstate commerce, Turner said they do clearly fall within FDAs jurisdiction. But its not just FDA, he added, the Federal Trade Commission could also act, as could state consumer protection agencies or state medical boards.

So why isnt FDA taking action? The agency did not respond to a request for comment and Turner said he has not received a straight answer from the agency.

Will they knock out these businesses? Talking with FDA, I didnt hear that, he said, adding that he did not get the impression that theres a comprehensive, organized plan to deal with the emergence of such a large and growing marketplace.

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Stem cell agency faces leadership challenge – Capitol Weekly

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by DAVID JENSEN posted 06.27.2017

Californias 12-year-old stem cell research effort is expected to give away tens of millions of dollars in public this week, but its most important matters issues that deal with its survival and future likely will be discussed behind closed doors at a meeting Thursday of its governing board.

On the table is the leadership of the $3 billion organization, which is scheduled to run out of cash in just three years, which amounts to a mere tick of the clock in the world of biomedical research. Beginning next week the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, will be minus its chief executive officer and its longtime counselor, who even predates the organizations actual creation in 2004.

CIRM has a checkered record in recruiting new presidents for a variety of reasons (seehere,hereandhere).

CIRM directors are scheduled to meet Thursday at the San Francisco Marriott hotel in Burlingame, Ca., to confirm the appointment of Maria Millan, CIRMs vice president of therapeutics, as interim president of the agency. She will assume the duties of Randy Mills, who is leaving CIRM next week to head the National Marrow Donor Progam.

Mills, who was paid $573,00 last year, also made it clear to the California Stem Cell Report in May that Millan is the appropriate person to take over the agency on a permanent basis after he leaves.

However, the decision is up to the 29-member board, which has scheduled an executive session Thursday to discuss the interim replacement for Mills. Hejoined the agency only three years ago but has left an impressive mark.

CIRM directors have also scheduled a July 17 meeting of their presidential search subcommittee to deal with the agencys leadership during what could be the last years of its life.

CIRM has a checkered record in recruiting new presidents for a variety of reasons (seehere,hereandhere). Some candidates have rejected offers. Other search efforts have been excessively prolonged.

The agency hopes to add 38 more trials over the next three years. But there are no guarantees that any will be successful.

Finding a new president from outside CIRM poses difficulties that would not have been in place, for example, five years ago. They include the tenuous future of CIRM along with the time needed for a normal executive search, plus the learning curve for a new CEO.

While CIRM is a small enterprise in some ways (less than 50 employees), it is an unusual mix of government, biotech business and academia, unlike any other state agency. The combination has raised hurdles in the past.

The clock is running out fast at the agency. Any alterations in the plan put in place by Mills, Millan and company could slow its efforts to fulfill voter expectations that the agency would actually generate a widely available therapy. CIRM is helping to finance 27 current clinical trials, which are the last stages in research prior to a product reaching the market. The agency hopes to add 38 more trials over the next three years. But there are no guarantees that any will be successful.

Millan can step in and pick up the job relatively seamlessly. Bringing in a CEO from outside could well take six months or more, including relocation. But serving as the head of an organization that could be out of business in three years may not be appealing to many and could prolong recruitment.

Looming in the background is a gossamer plan for another ballot initiative to fund CIRM beyond 2020.

If Millan is bypassed by the board, she may well leave the agency, triggering a cascade of departures as other CIRM employees also look to their own professional futures. An employee drain would hamper the agencys drive to come up with a commercial therapy.

James Harrison, the longtime counsel to the agency, is also leaving at the end of this week, returning to other pursuits at his private practice. Harrison has been a cornerstone of CIRM and has influence well beyond the not-so-simple legal matters involving the agency. He was also one of the authors of the 10,000-word ballot initiative that created the agency in 2004.

Scott Tocher, a longtime veteran of the agency, will replace Harrison. An announcement of the appointment is expected at the Thursday meeting.

Looming in the background is a gossamer plan for another ballot initiative to fund CIRM beyond 2020. Bob Klein, a Palo Alto real estate investment banker who led the campaign that created CIRM, is talking about a $5 billion bond measure on the ballot as early as November of next year. Some political observers have predicted a less-than-warm-reception for such a proposal, given that the agency has yet to measure up to its 2004 campaign promises.

Another, rival proposal is being mentioned that would, in fact, move stem cell funding away from the agency.

One stem cell scientist, Paul Knoepfler of UC Davis, wrote last week about the agencys presidential search.

Commenting on his blog, Knoepfler said that CIRM directors should pick a fantastic person to replace Mills. Knoepfler said the new president should have strong leadership skills, a big picture clinical vision and impeccable stem cell credentials, criteria that one could argue have not been met by most CIRM CEOs.

In the past, debate about presidential candidates centered on whether they should be stem cell stars or a leader who can execute an aggressive program that is already approved and in place. Given the current CIRM challenges, other criteria, such as speed and continuity, are also high.

The journal Nature this year said that the agency is in its last stage. CIRM directors may well have that admonition on their minds as they consider fresh leadership for the program. Sphere: Related Content

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Existing Drug Found to be Effective at Killing Cancer Stem Cells – Technology Networks

Researchers experiment with the Sam68 protein. Credit: McMaster University

A team of researchers at McMaster University has identified a unique feature of cancer stem cells that can be exploited to kill the deadly cells thought to be the reason that cancer comes back after therapy. Understanding this feature will be useful for delivering more targeted cancer therapeutics to the right patients.

The study, published today in the scientific journal Cell Chemical Biology, reveals that an existing set of drugs is effective in killing cancer stem cells and explains how this led the team to uncovering important details about how these cells are working in human tumors.

"The drugs helped us to understand the biology," said Mick Bhatia, principal investigator of the study and scientific director of the McMaster Stem Cell and Cancer Research Institute. "We've worked backwards, employing a series of drugs used in the clinic to understand a new way that cancer stem cells can be killed."

The researchers found that a particular protein, called Sam68, is an important actor in cancer stem cells, and that this protein allows existing drugs to work on cancer cells, causing them to die.

Bhatia hopes that this information can be used to deliver targeted therapies to the patients who would benefit from them, while sparing others from unhelpful treatments. He believes that treatment of blood cancers like leukemia and other cancers such as prostate, colon and renal will follow the example set in breast cancer, where patients receive treatments tailored to their specific form of the disease.

"In the case of breast cancer, other researchers have found new ways to make existing drugs more effective by only giving them to people who were likely to benefit based on their specific traits and using drugs that target these traits," Bhatia said.

He said while developing a new drug takes an average of about 15 years and comes with a price tag in the hundreds of millions, defining the role of existing drugs to use them better in patients will help to accelerate the process of bringing the right drugs to the right people.

Reference

Mickie Bhatia et al. Sam68 Allows Selective Targeting of Human Cancer Stem Cells. Cell Chemical Biology, June 2017 DOI: 10.1016/j.chembiol.2017.05.026

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Scientist-backed PAC endorses Dana Rohrabacher’s challenger – Salon

Republican Rep. Dana Rohrabacher of California is a well-known science denier, particularly when it comes to the issue of man-made climate change. In response,314 Action, a new PAC that exists to help elect scientists to public office, is officially endorsing a Democratic rival to opposeRohrabacher in his 2018 reelection campaign.

Dr. Hans Keirstead is aPhD neuroscientist, cancer doctor and former UC Irvine School of Medicine professor, as well as the first non-incumbent endorsement that 314 Action has made.

Scientists are trained to follow the facts no matter where they lead, Keirstead toldSalon through email. Many times, a hypothesis does not get borne out by the facts. Science isnt about opinions or how you feel. Its about the pursuit of truth, and as a scientist, I have learned the value of real evidence and data. I believe my career developing successful, breakthrough cancer treatments through stem cell research will speak to people.

Keirsteads work on stem cell research has helped with treatment of various cancers, multiple sclerosis, and Lou Gehrigs disease, among other medical conditions.

Rohrabacher claims that he loves science,a fact that Keirstead insists is only the first step toward actually using science in a responsible way as a policymaker.

Understanding how science effects every day Americans lives? Thats where a policy maker who understands science makes their impact, Keirstead explained. I have seen firsthand how it can save lives by investing in medical research that leads to curing cancer or changing lives by providing jobs and infrastructure to a community like Orange County.

TheTrump administrations budget is a war on facts that the scientific community knows all about, saidShaughnessy Naughton, a chemist who founded 314 Action.

Whether its his massive cuts to research budgets, his views on climate change, vaccines, the decision to pull out of the Paris Agreement, or countless others, science is under attack right now. While we dont have a set criteria of policies for candidates who come to us, support for research funding and a recognition of the urgency with which we need to act on combating climate change.

Compare that with what is happening in Washington today with Trumps budget proposal,Keirstead added. They are slashing funding for the National Institute of Health and doubling user fees on small businesses. That has a direct effect on the work I and many in the medical field do. I guarantee you that if our research labs fees were doubled, my cancer treatment would not have gone to clinical trials. We need representatives who understand the direct consequences of their proposals and, sadly, Im not convinced many do.

It remains to be seen whether Naughton and Keirsteads support for reason can triumph not only in the laboratory, but in voting booths as well.

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Large-scale production of living brain cells enables entirely new research – Medical Xpress

June 26, 2017

Important pieces of the puzzle to understand what drives diseases such as Alzheimer's and Parkinson's are still missing today. One crucial obstacle for researchers is that it is impossible to examine a living brain cell in someone who is affected by the disease. With the help of a new method for cell conversion, researchers at Lund University in Sweden have found a way to produce diseased, aging brain cells on a large scale in a cell culture dish.

After performing a biopsy on the patient, the skin cells are transformed into brain cells that effectively imitate the disease and the age of the patient. The fact that the cells can now be produced in large quantities enables researchers to carry out a series of experiments that were previously not possible.

A few years ago, Malin Parmar's research team was one of the first in the world to convert human skin cells directly into brain cells without passing the stem cell state. The discovery shocked the researchers and was perceived as almost impossible. The team is now approaching a point where the discovery is about to bear fruit on a wide scale. By following a new method that involves slightly changing the genetic code that triggers cell conversion, the researchers were able to multiply the production of disease-specific brain cells.

"Primarily, we inhibited a protein, REST, involved in establishing identity in cells that are not nerve cells. After limiting this protein's impact in the cells during the conversion process, we've seen completely different results. Since then, we've been playing around with changing the dosage of the other components in the previous method, which also proved effective. Overall, the efficiency is remarkable. We can now generate almost unlimited amounts of neurons from one skin biopsy", says Malin Parmar, professor of developmental and regenerative neurobiology at Lund University.

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The increase in production will have far-reaching effects. The new volumes enable research projects that were simply not viable before. Among other things, it opens up research areas linked to new drug testing, the establishment of more accurate disease models and the development of diagnostics to detect the diseases at an earlier stage.

The new cells are not only able to imitate the disease but also the patient's age. By studying the cell in the culture dish, the researchers can now monitor the mechanisms of the disease in an "old" brain cell over time. Neurodegenerative diseases are commonly referred to as "aging brain diseases" and in order to understand them, we must better appreciate how the age specifically affects the course of the disease. The Lund researchers' discovery can hopefully contribute a crucial piece to the puzzle with regard to the connection between the onset of disease and cell aging, something which previous research based on animal experiments and stem cells has failed to provide.

"This takes us one step closer to reality, as we can now look inside the human neurons and see what goes on inside the cell in these diseases. If all goes well, this could fundamentally change the field of research, as it helps us better understand the real mechanisms of the disease. We believe that many laboratories around the world would like to start testing on these cells to get closer to the diseases", says Johan Jakobsson, leader of the molecular neurogenetics research group at Lund University.

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The field of cell therapy, which aims to form new cells in the body in order to cure disease, has taken another important step in the development towards new treatments. A new report from researchers at Lund University in ...

Using human skin cells, University of California, Irvine neurobiologists and their colleagues have created a method to generate one of the principle cell types of the brain called microglia, which play a key role in preserving ...

Wellcome Trust Sanger Institute scientists and their collaborators at the University of Cambridge have created a new technique that simplifies the production of human brain and muscle cells - allowing millions of functional ...

Researchers at Karolinska Institutet have made significant progress in the search for new treatments for Parkinson's disease. By manipulating the gene expression of non-neuronal cells in the brain, they were able to produce ...

The first transplantation of stem cells in patients with Parkinson's disease is almost within reach. However, it remains a challenge for researchers to control stem cells accurately in the lab in order to achieve successful ...

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After two stem cell transplants and several rounds of chemo, ‘now he’s just like a normal 2-year-old’ – GoDanRiver.com

When Shannon DeAndrea saw a knot on her 18-month-old sons head last July, she thought he had just fallen.

But more popped up and wouldnt go away. He also began feeling sick.

I finally decided he needed to see a pediatrician, said DeAndrea, who lives in Blairs.

She was told he had ear infections and her son, Nathan, was put on rounds of antibiotics. The knots were normal, she was told.

Another medical provider said he looked anemic. Blood work revealed his hemoglobin was dangerously low.

We ended up in the ER, DeAndrea said. They couldnt figure out why he was anemic.

Shannon and Nathan were sent to Roanoke, where he was diagnosed with a stage 4 neuroblastoma on Aug. 23. He had a tumor in his abdomen that spread to his bone marrow. He had spots on his skull, ribs and spine.

Neuroblastomas are cancers that begin in early nerve cells of the sympathetic nervous system, according to the American Cancer Society.

Since his diagnosis, her son now 2 has had several rounds of chemotherapy and two stem cell transplants and is doing well.

Now hes just like a normal 2-year-old, DeAndrea said. Hes running around with his sister. Hes eating well.

Dr. William Clark is associate professor of medicine and attending physician at Virginia Commonwealth University Massey Cancer Center Stem Cell Transplantation Program. Clark said the procedure is used for conditions including multiple myeloma, lymphoma, sickle cell anemia and leukemia.

Stem cell transplants are used to replace bone marrow that has been destroyed by cancer or destroyed by the chemo and/or radiation used to treat the cancer, according to the American Cancer Society.

High doses of chemo (sometimes along with radiation), work better than standard doses to kill cancer cells. However, high doses can also kill the stem cells and cause the bone marrow to stop making blood cells, which are needed for life. The transplanted stem cells replace the bodys stem cells after the bone marrow and its stem cells have been destroyed by treatment, according to the American Cancer Society.

Two types of stem cell transplants include autologous, which uses stem cells from the patients own body, and allogeneic using stem cells from another person, Clark said.

For leukemia patients, most of the time, we give them stem cells from someone else, Clark said. Chemotherapy helps lower the leukemia disease burden, but the new immune system provided by the new stem cells can fight against the cancer cells and get rid of them, he said.

Virginia Commonwealth Universitys cancer center performs an average of about 160-195 stem cell transplants per year, Clark said. Slightly more than half are autologous procedures, and the rest are allogeneic, he said.

Whitt Clement, former delegate who represented the Danville area in the General Assembly, underwent a stem cell transplant for acute myeloid leukemia in September 2015.

The most important aspect for patients is being self-aware and their own best advocates, Clement said.

My experience was that the patient has to ask a lot of questions throughout the process, he said.

He suspected something was wrong when he noticed his platelet count declining over seven years. He went to a hematologist and had a bone marrow biopsy that revealed his condition.

If I had not taken the initiative myself and gone to see a hematologist, matters would have progressed to the point where I would have been symptomatic, Clement said.

Finding the perfect match in a donor is also important, Clement said. Fortunately, he had a sibling who met all the criteria and donated stem cells.

A person can get great matches from unrelated donors, but its preferable for a donor to be a sibling, said Clement, partner at Hunton & Williams law firm in Richmond.

Your body has an easier time tolerating the new stem cells, he said.

Clement served in the Virginia House of Delegates from 1988-2002, and as Virginias secretary of transportation from 2002-2005 under Gov. Mark Warner.

For someone with multiple myeloma, the transplant does not cure the disease but delays the time it returns by up to seven and a half years, Clark said.

Lymphoma, leukemia and sickle cell anemia can be cured with the procedure, Clark said. Lymphoma can be cured in about 50 to 80 percent of cases, depending on the lymphoma, Clark said.

The first 30 days after the transplant are the most critical, Clement said. During that time, different organs can have varying reactions to the new cells. It can affect the kidneys, liver, gastrointestinal tract, skin, and cause other side effects.

The idea is that the closer the match, the less likely youll have those adverse reactions, he said.

The process includes being put on an immunosuppressant to prevent the immune system from attacking the new cells, Clement said.

He credits the quality of his recovery to asking lots of questions and being his own advocate tape recording conversations with medical providers, coming in with written questions.

Ive been able to recover better because of that, he said.

Its a long journey and so a person confronted with the transplant situation has got to prepare himself for a long journey that requires a lot of questions along the way, Clement said.

There are about 20 million potential stem cell/bone marrow donors in the BeTheMatch Registry in the United States, Clark said.

Stem cell transplants began in the late 50s/early 60s with the first successful procedure done in an identical twin, Clark said. However, stem cell transplants were limited until medicines that prevent rejections became available.

The number of procedures increased in the 1980s, Clark said.

Danville resident Susan Mathena, cancer patient navigator at Danville Regional Medical Center, became a donor about 20 years ago because she wanted to help people. Mathena has also been an organ donor since she got her drivers license.

I see patients all the time that need stem cell transplants, Mathena said. We always need a source of bone marrow donation.

Though she will age out of the stem cell donor list soon, she could still be contacted if she is the only match for someone in need, she said.

Clark will speak next month on stem cell/bone marrow transplants at Ballou Recreation Center at an event held by the Cancer Research and Resource Center of Southern Virginia in Danville.

Thousands of patients with blood cancers like leukemia or other diseases like sickle cell anemia need a bone marrow/stem cell transplant to survive, including some of our own community members, said Kate Stokely Powell, coordinator at the center.

Clarks presentation offers an opportunity in Southside for people battling illness, medical students and professionals and the public to learn from an expert in the field of stem cell transplants, Powell said.

Doctors, hospitals and families affected by a blood cancer disease have done a great job of building a massive database of blood types for potential donor matches, Clement said.

For DeAndrea and her son, Nathan, the first transplant included four or five days of chemo. The new stem cells following the chemo that killed off his old stem cells from the transplant were like a rescue, she said.

Its wiping you out and then giving you your cells back to restart your immune system, DeAndrea said.

A second round of heavy chemo was to try to kill what was left of the cancer and replenish cells, she said.

It was rough, it was a nightmare, DeAndrea said. It was by far the worst phase of his treatment, but I believe, in the long run, its worth it.

She said the procedures should increase Nathans chances for survival and prevent a relapse.

Nathan just finished radiation Tuesday and will go in for a biopsy of his bone marrow this week, DeAndrea said.

Well find out next week where we stand as far as the cancer goes, she said.

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Scientists Take New Approach to Fighting Type 1 Diabetes – Wall Street Journal (subscription)

Wall Street Journal (subscription)

Scientists Take New Approach to Fighting Type 1 Diabetes Wall Street Journal (subscription) Semma, meanwhile, formed in 2014 around research from the Harvard Stem Cell Institute that led to a means of generating billions of insulin-making beta cells in the lab. Similar to ViaCyte, the cells would be placed in a device that is implanted in the ... and more »

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Stem cells: the future of medicine – Medical Xpress

June 23, 2017

Imagine being able to take cells from your skin, transform them into other types of cells, such as lung, brain, heart or muscle cells, and use those to cure your ailments, from diabetes to heart disease or macular degeneration. To realise this, however, challenges still remain, Professor Janet Rossant, a pioneer in the field, says.

All across the world, scientists have begun clinical trials to try and do just that, by making use of the incredible power and versatility of stem cells, which are special cells that can make endless copies of themselves and transform into every other type of cell.

While human embryos contain embryonic stem cells, which help them to develop, the use of those cells has been controversial. The scientists are using induced pluripotent stem cells instead, which are other cells that have been reprogrammed to behave like stem cells.

"There are still significant challenges that we need to overcome, but in the long run we might even be able to create organs from stem cells taken from patients. That would enable rejection-free transplants," said Professor Janet Rossant, a pioneer in the field.

The mouse that changed everything

A speaker at the recent Commonwealth Science Conference 2017 held in Singapore and organised by Britain's Royal Society and Singapore's National Research Foundation, Prof Rossant gave an overview of stem cells' origins, history, uses and potential.

Now a senior scientist at The Hospital for Sick Children (also known as Sick Kids) in Toronto, Canada, after a decade as its chief of research, she was the first scientist to demonstrate the full power of stem cells in mice.

In the early 1990s, scientists believed that stem cells could only become certain types of cells and carry out limited functions. Based on her own research and that of others, however, Prof Rossant believed that they were capable of far more.

Working with other scientists, she created an entire mouse out of stem cells in 1992, upending the conventional wisdom. "We went on to create many baby mice that were completely normal, and completely derived from stem cells grown in a petri dish," she said.

"That was an amazing experiment, and it was instrumental in making people believe that human embryonic stem cells could have the full potential to make every cell type in the body," she added.

When scientists learned how to remove stem cells from human embryos in 1998, however, controversy ensued. Many lobbied against the cells' use in medical research and treatment due to the moral implications of destroying even unwanted embryos to gain the cells.

In Canada, Prof Rossant chaired the working group of the Canadian Institutes of Health Research on Stem Cell Research, establishing guidelines for the field. These guidelines helped to keep the field alive in Canada, and were influential well beyond the country's borders.

In 2006, Japanese researchers succeeded in taking skin cells from adult mice and reprogramming them to behave like embryonic stem cells. These revolutionary, induced pluripotent stem (IPS) cells allowed scientists to sidestep the ongoing controversy.

The challenges in the way

While stem cells have been used for medical treatment in some cases bone marrow transplants, for example, are a form of stem cell therapy there are several challenges that need to be overcome before they can be used more widely to treat diseases and injuries.

"We need to get better at turning stem cells into the fully mature cells that you need for therapy. That's going to take more work. Another issue is that of scale-up. If you're going to treat a patient, you need to be able to grow millions of cells," said Prof Rossant.

She added: "Safety is another concern. One of the most exciting things about pluripotent stem cells is that they can divide indefinitely in the culture dish. But that's also one of the most scary things about them, because that's also how cancer works.

"Furthermore, because we need to genetically manipulate cells to get IPS cells, it's very hard to know whether we've got completely normal cells at the end of the day. These are all issues that need to be resolved."

She noted that some scientists are working on making "failsafe" IPS cells, which have a built-in self-destruct option if they become dangerous. "Bringing stem cells into regenerative medicine is going to require interdisciplinary, international collaboration," she said.

In the meantime, stem cells have been a boon to medical research, as scientists can use them to create an endless supply of different cells to study diseases and injuries, and test drugs. "That's the biggest use of IPS cells right now," Prof Rossant said.

Sick kids and how to help them

At SickKids, which is Canada's largest paediatric research hospital, she has been using stem cells to study cystic fibrosis, a frequently fatal genetic disorder that causes mucus to build up and clog some organs such as the lungs. It affects primarily children and young adults.

SickKids discovered the CFTR gene that, when mutated, causes the disease. It was also the first to produce mature lung cells, from stem cells, that can be used to study the disease and test drugs against it.

Even better, Prof Rossant and her team were able to turn skin cells from cystic fibrosis patients into IPS cells and then into lung cells with the genetic mutation specific to each of them. This is critical to personalising treatment for each patient.

"Drugs for cystic fibrosis are extraordinarily expensive, and patients can have the same mutation and yet respond differently to the same drug," Prof Rossant explained. "With our work, we can make sure that each patient gets the right drug at the right time."

In 1998, Prof Rossant also discovered a new type of stem cell in mice, now called the trophoblast stem cell. These surround an embryo and attach it to the uterine wall, eventually becoming the placenta. She is using such cells to study placenta defects and pregnancy problems.

By using IPS cells to create heart cells and other cells, pharmaceutical companies can also test their new drugs' effectiveness and uncover potential side effects, as well as develop personalised medicines.

"There are still huge amounts of opportunities in pluripotent stem cells," said Prof Rossant, who has won numerous awards for her research, including the Companion of the Order of Canada and the 2016 Friesen International Prize in Health Research.

She is also president and scientific director of the Toronto-based Gairdner Foundation, which recognises outstanding biomedical research worldwide, and a professor at the University of Toronto's molecular genetics, obstetrics and gynaecology departments.

"Meetings like the Commonwealth Science Conference are a fantastic opportunity for scientists to come together, learn about each other's work and establish new relationships, which will help to push science forward, including in stem cell research," she said.

She noted: "The world of science is becoming increasingly interdisciplinary, so this kind of meeting of minds across nations, cultures and scientific fields is really the way of the future."

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Clear View on Stem Cell Development – Technology Networks

Today, tracking the development of individual cells and spotting the associated factors under the microscope is nothing unusual. However, impairments like shadows or changes in the background complicate the interpretation of data. Now, researchers at the Technical University of Munich (TUM) and the Helmholtz Zentrum Mnchen have developed a software that corrects images to make hidden development steps visible.

When stem cells develop into specialized cells, this happens in multiple steps. But which regulatory proteins are active during the decisive branching on the development path? Using so-called time-lapse microscopy, researchers can observe individual cells at very high time resolutions and, using fluorescent labelling, they can recognize precisely which of these proteins appear when in the cell.

Once a stem cell has been identified, it can be closely observed over several days using cell-tracking software. Yet, this surveillance work often turns out to be difficult. The imaging data is frequently marred by irregular brightness and faded backgrounds in the time-lapse, explains Dr. Carsten Marr, heading the workgroup Quantitative Single Cell Dynamics at the Institute of Computational Biology (ICB) of the Helmholtz Zentrum Mnchen. This makes it difficult or impossible to detect proteins that are decisive when a cell opts for a specific development direction, so-called transcription factors.

Algorithms that filter out these kinds of artefacts exist, but they require either specifically prepared reference images, many images per dataset or complex manual adjustments. Furthermore, none of the existing methods correct alterations in the background over time, which hamper the quantification of individual cells.

Algorithm eliminates background changes Now, Dr. Tingying Peng, member of Dr. Carsten Marrs group at the Helmholtz Zentrum Mnchen and Professor Nassir Navab, head of the Chair for Computer Aided Medical Procedures and Augmented Reality at TU Munich, present an algorithm that corrects these artefacts using only a few images per dataset.

The software is called BaSiC and is freely available. It is compatible with many image formats commonly used in bioimaging, including mosaics pieced together from numerous smaller images and used, for example, to render large tissue regions. Contrary to other programs, however, explains Dr. Peng, BaSiC can correct changes in the background of time-lapse videos. This makes it a valuable tool for stem cell researchers who want to detect the appearance of specific transcription factors early on. Bringing significant details to light How well the new image correction program improves the analysis of individual stem cell development steps the scientists demonstrated with time-lapse videos of blood stem cells. They recorded the videos to observe cells over a six-day time span. At a certain point during this observation period undifferentiated precursor cells choose between two possible tacks of development that lead to the formation of different mature blood cells.

In images corrected using BaSiC, the researchers could identify a substantial increase in the intensity of a specific transcription factor in one of the two cell lines, while the amount of his protein in the other cell line remained unchanged. Without the image correction, the difference was not ascertainable.

Using BaSiC, we were able to make important decision factors visible that would otherwise have been drowned out by noise, says Nassir Navab. The long-term goal of this research is to facilitate influencing the development of stem cells in a targeted manner, for example to cultivate new heart muscle cells for heat-attack patients. The novel possibilities for observation are bringing us a step closer to this goal.

The BaSiC image correction program resulted from a close collaboration between the Chair of Mathematical Modeling of Biological Systems and the Chair of Computer Aided Medical Procedures & Augmented Reality at the Technical University of Munich and the Institute of Computational Biology (ICB) of the Helmholtz Zentrum Mnchen. Also involved were the Department of Biochemistry and Biophysics at the University of California in San Francisco (USA), as well as the Department of Biosystems Science and Engineering (D-BSSSE) at ETH Zrich and the Chair of Computer Aided Medical Procedure at Johns Hopkins University in Baltimore (USA).

This article has been republished frommaterialsprovided by the Technical University of Munich. Note: material may have been edited for length and content. For further information, please contact the cited source.

Reference:

Tingying Peng, Kurt Thorn, Timm Schroeder, Lichao Wang, Fabian J. Theis, Carsten Marr and Nassir Navab. BaSiC: A Tool for Background and Shading Correction of Optical Microscopy Images. Nature Communications 8, 14836 (2017) DOI: 10.1038/ncomms14836

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Clear View on Stem Cell Development - Technology Networks

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Former Titan Tim Shaw visits Bowling Green for book signing - Bowling Green Daily News