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Stem cells in the clinic: how are they regulated? – European Pharmaceutical Review

By Stem Cell Clinic

Dr Roger Barker, University of Cambridge, UK and Eric Anthony, International Society for Stem Cell Research (ISSCR), describe how stem cells are regulated around the world and why this is important for patient safety.

Stem cells are used to aid in the understanding and treatment of a range of diseases. According to the International Society for Stem Cell Research (ISSCR), the potential of stem cells is evident from the use of blood stem cells to treat haematological diseases. Furthermore, clinical trials involving stem cells are currently underway for many other conditions, such as diabetes and Parkinsons disease.

However, due to the relative newness of stem cells as a therapy, tight regulations are required to ensure their use poses no risk to patients and that their translation to the clinic is supported by pre-clinical data.

European Pharmaceutical Reviews Victoria Rees spoke with ISSCRs Public Policy Director, Eric Anthony and Dr Roger Barker, Professor of Clinical Neuroscience at the University of Cambridge, to discover more about the regulations regarding stem cells.

Anthony explained that in the EU, stem cells are considered advanced therapeutics, which are medicines for human use based on genes, tissues or cells. The European Medicines Agency (EMA) determines whether products fall under the advanced therapeutics category based on the level of manipulation of the product and whether it is used homologously or non-homologously. However, one notable exception to this is platelet rich plasma (PRP), which the EMA does not count as an advanced therapy.

Anthony said that the UK currently follows the rules that are adopted in the EU, which is likely to continue into next year at least. He suggested that after the UK discontinues its ties with the EU and its regulations, he expects its regulatory structure will remain similar.

The US Food and Drug Administration (FDA) also defines most stem cell products as advanced therapeutics, explained Anthony, based on minimal manipulation and homologous use. He highlighted that largely, stem cell products across the globe are defined in much the same way.

Barker explained that the key question every regulator has to ask relates to the source of the stem cells, whether in trials or in the clinic and the extent to which they have been manipulated. Other questions that regulators must answer include the consenting process behind the parent cells being used as well as determining what constitutes the final cell product. However, this latter question has proven to be quite complicated as it is often hard to know what every cell in a product is. Also, some therapies are given in an undifferentiated state with the aim of letting them differentiate and mature once grafted, which creates issues for defining the potency of the cells at the time of implantation. As stem cells will differentiate over months into the desired product, regulators need to know the correct processes are in place to ensure that this will happen in the way anticipated and that the right cells will develop out of the grafted stem cell product.

Another issue he discussed is the stability of stem cells. Once you have frozen them, how stable are they when you wake them up and transplant them at later stages?

In addition, one of the more pressing unresolved questions that Barker emphasised is the genetic variance of stem cells and their products and what this means for the safety of the cells. When researchers conduct whole genome sequencing of the stem cell products, it will convey many genetic variants but knowing what this means for the grafted cell or recipient patient is often an unknown.

Anthony explained that there are a number of consequences to giving patients unregulated stem cell treatments. The main factor is the risk posed to patients; in certain parts of the world, patients have died from stem cell therapies and others in the UK and US have been blinded, paralysed or infected by pathogens.

This, he explained, has a wider impact upon the whole field, as it can negatively impact those who have spent years developing techniques with great rationale which are then undermined by bad practice.

Companies that market unapproved stem cell therapies may not ensure their products are sourced correctly and there is also the danger of mishandling, contamination or undisclosed additives.

Barker highlighted that there is an ethical issue involved in the field of stem cells when unregulated stem cell products are used, it can exploit desperate patients. Therefore, regulations need to ensure patients stay safe and that the industry remains ethical, but not restrict pharma to the extent that it prevents any progress in the field.

A regulator cannot decide what a product is without actually examining the product, said Anthony, explaining this is one of the problems that regulators face. As regulators need to determine the safety and proper sourcing of stem cells physically, they are restricted by both time and financial constraints.

He also highlighted that the current regulations for stem cells mean some companies market their products as PRP, which are regulated as blood products, so are not treated in the same way as advanced therapies. However, these claims are not validated, making them unsubstantiated. As the EMA does not regulate PRP as an advanced therapy product, these companies exploit a loophole in regulation.

Despite this, Anthony does not believe there is a big hole in regulations that is allowing these companies to sell their products.

Instead, he argued that the wider issue for regulators is that these companies exist but the resources to properly inspect facilities and enforce regulations can be problematic. For example, there are up to 70 clinics in the UK, but there needs to be a substantial increase in the number of inspections, according to Anthony.

To improve the regulation of stem cells there needs to be more harmonisation across the globe, said Barker. If regulations across countries and continents could relate to one another, this would enable more consistency and clarity for companies and researchers. Issuing statements, documents and guidelines that anyone can use would be the ideal way to improve the industry, remarked Barker, especially as the definitions are already similar. This could also lead to an effective network for those in the field to connect to the relevant advisors.

Anthony concurred, arguing that there are providers and physicians who could use a better education about how certain products are regulated. For example, he explained, the UK and each EU member state decides its own hospital exemptions for stem cells however, in this regard, there could be better education for physicians about what is classified as an advanced therapy.

Both Barker and Anthony agree that the future of stem cell therapies requires collaboration, such as the synchronised education of clinicians, scientists and regulators. Enabling these groups to work together and earlier would streamline the process and ensure that products are safe and efficacious before going to market.

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Stem cells in the clinic: how are they regulated? - European Pharmaceutical Review

NHS’s oldest IVF clinic at risk of closure amid increasing privatisations – The Guardian

By Stem Cell Clinic

The UKs oldest NHS fertility clinic is at risk of closure and another has been put out to private tender, as IVF provision is increasingly privatised and rationed.

Hospital bosses want to close the internationally renowned department of reproductive medicine at St Marys hospital, Manchester, saying they cannot afford to fund a 10m upgrade of the unit, the Guardian has learned.

In Leeds, the entire NHS provision of fertility and other gynaecology services was put out to tender earlier this year, with private clinics invited to bid for a 10-year contract estimated at 70m to provide reproductive care.

Two years ago North Bristol NHS trust sold off its IVF clinic to a private provider, saying it was no longer feasible because of a reduction in NHS-funded patients.

In England, the proportion of fertility treatment funded by the NHS dropped from 39% in 2012 to 35% in 2017, according to figures published last year by the regulator, the Human Fertilisation and Embryology Authority (HFEA). This is at odds with the rest of the UK, where public funding has remained stable or increased.

When it opened in 1982, four years after the first test tube baby, Louise Brown, was born in nearby Oldham, St Marys was the UKs first fully NHS funded IVF unit. It now performs over 2,000 fertility treatments every year, including around 1,200 IVF cycles, and offers highly specialised fertility preservation for cancer patients. It is also a top research centre, which led on the use of ovarian reserve tests to guide ovarian stimulation, the development of stem cell lines from human embryos, and the effects of IVF on baby birth weights.

The Manchester University NHS foundation trust (MFT) said no decisions had been made over the units future. But staff were briefed last month that the HFEA and local clinical commissioning groups (CCGs) had been told that all licensed treatment and research on the site may end by April 2021 if an alternative solution cannot be found.

MFT, which runs the hospital, is also exploring options including redeploying services and some of its 107 staff including many highly specialised roles but confirmed to staff that closure was a possibility.

The Guardian spoke to 10 members of staff at St Marys aware of the mooted closure. One said they understood the matter to be settled: St Marys have taken a proposal to the MFT group board to discontinue the IVF service and the group board have said, Yes, OK. How they discontinue it is what they need to decide next, they said.

If the change goes ahead, CCGs, which fund fertility treatment, will have to pay private clinics to carry out IVF and other fertility services. But staff at St Marys warn that the private sector will not be able to carry out some of the most specialised services currently offered by the NHS.

We offer highly specialised procedures in the NHS which private providers wont touch because they dont make money and are too difficult. For example, we aim to see women diagnosed with cancer within a week who want to freeze their eggs before they start chemotherapy. Many of these women are already very poorly and need really high quality anaesthetic care during egg collection, and that is just not available in the private sector because of the medical complications, said one source.

They added: Private clinics are also unlikely to help patients with kidney problems or heart problems. But when they come to us, we can address these issues before they begin IVF: a huge advantage of being part of a multi-disciplinary NHS Trust. Those patients will be disadvantaged if this happens.

They also expressed concerns about screening procedures in the private sector. In the NHS, anyone applying for fertility treatment undergoes a series of stringent checks, including an assessment of the welfare of the child: Our checks and ethics advisory committee often flag issues including prison sentences, a serious history of domestic violence, even people on the sex offender register. At private clinics they dont do anything like the same background checks.

A number of separate proposals were put to MFT to try to save some or all of the clinic, including turning the service into a social enterprise and forming a partnership with a private provider, as is being proposed in Leeds.

The deadline to apply to run the Leeds service was 23 March, the day the government announced the coronavirus lockdown in the UK. Shortly afterwards, clinics stopped all new treatments and the HFEA ordered private and NHS clinics to stop treating patients in the middle of an IVF cycle by 15 April.

A spokesperson for the MFT, which runs St Marys hospital, said no decision had been taken to shut the clinic permanently.

They said: Services provided by the department of reproductive medicine at St Marys hospital are regularly reviewed as part of a usual cycle to ensure that we continue to provide the best possible care and treatments for all our service users. No decisions have been made, therefore it would be inappropriate to provide any further detail before the outcome of any review has been finalised.

The HFEA said it could not disclose informal discussions between clinics and inspectors.

Many St Marys staff are worried not just about their patients and their jobs, but the logistics of closing down the clinic. Moving thousands of sperm samples and embryos held in freezers, for use in both treatment and research, was a mind-boggling challenge, said one.

One staff member said: Although possible relocation was mentioned, the fact that no viable alternative has been identified and that the cost was described as being too high left us thinking that this is not being explored and that closing the unit is the direction of travel. We are worried for our jobs but our biggest concern is for our patients, particularly those with the most complex needs who cannot be served elsewhere without high costs.

IVF provision has been put under pressure, nationally, by NHS funding cuts over the past decade leading to a postcode lottery of provision. Now only a minority of English CCGs offer the recommended three funded IVF cycles, with some refusing to fund any NHS fertility treatment at all.

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NHS's oldest IVF clinic at risk of closure amid increasing privatisations - The Guardian

Stem cell activity linked to lifestyle – Harvard Magazine

By Stell Cell Research

Sleep, diet, exercise, and stress: these are factors known to change a persons risk of developing numerous non-communicable diseases. Such lifestyle impacts on healthbeneficial or harmfulexert much of their influence via inflammation. About 10 years ago, Matthias Nahrendorf began wondering just how inflammation and lifestyle might be linked biologically, and started thinking about how to pinpoint the mechanism in the cardinal case of cardiovascular disease.

A persons level of inflammation can easily be measured with a simple white blood cell test. White blood cells fight off bacterial invasions and repair damaged tissues, but they can also damage healthy tissue when they become too abundant. You can find them in atherosclerotic plaques, and you can find them in acute infarcts, says Nahrendorf, a professor of radiology who conducts high-resolution imaging research at Massachusetts General Hospital. You can find them in failing hearts and the brain, where they increase the risk of stroke.

By linking exercise to reduced white blood cell production, Nahrendorf shows how a lifestyle factor can modulate cardiovascular risk.

When Nahrendorf learned that the most potent, toxic, and pro-inflammatory white blood cells live only a few hours, or at most a day, he immediately realized that the paramount questionsgiven that they die off quickly yet remain abundant in the bloodare, where and why are they produced? What is their source? Perhaps, he hypothesized, lifestyle factors regulate hematopoiesis (blood production).

To test this idea, he decided to study the effects of exercise on the production of these leukocytes in healthy mice. First, though, he consulted the scientific literature on exercise in mice. Previous researchers, he learned, had found that exercise increases production of inflammatory immune cellswhich I thought was counterintuitive, Nahrendorf recalls. When he looked more carefully, he discovered that the type of exercise used in the studies was forced and thus possibly stressful because it was induced by electric shocks. He therefore decided to test only voluntary exercise. He and his colleagues put a wheel in each mouses cage, so the animals could choose to run if they were interested.

The mice never ran during the day. That is when they rest, Nahrendorf explains. But in the dark, they ran a lot, averaging six to seven miles every night. After three weeks, the exercising mice had measurably lower levels of circulating white blood cells. Exercise, he found, had pushed their blood stem cells (cells that can produce all the different types of blood cells) into a state of quiescence: a kind of dormancy in which they generate fewer pro-inflammatory white blood cells and platelets, without decreasing the number of oxygen-carrying red blood cells. Soon the exercising mice had fewer circulating white blood cells than their sedentary counterparts, dampening inflammationan effect that persisted for weeks.

The local signals within bone marrow that induce quiescence in blood stem cells were already well known, but the fact that exercise could trigger them was not. Nahrendorf next wanted to learn the identity of the trigger linking exercise to blood stem cell quiescence. Further investigation revealed that the only receptors with enhanced activity in the bone marrow niche where most blood stem cells exist were binding to a well-known hormone called leptin; it is produced by fat cells and regulates hunger.

Leptin is like the fuel gauge in a car. When the tank is fullmeaning energy (and food) are abundantleptin levels run high. As exercise uses up the gas in the tank, this lowers leptin levels, which signal that reserves are running low, thereby inducing hunger and the urge to eat in order to replenish depleted energy stores. Nahrendorf and his co-authors speculate in their 2019 Nature Medicine paper that leptins role in regulating energetically costly hematopoiesis may have evolved to produce blood cells only when whole body energy was abundantnot when people are exerting themselves. Contemporary sedentary behavior, they continue, which increases leptin and consequently hematopoiesis, may have rendered this adaptation a risk factor for cardiovascular disease (CVD) and perhaps also for other diseases with inflammatory components.

But with fewer circulating immune cells, would exercising mice be more vulnerable to infection? Nahrendorf challenged them with a protocol designed to induce infection in the blood, and found just the opposite: exercising mice had a more robust immune response, as semi-dormant blood stem cells swiftly sprang into activity and produced infection-fighting leukocytes, improving survival of the active mice as compared to those with no running wheels in their cages. Next, they investigated whether exercise would help mice with established atherosclerosis, and found that exercise was not only protective, it also reduced the size of existing plaques in the aorta.

Whether these associations would hold up in humans remained an open question. For answers, Nahrendorf turned to a study known as CANTOS, which had measured levels of inflammation in 4,892 patients who suffered heart attacks (see Raw and Red Hot, May-June 2019, page 46). When he approached the studys co-authors, Mallinckrodt professor of medicine Peter Libby and Braunwald professor of medicine Paul Ridker, he learned, serendipitously, not only that they possessed self-reported exercise levels for the participants, but also that they had tested leptin levels as well. They analyzed their raw data and found the same relationship among exercise, leptin, and leukocytes as in the mice. Data from a second human study cemented the result.

By identifying a previously unknown molecular mechanism linking voluntary exercise to reduced white blood cell production, Nahrendorf and his colleagues have highlighted how a lifestyle factor can modulate cardiovascular risk. Their discovery, the researchers hope, will point the way to wider adoption of healthy exercise regimens, and health-enhancing anti-inflammatory drugs.

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Stem cell activity linked to lifestyle - Harvard Magazine

Magenta Therapeutics Names John Davis Jr., M.D., M.P.H, M.S., Head of Research and Development – Business Wire

By Stell Cell Research

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Magenta Therapeutics (NASDAQ: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of immune reset to more patients, today announced that it has promoted John Davis Jr., M.D., M.P.H., M.S. to Head of Research and Development and Chief Medical Officer.

As Magenta continues its strong track record of progress in both Research and Development, we are further positioning the company for future success by strengthening the collaboration and synergies between these two crucial organizations within Magenta, said Jason Gardner, D.Phil., President and Chief Executive Officer, Magenta Therapeutics. John Davis is an experienced physician-scientist drug developer and the ideal patient-centric leader to guide our R&D organization in their singular focus to bring our multiple transformative new medicines to patients in the most effective and efficient manner.

Magenta is the only company that is solely focused on delivering curative immune reset to more patients with autoimmune diseases, blood cancers and genetic diseases. The Company has built its success upon a strong research platform and a promising early clinical pipeline, said Dr. Davis. With our world-class team, I look forward to harnessing our preclinical, translational and clinical expertise to deliver a portfolio of groundbreaking new medicines for patients.

Dr. Davis joined Magenta as Chief Medical Officer in 2018. Previously he served as Senior Vice President and Head of Early Clinical Development at Pfizer. Prior to that, Dr. Davis was Vice President and Global Therapeutic Area Head of Immunology at Baxalta/Shire and was Senior Group Director and Head of the Inflammation and Cardiovascular/Metabolism Group in the Early Clinical Development Group at Genentech. Dr. Davis spent nearly 10 years on faculty at The University of California San Francisco leading clinical research in multiple autoimmune diseases, and he was Professor of Clinical Medicine. Dr. Davis earned an M.D. from the University of Maryland where he graduated summa cum laude. Dr. Davis trained in Internal Medicine and Rheumatology at The University of California San Francisco. He continued training in clinical research and rheumatology at The National Institutes of Health NIAMS Intramural Program. He holds an M.P.H. in Epidemiology from the University of California Berkley, and an M.S. in Anatomical Science from the University of Maryland School of Medicine. He is a fellow of both the American College of Physicians and the American College of Rheumatology and continues to see patients at the Boston VA Medical Center.

About Magenta Therapeutics

Magenta Therapeutics is a clinical-stage biotechnology company developing medicines to bring the curative power of immune system reset through stem cell transplant to more patients with autoimmune diseases, genetic diseases and blood cancers. Magenta is combining leadership in stem cell biology and biotherapeutics development with clinical and regulatory expertise, a unique business model and broad networks in the stem cell transplant world to revolutionize immune reset for more patients.

Magenta is based in Cambridge, Mass. For more information, please visit http://www.magentatx.com.

Follow Magenta on Twitter: @magentatx.

Forward-Looking Statement

This press release may contain forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as may, will, could, should, expects, intends, plans, anticipates, believes, estimates, predicts, projects, seeks, endeavor, potential, continue or the negative of such words or other similar expressions can be used to identify forward-looking statements. The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation risks set forth under the caption Risk Factors in Magentas most recent Annual Report on Form 10-K, as updated by Magentas most recent Quarterly Report on Form 10-Q and its other filings with the Securities and Exchange Commission. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although Magenta believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither Magenta nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

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Magenta Therapeutics Names John Davis Jr., M.D., M.P.H, M.S., Head of Research and Development - Business Wire

Coronavirus threat to global Totipotent Stem Cell Market : Trends and Future Applications – Curious Desk

By Stell Cell Research

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Coronavirus threat to global Totipotent Stem Cell Market : Trends and Future Applications - Curious Desk

Pandemic reveals another shortfall in preparation: Scattershot, chaotic research for treatments – Seattle Times

By Stell Cell Research

In a desperate bid to find treatments for people sickened by coronavirus, doctors and drug companies have launched more than 100 human experiments in the United States, investigating experimental drugs, a decades-old malaria medicine and cutting-edge therapies that have worked for other conditions such as HIV and rheumatoid arthritis.

Development of effective treatments for COVID-19 would be one of the most significant milestones in returning the United States to normalcy. But the massive effort is disorganized and scattershot, harming its prospects for success, according to multiple researchers and health experts. Researchers working round-the-clock describe a lack of a centralized national strategy, overlapping efforts, an array of small-scale trials that will not lead to definitive answers and no standards for how to prioritize efforts, what data to collect or how to share it to get to answers faster.

Its a cacophony; its not an orchestra. Theres no conductor, said Derek Angus, chair of the department of critical care medicine at University of Pittsburgh School of Medicine, who is leading a COVID-19 trial that will test multiple therapies. My heart aches over the complete chaos in the response.

The global biomedical research establishment could be one of most powerful assets in the campaign against the new virus, with experts all over the world and especially the scientific and medical powerhouse of the United States in rare alignment in their focus on a single enemy. Some large trials designed to be definitive have launched. But with more than 500 human clinical trials worldwide, the lack of coordination puts the world at risk of ending up with a raft of inconclusive and conflicting studies and little idea of what interventions work for the next wave of illness.

Public-private partnership reportedly in the works

Francis Collins, director of the National Institutes of Health, the nations largest biomedical research agency, acknowledged researchers frustrations but said in an interview Wednesday he has been working behind the scenes to launch an unprecedented, public-private partnership to address the problems. He said the framework involves top pharmaceutical companies such as Pfizer and Johnson & Johnson, domestic and international government agencies, including the European Medicines Agency, and academic research centers.

Collins said the monthlong discussions have been kept under wraps to ensure buy-in for an approach likely to require sacrifices of personal recognition, scientific credit and profit a centralized decision, for example, not to proceed with tests of one companys drug to move faster on a competitors.

I think we have the necessary clout to steer this whole complicated ecosystem, he said. When you look at some of the things that are happening sporadically, we may be unlikely to learn what we need to from such disconnected, small trials. The whole point is to replace that with a coherent, evidence-based approach I want to know what works, and I want to have it answered by June or July.

Agency officials said further details would be released in coming days.

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), said in an email Tuesday that the partnership led by Collins is the functional equivalent of a National Strategy.

While Collins was working on developing that strategy, hospitals, drug companies, government labs and individual doctors were flooding the system with proposals for drugs and other interventions to test against the virus an outpouring that reveals how siloed and fragmented the research enterprise remains. For example, there are 26 separate U.S. trials listed for the anti-malarial drug hydroxychloroquine, all with different designs. Some use the drug as a preventive, others as a treatment. Some use it alone, some with other drugs or vitamins, and some have no comparison group to tell if the drug was responsible for the outcome. That will make it more difficult to conclude whether, or in what circumstances, the drug may work.

Collins said a working group is addressing this problem by sifting through about 100 possible COVID-19 treatments to decide which are the six to eight most promising drugs to move forward in large-scale trials. Those will be deployed in large clinical trial networks.

The new federal effort is motivated in part by what happened in China. Clifford Lane, deputy director for clinical research and special projects at NIAID, traveled to the origin of the outbreak in February as part of an international delegation to help the world learn from the Chinese experience. He was troubled by the lack of a strategic plan to prioritize and fast-track the most promising treatments, leading to a mosaic of inconclusive findings.

We do have to have a bigger strategy than every university, every institute and to be blunt every country working on their own research efforts, Lane said in an interview.

Urgency of outbreak pressures scientists

At the heart of the problem is the basic question of whether a drug really works. Typically, drugs and medical interventions are first tested in small clinical trials that establish safety before the most promising ones are funneled into bigger trials, in an iterative and yearslong process. These trials, which typically randomly assign patients to receive either a drug or a placebo, prove that medicines, vaccines and medical procedures are effective and safe. But with the urgency of the coronavirus threat, timelines have been squeezed, doctors are doing uncontrolled experiments as they administer regular care and the typical model for research is too slow.

David Boulware, an infectious disease physician and scientist at the University of Minnesota, has gotten at least 50 emails from companies and researchers with treatments they want to test. The urgency to find something anything for patients who have nothing other than supportive care has led researchers to pull everything off the shelf: a mix of existing drugs that show promise, stem cell treatments and brand new compounds designed specifically against COVID-19.

The energy is remarkable, but it needs to be channeled. Clinical trials, whether for an HIV drug or a brand new medicine, compete for many of the same patients. If there are too many trials at a hospital, none of them may enroll enough patients to get clear results. If there are too many similar small trials running in parallel, their results individually may be inconclusive, and the data could have so many differences they may not be able to be pooled.

Theres all sorts of people wanting to try anything, because people are desperate, Boulware said.

He and others who were unaware of Collins plans argue that national leadership whether guidance on how to prioritize trials, a central body coordinating efforts, or a mechanism to play matchmaker among institutions working on similar ideas could help channel the ubiquitous scientific desire to make a bigger, faster impact.

Some large-scale efforts are already underway: The World Health Organization has organized a massive trial in 90 countries of four promising therapies. The National Institutes of Health is conducting a test of the antiviral medication remdesivir at more than 50 institutions and last week launched a large trial for an anti-malarial medication. A $50 million effort at the Duke Clinical Research Institute will test hydroxychloroquine in 15,000 health care workers and create a registry that can be tapped to speed up future trials, such as for a vaccine.

People should not be fatalistic that were going to have a paucity of evidence for things that provide benefit, Collins said. I hope well have three to four of those [treatments] by the summer.

But as the federal effort has proceeded largely in secret, individual institutions have scrambled to set up committees of experts who evaluate which trials make sense to move forward. At the University of Pennsylvania, a weeks-old committee gives priority scores to trials based on criteria such as whether they will compete with existing efforts and how likely they are to enroll all the patients needed to get a result. A task force at Duke University does a similar review.

Theres a lot of stuff bubbling up. It would seem like a sensible thing to do would be to align everyone around the same trials, not one trial for each context and not have each institution do its own thing and at the end of the day everyone has done a small trial and we dont know what to make of it, said Steven Joffe, a bioethicist at the University of Pennsylvania. Lets get to an answer.

Many proposed trials overlap using the same drug, such as the anti-malaria treatment hydroxychloroquine that has been touted by President Trump, his lawyer Rudolph W. Giuliani and conservative talk-show host Laura Ingraham.

Boulware is halfway through one such hydroxychloroquine trial, which examines whether the drug is effective at preventing the disease or in treating people with mild cases. People who participate will receive either the drug or a vitamin in the mail.

He said he is motivated by his experience working on Ebola, when by the time a well-designed trial was up and running, the outbreak was dying down. He plowed ahead with his hydroxychloroquine trial weeks before he heard last Friday the National Institutes of Health had declined to fund it. He found international collaborators through chance and social media, when some Canadian researchers emailed to ask if he would share his trial design with them. He ended up connecting the Canadians with one another and is now working on overcoming the complex legal requirements to share data.

But now, his trial is potentially competing with a bunch of others that also test hydroxychloroquine all across the country and enrollment has slowed in recent days.

Hope and confusion about evidence

Small trials and even anecdotal reports of treatments that appear to have worked on small groups of patients are already being shared, sowing both hope and confusion about the evidence.

A study published Friday in the New England Journal of Medicine, for instance, reported on 53 people who took remdesivir, a failed Ebola drug Trump has praised and many families have already tried to get access to outside of trials. The results were impossible to interpret, though, since some of those patients might have gotten better on their own and there was no comparison group of patients who did not receive the drug. Hydroxychloroquine, the cheap and readily available anti-malarial drug, has also already been widely used in patients, despite only suggestive evidence that it might work.

As more small-scale studies are designed, the risks of inconclusive but suggestive results multiply and paradoxically, they could make it harder to conduct well-designed clinical trials that get to the bottom of whether a treatment works. Well-designed clinical trials require patients to be willing to be randomly assigned to receive the treatment or a placebo.

Emma Meagher, chief clinical research officer at the University of Pennsylvanias Perelman School of Medicine, said her institutions study of the malaria drug in severely ill patients does not have a comparison group that receives a placebo because the media around the drug has made it the standard of care despite the lack of evidence. Every meeting, she said, begins with a discussion about how to prevent the next experimental therapy from becoming like hydroxychloroquine.

In some ways, designing research studies when clinicians have an imperative to give their patients the best care possible is an inherently tricky situation. Outside of top-tier research hospitals, patients may not have access to trials, so clinicians may have little option but to give them drugs in what amounts to an uncontrolled experiment. The Infectious Diseases Society of America released guidelines last week that clinicians should give experimental drugs only in trials, but safety-net and small, rural hospitals are less likely to have access to those.

Do we really want to have [some] people trying new different things and the rest of you sit and wait? asked Benjamin Linas, an infectious disease physician working on oversight of clinical trial protocols at Boston Medical Center.

Many researchers have said they are hopeful a national strategy will help unify and speed the search, but lament the time already lost. The United States did not have a pandemic clinical trials network ready to be activated, but existing clinical trials networks, such as ones used to test HIV treatments, are now being repurposed. Collins said he had never seen research move faster, but in a pandemic that can still feel slow.

We have imperfect networks. I mean there are some there, but theyve never been tested in this way, said Adrian Hernandez, vice dean for clinical research at Duke University School of Medicine. Having a common infrastructure that can do rapid cycle trials that would be beneficial.

Collins said he began partnering with private companies, research institutions and other agencies in mid-March. Had he started sooner, he said, the urgency of the situation might not have been clear to the companies and agencies he had to convince to work together. He disagrees significant time has been lost and noted the efforts were able to piggyback on an existing framework for pursuing drugs with industry collaboration called the Accelerating Medicines Partnership.

Partnerships that previously took a year and a half to build were put together in a week, he said.

I think it is a world record for anything of this sort; it might have been difficult to get full unanimous agreement to what is clearly unprecedented for a willingness to give up control, Collins said.

As with other areas of pandemic planning, many hope the United States will learn from this lesson, that it needs a preparedness plan not only for allocating essential supplies and scaling up testing but also in plotting research.

The problem is we need to remember to invest in preparedness, at times when were not affected with a pandemic or epidemic, said Barbara Bierer, director of the regulatory foundations, ethics and the law program of the Harvard Clinical and Translational Science Center. And its hard to repurpose or commit resources to something that doesnt appear immediate on the horizon.

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Pandemic reveals another shortfall in preparation: Scattershot, chaotic research for treatments - Seattle Times

Study of Stem Cell Therapy for Highly Active RRMS Honored by CR Forum – Multiple Sclerosis News Today

By Stem Cell Treatment

The MISTPhase 2 clinical trial, supporting the potential of hematopoietic (blood cell-producing)stem cell transplant (HSCT) to significantly slow disability progression in highly activerelapsing-remitting multiple sclerosis (RRMS)patients, has received a Distinguished Clinical Research Achievement Award from the Clinical Research (CR) Forum.

Five years after the transplant, most treated patients showed no further disease progression or activity, a press release announcing the honor stated.

The CR Forum is a nonprofit association of clinical research experts and leaders at leading academic health centers in the U.S. Each year, it recognizes exceptional studies through itsTop 10 Clinical Research Achievement Awards.

Two of these awards are considered Distinguished Clinical Research Achievement Awards, and highlight clinical studies whose creativity, innovation, and novelty carry great promise for patients. Each carries a cash prize of $5,000.

One Distinguished Award wasgiven to Richard Burt, MD, the chief of Northwestern Medicinesimmunotherapy for autoimmune diseases division,who pioneered the use of HSCT to treat relapsing MS.

His project is titled Hematopoietic Stem Cell Transplantation for Frequently Relapsing Multiple Sclerosis.

HSCT is an intensive therapy that rebuilds a patients immune system. The first step is to collect a patients own (meaning, autologous) healthy hematopoietic stem cellsfrom the bone marrow, followed by a fairly non-aggressive combination of chemotherapy (non-myeloablative) that kills the rest of the patients immune cells.

The hematopoieticstem cellsare then infused back to the patient to generate a new, and healthy immune system.

The MISTPhase 2 clinical trial (NCT00273364), led by Burt in collaboration with an international team of researchers, compared the efficacy of non-myeloablative HSCT to continuous disease-modifying therapy (DMT) use.

A total of 110 patients, ages 18 to 55, with aggressive RRMS were enrolled. All had at least two relapses while undergoing treatment with a DMT in the previous year.

Patients were equally randomized to a chemotherapy regimen plus a suppressant of the immune system (to prevent HSCT rejection), followed byHSCT (55 patients), or as a control group to a stronger DMT, different from the one they had taken the previous year (55 patients).

The control group was given a wide selection of DMTs to choose among, including interferons,Tysabri(natalizumab),Tecfidera(dimethyl fumerate),Gilenya(fingolimod),Copaxone(glatiramer acetate), andNovantrone(mitoxantrone).Other immune therapies in the control group included corticosteroids, Cytoxan (cyclophosphamide), andrituximab.

Results, published in the journal JAMA in 2019,showed that significantly fewer patients in the HSCT group experienced disease progression (three out of 52) after one year compared to those in the DMT group (34 out of 51).

Progression did increase over time, but at a significantly lesser rate in the HSCT group.

Over the first year post-transplant, 36 patients in the DMT group experienced a relapse, while one patient relapsed in the HSCT group. During this period, scores on the Expanded Disability Status Scale(EDSS; a method of quantifying disability in MS with higher scores corresponding to greater disability) decreased in the HSCT group, dropping from 3.38 to 2.36. Scores over that year in the DMT group the score rose from 3.31 to 3.98.

Patients in the HSCT group also showed significantly less disease activity on MRI scans after one year.

No patient died during the study, and no potential life-threatening events (cardiac failure or generalized infection affecting multiple organs, called sepsis) occurred in the HSCT group.

HSCTs use is also thought to translate to a lower financial burden on both private insurance companies and public health, the release states. HSCT is estimated to have a one-time cost of around $98,000, while other MS therapies carry a yearly cost of around $80,000 and are required throughout a persons lifetime.

Most importantly, the CR Forum notes, HSCT achieved for the first time what no other therapy has the ability to nearly halt disease progression and relapses.

Most patients show no further progressive disability or evidence of new disease activity over 5 years. HSCT is markedly superior to the current, ongoing drug therapies in preventing relapses, slowing disease progression, decreasing the burden of disease in the brain, and improving a patients quality of life, the release states .

The other Distinguished Clinical Research Achievement Award was given to the CREDENCE Phase 3 trial, led by Kenneth Mahaffey, a professor of medicine(cardiovascular medicine) at theStanford University MedicalCenter.

This randomized study (NCT0206579) enrolled 4,401 people with type 2 diabetes and kidney disease due to diabetes. Patients were randomized to canagliflozin (sold as Invokana, among other brand names) or a placebo.

Results showed that canagliflozin lowered the risk of kidney failure by 30% in these patients, marking the first time a therapy has lowered the risk of kidney failure in this patient group. Treatment with canagliflozin lowered the risk of death due to heart attacks and strokes, as well as the rate of hospitalization due to heart failure.

Finally, The Herbert Pardes Clinical Research Excellence Award, which has a $7,500 prize, when to researchers who developed and studied an innovative skin-like sensor that is placed on an infants chest and foot to allow closer monitoring of health using wireless technology. According to the release, such monitoring dramatically improves medical outcomes for the most fragile patients, like premature infants.

The study was led by John Rogers and his engineeringteam at Northwestern Feinberg School of Medicine in collaboration with clinicians.

This years award winners demonstrate the immense value of our nations investment in clinical research, and the direct impact of that work on the health of millions of people in the United States, Harry P. Selker, MD, CR Forum board chair and dean of the Clinical and Translational Science Instituteat Tufts University, said in the release.

For many, these innovative studies and related clinical trials may represent the only hope for surviving a life-threatening disease. They also pave the way to advance new therapies and treatments that improve public health, Selker added.

The full list of the 2020 Top 10 Clinical Research Achievement Awardees is available here.

Patricia holds her Ph.D. in Cell Biology from University Nova de Lisboa, and has served as an author on several research projects and fellowships, as well as major grant applications for European Agencies. She also served as a PhD student research assistant in the Laboratory of Doctor David A. Fidock, Department of Microbiology & Immunology, Columbia University, New York.

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Patrcia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.

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Study of Stem Cell Therapy for Highly Active RRMS Honored by CR Forum - Multiple Sclerosis News Today

New Treatment Shows Vision Benefit in Age Related Macular Degeneration – Benzinga

By Stem Cell Treatment

MD Stem Cells reports results for Dry AMD from their clinical study SCOTS - the Stem Cell Ophthalmology Treatment Study. 63% of treated and evaluated eyes achieved improvement in vision while an additional 34% had vision remain stable in follow up. No complications occurred. Results were statistically significant.

Westport, CT, April 18, 2020 --(PR.com)-- Age Related Macular Degeneration - specifically dry AMD - will affect almost 200 million people worldwide in 2020. An approach, pioneered by MD Stem Cells, using bone marrow stem cells from the actual patient has now shown visual improvement for 63% of dry AMD eyes and stability in another 34%, demonstrating statistical significance in helping patients with this blinding disease. Results were recently published in the Medicines Journal - a highly regarded international medical journal. The title of the paper: Stem Cell Ophthalmology Treatment Study (SCOTS): Bone Marrow-Derived Stem Cells in the Treatment of Age-Related Macular Degeneration.

There is no FDA approved medication for treating dry AMD. Certain vitamins may reduce the risk of bleeding or wet AMD. But vitamins do not appear to stop the relentless loss of retinal cells and vision called geographic atrophy (GA) from AMD.

The highlight of the MD Stem Cell report was that 63% of dry AMD eyes treated and followed had vision improvement. This ranged from 2.5% to 44.6% with an average of 27.6% on a scientific vision scale called LogMAR. An additional 34% of eyes remained stable for the follow up period- important because many of the eyes had previously been losing vision. The findings were highly statistically significant with p < 0.001 meaning that the results overwhelmingly met that medical standard and confirming that the BMSC treatment was responsible for the improvements seen.

The Stem Cell Treatment Ophthalmology Study- both SCOTS and SCOTS2 - has been treating many different eye diseases since 2013 using the patients own bone marrow stem cells (BMSC) injected in the orbit around the eye. The study is Institutional Board Approved and National Institutes of Health registered on http://www.clinicaltrials.gov NCT 03011541. The physicians involved with MD Stem Cells now have 14 world class medical and scientific publications primarily reporting their clinical results in ophthalmology. This is vastly more than any other stem cell research group working with eye disease and should be reassuring to patients and health care providers seeking treatment options. Different optic nerve diseases, NAION, LHON, DOA, optic atrophy; as well as several retinal diseases including Retinitis Pigmentosa, Ushers and now AMD have all shown benefit. MD Stem Cells has worked to achieve the safest, most effective approach to dry AMD using BMSC - with gratifying success.

Following multiple patient treatments and over a dozen peer-reviewed papers, our studies have shown that a patients own bone marrow stem cells (BMSC) can have positive effects on different retinal and optic nerve diseases, explains Dr. Levy, CEO and Chief Science Officer for MD Stem Cells. As we have continued the study, other researchers have published numerous papers revealing how this may be occurring: release of exosomes with neurotrophic factors helping neurons and photoreceptors, transfer of cytoplasmic structures such as mitochondria to injured cells, and transdifferentiation of BMSC into neurons.

Dr. Levy concludes: The research has shown that patients with dry AMD choosing to participate in the SCOTS 2 may have a significant likelihood of either improving or stabilizing their vision.

Patients may receive information about SCOTS 2 by emailing stevenlevy@mdstemcells.com, using the contact us page on http://www.mdstemcellscom, or calling 203-423-9494. The Stem Cell Ophthalmology Study 2 is enrolling patients with different retina and optic nerve diseases. MD Stem Cells has no grant support and is not a pharmaceutical company; these are patient sponsored studies and the patients pay for both treatment and travel.

Contact Information:MD Stem CellsSteven Levy MD203-423-9494Contact via Emailwww.mdstemcells.com

Read the full story here: https://www.pr.com/press-release/810435

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New Treatment Shows Vision Benefit in Age Related Macular Degeneration - Benzinga

Preclinical Study Showing Beneficial Effects of Cymerus MSCs in Acute Respiratory Distress Syndrome Accepted for Publication in Leading Peer-Reviewed…

By Stem Cell Treatment

MELBOURNE, Australia, April 17, 2020 (GLOBE NEWSWIRE) --Cynata Therapeutics Limited (ASX: CYP), a clinical-stage biotechnology company specialising in cell therapeutics, is pleased to announce that a scientific paper describing the use of Cymerus mesenchymal stem cells (MSCs) in a model of Acute Respiratory Distress Syndrome (ARDS) has been accepted for publication in the American Journal of Respiratory and Critical Care Medicine (AJRCCM).1The AJRCCM, commonly known as The Blue Journal, is widely regarded as the foremost peer-reviewed journal in the field of respiratory and critical care medicine.

Background

The study was conducted in 14 sheep with severe ARDS supported by extracorporeal membrane oxygenation (ECMO), which were given an endobronchial infusion of either Cymerus MSCs (n=7) or placebo (n=7). Animals were monitored and supported for 24 hours, at which time the study concluded.

ARDS is an inflammatory process leading to build-up of fluid in the lungs and respiratory failure. It can occur due to a range of insults, including infection, trauma and inhalation of noxious substances. It has received significant global attention in recent times, as it is one of the most serious complications experienced by patients suffering from COVID-19. ARDS accounts for approximately 10% of all ICU admissions and almost 25% of patients requiring mechanical ventilation, and results in hospital mortality ofup to 46%.2 In addition, survivors of ARDS are often left with severe long-term illness and disability.3

ECMO is a last-line intervention used in patients whose lungs are unable to provide an adequate amount of oxygen to the blood, despite the use of ventilators and other interventions. ECMO circulates blood through an artificial lung, oxygenating the blood before returning it to the patients circulation. ECMO can help support the vital organs in patients with severe ARDS, but it is not in itself a treatment for ARDS and the mortality among patients supported by it remains high.

This study was conducted independently of Cynata by a group of leading academics known as the Combining Extracorporeal Life Support and Cell Therapy in Critical Illness (CELTIC)Investigators, led by Professor John Fraser of the Critical Care Research Group, The Prince Charles Hospital, Brisbane. The study was funded by the Queensland Government, the National Health and Medical Research Council (NHMRC), the Intensive Care Society UK, and the Prince Charles Hospital Foundation.

Key Results

Cymerus MSC treatment was shown to exert a number of important beneficial effects in this study:

There were no statistically significant differences in oxygenation index between groups. The authors of the paper suggested that this may have been due to the severity of the lung injury induced; the fact that the observation period may have been too short to observe all beneficial effects of the treatment; and practical challenges performing these assessments during ECMO.

The authors also observed that a different dose regimen and/or route of administration could lead to further improved outcomes.

The study also found that MSCs adhere to the membranes in the ECMO device, resulting in a significant increase in pressure, and there was a higher incidence of thrombosis in the lungs observed post-mortem. While this did not lead to failure of the ECMO device or other observed adverse events, the study team considered that it could potentially do so, and therefore concluded that they cannot currently recommend the use of MSCs in combination with ECMO. It is important to note that this finding is relevant to MSCs in general (regardless of source), as it is related to the propensity of MSCs to adhere to plastic, but it does not have implications for the treatment of patients with ARDS who are NOT receiving ECMO.

Dr Kilian Kelly, Cynatas Chief Operating Officer, commented:

We are very encouraged by the beneficial effects of Cymerus MSCs on a number of important, clinically-relevant endpoints in this model of ARDS. These results provide valuable guidance on the potential clinical utility of Cymerus MSCs in the treatment of ARDS. It is also very useful to learn more about the practical mechanical challenges associated with administering MSCs at the same time as ECMO, but it is important to note that most patients with ARDS do not receive ECMO. Furthermore, in humans with ARDS who are not receiving ECMO, we expect to be able to administer repeated intravenous infusions of MSCs, which may have advantages compared to the approach that was taken in this preclinical study. We are currently in discussions with leading key opinion leaders about a possible clinical trial in human patients with ARDS, including those who have developed ARDS as a result of the devastating COVID19 pandemic.

Authorised for release by Dr Ross Macdonald, Managing Director & CEO

About Cynata Therapeutics (ASX: CYP)

Cynata Therapeutics Limited (ASX: CYP) is an Australian clinical-stage stem cell and regenerative medicine company focused on the development of therapies based on Cymerus, a proprietary therapeutic stem cell platform technology. Cymerus overcomes the challenges of other production methods by using induced pluripotent stem cells (iPSCs) and a precursor cell known as mesenchymoangioblast (MCA) to achieve economic manufacture of cell therapy products, including mesenchymal stem cells (MSCs), at commercial scale without the limitation of multiple donors.

Cynatas lead product candidate CYP-001 met all clinical endpoints and demonstrated positive safety and efficacy data for the treatment of steroid-resistant acute graft-versus-host disease (GvHD) in a Phase 1 trial. Cynata plans to advance its Cymerus MSCs into Phase 2 trials for GvHD, critical limb ischemia and osteoarthritis. In addition, Cynata has demonstrated utility of its Cymerus MSC technology in preclinical models of asthma, diabetic wounds, sepsis, heart attack and cytokine release syndrome, a life-threatening condition stemming from cancer immunotherapy.

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1 Millar JE, Bartnikowski N, Passmore MR, et al. Combined Mesenchymal Stromal Cell Therapy and ECMO in ARDS: A Controlled Experimental Study in Sheep. Am J Crit Care Med, 2020.2 Bellani G, Laffey JG, Pham T, et al. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. Jama. 2016;315(8):788.3 Herridge MS, Tansey CM, Matte A, et al. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011;364(14):1293-304.

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Preclinical Study Showing Beneficial Effects of Cymerus MSCs in Acute Respiratory Distress Syndrome Accepted for Publication in Leading Peer-Reviewed...

Stem Cells and Silk Make a New Way to Study the Brain – Tufts Now

By Stem Cell Treatment

More than five million Americans, mostly sixty-five or older, suffer from Alzheimers disease (AD), and that number is expected to triple by 2060, as todays twenty-somethings become seniors. No treatments exist for this devastating disease, and its root causes remain as tangled as the curious brain deformities that German physician Alois Alzheimer first described in 1906.

Now a team of Tufts researchers from the School of Medicine and the School of Engineering has received a five-year, $5 million grant from the National Institute on Aging, part of the National Institutes of Health, to study the role of different cell types and mutations in AD. They will use a unique bioengineered mini brain that realistically simulates the human brain environment for years.

The work, which builds on years of collaboration among the researchers, will overcome two traditional stumbling blocks to such studies: the limited relevance of animal models and the inability of cell culture systems to reproduce the physiology of the human brain. While age is the biggest risk factor for AD, genetics also plays a role. Scientists have uncovered twenty gene variants that increase the risk of AD, said Giuseppina Tesco, professor of neuroscience and lead investigator on the research, who has devoted her career to studying the disease.

Recent studies show that most of the genes that carry these variants are expressed in glial cells, particularly astrocytes and microglial cells. Once dismissed as onlookers in the brain, glia are now front and center in Alzheimers research said glia expert Philip Haydon, a principal investigator on the project. Haydon, the Annetta and Gustav Grisard Professor of Neuroscience, likens these cells to the pit crew for the flashy race-car-like neurons, supporting top performance by, for example, preventing buildup of protein plaques.

But unlike neurons, human glial cells behave very differently from those of other mammals. What we can learn from mouse models is very limited. It is very important to study these genes in human cells, said Tesco. And we need to do this over time. It may take months to see the effect of genetic variation.

The Tufts team will use cells derived from patients with AD as well as healthy subjects, drawing on advanced stem cell technology that makes it possible to reverse engineer human primary cells into induced pluripotent stem cells, which can then differentiate into neurons, astrocytes, and microglia.

These glia and other brain cells will grow on a unique three-dimensional doughnut-shaped scaffold made of porous silk and collagenwhat the researchers have dubbed a mini brain. Bioengineer David Kaplan, Stern Family Professor and a principal investigator on the grant, and his team have spent six years perfecting the mini brain for research on AD, traumatic brain injury, and brain cancer.

This model allows us to put cells where we want, determine ratios of different cells to use in the system, and control interactions, so we can study electrophysiology, synaptic activity, and other functions as the tissue ages, said Kaplan. That control over the long term supports exploration of age-related questions about disease progression and contributes to reproducibility, a scientific pillar. Past experiments using these mini brains have mimicked structural and functional features and neural activity for up to two years.

In contrast, a two-dimensional culture systemlike the proverbial petri dishwont replicate the complexities of multiple cell types and physiologies. And organoidssimplified organs in miniature now in vogueare subject to cellular death after a few weeks or months.

To complement the in vitro studies with the scaffolds, scientists in Haydons lab will transplant some of the human cells, both mutated and normal, into mice. As they grow, the human glia cells will replace the mouse cells, giving researchers an opportunity to study human brain function. This is the first step towards translational studies, said Haydon.

The grant complements donations from Tufts alumni, parents, friends, and other private individuals who have experienced the pain of Alzheimers disease in their own lives. Donor dollars really got some of our early, exploratory work up and running, said Haydon. Now we are building on that.

The NIH support is a bright spot at a time when COVID-19 has forced Tufts scientists, like their peers around the world, to halt laboratory research, sometimes losing years of work.

Tesco said that while it is difficult to be away from her lab, safety is more important than anything else. Im from Italy, where we have more than 22,000 deaths, she said. Being healthy and having the possibility to continue to do some work, I feel lucky. Well be in the best position possible when were ready to start because well be able to start something completely new and very exciting.

Kim Thurler can be reached at kimberly.thurler@tufts.edu.

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Stem Cells and Silk Make a New Way to Study the Brain - Tufts Now

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