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Lay perceptions of diabetes mellitus and prevention costs and benefits among adults undiagnosed with the condition in Singapore: a qualitative study -…

Posted: August 22, 2022 at 2:54 am

Table 1 shows the demographic characteristics of 41 participants. There were 24 females and 17 males, with 16 participants in their 30s, 14 in their 40s, and 11 in their 50s. Ethnic distribution followed 61%, 15%, and 20% for Chinese, Malay, and Indian, respectively.

Table 2 presents a hierarchal thematic scheme of the novel findings. We identified 5 main themes, each with 3 sub-themes: (i) perceptions of diabetes, (ii) sources of perceptions, (iii) relational identity between food and T2D, (iv) perceived losses from healthy eating in T2D, and (v) perceived gains from physical activity in T2D. Even though the findings are categorized by the domains of inquiry, all the sub-themes are interrelated and create the narrative of the given context.

All the participants were aware of diabetes with a good understanding of its risk factors, like obesity, family history, dietary habits, and sedentary lifestyle. Commonly cited symptoms included increased thirst, frequent urination, changes in weight, and sweet pee which attracted ants. A few responded there would be no visual symptoms until a blood test has been taken. Participants also had a good understanding of the disease progression. Apart from the cost of treatment, the initial stages of the disease management were perceived as inconvenient due to the daily medications and diet considerations.

If I had it, I had to take medications regularly and properly. I had to bring medications with me. Its inconvenient. If I were to be in a social setting, Id be like, Oh, Im sorry, I cant eat this or drink that or like I need to take my medication. Then, people would look at me weirdly. Id be like, Should I explain or not? (30s, F, Chinese)

Later stages of T2D were perceived as disastrous to quality life due to the complications arising from T2D. Many participants were concerned that they may become a burden and be unable to care for others. Complications of T2D were associated with disabilities that could cause (loss of) ability to work, (and) ability to live independently.

There is a risk of complications like having kidney problems, amputations, or maybe even blindness, or losing your sensitivity, your extremities. These are the complications that someone with diabetes will have to anticipate. But if I develop complications that result in me developing blindness or limb amputation, that one will be quite disastrous to the quality of my life. (30s, M, Chinese)

However, most participants expressed that the development of these complications would be far away, and the progression from the initial stage to complications would be slow. They believed such a slower progression of diabetes compared to other diseases meant that it was not as life-threatening and that diabetic patients have an opportunity to control and manage diabetes with medication and lifestyle adjustment.

You may have diabetes, but it may not happen like a one-shot. For diabetes, first, you have medication to manage it. You have time for treatment. You still can control in a way. You can try to minimise potential injuries. It will not get fatal as compared to heart disease where it strikes up, the recovery time and saving the person is very acute (30s, M, Chinese)

Participants said they actively seek expert knowledge only after specific triggers like health screening results or hearing about T2D diagnosis from their social circles. Some participants found the amount of information and use of jargon overwhelming, and the information on actionable steps sometimes contradicting.

I usually inquire into a condition when somebody I know is diagnosed with the condition. It usually takes a few searches to understand because there are many sources, which tend to be overly clinical in their jargon, which is not very helpful and only targeted to medical professionals. Usually, the contradictions are not in the diagnosis but understanding if it is major or minor, or if any meaningful action should be taken. (50s, M, Chinese)

Hence, many lay perceptions were influenced by the media portrayal of diabetic patients. Participants recollected that the characters with diabetes in the media were often in the later stages with limb amputations, which were somewhat disturbing. However, diabetes was rarely reported as a cause of death, even if it was an underlying health condition.

To me, diabetes is a bit far away. We hear about stroke and heart attacks when the media reports that somebody collapsed while jogging. Whereas, when somebody dies from diabetes, we dont usually read it in the papers. You might die of heart attack with a pre-existing condition of diabetes. But people just report your heart attack. Diabetes tends to be at the back of everybodys mind. It exists, but the media doesnt put it in the spotlight that often. (30s, M, Chinese)

For participants who had family, relatives, or friends with T2D, their perceptions of the disease cause, risk, and consequence of diabetes were influenced by what they observed and heard from the patients. In particular, participants who had parents and relatives with late stage-associated conditions, their descriptions about the impact of T2D on life were specific and vivid.

She suddenly started to bleed very badly after just gently scratching a black spot, but she didnt feel any pain. She passed out at home because of the excess bleeding. We had to call the ambulance, and she had to go for another operation for her leg. When you have diabetes, it will take longer for the wounds to be healed, so it took her a long time to heal. This is a real problem. (40s, F, Indian)

Common factors influencing perceived risk among participants were poor health screening results, obesity, positive family history, and unhealthy practices, especially around dietary choices. Many participants perceived that having too much sugar was the main cause of diabetes, which translated to reduced perceived susceptibility of T2D among those who did not have many sugary foods.

I think my risk is very low. I am someone who is not into sugar - I dont drink bubble tea, I don't have a lot of sweets, biscuits or cakes or chocolates. I dont have that kind of craving. (40s, F, Chinese)

Several participants said when friends and families speak about diabetes, it is usually candidly referring to having too many sweet food items. However, the colloquial reference to sweet foods and sugar as the cause of diabetes did not reduce the consumption of these foods.

When you have a gathering, you look at the amount of food and sugar. Then, you casually say like this is going to get me diabetes. But its a form of a joke than anything serious. (40s, M, Malay)

Participants were asked to share how they thought their lives could be impacted if they were to be diagnosed with T2D. A common perceived loss was related to the restriction of diet to manage T2D.

If I had diabetes, I would have to have a more restrictive lifestyle. I would not be able to eat as much of the food that I enjoy snacking, eating ice cream and things like this. I myself have sweet tooth. For me having to be a bit more restrictive would be quite a downer (30s, M, Chinese)

Many participants shared that the diet restriction was particularly impactful in Singapore as the local food culture is important in shaping the Singaporean identity. With the variety of food, there were expectations of having a certain level of culinary experience during social gatherings.

Given that we are Singaporeans, we love to eat. It is difficult to maintain a healthy lifestyle or a healthy diet. Our culture is about eating we have a fusion of food and all kinds of foods from all around the world. Even if healthier, people do not want to meet friends over a fruit platter. They will meet for a Korean barbeque. So, from a cultural perspective, its very hard to disconnect from food. (30, M, Chinese)

Participants defined good food as tasty and cheap and shared that people are willing to travel significant distances in search of good food. Singaporeans take pride in finding food that has the best value for money, and this pursuit is often a topic of conversation among friends and family.

I think it is difficult for people to control their diet. Singaporeans like to travel around to find food to eat. They might be living in [a neighbourhood in the east], but they do not mind travelling to [a neighbourhood in the west]. They want the best food that they can get for the three dollars fifty cents. They will talk to each other about where to go and what to eat. They enjoy eating so much and want total value for money in getting the best bang for their buck. (40s, M, Indian)

Participants pointed out the convenience, ease of access, and budget-friendly options; hawker centres located within every public housing estate providing diverse local cuisines quickly and cheaply. Furthermore, in recent years options of delivery service and the availability of all types of cuisine, one can access cheaper and more delicious food any time, from the comfort of home.

When you are craving something, or you want to eat something, usually I must travel all the way there. But now everything is a lot easier to eat something, and it will come to your doorstep. Even if I am tired or it is late at night, and I feel like having ice cream, there is [food delivery platform]. So, there are a lot more opportunities to indulge in these kinds of things. (30s, F, Chinese)

Conversely, many participants pointed out that healthy food options are more expensive and can take a long time to prepare.

In Singapore, the faster and cheaper options are unhealthy. So, if you want to prepare healthy food, and you have working hours, you need to make a lot of sacrifices like wake up early or prepare it the night before. And the ingredients for healthy meals are not cheap. (40s, F, Malay)

When speaking of restrictive diet and healthy eating, participants alluded to a loss in their lifestyle due to reduced enjoyment and impaired social interactions associated with food. Social relationships and celebrations are centred on food, and declining food or refusing to eat could be interpreted as an insult to the host. This was mentioned by participants across all the ethnic groups.

Youre stopping me from eating my favourite food, you know? I rather die. What makes it really hard is that any form of Chinese celebration has got to do with food. The bigger the celebration, the more food we have. Its like, if you dont eat, youre extremely rude its insulting not to eat something that is placed before you. (50s, M, Chinese)

Many participants also shared that eating provided a source of enjoyment and that some participants turned to food when they were upset or stressed. While some participants shared that they exercise to de-stress, some participants shared that they eat to de-stress. A participant mentioned the endorphins released when exercising, while another said the same but when indulging in delicious food. While there was awareness for the need to mitigate the effects of unhealthy eating, it came in the form of compromising other meals instead of giving up the pleasure derived from unhealthy foods.

The only thing that Im doing now to control my eating is trying not to have breakfast in the morning. I will just try to have lunch and dinner, but it is usually not controlled. I should stop eating less fried food. But I dont think I can give up fried chicken that easily. Its just really too good to give up. (30, M, Chinese)

Similarly, some participants expressed that they justify their eating habits by having earned their calories after exercising and consider their indulgence as a reward. The influence of social media culture was also reported, where people post pictures of the aesthetics of the setting and the food. Participants shared that social identity is associated with food and enjoying life, and rarely with healthy eating in the context.

People eat to survive. But for me, I live to eat because I love to eat. So, if Im not happy, I need to eat to be happy. I love food. To continue eating unhealthy food, I compensate for it by doing more exercise. So, I had the calories burned to eat. If I dont exercise and eat, Ill get fat or something like that. But if I exercise and eat, it can balance out, right? Nowadays, people post their food on social media. Wow, theyre so yummy! But, if you burn a fish at home, you wouldnt post on social media. You will only post nice and presentable ones. (40s, F, Chinese)

Demanding work environments and familial responsibilities created multiple competing priorities even though exercise is desirable. These responsibilities often lead to sacrificing sleep, poor eating habits, and exercise time to meet these expectations. Participants shared that Singapores competitive work environment creates high-stress situations. There is an expectation to constantly improve skills and qualifications to ensure job security.

Stress is one contributing factor. People tend to eat more and badly when they have stress. People want to have job security. Now there is digital disruption, so you can become invalid, which is quite scary. So, we need to upgrade ourselves. I have attended many courses, and I will attend more, so there is no time to exercise sometimes even though I want to. (40s, M, Others)

Participants, especially mothers, shared that time for themselves when they could exercise is seen as a luxury or culturally challenging. A Muslim woman shared how she felt different and watched when running with a hijab, a head covering worn by many Muslim women. Internalised expectations of clothing worn during exercise contrasted with wearing a hijab, creating potential psychological barriers.

Im making a conscious effort, but it is really tough for me to find a time with kids, work, and everything. Most of the days, as a working mom, I seldom get time for myself to do what I want. You feel good about yourself with those endorphins. It is very good to mentally detox by getting away from home and kids. But, when I ran in the park, I used to feel a bit shy and embarrassed because I was wearing hijab, and then I felt like everyone was looking at me (30s, F, Indian)

Despite these challenges, there is interest to engage as several participants shared their rewarding experiences from physical activity. When talking about physical activity, participants alluded to a gain, citing how they feel lighter and good after exercising. Participants shared that initial adoption of physical activity was often in response to an external cue, including a worrying health screening result or a recent loss of life. Accountability through exercise programmes or friends or incentives were cited as facilitators of engaging in physical activity. However, the reasons to sustain behaviour were to ensure they could maintain their physical appearance, retain independence and physical mobility to continue doing the things they enjoy, or continue experiencing the immediate benefits and enjoyment of certain exercises.

I dont want to be obese or unhealthy. I dont want to inject myself all the time or spend my hard-earned money on doctors or medications. So, I exercise. Then, Ill feel lighter. Ill feel good, fit. Ill be happy, and I can do a lot of things. Through all these exercises, my muscle wont be so stiff. I can do a lot of things together with my children. I can cook for them and continue to work. Then I can go travel if money permits. (50s. F. Chinese)

Many participants also reported that observing self-improvement by tracking progress acted as positive feedback for their self-efficacy, and in return, motivated them to exercise further or longer. Participants who exercise regularly also pointed out that exercise is a more individual activity, and therefore it is not affected like healthy eating by its social context.

One day you cycle down a road, you see some things and buildings. Then the next time, you motivate yourself to cycle further. Its with running also in my mind, I will motivate myself to jog slowly. And then now I can run to this place, to that place, and then further. Then slowly, I can run back. It motivates me. So every time, you look for a new goal to achieve. I can go somewhere further, you know? (40s, F, Chinese)

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Don’t Wait for Symptoms! Annual Heart Failure Testing in Diabetes: New Recommendation – Medscape

Posted: August 22, 2022 at 2:54 am

This transcript has been edited for clarity.

I'm Dr Neil Skolnik. Today we're going to talk about Heart Failure: An Underappreciated Complication of Diabetes. A Consensus Report of the American Diabetes Association, which was put together with designated representation from the American College of Cardiology.

The big news here is that early detection of presymptomatic heart failure utilizing annual screening with N-terminal pro B-type natriuretic peptide (NT-proBNP) or troponin is now recommended. It turns out that although we don't think about diabetes and heart failure the same way that we think about diabetes and vascular disease or microvascular complications of diabetes, heart failure is a very common complication of diabetes. Approximately 22% of all patients with diabetes eventually develop heart failure. In fact, it's two to four times more common in people with either type 1 or type 2 diabetes than in those without diabetes.

Risk factors for heart failure in both for type 1 and type 2 diabetes include duration of diabetes, poor glycemic control, uncontrolled hypertension, hyperlipidemia, higher body mass index (BMI), microalbuminuria, renal dysfunction, ischemic heart disease and peripheral vascular disease.

Heart failure classification includes stage A, which is people who are at risk for developing heart failure. That's essentially everyone with diabetes. Stage B, which is our focus today, can be thought of as presymptomatic heart failure or preheart failure. These are people who have an echocardiogram with evidence of structural heart disease, abnormal cardiac function, or elevated natriuretic peptide or cardiac troponin levels. Classification of heart failure includes symptomatic heart failure (stages C and D), which are the subjects of a different discussion.

The reason for these new guidelines is recent good randomized trial evidence showing that appropriate treatment of people at risk for heart failure who have elevated NT-proBNP levels (eg, people who have preheart failure or stage B heart failure) can reduce the risk for left ventricular dysfunction, newly diagnosed heart failure, and heart failure hospitalization.

That leads to the main recommendation of this consensus statement: annual testing of brain natriuretic peptide (BNP), NT-proBNP, or high-sensitivity cardiac troponin to identify the presence of stage B heart failure. The cutoff value for BNP is 50 pg/mL, and for NT-proBNP, it is 125 pg/mL.

Patients who are identified in this manner should receive an echocardiogram and then, based on the results of the echo, be treated with appropriate medications that include renin-angiotensin system blockade (either an angiotensin-converting enzyme [ACE] inhibitor or an angiotensin receptor blocker [ARB]), a sodium-glucose co-transporter 2 (SGLT-2) inhibitor, and other medications per the AHA/ACC heart failure guidelines, summarized here.

These are big, important new recommendations that are easy to implement and have the potential to make a big difference for our patients with diabetes. I'm Dr Neil Skolnik, and this is Medscape.

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New drug candidate uses novel absorption method to target cancer cells in mice – Michigan Medicine

Posted: August 22, 2022 at 2:51 am

A team of University of Michigan researchers is developing a new anti-cancer drug that is absorbed through the guts lymphatic system rather than blood vessels, potentially outmaneuvering the molecular signaling pathways that lead to drug resistance while increasing cancer-fighting ability and reducing side effects.

In a study published today inNature Communications,the team reports on a novel kinase inhibitor that significantly reduced disease, limited toxicity and prolonged survival in mice with myelofibrosis, a precursor to acute leukemia.

SEE ALSO: Researchers find link between genetic mutations and cancer treatment resistance

They designed the oral medication LP-182 to simultaneously target phosphoinositide 3-kinase, also known as PI3K, and mitogen-activated protein kinase, known as MAPK, molecular signaling pathways that drive a high percentage of cancers.

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Cancer treatment often involves combination therapy to target different cancer cell vulnerabilities. But because these drugs circulate through and are absorbed and removed by the body at different rates, it can be challenging to sustain the right therapeutic balance of each individual drug at a concentration necessary to be effective while limiting drug toxicity and side effects, said lead authorBrian D. Ross, Ph.D., the Roger A. Berg Research Professor of Radiology at the University of Michigan Medical School.

Failure to strike this balance reduces the effectiveness of the drug combinations against cancer and can lead to drug resistance, as PI3K and MAPK crosstalk can activate downstream pathways to resist therapy. Even if a drug blocks one pathway, another can provide an escape survival pathway to compensate and continue growing.

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Unlike traditional oral drugs, which are often designed to be rapidly absorbed into the bloodstream, researchers treating mice with myelofibrosis found that LP-182 is absorbed by the guts lymphatic system first. The lymphatic system serves as a storage reservoir, separating the drug from the rest of the body and gradually releasing the therapy into the general circulation over time to maintain drug concentrations at an optimal therapeutic level.

SEE ALSO: Study Suggests New Approach to Improve Radiation Therapy Resistance in Glioblastoma

Within the therapeutic window, we are able to maintain the on-target inhibition of two distinct pathways that are talking to one another, said Ross, who is also the director of the Center for Molecular Imaging at Michigan Medicine and director of the Preclinical Molecular Imaging Shared Resource at the U-M Rogel Cancer Center. This demonstrates the feasibility of delivering anti-cancer agents directly into the lymphatic system, which opens tremendous new opportunity for improving cancer therapeutic outcomes and reducing the side effects of the agents themselves.

In myelofibrosis, excessive scar tissue forms in the bone marrow, disrupting normal blood cell production. Overactive molecular signaling leads to a proliferation of malignant stem cells, extensive fibrosis, enlarged spleen and progressive bone marrow failure.

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Lifting up NC Teachers of the Year and TFA alumni – EdNC

Posted: August 22, 2022 at 2:50 am

The summer has come and gone, and the fleeting school break is a reminder of the great weight that teachers carry throughout the year. Weve seen a noteworthy rise in stress levels among teachers and school level leaders, twice that of the general population of working adults according to a recent RAND Corporation survey; and though the summer months may appear to alleviate some level of stress, the burden is never fully relieved from our teacher force.

That is why we should take every opportunity to honor and uplift teachers for what they deliver to students and the broader school community all year long. In that spirit, here is a bright spot in the roundup of the 2021-2022 school year: an introduction to four of the dozen-odd educators in the Teach For America network in North Carolina awarded Teacher of the Year in their respective schools. Their commitment, creativity, and perseverance truly exemplify great teaching, and their stories are sure to inspire us all to meet their efforts with appreciation and support.

Daeja is a second-year special education teacher in Tarboro and joined Teach For America upon earning her bachelors degree from Hampton University. She takes every day as a middle school educator with a sense of humor. Looking back on the year, she is most proud of the growth of what she calls her exceptional children.

At the start of the school year, Daeja says, we had a student who struggled with adjusting to the setting of middle school and often would have tantrums run, hide, yell, and cry whenever they felt a big emotion they couldnt explain. By the end of the year, they would go to one of their safe spaces when they realized they were close to a boiling point. They would share their emotions verbally and by using a plushy.

This student also inspired Daeja to begin an art wall, decorated by students just like this one. Whatever it takes! Daeja says.

In part, she attributes her success to the opportunity to step into leadership, serving as co-chair of her department and learning more about school-level operations along the way. In this new position, she came to more deeply value relationships with students parents and families, and in May was recognized as Beginning Teacher of the Year at her school.

By the end of the 2021-2022 school year, Daeja fulfilled her corps member commitment. As for her future plans, shes chosen to remain in her placement school and will move into chair of her department.

No matter what I choose later, Daeja says, I know that, at the start of my career, my goal was to make a difference. Thats what I am going to continue to do.

Meghan has been a middle school STEM educator in Charlotte for four years, and in that time she has gained a reputation for her classrooms engaging science labs.

Fun-Lab Fridays are days all my students look forward to, and theyre some of my favorite memories from this year, Meghan says. For many students it was their aha moment, connecting all the work we did throughout the week to something tangible and real.

A specific lab we did was creating edible cells, where students would model a cell out of food items. The students worked with partners to create incredible pieces to demonstrate their understanding. And yes they did get to eat it all!

Meghan was recognized as Teacher of the Year in January, but continued to demonstrate resilience throughout the school year by embracing change. There were so many times the course of the year changed, from COVID procedures to grading standards, she says. When I was able to take a step back, look at the bigger picture, and follow those changes, I found more success. It led to more collaboration and communication with my team and deeper connections with students.

Since graduating from UNC-Wilmington and joining Teach For America in 2017, Robert has been an elementary school teacher primarily third and fourth grade in Guilford and Durham counties. When asked, he names the greatest reward of being a teacher is seeing the community of a classroom come together, where each student can let their freak flag fly and be themselves.

He attributes his success this year to the joint effort of his team while serving as a grade-level chair.

It was my first time in this position and it proved to be a sink or swim moment. My new teammates had greater experience, and perhaps better reason, to be in the leadership position, Robert says. However, Im proud of myself for building a team that was centered in honesty and collaboration. Every step of the way, every success and failure, we were in it together. By the end of the year, it became clear that not only was third grade the most fun team, but we were the most connected.

Robert intends to continue teaching and expanding his service to his school community.I really enjoy my current role, and I cant think of a greater honor than being a public school teacher, Robert says. It remains the professional joy of my life, and I cant wait to continue the work.

Rub has been a middle school English/language arts teacher in Charlotte for five years, and is currently pursuing her masters of education in literacy. As a proud Latina leader in a school district with few other Latinx educators, she also plans to pursue National Board certification and eventually a position in school administration. I rarely ever see Latinx educators in this role, so representation is needed. I have also always thought about becoming a principal, but we will see!

Rubs love for her students is evident in her generous spirit and indefatigable effort. Not only did her classroom have the highest proficiency growth in her school for the past two years, but she has taken special care to tutor students falling behind in their literacy. She cites being proud of her students for their growth in skill and confidence.

Her favorite moment from her classroom this year was an assignment based on Summer of the Mariposas, in which students were charged to write their own Mexican folklore narrative and create a website on which to publish them.

When I first presented them with this assignment, they looked at me like I was crazy for assigning this task, says Rub. There was some pushback and hesitation from them, and me because I was nervous about how to deliver this lesson but I was trusting the process. The websites they submitted left me speechless. As their teacher, I had the privilege to witness the incredible creativity that came from my students in that lesson.

In our organizations conversations with diverse leaders across the state, the consensus remains that teachers deserve more than a one-time celebration for all of their efforts day to day, semester to semester, year to year. They deserve sustained action and support, to ensure that they have access to improved benefits and compensation as well as relevant development and fewer financial barriers to advancement.

Teach For America is committed to supporting educators not only during their first two years in the classroom, but also for the remainder of their career in education by investing in professional programming that advances alumni of our program toward their goals. This is a critical component of our program if we are to reach our mission of achieving excellent and equitable education for all students.

Teachers like Daeja, Meghan, Robert, and Rub are the reason that, through all of the challenges of our current education landscape, we should remain hopeful about our future and be emboldened to partner with them in ensuring that all children can thrive.

Sarah Holder is the director of communications for Teach for America, North Carolina.

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RoosterBio and AGC Biologics Announce Collaboration to Accelerate Manufacturing of Cell and Exosome Therapies – GlobeNewswire

Posted: August 22, 2022 at 2:49 am

SEATTLE, Aug. 16, 2022 (GLOBE NEWSWIRE) -- AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced today a strategic partnership with RoosterBio Inc., a leading supplier of human mesenchymal stem/stromal cells (hMSCs), highly engineered media, and bioprocess development services.

The partnership creates an end-to-end solution for the development and production of hMSC and exosome therapeutics leveraging RoosterBios well-established cell and media products and process development services, coupled with AGC Biologics global cell and gene therapy manufacturing capabilities.

RoosterBio will utilize its extensive portfolio of cell and media products to develop robust, scalable processes for hMSC and exosome therapies. These capabilities include genetic engineering of cells and exosomes to express therapeutic targets, upstream processing in both 2D flask and 3D bioreactor systems, downstream purification to achieve desired purity and potency, and comprehensive analytical characterization of the resulting formulated cell or exosome therapy.

AGC Biologics will utilize its global network to provide full Process Development, cGMP Manufacturing, Quality Control and Regulatory services for pre-clinical and phase I/II clinical trials, with the ability to scale to Phase III and commercial production. The CDMO also offers a range of development and manufacturing scales that can be tailored to the specific needs of drug developers in different regions worldwide. The AGC Biologics scientific teams have over two decades of experience in advanced therapy production and manufacturing, and have brought three commercial products to market. The global CDMOs network of sites offers the latest cell therapy technologies and processes, including allogenic and autologous systems and techniques.

"AGC Biologics is happy to be partnering with RoosterBio. They have a reliable method for producing engineered cells and exosomes that can help developers create life-saving therapies," said Patricio Massera, Chief Executive Officer of AGC Biologics. "When you combine their work and expertise with AGC Biologics' scientific knowledge and global manufacturing services, it creates a comprehensive offering that can help these developers save time and money, and get their treatments in the hands of patients in need."

AGC Biologics has an outstanding track record of success in the manufacture of clinical and commercial advanced therapies and an ever-expanding global network to meet the needs of our customers, said Tim Kelly, Chief Executive Officer of RoosterBio. Biopharmaceutical companies striving to develop engineered cell and exosome therapies require proven, flexible technologies paired with reliable and scalable manufacturing solutions. This collaboration was conceived to deliver that end-to-end solution for our customers and I am thrilled to partner with AGC Biologics to translate our hMSC and exosome technologies into advanced therapy products that have the potential to bring curative treatments to patients in need.

More details on this partnership and the joint offering from RoosterBio and AGC Biologics will be released in the coming months.

AGC Biologics global cell therapy services and viral vector capabilities utilize proprietary platforms developed to address the evolving advanced therapies market. To learn more about the company and its complete list of CDMO services visit http://www.agcbio.com.

About RoosterBioRoosterBio accelerates human mesenchymal stem/stromal cell (hMSC) and extracellular vesicle (EV) product and process development to fuel the rapid commercialization of scalable regenerative cures. Our high-quality hMSCs, bioprocess media, genetic engineering tools, and EV production solutions are paired with expert bioprocessing knowledge to progress therapeutic developers from concept to first-in-human testing and commercial manufacturing at reduced cost and increased productivity. With optimized, scalable processes, Type 2 Drug Master Files, and cGMP products, we have enabled therapeutic programs to traverse their path to clinical translation in under 1 year. RoosterBio is driven by client's success and creating a world where safe and effective regenerative medicines are rapidly developed and widely available on a global scale.

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About AGC Biologics AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan and we currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients most complex challenges, including specialization in fast-track projects and rare diseases. To learn more, visitwww.agcbio.com.

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Patient Profile 1: A 63-Year-Old Female with Relapsed Multiple Myeloma – OncLive

Posted: August 22, 2022 at 2:49 am

Brea Lipe, MD: Hello and welcome to this OncLive My Treatment Approach program titled, "Recent Advances in the Treatment of Multiple Myeloma at First Relapse." I am Brea Lipe, and I'm the associate professor at the department of medicine at the University of Rochester in New York, and the director of the multiple myeloma program. I am joined today by my colleague, Dr Peter Forsberg, and I would like to welcome him to introduce himself.

Peter Forsberg, MD: Hi, Dr Lipe. I'm Peter Forsberg, I'm associate professor at the University of Colorado and the director of our myeloma program. So happy to participate in the conversation today. So welcome and thanks for joining us. And today we're going to discuss recent updates in the treatment of relapse/refractory multiple myeloma, and its impact on clinical practice. So, we'll be doing that by presenting two hypothetical patient cases, and then discussing our treatment approach to illustrate how we incorporate recent data in our clinical practice. So, let's go ahead and get started. So as Dr. Lipe said, our- the name of our presentation today is my treatment approach, recent advances in the treatment of multiple myeloma and early relapse specifically. And this is a patient profile to start with. So, this is a patient who was diagnosis, a 63-year-old female. This was in January 2017 when she presented with anemia, hypercalcemia, and after being evaluated by her primary care physician was found to have acute onset severe rib pain. And then radiographs had evidence of non-displaced rib fractures, bilaterally. Workup showed an IgG kappa multiple myeloma, and subsequent bone marrow biopsy demonstrated 35% clonal plasma cells. And cytogenetics included FISH, which showed a gain of chromosome 1q. So, she underwent a PET CT, which confirmed lytic disease throughout the spine and multiple rib lesions, and was treated initially with RVD, or lenalidomide, revlimid, bortezomib, Velcade, and dexamethasone starting in February 2017. Completed five cycles, achieved a very good partial response and then proceeded with autologous stem cell transplant with melphalan 200 milligrams meter squared conditioning, and after recovery was started on lenalidomide maintenance. So unfortunately, at follow up, on four years follow up state reevaluation was found to have progressive disease and at that time was started on isatuximab, carfilzomib, dexamethasone as second line therapy in May of 2021. So as of last follow up, the patient continues on the isatuximab, carfilzomib and dexamethasone in a very good partial response and is tolerating therapy well without issue. So, I believe, I think that brings us into discussion. In terms of my initial impressions of this case, I think it's a pretty standard consideration. A patient in 2017 diagnosed with new myeloma in their early to mid-60s. Treated with RVD induction, has long been a standard of care initial combination. And then followed by an autologous stem cell transplant and lenalidomide maintenance. And we know that based on recent data that patients with this combination of induction followed by transplant, followed by maintenance can have really stable long-lasting remissions potentially. So, patient experiencing relapse several years in- following the initiation of their induction, is pretty common. So, I think this is a pretty common scenario for us to be dealing with. And I think that the main consideration that's sort of become more prominent in the last couple of years is, do we start still with RVD or would we think about using a four-drug combination in this patient for initial induction, incorporating a CD38 monoclonal antibody like daratumumab plus RVD. So, I think that's probably the biggest practice change that might inform how we treat this patient that'd be a little different than what we might have been doing in 2017. Certainly, something that's does not uniform necessarily across myeloma providers, but is appropriate consideration, I think. And I- but otherwise I think still considering stem cell transplant and often lenalidomide based maintenance remains our kind of primary standard of care. I guess, I'd ask you if you had any additional thoughts. And then, I know the question of defining relapse, how we identify a progressive event. Defining with biochemical versus clinical relapse and sort of characteristics and standard criteria that define those. Maybe sort of delineating how you define progressive disease for [myeloma] in your practice.

Brea Lipe, MD: So, I always think it's fun to kind of look back and we see these patients in our practice, and they were started on therapy in 2017 or whenever that might have been, and to think about how our practice has changed. And I would agree that quads are something that I use a lot more frequently now, pretty much uniformly for induction in patients who are able. The only other thing that I thought was different about this case, that I might have done something different about even back in 2017 was the gain of 1q and that portending some higher risk features. And I often even back then used a more combination maintenance approach for those patients with higher risk cytogenetics. But regardless the patient did really well after transplant with just lenalidomide maintenance, which is great. And so, I think that it does come to this interesting question of what biochemical versus clinical relapse is and how those are defined. And so, the goal in my practice is to always have biochemical relapses because by the time we have clinical relapses, that's really defined by those CRAB criteria or symptomatic myeloma. So, my goal is to avoid symptoms because those can be compounding over time and can increase the toxicities of our therapy. So, my goal is always to catch it before it gets to the point where the patients are beginning to have suffering and side effects. And what we know is that biochemical relapse, so that's defined by the International Myeloma Working Group, the relapse criteria, and it's a biochemical relapse when we don't have those classic myeloma symptoms. And that's pretty much the standard IMWG relapse criteria, which includes changes of 25% to the paraprotein, as long as it's at least a rise of 0.5 and changes to the involved versus uninvolved light chains of at least 10. And so, there are pretty standard criteria for that, that you can follow over time for patients who achieve a CR, which this patient might not have. But anytime you start to see the reemergence of a paraprotein that's also a biochemical relapse. And so, I think that it's important to keep close track of our patients. I like to follow my patients in their labs, even when they're several years out closely, just so that I know that when they're starting to have these biochemical relapses, so I can intervene before they get a clinical relapse. We know that on average patients with biochemical relapses will have symptomatic development of myeloma defining events within about five months. So, I think that just highlights the need to identify those biochemical relapses. When you intervene on that is- can be up for debate but constitutes a biochemical relapse it's relevant for treatment versus those patients who will just kind of slowly progress biochemically and might be- might not progress within five months symptomatically. So, I think it's just important to keep an idea on.

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Patient Profile 1: A 63-Year-Old Female with Relapsed Multiple Myeloma - OncLive

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Canadian Blood Services Stem Cells for Life

Posted: August 22, 2022 at 2:48 am

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Canadian Blood Services Stem Cells for Life

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Scientists say they have created ’embryos’ without sperm or eggs – Medical News Today

Posted: August 22, 2022 at 2:48 am

Creating an embryo from cells other than sperm and egg cells and then growing them outside the uterus is an area of study that has developed significantly over the past 5 years. How long until we unlock the black box of human embryology?

This month, researchers announced that they have been culturing a mouse embryo model made entirely out of embryonic stem cells and without the use of a sperm and egg, or a uterus, for 8.5 days, about 2 days longer than previous experiments had achieved.

Genetic analysis revealed that the structures and cell activity in these embryo models were 95% similar to real mouse embryos and functional. This suggests that these models were similar enough to natural embryos that they could be studied to gain insight into how they work.

Research on both mice and human embryos can offer insight into the mechanisms that allow them to divide, implant, and develop. However, being able to build them from scratch helps researchers bypass potentially expensive and unethical experiments on embryos and also helps them verify if assumptions about how they work are correct.

A paper recently published in Cell outlines the achievement by researchers in Prof. Jacob Hannas laboratory at the Weizmann Institute of Science in Rehovot, Israel.

This is the latest step in a long line of incremental steps in recent years to create an embryo from scratch in the lab.

Prof. Hannas team had already published details of one particularly important part of the puzzle last year in Nature, when they outlined the process they had used to grow embryo models outside of a uterus.

The system they developed uses bottles filled with liquids that act as a culture for the cells, which can rotate or remain static at different points of development.

In an email to Medical News Today, Prof. Hanna noted: Since we know what it takes to support the growth of [natural mouse embryos] outside the uterus (device and conditions), we can finally test whether and which stem cells can generate an embryo ab initio [from the start] only from stem cells.

We couldnt do that before because how are you going to grow a synthetic embryo if you dont know how to grow a natural embryo? Low and behold indeed, the same device, the same media conditions, and the same parameters allowed aggregates of 27 cells of pluripotent stem cells to reach day 8.5-stage embryos when placed in this device after 8 days.

Prof. Jacob Hanna

The device and the media were critical. These embryos are whole embryos they have [a] yolk sac and placenta. But remarkably, we did not use placenta stem cells and yolk sac stem cells, but showed that everything can be made exclusively from naive pluripotent embryonic stem or induced pluripotent stem cell lines that are routinely expanded in labs around the world, he explained.

This was remarkable because previously, researchers had made embryo models that began to form the placenta, egg yolk, and amnion using a mixture of embryonic stem cells and stem cells taken from the trophoblast layer. This is the layer that normally differentiates into the placenta in embryos.

However, the failure rate in this latest set of experiments was high, with just 50 of 10,000 of these cell mixtures forming first into spheres and then into more egg-shaped structures such as an embryo.

Not only did these embryo models start to produce the structures that would support a pregnancy, but by the end of the 8.5 days in which they grew, they had formed a beating heart, blood stem cell circulation, a head region with folds, a neural tube and the beginnings of a gut tube.

The same week this paper appeared in Cell, the University of Cambridge-based laboratory of Prof. Magdalena Zernicka-Goetz published two papers on a preprint server: shared here and here. In fact, Prof. Zernicka-Goetzs team shared the latter on the same day the Cell study was published.

This paper outlines how the researchers from the Cambridge lab had observed similar organ structures start to form in their own research using embryo models.

Prof. Zernicka-Goetz told MNT in an interview that these papers would appear in peer-reviewed journals in the coming weeks and that their final versions were currently under embargo.

So it is [a] step by step [process] [] our paper is going to show even further developments, she told us.

This latest finding builds on the previous work of other laboratories and teams, both those of Prof. Zernicka-Goetz and others, said Prof. David Glover, her husband.

Profs. Glover and Zernicka-Goetz have teams at Cambridge and CalTech. They have carried out research together and appear as co-authors on one of the papers due to be published soon.

He told MNT in an interview: I think you have to go back to Magdas paper published in 2017, [whose] senior author was Sarah Harrison, which establishes the principle of being able to make an embryo-like structure using a mixture of extraembryonic cells and embryonic cells.

Extraembryonic cells include key components forming extraembryonic tissues, which are crucial to maintaining embryo survival. Extraembryonic tissues include the placenta, yolk sac, and amnion.

Being able to produce embryo models that feature the start of development of these tissues is so important because they help initiate the signaling that helps the embryo model develop and self-assemble much as a naturally developing embryo would, Prof. Glover noted.

The fact is that, because our own embryos develop inside the womb, they require extraembryonic tissues to develop properly. And those extraembryonic tissues have two functions. They provide, of course, a structural basis, they provide a yolk sac, [and] they provide the placenta, he explained.

But before they get to that stage, they also provide signals to the embryo to tell it how to properly develop. And if you dont have those signals there, then the embryo doesnt develop properly, the researcher added.

These particular models were just one type of embryo model currently being developed, said Prof. Glover.

Researchers have also developed other models, such as blastoids, which attempt to recreate the pre-implantation blastocyst stage of the embryo, and gastruloids, which do not have any extraembryonic tissues, and as a result, tend not to have a brain region.

Dr. Nicholas Rivrons laboratory at the Institute of Molecular Biotechnology at the Austrian Academy of Sciences, Vienna, Austria, has worked on developing embryo models to gain greater insight into the pre-implantation stage.

His group published a 2018 key paper in Nature. It outlined how they developed mouse embryo models using embryonic stem cells and stem cells from the trophoblast layer to create blastoids that could be implanted into the uterus of a mouse for a couple of days.

Then, in December 2021, the same team published another paper in Nature. This time, they outlined how they had created embryo models to the blastocyst stage made from human pluripotent stem cells, which they had induced to become able to differentiate into different types of cells.

Speaking to MNT, Dr. Rivron said: For the next stages of investigation, we need to actually understand how those embryos can be combined with the uterine cells in order to understand the processes of implantation into the uterus and how this can develop our knowledge to solve various health challenges of family planning, fertility decline, also the origin of diseases.

While the embryo models described in the latest paper demonstrated they had self-organized to form some structures that would go on to form the placenta, these embryo models were limited by how much further they could grow without one, said Dr. Rivron.

The limitation is the placenta the placenta is extremely important, he noted, due to the fact that it provides the nutrients and oxygen to the embryo that are essential for it to grow and develop further.

The latest paper also confirmed that the very first stages of organ development, known as organogenesis, could be observed in these model embryos.

This has typically been difficult to observe, as it typically occurs in the uterus. However, by establishing a process to develop these embryo models in the laboratory, the differentiation of the cells, the genetic control of this differentiation, and the environment needed for typical development can all be studied.

The latest paper used mouse embryonic stem cells to develop the model embryos, which will require ethical approval. By contrast, human embryo research is extensively regulated.

Guidelines for this regulation are released by the International Society for Stem Cell Research (ISSCR) approximately every 5 years, with the last set of guidelines released last year. This guidance addressed the existence of stem cell-derived embryo models and the possibility of chimeric embryo models built using cells from different species alongside human cells.

While it may prove technically possible to grow organs using embryo models, Dr. Rivron pointed out that this may not be necessary or, indeed, ethically desirable.

He pointed instead to the development of organoids, stem cell-derived models of organ tissues that can be used to investigate cellular behavior, and perhaps the development, of organs too.

In fact, a paper outlining how researchers at Harvard Unversity had bioengineered structures of the human heart appeared in Science in the same week as the latest article on embryo models.

Dr. Rivron contributed to the latest set of ISSCR guidelines and told MNT: If you want to study organogenesis or create organs, the political principle is that you have to use, morally, the least problematic way of studying these, and organoids offer a way to do this.

Both the development of organoids and embryo models have come in leaps and bounds in the past 5 years, and their basis, new genomic approaches we can use to understand and recreate mammalian structures, are similar.

It will be interesting to see how the disciplines converge in years to come, to give us an even greater set of tools to unlock the black box of our development.

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Many stem cell lines used for research and therapies carry large number of mutations, Cambridge researchers find – Cambridge Independent

Posted: August 22, 2022 at 2:48 am

The remarkable power of stem cells - which can be programmed to become almost any type of cell in the body - means they are key to many scientific studies.

Increasingly, they are also being used for new cell-based therapies to treat a range of diseases.

While originally we could only get stem cells from embryos, now we can derive them from a range of adult tissues, including skin or blood, using Nobel Prize-winning technology.

But Cambridge researchers have found DNA damage caused by factors such as ultraviolet radiation affected 72 per cent of the stem cell lines they studied that had been derived from human skin cells. This has important implications for research and medicine.

Prof Serena Nik-Zainal, from the Department of Medical Genetics at the University of Cambridge, said: Almost three-quarters of the cell lines had UV damage. Some samples had an enormous amount of mutations sometimes more than we find in tumours. We were all hugely surprised to learn this, given that most of these lines were derived from skin biopsies of healthy people.

Induced pluripotent stem cells (iPSCs), as those derived from other cell types or tissues are known, hold huge potential for tackling diseases, including rare conditions.

It is even suggested that iPSCs programmed to grow into nerve cells could be used to replace those lost to neurodegeneration in diseases such as Parkinsons.

The new research, published in Nature Genetics, represents the largest genetic study to date of iPSCs to date.

Dr Foad Rouhani, who carried out the work while at the University of Cambridge and the Wellcome Sanger Institute, said: We noticed that some of the iPS cells that we were generating looked really different from each other, even when they were derived from the same patient and derived in the same experiment.

The most striking thing was that pairs of iPS cells would have a vastly different genetic landscape one line would have minimal damage and the other would have a level of mutations more commonly seen in tumours.

One possible reason for this could be that a cell on the surface of the skin is likely to have greater exposure to sunlight than a cell below the surface and therefore eventually may lead to iPS cells with greater levels of genomic damage.

[Read more: Evidence of new causes of cancer uncovered as genomic data of 12,000 NHS patients is studied by University of Cambridge researchers]

DNA comprises three billion pairs of nucleotides - molecules represented by the letters A, C, G and T.

Damage from sources such as ultraviolet radiation or smoking leads to mutations, meaning a letter C might change to T, for example.

Studying the mutational fingerprints on our DNA can reveal what is responsible for the damage.

An accumulation of mutations can have a profound effect on cell function and in some cases lead to tumours.

Using whole genome sequencing, the researchers inspected the entire DNA of stem cell lines from different sources, including the HipSci cohort at the Wellcome Sanger Institute.

They found blood-derived iPSCs - which are increasingly common, due to the ease with which blood can be taken - also carried mutations but at a lower level than skin-derived iPS cells, and they had no UV damage.

Some 26.9 per cent of them, however, carried mutations in a gene called BCOR, which is an important gene in blood cancers.

Next the researchers investigated whether these BCOR mutations had any functional impact.

They differentiated the iPSCs, turning them into neurons and tracking their progress along the way.

[Read more: 4m funding for Cambridge scientists under Cancer Grand Challenges initiative]

Dr Rouhani said: What we saw was that there were problems in generating neurons from iPSCs that have BCOR mutations they had a tendency to favour other cell types instead. This is a significant finding, particularly if one is intending to use those lines for neurological research.

Analysis of the blood samples showed the BCOR mutations were not present within the patient.

So it seemed that the process of culturing cells increased the frequency of the mutations, which could have implications for other researchers working with cells in culture.

Typically, scientists using cell lines will screen them at the chromosomal level checking, for example, that the requisite 23 pairs of chromosomes are present.

Such analysis would not pick up the potentially major problems that this new study has identified, however,

The researchers warn that without looking in detail at the genomes of these stem cells, researchers and clinicians would be unaware of the underlying damage in them.

The DNA damage that we saw was at a nucleotide level, explained Prof Nik-Zainal. If you think of the human genome as like a book, most researchers would check the number of chapters and be satisfied that there were none missing. But what we saw was that even with the correct number of chapters in place, lots of the words were garbled.

Using whole genome sequencing, however, would enable errors to be discovered at the outset..

The cost of whole genome sequencing has dropped dramatically in recent years to around 500 per sample, though it's the analysis and interpretation that's the hardest bit, said Prof Nik-Zainal.

If a research question involves cell lines and cellular models, and particularly if we're going to introduce these lines back into patients, we may have to consider sequencing the genomes of these lines to understand what we are dealing with and get a sense of whether they are suitable for use.

Dr Rouhani adds: In recent years we have been finding out more and more about how even our healthy cells carry many mutations and therefore it is not a realistic aim to produce stem cell lines with zero mutations.

The goal should be to know as much as possible about the nature and extent of the DNA damage to make informed choices about the ultimate use of these stem cell lines.

If a line is to be used for cell based therapies in patients for example, then we need to understand more about the implications of these mutations so that both clinicians and patients are better informed of the risks involved in the treatment.

The research was funded by Cancer Research UK, the Medical Research Council and Wellcome, and supported by NIHR Cambridge Biomedical Research Centre and the UK Regenerative Medicine Platform.

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Many stem cell lines used for research and therapies carry large number of mutations, Cambridge researchers find - Cambridge Independent

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Scientists hope to revive extinct mammal through stem cells and gene-editing in a first – The Mirror

Posted: August 22, 2022 at 2:48 am

The group of scientists planned to take stem cells from a living marsupial species with a similar DNA, before using gene-editing technology to revive the extinct species - or a close approximation of it

Image: Popperfoto via Getty Images)

Scientists are launching a project aiming to bring the Tasmanian tiger back from extinction through stem cells and gene-editing technology.

The last of the extinct marsupials, which are officially called thylacines, died in the 1930s.

The team behind the project said the tiger could be recreated using stem cells and gene-editing technology.

If successful, the thylacine would be the first of its kind to be reintroduced to the wild in 10 years time.

However, some experts are sceptical, suggesting de-extinction is a thing of science fiction.

According to BBC reports , the thylacine was given its nickname of Tasmanian tiger due to the stripes along its back.

However, it was actually a marsupial, the variety of Australian mammal that raises its young in a pouch.

Image:

The mixed group of Australian and US scientists planned to take stem cells from a living marsupial species with a similar DNA, before using gene-editing technology to revive the extinct species - or a close approximation of it.

The project would require a number of scientific breakthroughs in order to be successful.

If carried out, it would represent a remarkable achievement for the researchers attempting it.

Professor Andrew Pask, who is leading the research from the University of Melbourne, said: "I now believe that in 10 years' time we could have our first living baby thylacine since they were hunted to extinction close to a century ago," .

Tasmanian tiger numbers declined when humans arrived in Australia tens of thousands of years ago.

The population dwindled even further when humans arrived in Australia tens of thousands of years ago and again when dingoes, a species of wild dog, appeared.

Image:

Tasmanian tigers eventually only roamed free on the island of Tasmania, where they were ultimately hunted to extinction.

The last captive Tasmanian tiger died in 1936, at Hobart Zoo.

De-extinction and the science behind it has its critics, with Associate Professor Jeremy Austin from the Australian Centre for Ancient DNA, calling de-extinction fairytale science.

Professor Austin, speaking to the Sydney Morning Herald, said the project was "more about media attention for the scientists and less about doing serious science".

The idea to bring back the Tasmanian tiger has been around for more than 20 years.

The Australian Museum started to pursue a project to clone the animal back in 1999 and various attempts have been made at intervals ever since either to extract or rebuild viable DNA from samples.

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Scientists hope to revive extinct mammal through stem cells and gene-editing in a first - The Mirror

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