Monthly Archives: October 2019

Acorn Biolabs partners with Executive Health Centre to become first clinic in North America to offer non-invasive stem cell collection – Canada…

Posted: October 25, 2019 at 2:51 pm

TORONTO, Oct. 23, 2019 /CNW/ -Acorn Biolabs, a pioneer in non-invasive stem cell collection, today announced a strategic partnership with Toronto-based Executive Health Centre, a medical wellness centre and leader in precision and personalized medicine. Under the agreement, Executive Health Centre will become the first clinic in North America to offer its patients the ability to have their stem cells banked through a method that involves simply plucking a few hair follicles from a person's head.

Acorn's innovative method allows for full genome collection without the need for surgery or other painful and invasive procedures, making stem cell collection significantly more affordable and accessible for everyone.

"Our partnership with Acorn is tremendously exciting for the future of healthcare," says Dr. Elaine Chin, founder of Executive Health Centre. "Stem cells play a critical role in predictive analytics and will allow us to identify and prevent diseases before they happen, in addition to creating the possibility for an array of personalized regenerative treatments in the future."

Once stem cells are collected, Acorn uses a proprietary method of keeping cells viable during transport and storage, turning collected hair follicles into a highly valuable and accessible resource for regenerative medicine and genetics. Not only are these stem cells securely stored for future use, but the company's scientists can also extract critical genetic information that will unlock valuable data about a person's health that has never been available before.With this partnership, Executive Health Centre patients will also have access to Acorn's genetic age reports that provide insights into a person's aging process.

"Dr. Chin has been a trailblazer in using biometric and monitoring technology with her patients, and has established herself as an eminent thought leader in this space. For Acorn to combine our technology with her clinic's expertise is a major win not just for patients, but also for the broader industry as a whole," says Dr. Drew Taylor, co-founder and CEO of Acorn. "Both Executive Health Centre and Acorn strongly believe that our cells are the future of healthcare, and we're thrilled to be working together in making regenerative medicine accessible to more and more people."

Media AvailabilityTime: 4:00 p.m.Location: Executive Health Centre, 4120 Yonge Street, Toronto, ONDr. Drew Taylor and Dr. Elaine Chin are available for interviews.

About Acorn Biolabs, Inc.Founded in 2017 by Steven ten Holder, Patrick Pumputis and Dr. Drew Taylor and borne out of years of research, Acorn is a healthcare technology company. Based at Johnson & Johnson INNOVATION JLABS in Toronto, Acorn is focused on giving every human being the best chance to experience more healthy years with its easy, affordable and non-invasive live-cell collection, analysis and cryopreservation service. Acorn helps you live a longer, healthier tomorrow by freezing the clock on your cells today.Visit http://www.acorn.me.

About Executive Health CentreThe Executive Health Centre is recognized for its visionary work in personalized, preventative healthcare. Dr. Elaine Chin, founder of the Executive Health Centre, established North America's first physician and naturopathic doctor-integrated health clinic in 1997 at the Mississauga Hospital (now Trillium Health Partners). Today, the combined expertise of this innovative model is unmatched in North America and provides its patients the best in seamless integrative medicine and rejuvenation therapies. Dr. Chin is also the author of "Lifelines Unlocking the Secrets of Your Telomeres for a Longer, Healthier Life," on The Globe and Mail's Top 10 Bestseller List. Visit: http://www.executivehealthcentre.com.

SOURCE Acorn Biolabs

For further information: Morgan McLellan, E: morgan@providentcomms.com, C: 647-802-4825

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New capsule can orally deliver drugs that usually have to be injected – Big Think

Posted: October 25, 2019 at 2:51 pm

Many drugs, especially those made of proteins, cannot be taken orally because they are broken down in the gastrointestinal tract before they can take effect. One example is insulin, which patients with diabetes have to inject daily or even more frequently.

In hopes of coming up with an alternative to those injections, MIT engineers, working with scientists from Novo Nordisk, have designed a new drug capsule that can carry insulin or other protein drugs and protect them from the harsh environment of the gastrointestinal tract. When the capsule reaches the small intestine, it breaks down to reveal dissolvable microneedles that attach to the intestinal wall and release drug for uptake into the bloodstream.

"We are really pleased with the latest results of the new oral delivery device our lab members have developed with our collaborators, and we look forward to hopefully seeing it help people with diabetes and others in the future," says Robert Langer, the David H. Koch Institute Professor at MIT and a member of the Koch Institute for Integrative Cancer Research.

In tests in pigs, the researchers showed that this capsule could load a comparable amount of insulin to that of an injection, enabling fast uptake into the bloodstream after the microneedles were released.

Langer and Giovanni Traverso, an assistant professor in MIT's Department of Mechanical Engineering and a gastroenterologist at Brigham and Women's Hospital, are the senior authors of the study, which appears today in Nature Medicine. The lead authors of the paper are recent MIT PhD recipient Alex Abramson and former MIT postdoc Ester Caffarel-Salvador.

Langer and Traverso have previously developed several novel strategies for oral delivery of drugs that usually have to be injected. Those efforts include a pill coated with many tiny needles, as well as star-shaped structures that unfold and can remain in the stomach from days to weeks while releasing drugs.

"A lot of this work is motivated by the recognition that both patients and health care providers prefer the oral route of administration over the injectable one," Traverso says.

Earlier this year, they developed a blueberry-sized capsule containing a small needle made of compressed insulin. Upon reaching the stomach, the needle injects the drug into the stomach lining. In the new study, the researchers set out to develop a capsule that could inject its contents into the wall of the small intestine.

Most drugs are absorbed through the small intestine, Traverso says, in part because of its extremely large surface area --- 250 square meters, or about the size of a tennis court. Also, Traverso noted that pain receptors are lacking in this part of the body, potentially enabling pain-free micro-injections in the small intestine for delivery of drugs like insulin.

To allow their capsule to reach the small intestine and perform these micro-injections, the researchers coated it with a polymer that can survive the acidic environment of the stomach, which has a pH of 1.5 to 3.5. When the capsule reaches the small intestine, the higher pH (around 6) triggers it to break open, and three folded arms inside the capsule spring open.

Each arm contains patches of 1-millimeter-long microneedles that can carry insulin or other drugs. When the arms unfold open, the force of their release allows the tiny microneedles to just penetrate the topmost layer of the small intestine tissue. After insertion, the needles dissolve and release the drug.

"We performed numerous safety tests on animal and human tissue to ensure that the penetration event allowed for drug delivery without causing a full thickness perforation or any other serious adverse events," Abramson says.

To reduce the risk of blockage in the intestine, the researchers designed the arms so that they would break apart after the microneedle patches are applied.

The new capsule represents an important step toward achieving oral delivery of protein drugs, which has been very difficult to do, says David Putnam, a professor of biomedical engineering and chemical and biomolecular engineering at Cornell University.

"It's a compelling paper," says Putnam, who was not involved in the study. "Delivering proteins is the holy grail of drug delivery. People have been trying to do it for decades."

In tests in pigs, the researchers showed that the 30-millimeter-long capsules could deliver doses of insulin effectively and generate an immediate blood-glucose-lowering response. They also showed that no blockages formed in the intestine and the arms were excreted safely after applying the microneedle patches.

"We designed the arms such that they maintained sufficient strength to deliver the insulin microneedles to the small intestine wall, while still dissolving within several hours to prevent obstruction of the gastrointestinal tract," Caffarel-Salvador says.

Although the researchers used insulin to demonstrate the new system, they believe it could also be used to deliver other protein drugs such as hormones, enzymes, or antibodies, as well as RNA-based drugs.

"We can deliver insulin, but we see applications for many other therapeutics and possibly vaccines," Traverso says. "We're working very closely with our collaborators to identify the next steps and applications where we can have the greatest impact."

The research was funded by Novo Nordisk and the National Institutes of Health. Other authors of the paper include Vance Soares, Daniel Minahan, Ryan Yu Tian, Xiaoya Lu, David Dellal, Yuan Gao, Soyoung Kim, Jacob Wainer, Joy Collins, Siddartha Tamang, Alison Hayward, Tadayuki Yoshitake, Hsiang-Chieh Lee, James Fujimoto, Johannes Fels, Morten Revsgaard Frederiksen, Ulrik Rahbek, and Niclas Roxhed.

Reprinted with permission of MIT News. Read the original article.

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What Is a Fertility Coach?: What a Fertility Coach Does and Who Needs One – Parade

Posted: October 25, 2019 at 2:51 pm

Its a fact that as a womans age increases, fertility decreases. (This is why pregnancy at the age of 35 or later is often referred to as a geriatric pregnancy.) While there is no specific age recommendation for when to discuss your fertility with your doctorthough it does start its marked decline at the age of 30the recommendation from the Centers for Disease Control and Prevention (CDC) is to see a doctor after six months of unsuccessfully trying to conceive.

While your doctor is an invaluable resource, many people are now turning to fertility coaches to help boost their chances of conceiving. How is that different from what youll get from your visits with your obstetrician-gynecologist (OB-GYN)? The level of support, for one, as well as a deep dive into more than just what is going on inside your body that may be affecting your fertility.

Related: Should You Freeze Your Eggs to Preserve Your Future Fertility?

During my first introduction to sexual education, I believed that if you had vaginal intercourse it would result in pregnancy. While that is the case for some people, there are a lot of things that need to occur perfectly and simultaneously for conception. In fact, I lamented with friends how I wish we had been told that getting pregnant can take time (though that would have undermined the priority of sex ed teachings of a religious private school). Kate Potvin, ERYT-500, CiPP, fertility coach and creator of Flourish Fertility admits that this myth is perpetuated at a young age and that it is common for it to take several months to get pregnant. Why is this? Overall fertility does play a part, but it isnt as simple as that.

The fertile window of a womans cycle is only six days maximum, for some couples, adds Lindsay Meisel, chief science editor and head of content at Ava. Depending on sperm health, cervical mucus quality, age, and other factors, the effective fertile window may be even shorter than that.

The optimal menstrual cycle is actually affected by your overall health and fertility and can actually serve as a barometer for your lifestyle choices, saysKirsten Karchmer, CEO of Brazen, founder and clinical director of The Texas Center for Reproductive Acupuncture and author of Seeing Red.You want to be eating high quality nutrients (for high quality hormones and blood for good lining and implantation), limit alcohol and cannabis (occasional consumption is often fine) and avoid over-exercising (to keep from depleting your energy reserves).

What youre looking for is to have a lifestyle to help produce an optimal menstrual cycle (or as close as possible), Karchmner notes. You want to look for a 28-day cycle, oscillating on cycle day 14 with good cervical stretchy discharge, no PMS whatsoever, no cramping or clotting, and having enough blood to soak a tampon or pad or fill a Diva Cup or menstrual cup about every four hours without cramping or clotting. When you have thatplus having basal temperatures that are averaging around 97 to 98.2at the luteal phase, youre in your optimal state.

Of course, even if you are eating a clean diet, avoiding alcohol, trying to steer clear of environmental toxins (as much as possible) and exercising, fertility isnt that simple. Elizabeth Bechard, RYT, NBC-HWC, an integrative fertility coach, reminds us that there are underlying conditions that may come into play, such as polycystic ovarian syndrome (PCOS), endometriosis, eating disorders and even a history of cancer.

All of that said, infertility is also often caused by factors that may be out of an individuals control; unexplained infertility is painfully common across genders, Bechard stresses. Unexplained infertility and/or pregnancy loss can be especially difficult to navigate.

Related: Top Chef Host Padma Lakshmi Opens Up About Endometriosis

As you can see, it can be difficult to navigate fertility in general. This is where a fertility coach comes in (as early or as far along in the process as needed). Often their goal will be to help you achieve as close to that optimal menstrual cycle as possible, which is what you would probably assume from a fertility coach, but Bechard adds they can even counsel you through assisted reproductive techniques and adoption, as well.

While there are lots of different styles of health coaching and fertility coaching, in general, a fertility coach is someone who supports an individual on their journey to become a parent (whether parenthood occurs through unassisted conception, assisted reproductive technology, or in some cases, adoption), Bechard explains. Some fertility coaches offer detailed nutritional and lifestyle advice, whereas others primarily support clients in the process of creating lifestyles that support an environment of optimal fertility. The style of coaching generally depends on the coachs training and background.

It may seem counterintuitive to be working with someone else besides your OB-GYN to conceive, but Potvin notes that they often just look at your hormone levels and make sure your uterus and ovaries are healthy. Because there is more to fertilityincluding the lifestyle factorsa fertility coach actually helps you put it all into practice in everyday life. The other benefit is the one-on-one relationship that is built between coach and patient; your coach gains intimate knowledge of your specific situation and lifestyle, including documenting what has and hasnt been tried to improve chances of conception.

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Fertility coaches general spend significantly more time with their patients than OB-GYNs, as they largely set their own hours, reveals Bechard. In many medical offices, doctors rotate and a patient may see a different doctor every time, whereas fertility coaches usually have the chance to develop deeper relationships with their clients.

She adds that fertility coaches can work with a patients OB-GYN if requested, as coaches often cant order lab tests or prescribe medications. Patients who are undergoing in vitro fertilization (IVF) and choose to have a fertility coach may want the added layer of communication between their fertility coach and fertility doctor or reproductive endocrinologist.

When it comes to choosing a fertility coach, it is important to know what type of support you need because, as Karchmer stresses, a fertility coach can mean a lot of different things. She notes that there are a wide range of credentialsthey could have taken a weekend workshop, be a certified nutritionist, have a Ph.D. in traditional Chinese medicine or more. This is where the distinction can help you determine which coach is right for you.

One thing thats really important is that you determine exactly what kind of support that you need, whether thats on an emotional level on a physical level, and a nutrition level, or on a lifestyle level, Karchmer advises. As we know, the data are really clear that all of the lifestyle factorsincluding diet, stress, sleep mindsetall can make a significant impact on your menstrual cycle and your overall fertility.

This distinction between needing emotional or physical supportor bothis important. The physical part can be a bit easier to navigate as you rework your routine; emotionally, however, it can be lonely. There are a lot of ups and downs when it comes to trying to conceive; a fertility coach can act as a crucial form of support during those times (especially when youd rather not talk to family or friends about what youre going through).

The biggest thing I see with my clients is the emotional toll it can take on women and couples, says Potvin. One in eight couples will struggle to conceive, so I think its important for everyone to be sensitive around baby talk. If your friend isnt that excited about your pregnancy announcement, she might be struggling herself. And I think its time we dropped the, So when are you guys starting a family? question from small talk conversationsyou never know whos been struggling.

Thanks to technological advances, an in-person coach isnt your only option (of physical and emotional support). Products like Avaa fertility tracking bracelettrack physiological signals to tell you when you are fertile. Not only will their app give you guidance on boosting your chances of getting pregnant, it will also give you access to an online global network of other users who are going through similar stages of the process.

Women can join specific groups based on where they are in their fertility journeys and meet women from around the world who are going through the same thing, shares Meisel. We have women who have formed friendships while trying to get pregnant who now have babies the same age and fly across the country to visit each other!

You may even choose to use a wearable fertility tracker such as Ava to identify any physiological barriers making it difficult to conceive before you decide to get additional one-on-one support from a fertility coach.

A fertility coach doesnt just support a woman, however; men can benefit from seeing one, too. The American College of Obstetricians and Gynecologists (ACOG) notes that a mans fertility declines with age as a womans doesbut not as predictably. And just as a womans fertility can benefit from healthy lifestyle changes, the same can be said for men. Bechard stresses that while we often think of fertility as a womans problem, research shows otherwise.

Research shows that only one-third of infertility cases are the result of female-only factors, Bechard notes. Another one-third of cases are the result of male-only factors and one-third are the result of factors from both parties. So two-thirds of the time, fertility challenges involve some issue with sperm!

Should sperm not be the issue after testing, it is still beneficial for both parties to see the fertility coach together. As stated above, trying to conceiveespecially if unsuccessfullycan take a huge emotional toll (and can feel like work, at times). Having both members of a couple present and involved can only add to the emotional support available (and lets face it, men may need that support, too).

We want to recognize that fertility and conception arent just limited to men and women. This is an important point fertility coaches acknowledge: Not everyone trying to conceive will fit neatly into a gender binary.

Many of my clients are queer-identified, and its absolutely possible for individuals who do not identify as women (such as transmen or nonbinary individuals) to conceive if they have a uterus, Bechard concludes. As fertility coaches support individuals in cultivating lifestyles and making changes that support optimal fertility, anyone who is trying to conceivemale, female, transgender, or nonbinarycould benefit from the support of a coach, particularly if there have been challenges already.

Read our exclusive interview with Fox and Friends Weekend co-host Jedediah Bila on her infertility journey.

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NIH, Gates Foundation aim to bring genetic cures to the poor – STAT

Posted: October 24, 2019 at 11:47 pm

The National Institutes of Health and the Bill and Melinda Gates Foundation will together invest at least $200 million over the next four years to develop gene-based cures for sickle cell disease and HIV with an attribute even rarer in the world of genetic medicine than efficacy, the groups announced on Wednesday: The cures, they vowed, will be affordable and available in the resource-poor countries hit hardest by the two diseases, particularly in Africa.

The effort reflects growing concerns that scientific advances in genetic medicine, both traditional gene therapies and genome-editing approaches such as CRISPR, are and will continue to be prohibitively expensive and therefore beyond the reach of the vast majority of patients. Spark Therapeutics Luxturna, a gene therapy for a rare form of blindness, costs $425,000 per eye, for instance, and genetically engineered T cells (CAR-Ts) to treat some blood cancers cost about the same.

With CRISPR-based treatments already being tested in clinical trials for sickle cell disease, the blood disorder beta thalassemia, and another form of blindness, and with additional CRISPR treatments in development, scientists, ethicists, and health policy experts have grown increasingly concerned that the divide between haves and have-nots will grow ever-wider.

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Gene-based treatments are largely inaccessible to most of the world by virtue of the complexity and cost of treatment requirements, which currently limit their administration to hospitals in wealthy countries, the NIH said in a statement. To help right that, its collaboration with the Gates Foundation aims to develop curative therapies that can be delivered safely, effectively and affordably in low-resource settings.

Scientists whose research focuses on gene-based cures welcomed the infusion of funding and the recognition that genetic cures are on track to be unaffordable to the majority of patients. But they noted one irony. The most effective sickle cell drug, hydroxyurea, has hardly even been studied in sub-Saharan Africa, let alone made widely available. Yet a 2019 study found that giving children the drug cut their death rate by two-thirds and halved the pain crises that are common in sickle cell disease, caused by misshapen red blood cells that cannot flow through blood vessels.

The NIH-Gates collaboration is tremendously exciting and has the potential to have a great impact on sickle cell disease in sub-Saharan Africa, said Dr. Vijay Sankaran of the Dana-Farber/Boston Childrens Cancer and Blood Disorders Center, who has done pioneering research on genetic cures for the disease. But my hesitation is that even the inexpensive therapies we have today, such as hydroxyurea, are largely unavailable there. The question is, how do we best approach this disease, with therapies that are working today or with genetic therapies that might work?

The same concerns surround HIV. Very inexpensive less than $100 per year in the U.S. antiretroviral drugs can keep the virus in check, but only 67% of HIV-positive adults and 62% of HIV-positive in children in east and southern Africa are estimated to be on antiretroviral treatment.

The new collaboration aims to move gene-based cures into clinical trials in the U.S. and countries in sub-Saharan Africa within the next seven to 10 years, and to eventually make such treatments available in areas hardest hit by sickle cell disease and HIV/AIDS. The idea is to focus on access, scalability, and affordability to make sure everybody, everywhere has the opportunity to be cured, not just those in high-income countries, NIH Director Francis Collins said in a statement. We aim to go big or go home. But the challenge is enormous, he told reporters on Wednesday: Im not going to lie. This is a bold goal.

An estimated 95% of the 38 million people with HIV live in the developing world, with 67% in sub-Saharan Africa. Up to 90% of children with sickle cell disease in low-income countries die before they are 5 years old. In the U.S., the life expectancy for people with sickle cell disease is in the low 40s.

The NIH and the Gates Foundation will fund research to identify potential gene-based cures for sickle cell and HIV, and also work with groups in Africa to test those cures in clinical trials.

The science of genetic cures for both diseases is within reach, experts say. CRISPR Therapeutics and Vertex (VRTX) are already running a clinical trial for sickle cell disease, using the CRISPR genome editor to do an end-run around the disease-causing mutation in the hemoglobin gene: The therapy releases the brake on red blood cells production of fetal hemoglobin, whose production shuts off in infancy but which does not have the sickling damage of adult hemoglobin.

Developing effective, safe genetic cures for sickle cell and HIV would be only a first step, however. As currently conceived, such therapies require advanced medical facilities to draw blood from patients, alter their cells genomes in a lab, give the patients chemotherapy to kill diseased blood-making cells, and then perform whats essentially a bone marrow transplant, followed by monitoring patients in a hospital for days to prevent infection and provide intensive medical support, said Dr. Dan Bauer, a sickle cell expert at Boston Childrens.

He called the NIH-Gates effort terrific, but cautioned that delivering advanced gene therapies requires tremendous effort, extended hospitalization, and large supplies of blood products. All of those requirements mean that even if a CRISPR-based cure for sickle cell disease or HIV were provided at cost, there will still be barriers to access.

Recognizing that, Collins said, a genetic cure would have to be given directly into patients (in vivo), presumably through an infusion, rather than by treating blood or other cells removed from patients and genetically transformed in a lab (ex vivo). That could avoid the resources needed for and the complications that can occur with ex vivo therapies, said Sankaran, who has discussed the approach with Gates officials.

This story has been updated with additional comments.

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American Academy of Stem Cell Physicians Announced Today That Their Safety Panel Session is Open and Free to the Public – Valdosta Daily Times

Posted: October 24, 2019 at 11:47 pm

MIAMI - October 24, 2019 - ( Newswire.com )

The AASCP has recently created guidelines thatare current safety recommendations given to physicians who are using biologics in their medical practice. A highly anticipated and sought after Safety StandardsPanel session, hosted by AASCP on Nov. 2, 2019, will be moderated by The Alliance for Cell Therapy Now,with President Ms. Janet Marchbrody.The sessions normally are closed to the public but this particular SafetyStandard Panel discussion will be open to the public, covering the growing safety concerns of the industry.

Alliance for Cell Therapy Now is a coalition of organizations representing patients, health care providers and the academic and scientific community, who are working together to advance safe and effective regenerative cell therapies. The mission is to advance the development, manufacturing and delivery of safe and effective regenerative cell therapies through policy development, consensus and advocacy. Alliance for Cell Therapy Now is bringing together experts and stakeholders to gain consensus on and advocate for policies that will advance the science and the field, including those focused on promoting clinical research, assuring the adoption of consensus standards to promote safety and quality, building capacity and expertise within the workforce, and establishing a national outcomes database to advance the science, promote improvements in quality and safety, and inform regulatory, paymentand patient decision-making.

Alliance for Cell Therapy Now is guided by an Advisory Board comprised of leaders in the scientific, academicand patient communities; Ms. Janet M. Marchibroda President, Alliance for Cell Therapy Now Fellow, Bipartisan Policy Center Senior Vice President, Health Policy, Bockorny Group, has agreed to join theAASCP as a moderator for their SafetyPanelat The Hyatt Regency in Miami. This particular coveted safetypanel session will be open to the public and broadcast live on YouTube at 3:00 p.m. on Nov. 2, 2019.

According to AASCP, if you are using biologics in your practice, whether you are using SVF, PRP, bone marrow, UCB, amniotic products,exosomes,xenografts, or peptides, there are key considerations to take into account to achieve the best safety for your patients. The AASCP also recommends communication with the Chief Scientific Officer from the laboratory you work with.AASCP advises that just talking to a sales agent is not sufficient enough when determining the quality of products for your patients. Sales agents typically do not have a medical or scientific background.

The spokesman for the AASCP, Dr. AJFarshchian,said earlier: The American Academy of Stem Cell Physicians is a group of physicians, scientists and researchers who collectively represent the most authoritativenon-federal group advocating for guidelines and education on stem cell therapy and regenerative medicine. AASCP members are experts within all fields of stem cell therapy from: SVF, BM, UCB, Exosomes, Peptides, Xenografts, Allografts and Amniotic Fluids and are considered the most experienced leaders for proper advocacy in the field. The AASCP is involved directly with other authorities within the field and seeks only to bring knowledge and awareness for the ever growing regenerative medicine industry.My hope is that the SafetyPanel discussion on Nov.2, 2019, is to help get rid of the bad actors that are damaging the field for everyone.

AASCP is hosting their medical conference in Miami on Nov. 1-3 , 2019. Sessions are normally closed to the public and, therefore, require registration. The conference is taking place at the downtown MiamiHyatt Regency, located at 400 SE 2nd Ave, Miami, FL 33131.Becauseof limited seating, we encourage everyone to please RSVP ataascp.net andto register.

The American Academy of Stem Cell Physicians (AASCP) is an organization created to advance research and the development of therapeutics in regenerative medicine, including diagnosis, treatmentand prevention of disease related to or occurring within the human body. Secondarily, the AASCP aims to serve as an educational resource for physicians, scientistsand the public in diseases that can be caused by physiological dysfunction that areameliorableto medical treatment.

For further information, please contact Marie Barbaat AASCP 305-891-4686 and you can also visit us at http://www.aascp.net.

Related Links AASCP Safety guidelinesAASCP website / registration

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MaxCyte Advances Phase I Clinical Trial of Lead CARMA(TM) mRNA-based Cell Therapy to Third Cohort of Patients – Herald-Mail Media

Posted: October 24, 2019 at 11:47 pm

GAITHERSBURG, Md., Oct. 24, 2019 /PRNewswire/ --MaxCyte, the global cell-based therapies and life sciences company, announces today that, having completed dosing of the second cohort of patients, clinical investigators have initiated dosing in the third cohort of patients of MaxCyte's Phase I clinical trial with the next higher cell dose of MCY-M11. This lead, wholly-owned, non-viral mRNA-based cell therapy candidate from MaxCyte's CARMA platform is a mesothelin-targeting chimeric antigen receptor (CAR) therapy being tested in individuals with relapsed/refractory ovarian cancer and peritoneal mesothelioma.

The dose escalation trial is evaluating the safety and tolerability, as well as preliminary efficacy, of MCY-M11 administered intraperitoneally across a series of ascending dose-level cohorts. In the first two cohorts, the infusion of MCY-M11 has been well tolerated in all patients treated. No dose-limiting toxicities, infusion-related adverse events, on-target or off-target toxicities, or other unwanted events were observed.

"We are making significant progress with our lead CAR therapeutic and our proprietary CARMA autologous cell therapy platform. Furthermore, the on-going trial continues to demonstrate the feasibility of our one-day cell therapy manufacturing process," said Claudio Dansky Ullmann, MD, Chief Medical Officer. "We are very excited about the potential of MCY-M11 as a new, effective therapeutic in solid tumors where the majority of patients still have very limited treatment options."

About the Phase I Clinical TrialThe multi-center, non-randomized, open label, dose-escalation Phase I clinical trial is evaluating the safety and preliminary efficacy of intraperitoneal infusions of MCY-M11 in individuals with platinum-resistant, high-grade, serous adenocarcinoma of the ovary, primary peritoneum or fallopian tube, or individuals with advanced peritoneal mesothelioma with recurrence after prior chemotherapy. MaxCyte anticipates approximately 15 study participants will be enrolled across the two clinical sites participating in the study (the National Cancer Institute (NCI) at the National Institutes of Health (NIH) and Washington University at St. Louis (WUSTL)). More information about the study can be found at ClinicalTrials.gov.

About the CARMA PlatformCARMA is MaxCyte's clinical-stage, non-viral, mRNA-based cell therapy platform that allows for the transfection of mRNA into cells and provides a simple, rapid-to-manufacture, dose-controllable product. CARMA requires less than one day for manufacture therapies for patients, where existing CAR-T therapies require one to two weeks or more to manufacture. MaxCyte's wholly-owned lead CARMA candidate, MCY-M11, is currently being evaluated in a Phase I clinical trial in patients with advanced ovarian cancer and peritoneal mesothelioma. MaxCyte management is evaluating independent sources of financing for CARMA. More information on the CARMA platform and pipeline is available at http://www.maxcyte.com/car/.

About MaxCyte MaxCyte is a clinical-stage global cell-based therapies and life sciences company applying its proprietary cell engineering platform to deliver the advances of cell-based medicine to patients with high unmet medical needs. MaxCyte is developing novel CARMA therapies for its own pipeline, with its first drug candidate in a Phase I clinical trial. CARMA is MaxCyte's mRNA-based proprietary therapeutic platform for autologous cell therapy for the treatment of solid cancers. In addition, through its life sciences business, MaxCyte leverages its Flow Electroporation Technology to enable its biopharmaceutical partners to advance the development of innovative medicines, particularly in cell therapy. MaxCyte has placed its flow electroporation instruments worldwide, including with all of the top ten global biopharmaceutical companies. The Company now has more than 80 partnered programme licenses in cell therapy with more than 45 licensed for clinical use, including six commercial licenses. With its robust delivery technology platform, MaxCyte helps its partners to unlock the full potential of their products. For more information, visit http://www.maxcyte.com.

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Global Stem Cell and Regenerative Therapy Market – Yahoo Finance

Posted: October 24, 2019 at 11:47 pm

Report Scope: The scope of this report is broad and covers various type of product available in the stem cell and regenerative medicines market and potential application sectors across various industries.

New York, Oct. 24, 2019 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Stem Cell and Regenerative Therapy Market" - https://www.reportlinker.com/p05791357/?utm_source=GNW The current report offers a detailed analysis of the stem cell and regenerative medicines market.

The report highlights the current and future market potential of stem cell and regenerative medicines and provides a detailed analysis of the competitive environment, recent development, merger and acquisition, drivers, restraints, and technology background in the market. The report also covers market projections through 2024.

The report details market shares of stem cell and regenerative medicines based on products, application, and geography.Based on product the market is segmented into therapeutic products, cell banking, tools and reagents.

The therapeutics products segments include cell therapy, tissue engineering and gene therapy. By application, the market is segmented into oncology, cardiovascular disorders, dermatology, orthopedic applications, central nervous system disorders, diabetes, others

The market is segmented by geography into the following regions: North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The report presents detailed analyses of major countries such as the U.S., Canada, Mexico, Germany, the U.K. France, Japan, China and India. For market estimates, data is provided for 2018 as the base year, with forecasts for 2019 through 2024. Estimated values are based on product manufacturers total revenues. Projected and forecasted revenue values are in constant U.S. dollars, unadjusted for inflation.

Report Includes: - 28 data tables - An overview of global markets for stem cell and regenerative medicines - Analyses of global market trends, with data from 2018, estimates for 2019, and projections of compound annual growth rates (CAGRs) through 2024 - Details of historic background and description of embryonic and adult stem cells - Information on stem cell banking and stem cell research - A look at the growing research & development activities in regenerative medicine - Coverage of ethical issues in stem cell research & regulatory constraints on biopharmaceuticals - Comprehensive company profiles of key players in the market, including Aldagen Inc., Caladrius Biosciences Inc., Daiichi Sankyo Co. Ltd., Gamida Cell Ltd. and Novartis AG

Summary The global market for stem cell and regenerative medicines was valued at REDACTED billion in 2018.The market is expected to grow at a compound annual growth rate (CAGR) of REDACTED to reach approximately REDACTED billion by 2024.

Growth of the global market is attributed to the factors such as growingprevalence of cancer, technological advancement in product, growing adoption of novel therapeuticssuch as cell therapy, gene therapy in treatment of chronic diseases and increasing investment fromprivate players in cell-based therapies.

In the global market, North America held the highest market share in 2018.The Asia-Pacific region is anticipated to grow at the highest CAGR during the forecast period.

The growing government funding for regenerative medicines in research institutes along with the growing number of clinical trials based on cell-based therapy and investment in R&D activities is expected to supplement the growth of the stem cell and regenerative market in Asia-Pacific region during the forecast period.

Reasons for Doing This Study Global stem cell and regenerative medicines market comprises of various products for novel therapeutics that are adopted across various applications.New advancement and product launches have influenced the stem cell and regenerative medicines market and it is expected to grow in the near future.

The biopharmaceutical companies are investing significantly in cell-based therapeutics.The government organizations are funding research and development activities related to stem cell research.

These factors are impacting the stem cell and regenerative medicines market positively and augmenting the demand of stem cell and regenerative therapy among different application segments.The market is impacted through adoption of stem cell therapy.

The key players in the market are investing in development of innovative products. The stem cell therapy market is likely to grow during the forecast period owing to growing investment from private companies, increasing in regulatory approval of stem cell-based therapeutics for treatment of chronic diseases and growth in commercial applications of regenerative medicine.

Products based on stem cells do not yet form an established market, but unlike some other potential applications of bioscience, stem cell technology has already produced many significant products in important therapeutic areas. The potential scope of the stem cell market is now becoming clear, and it is appropriate to review the technology, see its current practical applications, evaluate the participating companies and look to its future.

The report provides the reader with a background on stem cell and regenerative therapy, analyzes the current factors influencing the market, provides decision-makers the tools that inform decisions about expansion and penetration in this market.Read the full report: https://www.reportlinker.com/p05791357/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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BrainStorm Cell Therapeutics’ President and CEO to be Featured as Keynote Speaker at Cell Series UK 2019 – GlobeNewswire

Posted: October 24, 2019 at 11:47 pm

NEW YORK, Oct. 24, 2019 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in the development of innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, today announced, Chaim Lebovits, President and CEO, will serve as a Keynote Speaker at Cell Series UK.Cell Series UK, will be held October 29-30, 2019, at London Novotel West, London, UK. The Conference, organized by Oxford Global, is one of the foremost events in Europe focused on regenerative medicine and cellular innovation.

Ralph Kern MD, MHSc, Chief Operating and Chief Medical Officer of Brainstorm, who will also participate at Cell Series UK stated, We are very pleased to have Chaim Lebovits presenting at this prestigious conference where global leaders in stem cell and regenerative medicine will have the opportunity to learn more about NurOwn and the critical research being conducted by the Company. Mr. Lebovits Keynote Address, Stem Cell Therapeutic Approaches For ALS, will be presented to leading members of the scientific and business community including potential partners and investors.

About NurOwnNurOwn (autologous MSC-NTF cells) represent a promising investigational approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. NurOwn is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

AboutBrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

Safe-Harbor Statements Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could causeBrainStorm Cell Therapeutics Inc.'sactual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorms need to raise additional capital, BrainStorms ability to continue as a going concern, regulatory approval of BrainStorms NurOwn treatment candidate, the success of BrainStorms product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorms NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorms ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorms ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate:Uri YablonkaChief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188uri@brainstorm-cell.com

Media:Sean LeousWestwicke/ICR PR Phone: +1.646.677.1839sean.leous@icrinc.com

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What Did the Winners of the Nobel Prize in Medicine Discover? – JSTOR Daily

Posted: October 24, 2019 at 11:47 pm

Its Nobel Prize season! In the biological sciences, the prestigious prizes are often awarded for discoveries that unlock lifes most basic mechanisms. Nobel-prize-winning work often invokes concepts so fundamental that most people take them for granted. This years Nobel Prize for Physiology and Medicine is no exception. Awarded to William Kaelin Jr, Sir Peter Ratcliffe, and Gregg L. Semenza, the 2019 prize honors the discovery of how cells adapt to the presence of oxygen.

In a 2007 Science article, one of the winners, Gregg Semenza, describes portions of the groundbreaking work. The major issue, as Semenza describes it, is that while many of lifes essential functions depend on oxygen, the amount available is not always consistent. For example, oxygen availability has not been consistent throughout evolutionary history. Early organisms began utilizing oxygen for energy production in increasing degrees, starting around 2.5 billion years ago, about a billion years after life began. After photosynthetic organisms that produced oxygen as a byproduct emerged, the atmospheric oxygen concentration increased dramatically.

Early life, and the cells of more complicated organisms, had to get used to this newly abundant resource. Non-photosynthetic organisms became dependent on oxidative phosphorylation, a means by which the energy of sugar is unlocked for use by cells. Within the cell, in the face of changing external conditions, the amount of available oxygen must be relatively constant. Too little, and it will be impossible to generate energy; too much, and potentially deadly waste products can build up.

Enter HIF-1, aka Hypoxia Induced Factor 1, a protein known as a transcription factor. Transcription factors control the conditions under which a specific gene or genes is expressed, and HIF-1 controls hundreds, perhaps thousands, of genes. The amount of HIF-1 available varies depending on the available oxygen, increasing or decreasing how often the suite of genes controlled by HIF-1 gets expressed.

Semenza and his colleagues teased out the details of the incredibly complicated mechanism by which HIF-1 functions to maintain constant oxygen levels. There are more than a dozen steps, and related biochemical components, in the process. They have found versions of the HIF-1 process in much simpler animals, such as roundworms and flies, helping them trace the evolutionary origins of the adaptation to oxygen.

The work was doubly significant. Not only did the team come to a detailed understanding of one of lifes key processes, the discovery has great potential in medicine as well. Some of the most common cardiovascular diseases, such as stroke or heart attack, restrict the oxygen supply to cells. If a medication or procedure can be devised to control how cells respond to the drop in oxygen, it may be possible to prevent or even reverse the damage from cardiovascular disease. The mechanism may even be manipulated to limit the growth of tumors. Congratulations to doctors Kaelin, Ratcliffe, and Semenza!

JSTOR is a digital library for scholars, researchers, and students. JSTOR Daily readers can access the original research behind our articles for free on JSTOR.

By: Gregg L. Semenza

Science, New Series, Vol. 318, No. 5847 (Oct. 5, 2007), pp. 62-64

American Association for the Advancement of Science

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Researchers identify genetic variations linked to oxygen drops during sleep – National Institutes of Health

Posted: October 24, 2019 at 11:47 pm

News Release

Thursday, October 24, 2019

Researchers have identified 57 genetic variations ofagenestrongly associated withdeclinesinbloodoxygen levelsduring sleep. Low oxygen levels during sleep are a clinical indicator of the severity of sleep apnea, a disorder that increases the risk of heart disease, dementia, and death. The study, published today in theAmerican Journal of Human Genetics, was funded by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health.

A persons average blood oxygen levels during sleep are hereditary, and relatively easy to measure, said study author Susan Redline, M.D., senior physician in the Division of Sleep and Circadian Disorders at Brigham and Womens Hospital, and professor at Harvard Medical School, Boston. Studying the genetic basis of this trait can help explain why some people are more susceptible to sleep disordered breathing and its related morbidities.

When we sleep, the oxygen level in our blood drops, due to interruptions in breathing. Lung and sleep disorders tend to decrease those levels further, and dangerously so. But the range of those levels during sleep varies widely between individuals and, researchers suspect, is greatly influenced by genetics.

Despite the key roleblood oxygen levelsplayin health outcomes,theinfluenceof genetics on theirvariabilityremains understudied. The current findings contribute toa betterunderstanding, particularly because researcherslookedat overnight measurementsof oxygen levels. Thoseprovide more variability than daytime levelsdue to the stressesassociated withdisordered breathing occurring during sleep.

The researchers analyzed whole genome sequence data from the NHLBIs Trans-Omics for Precision Medicine (TOPMed) program. Tostrengthenthe data,they incorporated results of family-basedlinkage analysis, a method for mapping genes that carry hereditary traits to their location in the genome. Themethod usesdata fromfamilies with several members affected by aparticulardisorder.

This study highlights theadvantage of using family data in searching for rare variants, which is often missed in genome-wide association studies, said James Kiley, Ph.D., director of the Division of Lung Diseases at NHLBI. It showed that, when guided by family linkage data, whole genome sequence analysis can identify rare variants that signal disease risks, even with a small sample. In this case, the initial discovery was done with fewer than 500 samples.

The newly identified 57 variants of the DLC1 gene were clearly associated with the fluctuation in oxygen levels during sleep. In fact, they explained almost 1% ofthevariability in the oxygen levels in European Americans, which is relatively high for complex genetic phenotypes, or traits, that are influenced by myriad variants.

Notably,51 of the 57genetic variantsinfluence and regulate human lung fibroblast cells, a type of cell producing scar tissue in the lungs, according to study author XiaofengZhu, Ph.D., professor at the Case Western Reserve University School of Medicine, Cleveland.

This is important becauseMendelian Randomization analysis, a statistical approach for testing causal relationship between an exposure and an outcome, shows a potential causal relationship between how the DLC1 gene modifies fibroblasts cells andthechanges in oxygen levels during sleep, he said.

Thisrelationship,Kileyadded,suggests thata shared molecular pathway, or a common mechanism,may beinfluencing a persons susceptibility to the lack of oxygen caused by sleep disordered breathingand other lung illnesses such as emphysema.

The project was jointly led by Zhu and Redline, who also directs the National Sleep Research Resource, supported by NHLBI.

About theNational Heart, Lung, and Blood Institute (NHLBI): NHLBI is the global leader in conducting and supporting research in heart, lung, and blood diseases and sleep disorders that advances scientific knowledge, improves public health, and saves lives. For more information, visithttps://www.nhlbi.nih.gov.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

Sequencing analysis at 8p23 identifies multiple rare variants in DLC1 associated with sleep related oxyhemoglobin saturation level.

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