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U. S. Surgeon General Dr. Jerome M. Adams and CNN Chief Medical Correspondent Dr. Sanjay Gupta Join Chef David Bouley and Dr. Mark Hyman at The WELL…

Posted: February 22, 2020 at 11:43 am

The leading federal spokesperson on matters of public health, CNNs chief medical correspondent, functional medicine advocate and New Yorks favorite chef to speak at the inaugural wellness event March 29 April 1, 2020.

Two globally recognized physicians, a renowned integrative medicine expert, and one of the worlds leading restaurateurs will join the more than 50 leading designers, architects, business leaders, academicians and public health professionals speaking at The WELL Conference, March 29-April 1, 2020, in Scottsdale, Arizona.

Dr. Jerome M. Adams, the 20th Surgeon General of the United States, is an American anesthesiologist and a vice admiral in the U.S. Public Health Service Commissioned Corps, which represents the whole gamut of public healthfrom engineers to doctors to nurses to pharmacists to environmental health officers. Prior to becoming Surgeon General, he served as the Indiana State Health Commissioner from 20142017.

Dr. Sanjay Gupta, Chief Medical Correspondent, CNN, multiple award-winning journalist, author and neurosurgeon, is frequently referred to as "everyones doctor." He recently anchored a six-part CNN docuseries called "Chasing Life," exploring unusual traditions and modern practices around the world that constitute a healthy and meaningful life.

Chef David Bouley, one of New Yorks most famous chefs, earned several four-star reviews in The New York Times, multiple James Beard Foundation awards including Best Chef in America, and countless others. He hosts The Chef & the Doctor, a collaborative lecture and dinner event with world-renowned doctors and nutritionists at his New York restaurant, Bouley at Home, demonstrating a practice of well-being that is accessible to home cooks anywhere.

Dr. Mark Hyman is leading a health revolutionone that revolves around using food as medicine to support longevity, energy, mental clarity, happiness and so much more. A practicing family physician and an internationally recognized author, speaker, educator and advocate in the field of functional medicine, Dr. Hyman is a regular participant in The Chef & the Doctor series and will join Chef Bouley onstage for a lively discussion on how what we eat is at the top of the list for creating the vibrant health we deserve.

"In different ways, each of these globally renowned leaders is instrumental in shaping this movement towards a healthier future," said Rick Fedrizzi, chairman and CEO of the International WELL Building Institute, the presenter of the conference. "They are tremendous ambassadors for health and well-being and their expertise will further the innovative and inspiring experience The WELL Conference is set to be."

The WELL Conference features an expanding roster of thought leaders who are committed to improving the health and well-being of people through better buildings and communities and stronger organizations. The education sessions are structured around six distinct tracksLead WELL, Learn WELL, Work WELL, Live WELL, Design WELL and Connect WELL. Attendees will hear perspectives that range from working dads (and their kids) discussing how wellness is advanced when they have more time with each other, to storytellers like Robin Raj, an expert in building "citizen brands" for organizations interested in living their purpose. Top editors of design publications Contract, Hospitality Design, Healthcare Design and Environments for Aging will report on changes, shifts and the creative thinking they expect to see in the new decade.

Visit thewellconference.com to register and review the schedule of events and speakers and follow along on social media: Twitter, Facebook, LinkedIn and Instagram.

About The WELL Conference

A first-of-its-kind wellness gathering, The WELL Conference is a curation of information and inspiration from thought leaders, experts and innovators representing multiple sectors of the wellness movement. Presented through thought-provoking and immersive content focused on how our buildings and everything in them can enhance, not compromise our health, this gathering will provide a deeper understanding how to live well at every turn. The event will take place March 29-April 1, 2020, at the Fairmont Princess in Scottsdale, Arizona. The WELL Conference is presented by the International WELL Building Institute in collaboration with the American Society of Interior Designers and powered by Emerald.

International WELL Building Institute, IWBI, the WELL Building Standard, WELL v2, WELL Certified, WELL AP, WELL, WELL Portfolio, The WELL Conference, the WELL Community Standard and others, and their related logos are trademarks or certification marks of International WELL Building Institute pbc in the United States and other countries.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200220005961/en/

Contacts

Press Wanita Niehaus Media@thewellconference.com

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U. S. Surgeon General Dr. Jerome M. Adams and CNN Chief Medical Correspondent Dr. Sanjay Gupta Join Chef David Bouley and Dr. Mark Hyman at The WELL...

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Acupuncture: Benefits, Side Effects and Does Insurance Cover Acupuncture? – Parade

Posted: February 22, 2020 at 11:43 am

If youre needle-phobic, the thought of getting acupuncturewhere thin needles are inserted into the skinmay seem unnerving. But, the traditional Chinese medicine practice has been around for centuries, and now its often used along with western medicine to treat a variety of conditions.

Plenty of celebrities have even shared their love for acupuncture. Meghan Markle and Ashley Graham used acupuncture during their pregnancies to keep their bodies healthy. And, Gwyneth Paltrow posted a video of her own acupuncture session on her Goop YouTube channel.

Even though acupuncture has become mainstream, and research backs its benefits, there are still a few misconceptions about the treatment, says George Stretch, interim assistant dean of acupuncture and oriental medicine at National University of Health Sciences.

How can a needle being inserted help me? How can that be medicine? he says hes often asked. The answer is, this is very intricate. Its a very long history, and the studies are out there now.

Acupuncture involves inserting thin-gauge needles through the skin at specific points on the body to control pain or other symptoms.

When you look at the acupuncture practice, three things are most important: needling, specific points and stimulation, explains Jinhua Xie, an acupuncturist and professor of oriental medicine at Midwest College of Oriental Medicine.

Inserting needles at specific acupuncture points, not random locations, stimulates the body, regulating its physiological activities and helping it deal with symptoms of a health issue, he says.

In traditional Chinese medicine, acupuncture focuses on the meridian system, an invisible energy channel in the body. The purpose is to regulate and balance the bodys energy by focusing on yin and yang, qi and blood, cold and hot, and excess and deficiency. Xie says needle insertion and the stimulation it creates is essential for good therapeutic effect.

Dont walk barefoot around the house. This can stress the tissue in the bottom of the foot, exacerbating painful conditions like plantar fasciitis. Sneakers are your best bet.

Over the past few decades, researchers have been working to understand how acupuncture works from a biomedical standpoint, Xie says.

The local effect of acupuncture stimulation may produce an effect of improved blood circulation and anti-inflammatory effect, which may improve arthritis and muscle pain, he says. And, acupuncture stimulation may improve the neurotransmitter balance in our brain which may be related to the effect of acupuncture on pain and mood disorders. However, there is so much we do not know.

Related: What Is Cupping and Should You Try It?

Even though the procedure involves needles inserted into your skin, acupuncture is essentially painless.

This is the most common misunderstanding about acupuncture, Xie says.

He tells patients to think of a 10-point scale. If the pain linked to having blood drawn is a 10, acupuncture needling is 0.5 to 1.

Acupuncture is an energetic medicine, Stretch says. We move energy, and we treat different types of disorders and pathology through acupuncture and in using the bodys own innate way of healing itself with it.

The placement of needles is based on the conditions in the body being treated. In traditional Chinese medicine, the tongue and pulse are used to determine which organs of the body are involved, he says.

There are meridians throughout the body that are lined up with those organs, and we make a determination as far as what points were going to needle in and what kind of protocol were going to use in regards to that, he explains. So, if I want an effect, Im going to hit this point, and I know exactly what that points going to do.

Related: Everything You Need to Know About Red Light Therapy and Its Benefits

Acupuncture treatment can help maintain health, improve the symptoms of health problems, promote recovery from a disease, and reduce the side effects of some conventional medical treatments, Xie says.

Pain is the most common reason people seek acupuncture. Research published in the Journal of Pain found that acupuncture is an effective treatment for chronic pain, including musculoskeletal pain, headaches and osteoarthritis pain, and the treatment effects last over time.

Acupuncture treatment may also activate certain regions of the brain and control certain neurotransmitters, and could help with nerve-related disorders, like cardiovascular diseases, epilepsy, anxiety, circadian rhythm disorders, polycystic ovary syndrome and others.

Mood disorders, gastrointestinal conditions, womens health, fertility and post-traumatic stress disorder can also be treated with acupuncture. It can also help you quit smoking and sleep better.

Acupuncture is also often used as a complement to prescription medication and other medical treatments and in integrative and functional medicine, Stretch says. Many insurance companies, and even Medicare, cover acupuncture treatment.

How acupuncture treatments you need and often you seek treatment depends on your condition. For most conditions, Xie recommends trying three to six treatments.

Sometimes, you can stop treatment once symptoms are gone, but for chronic conditions, he suggests maintaining treatment about once a month for several years.

Dry needling is becoming more popular with athletes to aid in performance and recovery. But, it isnt necessarily the same as acupuncture.

Xie considers dry needling a newer style of acupuncture since it uses needles and stimulates points on the body, but not in the traditional Chinese medicine sense.

Dry needling doesnt follow the 14-meridian system when determining where to place the needles. Instead, he says needles may be placed in a more localized spot on the body, such as where the injury or pain is occurring.

The needles used in acupuncture are sterile and single-use, and licensed acupuncturists are also certified in Clean Needle Technique, so theres no risk of cross-contamination, Stretch says.

There are few side effects with acupuncture, Xie says. Some patients could see some bruising or bleeding, but instances are rare.

Patients are evaluated on a case-by-case basis before undergoing acupuncture. People with bleeding disorders, surgical conditions and malignant tumors, or who take blood-thinning medication, generally shouldnt try acupuncture. But, Xie says acupuncture could be used for cancer patients to complement other treatments, to relive pain or side effects of chemotherapy.

Find out if a sound bath can banish your inner demons.

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Alternatives to Drinking: How to Relax Without Alcohol – LIVESTRONG.COM

Posted: February 22, 2020 at 11:43 am

When most people clean up their diets to lose weight or boost their overall health, one of the first things they're told to cut out is alcohol. After all, no amount of alcohol is particularly "good" for you, per an August 2018 analysis in The Lancet and it's certainly not low in calories, no matter which type you're sipping.

Meditation is one way to relax without alcohol.

Credit: Westend61/Westend61/GettyImages

But for many, a glass of wine or a cold beer at the end of a long workday is a go-to way to de-stress and unwind. And that's nothing to sneeze at, because lowering your stress levels can be key for weight loss, too.

While a casual drink may seem harmless, there's often a biological component at play that keeps alcohol at the top of the list of favorite de-stressors, Roger Adams, PhD, personal trainer, doctor of nutrition and owner of eatrightfitness, tells LIVESTRONG.com.

"At its basic level, alcohol of any kind is a depressant, meaning it slows down the activity and processes of the brain and central nervous system," Adams says. "If used only occasionally for stress relief, alcohol is likely to be quite effective in the short-term. However, we tend to need to consume more over time to get the same de-stressed feeling, so consumption is likely to increase."

This increased alcohol consumption over time can cause myriad health problems, including mood and behavior disruptions, high blood pressure, stroke, liver disease and even cancer, according to the National Institute on Alcohol Abuse and Alcoholism.

Many of us may find it difficult to relax without alcohol, but there are compelling health benefits to limiting your intake.

Credit: BrianAJackson/iStock/GettyImages

On the other hand, stress is also a major health issue. One March 2018 study in the journal Psychological Science found that even stress that is seen as small and insignificant can lead to health problems including heart disease, anxiety and depression, chronic pain and more.

Another November 2018 study in Neurology discovered that a high-stress lifestyle could lead to memory loss and brain shrinkage before the age of 50.

And, like alcohol, stress doesn't help your waistline either. Those who suffer from long-term stress are more likely to be obese, according to a study published February 2017 in the journal Obesity. The main culprit is cortisol, a stress-induced hormone that can encourage your body to hold onto fat.

In short: If both stress and drinking are bad for you, the healthiest lifestyle is one that includes less of both.

Luckily, there are plenty of stress-relieving solutions that can help you whittle your waistline and boost your health. Here, experts share their science-backed alternatives to drinking that can still help relieve stress.

Exposure to nature has a lot o benefits, including a better mental state of wellbeing as you leave all the noise of life behind, Adams says.

This was shown in an April 2019 study published in Frontiers in Psychology, which examined two biomarkers of stress when exposed to nature: salivary cortisol, a measure of the amount of stress hormone in the saliva, and alpha-amylase, digestive enzymes. They found that both stress biomarkers dropped in people when they were exposed to nature.

So instead of happy hour after work, suggest taking a walk or throwing a frisbee in the park with your pals, or simply take a walk through the trees after dinner instead of parking yourself on the sofa with a cold one.

Did you know that keeping a food diary is one of the most effective ways to manage your weight? Download the MyPlate app to easily track calories, stay focused and achieve your goals!

Meditation can be a powerful stress-reliever, according to a systematic review and meta-analysis published March 2014 in JAMA Internal Medicine. After reviewing 47 trials, the researchers concluded that mindfulness meditation can improve levels of anxiety, depression and pain as well.

Another study, published July 2019 in Scientific Reports, found that it takes as little as 40 days of meditating to change your brain waves enough to improve stress.

"Progressive relaxation meditation involves a guided experience where you relax each part of your body, as well as calm the inner chatter that often feeds stress and worry and keeps us too stimulated for sleep," Roseann Capanna-Hodge, PsyD, psychologist and certified integrative medicine mental health provider, tells LIVESTRONG.com.

One of the best parts about meditating is that it's easy to do anywhere all you need is a safe and quiet place to sit, reflect and calm your mind. If you're looking for a little guidance, consider downloading one of the many meditation apps out there, such as InsightTimer or Calm.

Practice yoga as a healthy alternative to alcohol for stress relief.

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Like meditation, yoga is a good alternative to drinking that can provide boundless benefits for the body and mind, particularly when it comes to reducing levels of stress, anxiety and depression, per a February 2018 study in the International Journal of Preventive Medicine.

"By performing yoga moves and breathing properly, you can promote your mental health through the relief of stress," Jamie Bacharach, medical acupuncturist and yoga practitioner, tells LIVESTRONG.com. "Due to its use of meditation-like posing and deliberate breathing, yoga has the ability to increase your own body awareness, relax the mind and give you a sharper focus, all of which contribute to optimized mental health."

Being mindful of one's surroundings and using visualization to reduce stress has become an increasingly popular technique. Though it sounds quite similar, visualization is different than mindfulness or meditation.

"Visualization involves actually visualizing what you want and honing in on one's authentic purpose to create goals around it," explains Dr. Capanna-Hodge. "It's a powerful way to not only get clarity on your goals but to help manifest them."

To incorporate visualization into your day-to-day, Dr. Capanna-Hodge suggests taking a few minutes to sit in a quiet place and visualize what you want to accomplish and pair it with action around those goals that move them to positive outcomes.

"Whether you have a goal to better manage stress or address a specific issue, intent-oriented visualization is a great way to create positive momentum by getting to the core of the issue and its resolution," she says.

"The lasting effects throughout the day of a short workout can provide the calming effect that you may be looking for in that after-work cocktail."

It might sound simple and it is but getting your heart rate up is one of the best ways to reduce the effects of stress.

When you exercise, your body amps up its production of the "feel-good" hormone known as endorphins, while stress does the complete opposite, explains Joseph De Santo, MD, board-certified physician and addiction specialist for the BioCorRx Recovery Program.

Indeed, in responses gathered for the American Psychological Association's Stress in America 2019 survey, a whopping 53 percent of adults reported that they feel good about themselves after exercising, and 30 percent reported feeling less stressed.

"No matter what you are doing, if you are moving, oxygen is getting to the brain more efficiently and endorphins are being released," Dr. De Santo says. "The lasting effects throughout the day of a short workout can provide the calming effect that you may be looking for in that after-work cocktail."

Using essential oils is one way to relax without alcohol.

Credit: JGI/Tom Grill/Tetra images/GettyImages

Essential oils not only smell nice, but they can have a beneficial effect on both your brain and body.

Lavender oil in particular, has been shown to help alleviate symptoms of anxiety, according to one July 2017 study published in The Mental Health Clinician.

"When essential oil molecules enter the nose or mouth, they pass to the lungs and eventually the brain and other parts of the body, stimulating the olfactory system, which is the part of the brain connected to smell," Dr Capanna-Hodge explains. "As the molecules reach the brain, they affect several regions, including the limbic system, which is linked to the emotions, our memory and attentional systems, as well as our hormone and immune systems, and can lower cortisol and stress levels."

She recommends using an infuser to disperse essential oils around your home or workplace to keep your stress levels low and your body relaxed.

This nutrient has numerous health benefits, including enhancing bone health and reducing one's risk for diabetes, heart disease and anxiety. It also has impressive stress-relieving perks, as shown in a May 2017 study published in Nutrients, which found magnesium supplementation to be beneficial in relieving anxiety as well as stress.

"By supplementing with magnesium, you not only calm the nervous system, you help your body combat stress and give it what it needs to work at an optimal level," says Dr. Capanna-Hodge.

You can take a magnesium supplement, but you can also score the nutrient in certain foods, particularly spinach, almonds, avocado, tofu and dark chocolate.

Keep in mind the recommended daily intakes for magnesium, according to the National Institutes of Health:

Most Americans (1 in 3) are not getting their fair share of shut-eye and it's having a negative affect on their health and overall wellbeing, according to the Centers for Disease Control and Prevention.

What's more: Oftentimes stress is the cause of inability to sleep well. A National Sleep Foundation poll found that 43 percent of young and middle-aged adults report difficulty sleeping at night as a result of stress at least once a month.

"Getting to bed and getting enough sleep for four to five REM cycles (typically six hours minimum) can provide your brain the healing time that allows it the chance to re-organize and refresh, so you don't carry stress over from the previous day," Dr. De Santo says.

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UI doctors discover new genetic mutation that causes fatal heart arrhythmias – UI The Daily Iowan

Posted: February 22, 2020 at 11:42 am

After several Mennonite children suffered fatal cardiac arrests and there were no answers to why, a team of UI doctors set out to discover an unknown genetic mutation that caused these deaths.

After several children died from sudden cardiac arrests, a team of doctors discovered a genetic mutation to be the cause of their fatal heart arrhythmias a disorder of the movement of the heart that disturbs its typical contracting rhythm.

Ian Law, pediatric cardiologist at the University of Iowa Hospitals and Clinics, said a Mennonite family moved to Iowa in 2013 just before one of the children died suddenly of cardiac arrests.

Doctors ran further tests and found other Mennonite children to be at a similar risk for heart problems, Law said, and had been so for years. Ultimately, the cardiac arrests were the result of genetically inherited heart arrhythmias.

We determined that the children had inherited gene mutations and the mother and father both had one good copy and one bad copy, causing their children to have different combinations of the gene, Law said.

One bad copy plus one good copy would give a child more of a predisposition to the heart defects but not make them at risk, two bad copies would mean they are indeed at risk of the fatal mutation, while two good copies would mean they bear no trace of the gene, Law said.

As of right now, Law said, there is no cure for the recently discovered genetic mutation, but physicians can prophylactically place pacemaking devices or beta blockers in children who test positive for the gene before they have an episode.

In a letter written to Law at UIHC, the mother of the children affected said that the family was thankful for the doctors putting in implantable cardioverter defibrillators the children, and understands that they need to pay more attention to how the kids take medications daily and watch their activity when sick because most of the cardiac episodes occurred when they were feeling under the weather.

[We are] glad to know if we can do a blood test to find out if the children and grandchildren will be affected I still have a hard time fully believing we can totally rely on these tests, the letter said.

The new genetic mutation is unnamed at the moment, because it had not been discovered or identified before now, Law said. Moving forward, precaution against it can now be taken.

Knowledge is power, so ideally what will happen is that we genetically test those who want to get married and counsel them, whether or not they have any trace of the mutated gene, Law said.

RELATED: Labs from UI, Texas share credit for simultaneous genetic discovery

Hannah Bombei, a genetic counselor in pediatric cardiology at the Stead Family Childrens Hospital, defined genetic arrhythmias as an abnormal heart rhythm which can stem from a variety of causes.

You can think about this like a factory assembly line. The genetic code is the blueprint to make certain products such as calcium, potassium, or sodium channels in the heart muscle cells, Bombei said. If the blueprints arent correct due to a genetic mutation, the resulting products wont be produced and/or function properly.

In the future, Bombei said doctors hope to move toward more personalized medicine. This means they would determine the most effective treatment based on the particular underlying genetic cause of an anomaly in a patients heart.

UI pediatric cardiology Professor Emerita Dianne Atkins said there are multiple mutations similar to this one which has been found only in Mennonite families, and that by the doctors discovered it they were anxious and then moved on to figure out why it happened.

Now that we have found this specific mutation it is very likely that we will continue to find it other communities and families, Atkins said.

RELATED: UI researchers find potential link between DNA changes and suicidal behavior

Its hard to pinpoint how many people are affected by arrhythmias, Atkins said, because the condition presents very differently in different people and doctors only know about those who show symptoms. Some are extremely rare, she said, and others are more common.

This mutation differs from others because doctors can discover who is at risk and who isnt, Atkins added, so treatment can begin before a fatal event.

Atkins said this discovery was important as a collaboration because doctors agreed that they were all helping patients with unclearly defined abnormalities and had to work together to find answers.

Law said they had to work to define the mutation itself, as well as keep track of who carried and showed symptoms of it.

Persistence, curiosity and teamwork is key, Law said. If we didnt have a community working together, these people and those in similar positions, would have continued to die.

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Jatenzo, an Oral Testosterone Replacement Therapy, Now Available – Renal and Urology News

Posted: February 21, 2020 at 3:46 pm

Jatenzo (testosterone undecanoate; Clarus Therapeutics), an oral testosterone replacement therapy, is now available for the treatment of hypogonadism.

Specifically, Jatenzo is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

Jatenzo is not intended for use in males with age-related hypogonadism and its safety and efficacy have not been established in males <18 years old.

The treatment carries a Boxed Warning related to blood pressure (BP) increases that could potentially increase the risk of major adverse cardiovascular events. In a clinical trial, Jatenzo increased systolic BP during 4 months of treatment by an average of 4.9 mmHg based on ambulatory BP monitoring and by an average of 2.8 mmHg from baseline based on BP cuff measurements. For this reason, baseline cardiovascular risk should be considered before initiating therapy and BP should be adequately controlled. Among study patients treated with Jatenzo, 7% were started on antihypertensive medications or required intensification of their antihypertensive medication regimen during the 4-month trial.

Jatenzo, a Schedule III controlled substance, is available in 158mg, 198mg, and 237mg softgels. Dosage should be individualized based on serum testosterone concentrations.

Jatenzo offers patients a convenient softgel formulation, and eliminates the worry of gel transference, skin irritation from patches, or pain from injections that other testosterone treatments carry, said Dr Ronald S. Swerdloff, lead investigator of the inTUne trial, the pivotal study that established the safety and efficacy of the treatment.

For more information visit jatenzo.com.

This article originally appeared on MPR

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Clarus Therapeutics Lauches JATENZO – Oral Testosterone Replacement Therapy – MedicalResearch.com

Posted: February 21, 2020 at 3:46 pm

MedicalResearch.com Interview with:

Robert E. Dudley, Ph.D.Chairman, Chief Executive Officer and PresidentClarus Therapeutics

Dr. Dudley discusses the recent announcement that Clarus Therapeutics, Inc. has launched JATENZO (testosterone undecanoate) capsules for the treatment of appropriate men with testosterone deficiency (hypogonadism):

MedicalResearch.com: What is the background for this announcement?

Response: JATENZOis the first and only oral softgel testosterone undecanoate and the first oral testosterone product approved by the U.S. FDA in more than 60 years.JATENZO is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

The launch of JATENZO means that physicians and men living with testosterone deficiency due to genetic or structural abnormalities finally have a safe and effective oral testosterone replacement therapy. We are proud to commercially launch this unique oral formulation to healthcare providers and the appropriate patients who they treat. JATENZO is now available at pharmacies across the country.

MedicalResearch.com: What are the main findings of the underlying studies?

Response: JATENZO was evaluated in a Phase 3 pivotal trial among 166 adult, hypogonadal men in a 4-month, open-label study with a topical testosterone comparator arm. The starting dose was 237 mg twice daily (BID) with meals. Dose adjustments (minimum 158 mg BID; maximum 396 mg BID) were made roughly 3 and 7 weeks after initiation of JATENZO based on average circulating testosterone concentration levels. 87% of JATENZO patients reached testosterone levels within the normal eugonadal range at the end of the study; peak testosterone levels were in close alignment with FDA targets.

Across all Phase 2 and Phase 3 trials combined, the safety of JATENZO has been evaluated in 569 patients who were treated with JATENZO for up to two (2) years. Liver toxicity was not observed with JATENZO in clinical trials.

Mild gastrointestinal adverse events observed with JATENZO were transient, manageable and did not lead to discontinuation.Decreased HDL cholesterol and increased hematocrit were associated with JATENZO use but did not lead to discontinuation of JATENZO. Only three of the 166 patients (1.8%) in the 4-month study experienced adverse reactions that led to premature discontinuation from the study, including rash (n=1) and headache (n=2). JATENZO was associated with an increase in systolic blood pressure. A boxed warning about the potential risks associated with elevated blood pressure appears on JATENZO labeling. Patients on JATENZO should have their blood pressure monitored.

Among the 569 patients who received JATENZO in all Phase 2 and 3 trials combined, the following adverse reactions were reported in >2% of patients: polycythemia, diarrhea, dyspepsia, eructation (i.e., burping), peripheral edema, nausea, increased hematocrit, headache, prostatomegaly (i.e., enlarged prostate), and hypertension.

MedicalResearch.com: How doesJATENZO differ from other treatments for testosterone deficiency?

Response: The launch of JATENZO is an important step forward in testosterone replacement therapy. The only other oral testosterone replacement therapy product ever approved by the FDA is methyltestosterone (an alkylated androgen) that has been associated with serious liver toxicity and is rarely, if ever, used today. Because JATENZO is formulated as a lipophilic prodrug, it bypasses the first-pass hepatic metabolism. No liver toxicity-related events were observed in clinical studies of JATENZO including in patients who took JATENZO at higher doses than recommended in current product labeling for two (2) years.

We believe JATENZO addresses a long-standing need for a safe and effective oral testosterone replacement product that meets current day FDA safety and efficacy standards. JATENZO enters a market where the vast majority of hypogonadal men are treated with injectable or topical testosterone products. JATENZO avoids administration challenges seen with these non-oral treatments it presents no injection site pain, no transfer risk, no mess, no skin irritation and no surgical procedure. Therefore, we believe a significant number of hypogonadal men will prefer JATENZO as an alternative to other forms of testosterone therapy.

MedicalResearch.com: How are men tested to determine ifJATENZO therapy is appropriate for them?

Response: According to the American Urological Association and Endocrine Society clinical guidelines, diagnosis of hypogonadism is determined by both the identification of symptoms and/or signs consistent with hypogonadism and blood test measurement of low morning total serum testosterone concentration (defined as <300 ng/dL, on two separate days). Healthcare providers should assess each patient individually for the appropriateness of JATENZO to treat their clinical hypogonadism.

MedicalResearch.com: What else should readers take away from your report?

Response: Clinical hypogonadism can be more complex than most people realize and left untreated, can have a profound negative impact for the individual. Men with the symptoms of hypogonadism have a real medical need that deserves appropriate diagnosis and treatment.

Any disclosures?

Pleaseclick herefor full Prescribing Information, including BOXED WARNING on increases in blood pressure.

Citation:

CLARUS THERAPEUTICS ANNOUNCES COMMERCIAL LAUNCH AND AVAILABILITY OF JATENZO (TESTOSTERONE UNDECANOATE) CAPSULES, CIII FOR THE TREATMENT OF HYPOGONADISM

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Feb 19, 2020 @ 12:05 pm

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Testosterone Replacement Therapy analysis by stage of development – TechNews.mobi

Posted: February 21, 2020 at 3:46 pm

This intelligence report provides a comprehensive analysis of the Testosterone Replacement Therapy Market. This includes Investigation of past progress, ongoing market scenarios, and future prospects. Data True to market on the products, strategies and market share of leading companies of this particular market are mentioned. Its a 360-degree overview of the global markets competitive landscape. The report further predicts the size and valuation of the global market during the forecast period.

Testosterone is responsible for the development of male sexual characteristics and this hormone formed by the testicles. Insufficient production of testosterone causes erectile dysfunction. Testosterone Replacement Therapy (TRT) is generally termed as hormone therapy for men, designed to counteract the effects of reduced activity in the gonads or hypogonadism. Hypogonadism in men is clinical syndrome, which results in the failure of the testes to produce physiological levels of testosterone. Erectile dysfunction arises due to reduce testosterone production to overcome this testosterone replacement therapy is used to improve the problem.

Major Players in this Report Include,

AbbVie Inc. (United States), Endo International (Ireland), Eli Lilly and Company (United States), Pfizer (United States), Bayer (Germany), Actavis (Allergan) (United States), Novartis (Switzerland), Teva (Israel), Ferring Pharmaceuticals (Switzerland), Kyowa Kirin (Japan) and Mylan (United States).

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Each segment and sub-segment is analyzed in the research report. The competitive landscape of the market has been elaborated by studying a number of factors such as the best manufacturers, prices and revenues. Global Testosterone Replacement Therapy Market is accessible to readers in a logical, wise format. Driving and restraining factors are listed in this study report to help you understand the positive and negative aspects in front of your business.

This study mainly helps understand which market segments or Region or Country they should focus in coming years to channelize their efforts and investments to maximize growth and profitability. The report presents the market competitive landscape and a consistent in depth analysis of the major vendor/key players in the market.

Market Drivers

Market Trend

Restraints

Opportunities

Challenges

Furthermore, the years considered for the study are as follows:

Historical year 2013-2017

Base year 2018

Forecast period** 2019 to 2025 [** unless otherwise stated]

**Moreover, it will also include the opportunities available in micro markets for stakeholders to invest, detailed analysis of competitive landscape and product services of key players.

The titled segments and Market Data Breakdown are illuminated below:

By Type: Creams or Gels, Patches, Injections, Buccal Adhesives, Implants, Oral

Application: Hospitals, Clinics

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Region Included are: North America, Europe, Asia Pacific, Oceania, South America, Middle East & Africa

Country Level Break-Up: United States, Canada, Mexico, Brazil, Argentina, Colombia, Chile, South Africa, Nigeria, Tunisia, Morocco, Germany, United Kingdom (UK), the Netherlands, Spain, Italy, Belgium, Austria, Turkey, Russia, France, Poland, Israel, United Arab Emirates, Qatar, Saudi Arabia, China, Japan, Taiwan, South Korea, Singapore, India, Australia and New Zealand etc.

Strategic Points Covered in Table of Content of Testosterone Replacement Therapy Market:

Chapter 1: Introduction, market driving force product Objective of Study and Research Scope the Testosterone Replacement Therapy Market.

Chapter 2: Exclusive Summary the basic information of the Testosterone Replacement Therapy Market.

Chapter 3: Displaying the Market Dynamics- Drivers, Trends and Challenges of the Testosterone Replacement Therapy

Chapter 4: Presenting the Testosterone Replacement Therapy Market Factor Analysis Porters Five Forces, Supply/Value Chain, PESTEL analysis, Market Entropy, Patent/Trademark Analysis.

Chapter 5: Displaying the by Type, End User and Region 2013-2018

Chapter 6: Evaluating the leading manufacturers of the Testosterone Replacement Therapy market which consists of its Competitive Landscape, Peer Group Analysis, BCG Matrix & Company Profile

Chapter 7: To evaluate the market by segments, by countries and by manufacturers with revenue share and sales by key countries in these various regions.

Chapter 8 & 9: Displaying the Appendix, Methodology and Data Source

Finally, Testosterone Replacement Therapy Market is a valuable source of guidance for individuals and companies.

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Key questions answered

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Tags: Global Testosterone Replacement Therapy MarketTestosterone Replacement Therapy MarketTestosterone Replacement Therapy Market GrowthTestosterone Replacement Therapy Market ShareTestosterone Replacement Therapy Market SizeTestosterone Replacement Therapy Market Trends

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Once-Weekly Treatment for Adult GH Deficiency Effective in Phase 3 Trial – Endocrinology Advisor

Posted: February 21, 2020 at 3:46 pm

In a multinational randomized phase 3 trial, once-weekly somapacitan demonstrated superiority over placebo for treatment of patients with adult growth hormone (GH) deficiency, according to study results published in The Journal of Clinical Endocrinology & Metabolism.

Hormone replacement is a common component of care for patients with hypopituitarism, but its daily subcutaneous injections can be burdensome for some patients. This burden may result in reduced compliance or adherence or in an unwillingness on the part of physicians to add to their patients treatment burden. Long-acting alternatives to daily injections could reduce the burden of treatment and thus lower the barrier to therapy.

Somapacitan is a novel once-weekly reversible albumin-binding GH derivative, with a similar long-lasting mechanism as insulin detemir. Studies have shown once-weekly somapacitan to be well tolerated in healthy adults, but none have examined its efficacy in adult GH deficiency treatment.

To evaluate this, researchers randomly assigned 301 patients with adult GH deficiency at 92 sites in 17 countries in a 2:1:2 ratio to receive once-weekly somapacitan, once-weekly placebo, or daily GH for 34 weeks. Patients 23 to 79 years of age with a diagnosis of adult- (69.7%) or childhood-onset (30.3%) adult GH deficiency who were naive to GH treatment or had no exposure to GH therapy for 180 days prior to treatment assignment were included. This main period of 34 weeks was followed by an extension period to examine longer-term use.

The main period was double blinded for the somapacitan and placebo cohorts but open label for daily GH use. Investigators and trial sites remained blinded throughout the entire trial. Dose titration occurred during the first 8 weeks of the main trial until a steady state insulinlike growth factor-1 (IGF-1) standard deviation score (SDS) of -0.5 to +1.75 was achieved. The remaining 26 weeks consisted of fixed-dose treatment.

The 52-week open-label extension period allowed for evaluation of efficacy and safety of somapacitan for up to 86 weeks of treatment. Patients who had been receiving somapacitan continued to do so (somapacitan/somapacitan group), those receiving placebo were switched to somapacitan (placebo/somapacitan group), and those receiving daily GH were randomly assigned 1:1 to continue with daily GH (daily GH/daily GH group) or to switch to somapacitan (daily GH/somapacitan group).

At week 34, somapacitan reduced truncal fat percentage from baseline by 1.06% compared with a 0.47% increase for placebo (estimated treatment difference, -1.53%; 95% CI, -2.68 to -0.38; P =.009), demonstrating superiority over placebo. Compared with placebo, the somapacitan group also had decreased visceral fat and increased lean body mass and appendicular skeletal muscle mass at week 34.

Similar changes in visceral fat, total lean body mass, and appendicular skeletal muscle mass were observed in the somapacitan and daily GH groups at week 34. A less pronounced reduction in truncal fat percentage was observed with somapacitan treatment compared with daily GH treatment at week 34. No significant difference in body weight from baseline to week 34 was observed for the somapacitan (+1.40 kg) or placebo (+0.39 kg) groups, but was observed between somapacitan and daily GH (+0.27 kg; estimated treatment difference, 1.13 kg; 95% CI, 0.13-2.12) groups.

At week 86, there were no notable differences between the somapacitan and daily GH groups for percentage change in visceral fat, lean body mass, or appendicular skeletal muscle mass, and improvements in visceral fat and lean body mass were maintained. However, treatment effects on other body composition measures were less pronounced with somapacitan treatment vs daily GH therapy. For patients who switched from placebo to somapacitan in the extension period, improvements were observed in all body composition measures to a similar degree as with long-term daily GH treatment.

No significant differences in mean levels of corrected total bone mineral content or density from baseline to week 86 in the somapacitan and daily GH groups were observed, nor was there a significant difference in these levels between these 2 groups.

Two individuals had severe adverse events that were possibly related to trial products during the study period. One was a patient in the daily GH/no treatment group, who was also receiving testosterone and suffered a life-threatening hemoconcentration, but recovered with treatment. The other patient was in the daily GH/somapacitan group and was diagnosed with bladder transitional cell carcinoma in week 80, but went on to complete the trial.

One of the concerns about continuous exposure to GH is that it may result in negative effects on insulin sensitivity and glucose metabolism. In this trial, fasting plasma glucose and hemoglobin A1c values did not increase over 86 weeks, and there were no new cases of diabetes in patients treated with somapacitan. The limited negative effects paired with somapacitans potentially superior effects on visceral fat reduction vs placebo by week 34 of treatment suggest that somapacitan may provide an effective alternative to daily GH in adults with GH deficiency.

Some limitations of this study included the reliance on patient reporting for adherence to treatment as well as the open-label nature of the daily GH treatment group. In addition, some patients in the active drug groups had IGF-1 SDS values below -2 at the end of the titration period and so may not have received the full benefit of GH replacement. Finally, the less pronounced effect of somapacitan on truncal fat and body weight when compared with daily GH over the long term cannot be explained by a different response in IGF-1 SDS, as mean levels and distributions were similar.

Disclosure: This study was funded by Novo Nordisk, the manufacturer of somapacitan. All but one author on the study has received either employment, contract work, or funding from Novo Nordisk.

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Reference

Johannsson G, Gordon MB, Rasmussen MH, et al. Once-weekly somapacitan is effective and well tolerated in adults with GH deficiency: a randomized phase 3 trial [published online February 5, 2020]. J Clin Endocrinol Metab. doi:10.1210/clinem/dgaa049

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Latest Study explores the Fire Damper Market Witness Highest Growth in near futu – ITResearchBrief.com

Posted: February 21, 2020 at 3:46 pm

The ' Fire Damper market' research report now available with Market Study Report, LLC, is a compilation of pivotal insights pertaining to market size, competitive spectrum, geographical outlook, contender share, and consumption trends of this industry. The report also highlights the key drivers and challenges influencing the revenue graph of this vertical along with strategies adopted by distinguished players to enhance their footprints in the Fire Damper market.

The recent study of the Fire Damper market is an exhaustive examination of this industry, and contains insights pertaining to important parameters of this business space. The research report provides details about the prevailing market share, industry trends, market size, renumeration estimates, periodic deliverables, and price projections over the analysis period.

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The document gives credible data regarding the key investment pockets of the Fire Damper market, alongside the growth pattern followed by the industry over the forecast period. Having said that the report focuses on the challenges present in the industry and growth projections which are anticipated to dictate this industry in the coming years.

Key highlights of the Fire Damper market report:

Exploring the geographical hierarchy of the Fire Damper market:

Fire Damper Market segmentation:

Key takeaways of regional assessment presented in Fire Damper market study:

Product type and application scope of Fire Damper market:

Product scope:

Product types:

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Application partition:

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Industry majors:

Key parameters included in the report which define the competitive spectrum:

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Some of the Major Highlights of TOC covers:

Executive Summary

Manufacturing Cost Structure Analysis

Development and Manufacturing Plants Analysis of Fire Damper

Key Figures of Major Manufacturers

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2. Global Air Separation Plant Market Growth 2020-2025Air Separation Plant Market report begins from overview of Industry Chain structure, and describes industry environment, then analyses market size and forecast of Air Separation Plant by product, region and application, in addition, this report introduces market competition situation among the vendors and company profile, besides, market price analysis and value chain features are covered in this report.Read More: https://www.marketstudyreport.com/reports/global-air-separation-plant-market-growth-2020-2025

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Stem cells and the heartthe road ahead – Science Magazine

Posted: February 21, 2020 at 3:44 pm

Heart disease is the primary cause of death worldwide, principally because the heart has minimal ability to regenerate muscle tissue. Myocardial infarction (heart attack) caused by coronary artery disease leads to heart muscle loss and replacement with scar tissue, and the heart's pumping ability is permanently reduced. Breakthroughs in stem cell biology in the 1990s and 2000s led to the hypothesis that heart muscle cells (cardiomyocytes) could be regenerated by transplanting stem cells or their derivatives. It has been 18 years since the first clinical trials of stem cell therapy for heart repair were initiated (1), mostly using adult cells. Although cell therapy is feasible and largely safe, randomized, controlled trials in patients show little consistent benefit from any of the treatments with adult-derived cells (2). In the meantime, pluripotent stem cells have produced bona fide heart muscle regeneration in animal studies and are emerging as leading candidates for human heart regeneration.

In retrospect, the lack of efficacy in these adult cell trials might have been predicted. The most common cell type delivered has been bone marrow mononuclear cells, but other transplanted cell types include bone marrow mesenchymal stromal cells and skeletal muscle myoblasts, and a few studies have used putative progenitors isolated from the adult heart itself. Although each of these adult cell types was originally postulated to differentiate directly into cardiomyocytes, none of them actually do. Indeed, with the exception of skeletal muscle myoblasts, none of these cell types survive more than a few days in the injured heart (see the figure). Unfortunately, the studies using bone marrow and adult resident cardiac progenitor cells were based on a large body of fraudulent work (3), which has led to the retraction of >30 publications. This has left clinical investigators wondering whether their trials should continue, given the lack of scientific foundation and the low but measurable risk of bleeding, stroke, and infection.

Additionally, investigators have struggled to explain the beneficial effects of adult cell therapy in preclinical animal models. Because none of these injected cell types survive and engraft in meaningful numbers or directly generate new myocardium, the mechanism has always been somewhat mysterious. Most research has focused on paracrine-mediated activation of endogenous repair mechanisms or preventing additional death of cardiomyocytes. Multiple protein factors, exosomes (small extracellular vesicles), and microRNAs have been proposed as the paracrine effectors, and an acute immunomodulatory effect has recently been suggested to underlie the benefits of adult cell therapy (4). Regardless, if cell engraftment or survival is not required, the durability of the therapy and need for actual cells versus their paracrine effectors is unclear.

Of particular importance to clinical translation is whether cell therapy is additive to optimal medical therapy. This remains unclear because almost all preclinical studies do not use standard medical treatment for myocardial infarction. Given the uncertainties about efficacy and concerns over the veracity of much of the underlying data, whether agencies should continue funding clinical trials using adult cells to treat heart disease should be assessed. Perhaps it is time for proponents of adult cardiac cell therapy to reconsider the approach.

Pluripotent stem cells (PSCs) include embryonic stem cells (ESCs) and their reprogrammed cousins, induced pluripotent stem cells (iPSCs). In contrast to adult cells, PSCs can divide indefinitely and differentiate into virtually every cell type in the human body, including cardiomyocytes. These remarkable attributes also make ESCs and iPSCs more challenging to control. Through painstaking development, cell expansion and differentiation protocols have advanced such that batches of 1 billion to 10 billion pharmaceutical-grade cardiomyocytes, at >90% purity, can be generated.

Preclinical studies indicate that PSC-cardiomyocytes can remuscularize infarcted regions of the heart (see the figure). The new myocardium persists for at least 3 months (the longest time studied), and physiological studies indicate that it beats in synchrony with host myocardium. The new myocardium results in substantial improvement in cardiac function in multiple animal models, including nonhuman primates (5). Although the mechanism of action is still under study, there is evidence that these cells directly support the heart's pumping function, in addition to providing paracrine factors. These findings are in line with the original hope for stem cell therapyto regenerate lost tissue and restore organ function. Additional effects, such as mechanically buttressing the injured heart wall, may also contribute.

Breakthroughs in cancer immunotherapy have led to the adoption of cell therapies using patient-derived (autologous) T cells that are genetically modified to express chimeric antigen receptors (CARs) that recognize cancer cell antigens. CAR T cells are the first U.S. Food and Drug Administration (FDA)approved, gene-modified cellular pharmaceutical (6). The clinical and commercial success of autologous CAR T cell transplant to treat B cell malignancies has opened doors for other complex cell therapies, including PSC derivatives. There is now a regulatory path to the clinic, private-sector funding is attracted to this field, and clinical investigators in other areas are encouraged to embrace this technology. Indeed, the first transplants of human ESC-derived cardiac progenitors, surgically delivered as a patch onto the heart's surface, have been carried out (7). In the coming years, multiple attempts to use PSC-derived cardiomyocytes to repair the human heart are likely.

What might the first human trials look like? These studies will probably employ an allogeneic (non-self), off-the-shelf, cryopreserved cell product. Although the discovery of iPSCs raised hopes for widespread use of autologous stem cell therapies, the current technology and regulatory requirements likely make this approach too costly for something as common as heart disease, although this could change as technology and regulations evolve. Given that it would take at least 6 months to generate a therapeutic dose of iPSC-derived cardiomyocytes, such cells could only be applied to patients whose infarcts are in the chronic phase where scarring (fibrosis) and ventricular remodeling are complete. Preclinical data indicate that chronic infarcts benefit less from cardiomyocyte transplantation than do those with active wound-healing processes.

Adult cells from bone marrow or the adult heart secrete beneficial paracrine factors but do not engraft in the infarcted heart. Pluripotent stem cells give rise to cardiomyocytes that engraft long term in animal models, beat in synchrony with the heart, and secrete beneficial paracrine factors. Long-term cardiomyocyte engraftment partially regenerates injured heart, which is hypothesized to bring clinical benefits.

The need for allogeneic cells raises the question of how to prevent immune rejection, both from innate immune responses in the acute phase of transplantation or from adaptive immune responses that develop more slowly through the detection of non-self antigens presented by major histocompatibility complexes (MHCs). A current strategy is the collection of iPSCs from patients who have homozygous MHC loci, which results in exponentially more MHC matches with the general population. However, studies in macaque monkeys suggest that MHC matching will be insufficient. In a macaque model of brain injury, immunosuppression was required to prevent rejection of MHC-matched iPSC-derived neurons (8). Similarly, MHC matching reduced the immunogenicity of iPSC-derived cardiomyocytes transplanted subcutaneously or into the hearts of rhesus macaques, but immunosuppressive drugs were still required to prevent rejection (9).

Numerous immune gene editing approaches have been proposed to circumvent rejection, including preventing MHC class I and II molecule expression, overexpressing immunomodulatory cell-surface factors, such CD47 and human leukocyte antigen E (HLA-E) and HLA-G (two human MHC molecules that promote maternal-fetal immune tolerance), or engineering cells to produce immunosuppressants such as programmed cell death ligand 1 (PDL1) and cytotoxic T lymphocyteassociated antigen 4 (CTLA4) (10). These approaches singly or in combination seem to reduce adaptive immune responses in vitro and in mouse models. Overexpressing HLA-G or CD47 also blunts the innate natural killer cellmediated response that results from deleting MHC class I genes (11). However, these manipulations are not without theoretical risks. It could be difficult to clear viral infections from an immunostealthy patch of tissue, and possible tumors resulting from engraftment of PSCs might be difficult to clear immunologically.

Ventricular arrhythmias have emerged as the major toxicity of cardiomyocyte cell therapy. Initial studies in small animals showed no arrhythmic complications (probably because their heart rates are too fast), but in large animals with human-like heart rates, arrhythmias were consistently observed (5, 12). Stereotypically, these arrhythmias arise a few days after transplantation, peak within a few weeks, and subside after 4 to 6 weeks. The arrhythmias were well tolerated in macaques (5) but were lethal in a subset of pigs (12). Electrophysiological studies indicate that these arrhythmias originate in graft regions from a source that behaves like an ectopic pacemaker. Understanding the mechanism of these arrhythmias and developing solutions are major areas of research. There is particular interest in the hypothesis that the immaturity of PSC-cardiomyocytes contributes to these arrhythmias, and that their maturation in situ caused arrhythmias to subside.

A successful therapy for heart regeneration also requires understanding the host side of the equation. PSC-derived cardiomyocytes engraft despite transplantation into injured myocardium that is ischemic with poor blood flow. Although vessels eventually grow in from the host tissue, normal perfusion is not restored. Achieving a robust arterial input will be key to restoring function, which may require cotransplanting other cell populations or tissue engineering approaches (13, 14). Most PSC-mediated cardiac cell therapy studies have been performed in the subacute window, equivalent to 2 to 4 weeks after myocardial infarction in humans. At this point, there has been insufficient time for a substantial fibrotic response. Fibrosis has multiple deleterious features, including mechanically stiffening the tissue and creating zones of electrical insulation that can cause arrhythmias. Extending this therapy to other clinical situations, such as chronic heart failure, will require additional approaches that address the preexisting fibrosis. Cell therapy may again provide an answer because CAR T cells targeted to cardiac fibroblasts reduced fibrosis (15).

Developing a human cardiomyocyte therapy for heart regeneration will push the limits of cell manufacturing. Each patient will likely require a dose of 1 billion to 10 billion cells. Given the widespread nature of ischemic heart disease, 105 to 106 patients a year are likely to need treatment, which translates to 1014 to 1016 cardiomyocytes per year. Growing cells at this scale will require introduction of next generation bioreactors, development of lower-cost media, construction of large-scale cryopreservation and banking systems, and establishment of a robust supply chain compatible with clinical-grade manufacturing practices.

Beyond PSC-cardiomyocytes, other promising approaches include reactivating cardiomyocyte division and reprogramming fibroblasts to form new cardiomyocytes. However, these approaches are at an earlier stage of development, and currently, PSC-derived cardiomyocyte therapy is the only approach that results in large and lasting new muscle grafts. The hurdles to this treatment are known, and likely addressable, thus multiple clinical trials are anticipated.

Acknowledgments: C.E.M. and W.R.M. are scientific founders of and equity holders in Sana Biotechnology. C.E.M. is an employee of Sana Biotechnology. W.R.M. is a consultant for Sana Biotechnology. C.E.M. and W.R.M. hold issued and pending patents in the field of stem cell and regenerative biology.

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