By Dr Edward Nazareth

Jun 9: During our school days, most of us had learnt in biology classes that we have a cardiovascular system, a respiratory system, a digestive system, a reproductive system and a nervous system but had not learnt about the immune system. With COVID 19 infection spreading everywhere, a lot of discussion about the immune system is going on. People with a good immune system are unlikely to get the disease and those with a poor immune system may be unlucky to get a fatal version of the disease from the same virus. Meanwhile there are a lot of promotions for immune boosters, which are supposed to make our immune system strong. It is worthwhile to understand the basics of the immune system and learn how to make it strong naturally.

Military of the body

The immune system is a defense system of body. It can be compared to the military of any nation. Each nations military system is unique, it has its own mechanisms to identify the enemy, remember who its enemy is and, fight to protect the nation from any attack. Every individuals immune system is unique and works similarly.

In general, the immune system is made up of special organs, cells and chemicals that fight infection (microbes) and the toxins that may be produced by them. The main parts of the immune system are: white blood cells, antibodies, the complement system, the lymphatic system, the spleen, the thymus, and the bone marrow. These are the parts of the immune system that actively fight infection. These different systems and cell types work in perfect synchrony (most of the time) throughout the body to fight off pathogens and clear up dead cells. However the front line soldiers of this system are lymphocytes, a type of white blood cells.

Identify, destroy and remember

Our immune system has different wings similar to a military system - a surveillance wing to identify the enemy, a destroyer (fighter) wing to eliminate the enemy and an intelligence wing to remember the enemy. All these different wings are managed by lymphocytes.

Whenever a foreign material - such as bacteria, virus, fungi or any other matter with protein or, the toxins produced by these organisms enter the body, the immune system identifies it as foreign. The immune system is able to identify self from non-self. This is done by detecting the proteins that are found on the surface of the cells or by the chemicals produced by the organisms. Like the defense personnel, the immune system learns to ignore its own or self-proteins and identify the intruder. The intruder is now known as antigen. An antigen is any substance that can spark an immune response.

In many cases, an antigen is a bacterium, fungus, virus, toxin, or foreign body. But it can also be one of our own cells that are faulty or dead (like our own people turning as terrorists).

In the immune system we have two important types of white blood cells- B lymphocytes and T lymphocytes.

The B lymphocytes spot the antigen and they begin to secrete antibodies. The antibodies are special proteins (called immunoglobulins) that lock on to specific antigens. Antibodies are the ammunition to eliminate a particular antigen. The specialty of the immune system is that it produces specific ammunition to kill a particular enemy. For example to eliminate COVID 19 viruses the antibodies produced can eliminate only COVID 19 viruses and cannot act against the viruses that produce common cold, even though both the viruses belong to the same family of corona viruses.Antibodies lock onto the antigen, but they do not kill it, only mark it for death. (B lymphocytes arrest the enemy). There are three main types of T lymphocytes: Helper T cells, killer T cells and memory T cells. Helper T cells they coordinate the immune response and stimulate B cells to produce more antibodies. Killer T cells (cytotoxic T lymphocytes) as the name suggests, these T cells attack the antigen. They are particularly useful for fighting viruses. They work by recognizing small parts of the virus on the outside of infected cells and destroy the infected cells. The memory T cells are produced following an infection; they are antigen-specific and live long. Memory T cells are important because they can quickly respond to re-exposure to the antigen. They provide the immune system with memory against previously encountered antigens. Once an antibody has been produced, a copy remains in the body system, and should the same antigen invade again, it can be dealt with more swiftly. That is why with some diseases, such as measles or chickenpox we only get infected once as the body has the measles or the chickenpox antibodies stored, ready and waiting to destroy them next time when they attack. This is called immunity.

In COVID 19 infections it takes about two to four weeks for the human body to eliminate all the viruses by producing specific antibodies against them. Then these antibodies remain in the system and will not allow the virus to multiply in the body. But here two issues are to be understood. We are not yet sure if the antibodies will remain forever or disappear after a few months or years. Another point is the virus changes its protein component called genome and can attack in a new form. This is exactly like terrorists who keep on changing the names of their organization, but have the same motto.

Immunization, infection and immunity

Before the advent of immunization many people used to die from infective diseases as it happens in COVID 19 infection now. Thousands of people have died due to small pox. Babies used to die due to measles, whooping cough, tetanus and similar other illnesses. The babies are now immunized using vaccines. A particular vaccine against an infective organism is produced using the same organism. The disease causing pathogens are attenuated (weakened) or part of their protein is extracted and introduced into the healthy individual. This material is termed as vaccine. Once the vaccine enters the system, it produces antibodies and when the real organism, invades the system it is eliminated. By immunization, deadly diseases like small pox have been totally eliminated and poliomyelitis is now almost removed completely.

As we are exposed to certain other organisms, we get infected and then our system develops antibodies and we remain immune thereafter. For example most of us were infected by chickenpox when we were children. As we had been infected by the chickenpox virus once, we will not get it again. In this way we build up a store house of antibodies to different pathogens. This protection from pathogens develops as we go through life. This is also referred to as immunological memory because our immune system remembers its previous enemies.

Elderly and immunity

As humans age, the immune response becomes weak, which leads to more infections. This is again comparable to a nation with a weak military system which can be attacked and defeated easily. It is a known fact that compared with younger people, the elderly are more likely to contract infectious diseases and, more likely to die from them. Respiratory infections, influenza and the COVID 19 causes pneumonia which are a leading cause of death in people over the age of 65 worldwide. It is now known that this increased risk correlates with a decrease in T cells, because as we age fewer T cells are produced to fight off infection. It is believed that the bone marrow becomes less efficient at producing stem cells that give rise to the cells of the immune system.

Immune deficiency

In some individuals the immune system may be weak. The most common causes for deficiency of immunity worldwide include malnutrition, poor sanitary conditions and human immune deficiency virus (HIV) infection. Other causes of temporary or permanent damage to the immune system include old age, medications (e.g. cortisone, cytostatic drugs used to treat malignancies), radiotherapy, stress after surgery and malignant tumors of the bone marrow and the lymph nodes. Innate deficiencies of the immune system are comparatively rare.

This is the reason people with these diseases, probably with deficient immune system are required to be cautious of contracting the COVID 19 infection. If they are infected, their immune system may not be able to eliminate the virus and they might get severe illness.

Herd immunity

When most of the members of a community are immune to an infectious disease, it is known as herd immunity (also called herd protection). For example, if 80% of people in a community are immune to COVID 19 virus, eight out of every ten people who get infected will not become sick from the disease. In this way, the spread of infectious diseases is kept under control. Depending on how contagious an infection is, usually 70% to 90% of a population needs immunity to achieve herd immunity.

Small pox, measles, mumps and polio are examples of infectious diseases that were once very common but are now rare in our region because vaccines helped to establish herd immunity. For infections without a vaccine, even if many adults have developed immunity because of prior infection, the disease can still circulate among children and can still infect those with weakened immune systems. Chickenpox is an example for this.

Can we achieve herd immunity against COVID 19 infection? As with any other infection, there are two ways to achieve herd immunity: A large proportion of the people either gets infected or gets a protective vaccine. Based on early estimates of this viruss infectiousness, we will likely need at least 70% of the population to be immune to have herd protection. As we do not have vaccine against COVID 19 infection now, it may take years for us to develop herd immunity for it.

Can medicines boost the immune system?

As the COVID 19 infection is spreading widely and people with good immunity are reported as unaffected, a lot of information about boosting immunity is circulated in the media.

Many products claim to boost or support immunity. But the concept of boosting immunity makes little sense scientifically. Boosting immunity actually means boosting the lymphocytes (the soldiers of immune system, as explained above). In fact, boosting the number of cells in the body immune cells or others is impossible. What is known is that the body is continually generating immune cells. In fact, it produces many more lymphocytes than it can possibly use. The extra cells remove themselves through a natural process of cell death called apoptosis.

As already stated above, efficacy of herbs or any substance enhancing the immunity is a highly complicated matter. There is no research supporting that any herb or substance can increase the levels of antibodies in the body.

Healthy ways to strengthen the immune system

The best way to improve the immune system is to choose a healthy life style. A healthy life style has to be followed from a young age and attempts should be made to maintain good health naturally. Immunity depends on general health and general health depends on good immunity. Every part of the body, including the immune system, functions better when protected and improved by healthy-living strategies such as these:

Smoking has to be stopped. Smoking is bad for overall health. Many elderly who have succumbed to COVID 19 infection were chronic smokers. A diet high in fruits and vegetables is good for health. The deficiencies of zinc, selenium, iron, copper, folic acid, and vitamins A, B6, C, and E alter immune responses in experimental animals. These micronutrients are commonly present in fruits and vegetables. If not possible to consume the fruits or vegetables, dietary supplements may be used. Regular exercise is a boost to health, it is one of the pillars of healthy living. It improves cardiovascular health, helps to control body weight, and protects against a variety of diseases. Just like a healthy diet, exercise can contribute to general good health and therefore to a healthy immune system. It may contribute even more directly by promoting good circulation, which allows the cells and substances of the immune system to move through the body freely and do their job efficiently. Adequate sleep is also a natural immune booster. The human body prepares and releases cytokines, a type of protein that targets infection effectively creating an immune response. It is proved that chronic deficiency of sleep reduces bodys ability to respond to infection. Try to reduce stress. When a person is stressed, the immune system's ability to fight off antigens is reduced. That is why humans are more susceptible to infections during stressful situations. The stress hormone corticosteroid can suppress the effectiveness of the immune system (e.g. lowers the number of lymphocytes).

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Immune system, COVID 19 infection, and building up immunity - By Dr Edward Nazareth - Daijiworld.com

Stephanie Matto suffers from a rare and life-threatening disease. Pic credit: @stepankamatto/Instagram.

Stephanie Matto has one of the most interesting storylines on this season of 90 Day Fiance: Before the 90 Days.

Matto and Erika Owens made headlines as the first same-sex couple on the TLC show, but its Stephanies personal battle with a rare illness that caught viewers by surprise.

The 29-year-old New Yorker was diagnosed with the disease only two years ago.

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Throughout the show, Stephanie has shared information about her battle and how it has affected her.

She has spoken about the limitations it has put on her life, which we saw during an episode of the show, as she prepared to make the long journey to Australia to meet Erika.

Clad in a surgical mask while equipped with hand sanitizers and a bag full of medication viewers got a glimpse of the seriousness of Stephanies illness.

Matto is battling this rare blood disorder that occurs when the bone marrow does not make enough new blood cells for the body to work in a normal way.

It means that the stem cells inside the bone marrow are damaged, thus restricting the ability to make enough white blood cells, red blood cells, and platelets.

The bone marrow can become damaged due to a variety of different diseases and conditions, but the most common cause is when the immune system attacks and destroys the stem cells in the bone marrow.

The symptoms can range from mild to severe and cause the sufferer to bruise and bleed easier than the average person. It can also cause infections to last longer than normal. When the blood cell levels are low it can increase the risks for leukemia, blood disorders, and other complications.

Furthermore, when left untreated, it can lead to very serious issues such as arrhythmia and even heart failure.

The disease can be treated via blood and bone marrow transplants and blood transfusions.

As for Matto, she needs a bone marrow transplant, which has been known to cure the disease in some people.

So far, her search has been futile and she recently shared an update on Instagram about how rare it is for patients like her to find a match.

Did you know that less than 30% of patients seeking a bone marrow transplant have a full match? I remember meeting my transplant doctor last year and hearing from him that I had absolutely no matches in the registry.

She added, I am lucky, however. My immunosuppressive therapy has bought me time and so the urgency for transplant has faded away.

The TLC alum also shared in the post that the relapse rate is high for people who battle aplastic anemia, I have already suffered one complete relapse since my diagnosis.

Matto urged her followers to join the Be The Match Registry in order to get tested and become a donor for people battling the deadly disease.

90 Day Fiance: Before the 90 Days airs Sundaya at 8/7c on TLC.

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Aplastic anemia: Heres what to know about Stephanie Mattos life-threatening illness - Monsters and Critics

By Charles PillerJun. 8, 2020 , 7:00 PM

Sciences COVID-19 reporting is supported by the Pulitzer Center.

Three unlikely collaborators are at the heart of the fast-moving COVID-19 research scandal, which led to retractions last week by The Lancet and The New England Journal of Medicine (NEJM), and the withdrawal of an online preprint, after the trove of patient data they all relied on was challenged. The three physician-scientists never were at the same institution nor had they ever before written together, but they are the only authors in common on the disputed papers, and the other co-authors all have ties to at least one of them. Their partnership, which seized a high-impact role during a global public health crisis, has now ended disastrously.

The first author for both retracted papers was cardiac surgeon Mandeep Mehra, an eminent Harvard University professor who works at Brigham and Womens Hospital (BWH) and is known internationally for cardiovascular medicine and heart transplants. He provided the kind of gravitas that can fast-track papers to leading journals. In a statement provided by BWH, Mehra said he had met another of the trio, cardiac surgeon Amit Patel, in academic and medical circles, and that Patel had introduced him to Sapan Desai, a vascular surgeon and founder of Surgisphere, the tiny company that supplied the data. Journal disclosures, however, also indicate Mehra received compensation from Triple-Gene, a gene therapy company Patel co-founded to develop cardiovascular treatments.

Desai publicly aspired to combine big data and artificial intelligence (AI) in ways that he said can replace randomized controlled clinical trials. For a brief moment, it seemed that Surgispheres enticing data set, said to include nearly 100,000 detailed patient records from about 700 hospitals on six continents, would settle questions about the possible benefits of various drugsincluding the controversial antimalarial hydroxychloroquinefor COVID-19 patients.

Patel once apparently headed cardiac surgery at the University of Miami Miller School of Medicine. A university press release announcing his arrival in 2016 is no longer posted on the university website, however, and the school has not confirmed his job duties there. More recently, he has been a volunteer adjunct professor at the University of Utah. But, as STAT first reported yesterday, Patel tweeted on Friday that he had severed his relationship with the university, which a school spokesperson confirmed. In recent years Patel has developed and commercialized experimental stem cell therapies purported to cure heart problems, reverse aging, or treat sexual dysfunction. He is also part of a network of physicians that just launched a trial to use stem cells from umbilical cord blood to treat COVID-19 patients.

Normally co-authors of high-profile papers share subject area expertise or have clear professional ties, says Jerome Kassirer, chief editor ofNEJMduring the 1990s. He calls the collaboration of the apparently disparate individuals completely bizarre, and a red flag that the studies warranted intensive scrutiny that the journals failed to provide.

None of the three co-authors responded to requests for comment. Patel spoke with aSciencereporter initially but said he wanted to wait for audits of the Surgisphere data to comment, and Desais spokesperson stopped communicating after the retractions. Still, interviews with former colleagues and a long paper trail shed some light on each of them.

Desai had a history of convincing respected researchers of his skill and integrity. One of them, Gilbert Upchurch, department of surgery chair at the University of Florida, wrote last year in a journal commentary that he had never met Desai but had nonetheless mentored him remotely and developed an online friendship with him. Upchurch placed the scientist in a group of amazing and talented young vascular surgeons.

Illinois court records show Desai is facing two medical malpractice lawsuits filed last year. He told The Scientist that he deems any lawsuit naming him to be unfounded.

Desai has a history of big aspirations and entrepreneurial venturessome short-lived. His science-fiction blog, corewardfront.com, was meant to find the most parsimonious route for mankind to establish a meaningful presence in space. In 2009, he wrote that the site would publish fiction grounded in facts and reality, adding, the scientific method must be followed religiously. The blog is no longer published.

As a student, Desai won several small National Institutes of Health (NIH) grants for studies of the vestibular system. He started Surgisphere in 2007, when he was a medical resident at Duke University. Surgispheres initial products were medical guides and textbooks, although Desai has said he was working on big data projects for the company from its birth. In 2010, under the firms auspices, he founded the Journal of Surgical Radiologywhose editors included researchers with well-established publishing records. It folded in January 2013. Articles from the journal were cited only 29 times in its history, according to Scimago, a journal rating service. Yet an undated Surgisphere web page, no longer accessible online, said the online-only publication had 50,000 subscribers and nearly 1 million page views monthlywhich would have placed it in elite company in academic publishing.

Surgisphere appears over time to have shifted its efforts into developing a database of hospital records that could be used for research. When the pandemic erupted, Desai declared that his data set could answer key questions about the efficacy and safety of treatments. Speaking about the finding that hydroxychloroquine increases mortality in COVID-19 patients, the main finding from the now retracted Lancet paper, he told a Turkish TV reporter, with data like this, do we even need a randomized controlled trial? Soon after, the World Health Organization temporarily suspended enrolling patients for its COVID-19 trial of the drug.

Immediately after the Lancet and NEJM studies appeared, however, critics identified anomalies in the data. And they doubted that a tiny firmwith a scant public track record in AI, few employees, and no publicly named scientific boardcould convince hundreds of unidentified hospitals in dozens of nations to share complex, protected, and legally fraught patient data. Ultimately, despite Desai promising repeatedly to allow an independent audit of Surgisphere, the firm refused to release the raw patient data and agreements with hospitals for an audit, so no one could validate the authenticity of its database.

No hospitals have come forward to acknowledge working with Surgisphere. Indeed, NHS Scotland, which is mentioned as a case study on the companys website, says none of its hospitals worked with Surgisphere and that it would ask the firm to remove an image of a Glasgow hospital from its website.

Science contacted several of Desais current or former employees or colleagues. Most would not comment. But Fred Rahimi, an Illinois podiatrist and co-author of a paper with Desai, praises the surgeon as highly capable for salvaging limbs, and easy to work with. Through his publicist, Desai cited Mark Melin, a University of Minnesota, Twin Cities, vascular surgeon, as a supporter. Before the retractions, Melin called Desai a gentleman of the highest integrity who has nothing to cover up.

But one physician-scientist who worked closely with Desai several years ago, says, Just about everyone who knew him would say: I just didnt have a good feeling about him. After theyd been with him, most people dissociated themselves from him, the scientist says, declining to be named to avoid personal and institutional embarrassment.

In the decade since completing his medical residency, Desai moved from job to jobat Duke, the University of Texas, Southern Illinois University, and two private Illinois hospitals, according to his LinkedIn profile. You might say we should have stopped him, which now seems obvious, Desais former colleague says. We should have found a way to get together and say, Whats going on here? rather than allowing him to move from place to place. We should have done better as a medical community. We looked the other way.

Before and after his stint at the University of Miami, which appears to have started in late 2016 or early 2017, Patels academic home was the University of Utah. He started as a full-time faculty member at Utah in 2008 and kept that position until he left for Miami. The website for Foldax, a heart valve company that he serves as medical adviser, describes him as a Tenured Professor of Surgery in the Division of Cardiothoracic Surgery at the University of Utah School of Medicine and Director of Clinical Regenerative Medicine and Tissue Engineering at the University of Utah.

The university confirmed Patel had tenure there, but says the directorship was an unofficial title. And among more than 100 publications listed on his University of Utah profile, nearly two-thirds were actually co-authored by other scientists who share the same surname. The page was removed from the university website after inquiries from Science.

According to the NIH database, Patel has never received funding from the agency. Before the recent COVID-19 papers, one of his most notable publications was a 2016 paper in The Lancet, which reported that extracting stem cells from the bone marrow of a person with end-stage heart failure and then reinjecting them could reduce the number of cardiac events that produced deaths or hospital admissions by 37%. The 126 patient, 31-site, phase II trial was billed in a press release, now not available on the University of Utah website but stored elsewhere, as the largest cell therapy trial for heart failure to date. Despite the apparent positive results, the sponsoring company Vericel no longer is developing stem cells for heart disease and, according to its webpage, is focused on advanced cell therapies for the sports medicine and severe burn care markets.

Patel left Miami under unclear circumstances, but has retained ties with Camillo Ricordi, an influential stem cell researcher at the University of Miami School of Medicine who is also the founder of a nonprofit called the Cure Alliance. The alliance previously focused on testing whether stem cells derived from umbilical cord blood could treat diabetes or Alzheimers, but has now pivoted to fighting COVID-19, according to its website. Ricordi is the principal investigator on a multisite trial to see whether the stem cells can treat lung inflammation in severe COVID-19 patients and Patel is listed in various references to the trial as a key contributor or coprincipal investigator. Ricordi did not reply to requests for comments on his relationship with Patel.

Patel recently tweeted that he is related to Dr. Desai by marriage but called that old news and added, Despite this I still do not have the information of what happened at Surgisphere. In addition to apparently connecting Mehra and Desai, Patel had prior connections with other authors of the NEJM paper and the preprint. David Grainger, co-author of the preprint, is a professor of biomedical engineering at the University of Utah and also works with Foldax. Grainger declined to comment.

Timothy Henry, a cardiovascular clinician and scientist at the Christ Hospital in Cincinnati and a co-author on the NEJM article, has written several scholarly articles with Patel, including the 2016 Lancet paper. Henry, who also declined to comment, advises Patels Triple-Gene, which develops cardiovascular gene therapy treatments. Henry and Patel adviseand Patel is a board member ofCreative Medical Technology Holdings, a Phoenix company that develops and markets stem cell therapies, including treatments purported to reverse aging and cure sexual disfunction.

Creative Medicals CaverStem and FemCelz kits are distributed to physicians who use them to extract stem cells from a patients bone marrow, then inject the cells into the penis or clitoral area to stimulate blood flow, according to a statement filed with the U.S. Securities and Exchange Commission. (As of the market close Friday, the publicly traded firms shares were valued at one-third of 1 cent.) The CaverStem treatments are advertised by the company as successful in more than 80% of patients, based on a 40-person phase I clinical trial that was not randomized or controlled, and on observations of 100 other patients. Phase I trials typically measure safety, not health benefits of a potential treatment.

Science contacted multiple colleagues or co-authors of Patel. None would comment. Before the retractions, two high-profile researchersDeepak Bhatt, who directs interventional cardiovascular programs at BWH; and Peter Gruber, a pediatric cardiothoracic surgeon at Yale Universityendorsed Patel on his LinkedIn page. Bhatt says he doesnt know Patel and attempted to remove his endorsement after being contacted by Science. Gruber says he overlapped with Patel at the University of Utah about a decade ago, but doesnt know his work in detail.

In contrast, Mehraauthor of more than 200 scholarly articles, editor of The Journal of Heart and Lung Transplantation, and head of the cardiology division of theUniversity of Maryland before moving to BWH in 2012enjoys considerable support even after the unraveling of the recent studies. Obviously, you dont rise to the position hes risen to without being ambitious, but Ive never had any indication whatsoever that he would do anything unethical, says Keith Aaronson, a cardiologist at the University of Michigan, Ann Arbor, who collaborated with Mehra on several studies, including a clinical trial of a mechanical pump for heart failure patients.

Mehra, the first author on both retracted papers, was the only one to issue a personal statement of apology, for failing to ensure that the data source was appropriate for this use. BWH and Harvard declined to say whether further investigation of Mehras roles in the papers would occur. (Mehra has written papers recently with another co-author of the Lancet paper, Frank Ruschitzka of University Hospital Zrich.)

I think he just fell into thisperhaps a little navely, says another former collaborator, cardiothoracic surgeon Daniel Goldstein of the Albert Einstein College of Medicine. Given the amount of data that was in the [Surgisphere] database, its just hard to believe someone would [fabricate] something like this.

Kassirer offers a harsher view: If youre a scientist and youre going to sign on to a project, by God you should know what the data are.

With reporting by Kelly Servick and John Travis.

This story was supported by theScienceFund for Investigative Reporting.

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Who's to blame? These three scientists are at the heart of the Surgisphere COVID-19 scandal - Science Magazine

Five years ago, we had only one treatment for sickle cell disease, a disease that should not be taken lightly.

This disease can be a pain-generating disease that actually affects all organs of the body. This can start at the heart, blood vessels, brain, joints, bones and also the lungs.

Sickle cell is due to a mutation of a tiny gene that leads to an unstable hemoglobin. The sickles in the hemoglobin, when stressed, deprive tissue from oxygen that can lead to what we call crisis.

Crisis starts with pain, but it can also lead to stroke, heart attack and limb loss. Sickle cell crisis is when the abnormal cell gets stuck in the small blood vessels.

Sickle cell disease affects approximately 100,000 people in the United States. For years, the only therapeutic option was Hydroxyurea. This drug has been in existence since 1984. We know that this drug works, since it has proved to be effective in increasing hemoglobin, reducing pain and acute chest syndrome.

This drug has also decreased the number of blood transfusions in patients who suffer from sickle cell disease. Unfortunately, Hydroxyurea is chemotherapy and requires close monitoring. This therapy works over time with each patient; therefore, not all patients will respond equally. Since Hydroxyurea was introduced, there has been a need for new treatments. For the past several years, more therapies have started to emerge.

The first notable drug that has been FDA approved in 2017, since Hydroxyurea, is L-glutamine (Endari). This drug works on the inflammatory part of the disease. It has also proved to decrease the number of pain crisis and lessen acute chest syndrome.

The second drug is Voxelotor. This drug is a once-daily pill that stabilizes the oxygenated hemoglobin. Trials have proved to make patients less anemic, but events are not necessarily less painful. More long-term studies are looking at this issue. This drug is available, and FDA approved, through an accelerated program.

The third drug is Crizanlizumab. This drug helps with the stickiness of the red blood cells against the sticky vessel wall. This is one of the detrimental aspects of this disease. A randomized study called SUSTAIN proved that this intravenous drug decreases the number of painful crisis. This drug was FDA approved through a breakthrough therapy program.

Lastly, there is gene therapy. This type of treatment consists of an auto stem cell transplant of a viral infected, anti-sticking hemoglobin. This therapy still requires chemotherapy to wipe out the bone marrow so that space can be made for the transplant. The results of this treatment have been very successful.

Many promising therapies are seeing the light and are changing the care of this complex disease so that patients with sickle cell disease can lead a semi-normal lifestyle.

Dr. Ziad Skaff is board certified in hematology and oncology. He serves as chief of staff of MUSC Health-Florence Medical Center and Medical Director of Oncology Services. Dr. Skaff is associated with MUSC Health Hematology & Oncology, located at 805 Pamplico Highway, Medical Pavilion A, Suite 315. To schedule an appointment, call 843-674-6460.

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Sickle cell treatment then and now - SCNow

Yoni Yahav, 43, has been in prison five times. When he was released for the fifth time about two weeks ago, after nine months imprisonment, he swore that it would also be his last time. Despite his lengthy history behind bars, what broke him was actually a few months in Sharon prison. Conditions there are intolerable, he said. Its terribly overcrowded, eight in a cell. People were worried during the coronavirus.

Yahav decided not to remain silent. Already in prison he started a Facebook page called Protest of the Prisoners describing the tough conditions in Israeli prisons. Since his release he has gone public, and demonstrates with families of prisoners against the overcrowded cells and the poor living conditions.

LISTEN: Annexation vexation comes between Bibi and the settlersHaaretz

Prisoners are afraid to unite because its easy for the Israel Prison Service to separate them, he says. Theyre in charge of everything family visits, conjugal visits. A prisoner knows that if he opposes the system he wont be able to embrace his child. Prisoners have no lobby and no elected official wants to help them. To date he has organized demonstrations in front of the Knesset and the home of Public Security Minister Amir Ohana, against the proposed law to prevent attorneys visits to prison.

The prisoners stories led him to an awakening years after he became debt-ridden and entered the world of crime. He describes his time in crime organizations, when he was involved in fraud, money laundering and extortion, as a horrible life. Its a life of greed and wars of survival. Youre always looking who has a more expensive car, who lives on a higher floor but its also living all day looking behind your shoulder, sideways, checking the bottom of your car and your wifes car. It means switching cars and being afraid of the police.

He adds that prison doesnt do its job of rehabilitation just the opposite. You enter prison and leave twice as much a criminal, because you connect to people there, and if you take sides, immediately youre the enemy of the other camp and youre marked. He says, The IPS isnt interested in people, or in prisoner rehabilitation, because fewer prisoners means less money. For them were a money factory, were returning clients, and they make sure to maintain us.

Instead of the therapy he didnt receive, hes trying now to help prisoners who were left behind. I realized that I can take care of myself only if I help others, those who ate from the same plate as me. He recruited lawyers and prisoner activists, and last week they demonstrated in front of the Knesset during an Internal Affairs Committee meeting about prison living conditions.

They are planning additional demonstrations against the IPS commissioner and legal adviser, and meanwhile Yahav wants one other thing: For the public to know what happens in prison. How the fleas take over the cells, mice, inferior conditions. Arent people in prison human beings? So theyll say Im a criminal, but this criminal is now speaking for the others who cant speak, and he wont rest until the criminals with rank obey the [Basic] Law on Human Dignity and Freedom, just as I paid my debt to society when I broke the law and went to prison. I wont let them get away with it.

The system may be able to easily dismiss Yahavs complaints because of his serious crimes, and the IPS believes that all he wants is revenge. But hes right: Already in 2017 the High Court of Justice decided that the government must provide every prisoner with living space of at least 4.5 square meters, but although this was supposed to happen by May 2020, the IPS claimed that the space is available to only 40 percent of prisoners. In Europe the average is 8 square meters. In the end the court postponed implementation to an unknown date.

Previously, in an attempt to carry out the ruling, the government took several steps: First, building a state-of-the-art prison in Megiddo with 2,000 places, in a project including tourism initiatives. The second important step was moving releases through expanded administrative release, in which prisoners are sometimes released even six months early, regardless of their crimes or whether theyre still considered dangerous.

Former Public Security Minister Gilad Erdan decided that expanded administrative release should apply as long as there are over 14,000 prisoners. But the coronavirus reduced the number of arrests to 70 percent of their number in the same period last year, leaving the lowest number of prisoners in Israel in the past 20 years. The number is now 13,800 (compared to 18,000 in 2010). So the early releases were halted and construction of the new prison was frozen.

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The Finance Ministry said that due to the low number of inmates there is no longer a need for a new, spacious prison, adding that the IPS can observe the court rulings without it. The law enforcement system claimed that the number of prisoners who receive the required space is greater than the IPS claims.

The decline in the number of prisoners is now resulting in complaints about the inflated manpower in the IPS, with the treasury demanding that the agency most of whose budget is invested in salaries and pensions streamline its operations. But that wont improve the poor conditions of the prisoners: The prisons are obsolete, there are fleas everywhere and crowded conditions are still prevalent.

The small number of prisoners is a problem for the IPS: On one hand, the fewer the prisoners, the lower the budgets. That means that no new prisons will be built and there will be less manpower. On the other hand, a decline in the number of prisoners would increase the living space per prisoner. Ohana now has to decide whether to restore the early releases by lowering the maximum number to 13,000, which would mean fewer prisoners and less money.

Its a cynical battle between the treasury and the IPS, says Avi Himi, chairman of the Israel Bar Association. He said the expanded administrative releases should be instituted immediately, because of the poor prison conditions.

Acting IPS Commissioner Asher Vaknin said the numbers will increase to 17,000, and even if there are 1,000 vacant places designated for Palestinian security prisoners, he cant put regular criminals there. He insisted that only the IPS can plan prison arrangements. However, the enforcement authorities says that the IPS wants as many prisoners as possible, but we have dropped to 13,000 prisoners, and the crime situation hasnt worsened.

The IPS stated: The IPS is responsible only for the supply of places in prison, and not for populating them. The IPS takes care of prisoner welfare and security and is constantly trying to improve the treatment and rehabilitation of criminal prisoners, prevent recidivism and help prisoners return to the community. In the past two years millions of shekels were invested in improving living conditions and increasing living space. The first stage of the High Court decision has been completed and we are beginning the second stage.

Continued here:
Vowing to never go back, Ex-con seeks to improve intolerable conditions in Israeli jails - Haaretz

Photo credit: University of Pittsburgh

From Prevention

Scientists have grown tiny human livers that functioned after transplant into rats.

Trying to improve transplant numbers and outcomes is a major research area for biologists.

The scientists began by making "decellularized scaffolds" on which human stem cells were grown into liver cells.

Scientists from the University of Pittsburgh and their colleagues have grown tiny human livers and successfully implanted them into rats. The livers began as stem cells that are cultivated into skin and vascular cells that form a complete microenvironment. The organ-like microenvironment further matures some liver functions and produces tissue structures similar to those found in human livers, their paper in Cell Reports explains.

In their summary, the scientists say previous research has mostly used existing structures of rat cells to grow their organlike environments. They explain:

Whereas previous studies recellularized liver scaffolds largely with rodent hepatocytes, we repopulated not only the parenchyma with human iPSC-hepatocytes but also the vascular system with human iPS-endothelial cells, and the bile duct network with human iPSC-biliary epithelial cells. The regenerated human iPSC-derived mini liver containing multiple cell types was tested in vivo and remained functional for 4 days after auxiliary liver transplantation in rats.

This cutting-edge science begins with human volunteers who gave skin cell samples. These were reverse engineered into stem cells and then redirected to become different needed cells to form a liver. From there, the scientists seeded a liver scaffolda rat-based extracellular matrix (ECM) structure with, miraculously, its cells removedwith their new human liver cells.

The goal of decellularization is to remove cells while maintaining the structural, mechanical, and biochemical properties of the ECM scaffold, the researchers explain.

There were traces of DNA left in the rat scaffolds, though. DNA content, a commonly used marker of decellularization, was 3 [to] 10 times higher than in previous studies, which may lead to an adverse immune response if animal-derived scaffolds are to be used in humans, however, this remains to be tested.

Story continues

Inverse reports that while the resulting liver-growing process has taken 10 years to perfect, this batch of miniature livers took under a month to growcompared with two years in the human body. The team then transplanted the livers into a small group of specially prepared rats, which had their immune systems suppressed to encourage the transplant and their liver lobes removed to encourage regeneration.

Five is a tiny sample, to be sure, but all five livers worked during the four-day experimental period, producing and secreting bile and urea. Some had problems around the graft site, which makes sense for an almost completely human organ transplanted into a rat.

Harvested human iPSC-liver grafts measure 2.5 [to] 3 [centimeters] and showed liver-like tissue texture, the scientists say. Despite a handful of understandable problems, they feel optimistic about the future of lab-grown human livers on decellularized scaffolds. They conclude:

Future studies should concentrate on procedures to allow continued vascular development using, for instance, nanoparticles and growth-factor-hydrogel modification of acellular scaffolds. The strategy shown here represents a significant advance toward our understanding of the production of bioengineered autologous human-liver grafts for transplantation.

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Scientists Grow Tiny Human Livers, Changing the Course of Organ Transplants - Yahoo News

Myeloproliferative disorders are disease of blood and bone marrow which have unknown cause and there are wide range of symptoms. The treatment of myeloproliferative disorders generally depends on the type and presence of symptoms. Myeloproliferative disorders is generally considered as clonal disorder which begins with one or more change in the DNA of a single stem cells in the bone marrow. The changes to the hematopoietic stem cell cause the cell to reproduce repeatedly, creating more abnormal stem cells and these abnormal cells become one or more types of blood cells. Myeloproliferative disorders gets worst with time as the number of extra blood cells build up in the bone marrow and bloodstream.

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Emergence of new treatment for the myeloproliferative disorders and availability of novel drug drive the market for myeloproliferative disorders drugs market in the near future. Rising incidence of myeloproliferative disorders and presence of strong product pipeline spur the myeloproliferative disorders drugs market. Growing geriatric population, change in lifestyle and growing awareness among general population is expected to drive the market of myeloproliferative disorders in the forecast period.

Advancement in the treatment for oncology further expand the treatment option for myeloproliferative disorders. Various clinical trial undergoing for the treatment of myeloproliferative disorders which further drive the growth of the myeloproliferative disorders drugs market. However, high cost of drug and treatment along with the lack of awareness among the population in developing and under developed nations hinder the growth of myeloproliferative disorders drugs market.

The global myeloproliferative disorders drugs market is segmented on basis of Type, Drug Type, Distribution Channel, End User and Geography.

Improvement in the symptoms and reduction of in splenomegaly among patients receiving available therapy is expected to boost the market of myeloproliferative disorders. Development in new therapeutic drug and target therapy further drive the market growth of myeloproliferative disorders. Increased research and development and increased funding by the government towards the development of novel therapy spur the market growth. With the discovery of specific gene mutations in myeloproliferative disorders the market is expected to grow in the forecast period owing to increased adoption of new drugs and increased awareness along with the favorable reimbursement scenarios for the treatment of myeloproliferative disorders.

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The North America market holds the largest revenue share for myeloproliferative disorders drugs, due to presence of major pharmaceutical players undergoing various clinical innovation, government initiative and increase research and development funding for the Myeloproliferative disorders. Europe is expected to contribute for the second largest revenue share after North America in the global myeloproliferative disorders drugs market, owing to merging treatment option and development of oncology drug discovery and rising prevalence of myeloproliferative disorders.

Asia Pacific is expected to show rapid growth, due to increasing number of vascular surgeons and low cost of peripheral interventions. China is expected to register fast growth, due to significant increase in the number of innovative firm and research organization and increasing importance of pharmaceutical research & development activities and investments in research for developing new drugs. Latin America and Middle East & Africa are projected to exhibit sluggish growth in myeloproliferative disorders Drugs market, due to proper healthcare systems and adoption of new drug and therapy.

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Examples of some of the key manufacturer present in the global myeloproliferative disorders drugs market are,

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Myeloproliferative Disorders Drugs Market Industry Trends and Developments Through 2026 - Cole of Duty

Prophecy Market Insights Cell Therapy Manufacturing market research report provides a comprehensive, 360-degree analysis of the targeted market which helps stakeholders to identify the opportunities as well as challenges. The research report study offers keen competitive landscape analysis including key development trends, accurate quantitative and in-depth commentary insights, market dynamics, and key regional development status forecast 2020-2029. It incorporates market evolution study, involving the current scenario, growth rate, and capacity inflation prospects, based on Porters Five Forces and DROT analyses.

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An executive summary provides the markets definition, application, overview, classifications, product specifications, manufacturing processes; raw materials, and cost structures.

Market Dynamics offers drivers, restraints, challenges, trends, and opportunities of the Cell Therapy Manufacturing market

Segment Level Analysis in terms of types, product, geography, demography, etc. along with market size forecast

Regional and Country- level Analysis different geographical areas are studied deeply and an economical scenario has been offered to support new entrants, leading market players, and investors to regulate emerging economies. The top producers and consumers focus on production, product capacity, value, consumption, growth opportunity, and market share in these key regions, covering

The comprehensive list of Key Market Players along with their market overview, product protocol, key highlights, key financial issues, SWOT analysis, and business strategies. The report dedicatedly offers helpful solutions for players to increase their clients on a global scale and expand their favour significantly over the forecast period. The report also serves strategic decision-making solutions for the clients.

Competitive landscape Analysis provides mergers and acquisitions, collaborations along with new product launches, heat map analysis, and market presence and specificity analysis.

Segmentation Overview:

Cell Therapy ManufacturingMarket Key Companies:

harmicell, Merck Group, Dickinson and Company, Thermo Fisher, Lonza Group, Miltenyi Biotec GmBH, Takara Bio Group, STEMCELL Technologies, Cellular Dynamics International, Becton, Osiris Therapeutics, Bio-Rad Laboratories, Inc., Anterogen, MEDIPOST, Holostem Terapie Avanazate, Pluristem Therapeutics, Brammer Bio, CELLforCURE, Gene Therapy Catapult EUFETS, MaSTherCell, PharmaCell, Cognate BioServices and WuXi AppTec.

The Cell Therapy Manufacturing research study comprises 100+ market data Tables, Graphs & Figures, Pie Chat to understand detailed analysis of the market. The predictions estimated in the market report have been resulted in using proven research techniques, methodologies, and assumptions. This Cell Therapy Manufacturing market report states the market overview, historical data along with size, growth, share, demand, and revenue of the global industry.

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The study analyses the manufacturing and processing requirements, project funding, project cost, project economics, profit margins, predicted returns on investment, etc. This report is a must-read for investors, entrepreneurs, consultants, researchers, business strategists, and all those who have any kind of stake or are planning to foray into the Cell Therapy Manufacturing industry in any manner.

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Researchers believe the link is so strong that they have called for baldness to be listed as a risk factor called the Gabrin sign This is after Dr Frank Gabrin, the first US physician to die of coronavirus, who was also bald. Lead author of the study, Professor Carlos Wambier of Brown University, told The Telegraph: "We really think that baldness is a perfect predictor of severity."

Recently scientists have hypothesised that coronavirus is more deadlier for men due than women because of testosterone.

Italian doctors have previously found patients given androgen deprivation therapy, which radically cuts testosterone levels, were four times less likely to die from coronavirus.

A protein, TMPRSS2, is driven up by testosterone and scientists think the virus could use this protein to help it unlock cells.

Researchers at Londons Institute for Cancer Research are examining the link further, whilst the University of California, Los Angeles is looking at testosterone-blocking therapy to help with coronavirus treatment.

Testosterone can produce dihydrotestosterone (DHT) which can lead to hair loss.

Though as per South China Morning Post, it is possible to have low levels of testosterone but high levels of DHT.

The further data on baldness further raises the possibility that treatments that cut testosterone could be used to slow the virus down.

Discussions have taken place about a trial using baldness drugs to treat coronavirus.

READ MORE:Chinas Xi Jinping vows to strengthen public health system

A study of 122 patients in three Madrid hospitals found 79 percent of the men were bald.

Howard Soule, executive vice president at the Prostate Cancer Foundation, told Science Magazine: "Everybody is chasing a link between androgens and the outcome of Covid-19.

Karen Stalbow, Head of Policy at Prostate Cancer UK, said: There have been several recent pieces of research which indicate there may be a link between male hormones and increased risk of Covid-19.

This has led some researchers to investigate whether hormone therapies commonly used to treat prostate cancer, such as enzalutamide, could reduce this risk.

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However, most of the research so far has been in the lab, and there is conflicting evidence over whether the hormone therapies have the same impact in the lungs as they would in prostate cells.

There are now several clinical studies starting which hope to address these issues, but much more evidence is needed before we can know whether these hormone therapies would be an effective treatment for Covid-19.

Professor Nick James of the Institute for Cancer Research has warned against using testosterone cutting treatment as a preventive measure due to their severe side effects.

He explained to the Mail on Sunday: Being on these drugs is the male equivalent of going through the menopause.

You would almost certainly cause more harm than good.

According to the NHS, the following people are considered clinically extremely vulnerable: people who have had an organ transplant, people undergoing chemotherapy or antibody treatment for cancer, intense radiotherapy, cancer treatments which affect the immune system, people who have blood or bone marrow cancer, those have had a bone marrow or stem cell transplant in the previous six months, or are still taking immunosuppressant medicine, those with a severe lung condition, those with a condition which puts them at high risk of infection or taking medicines which makes them more likely to do so and expecting mothers with heart conditions.

The list of people are considered at moderate risk includes: Those over 70, expecting mothers, those who have lung conditions which are not severe, those with heart disease, diabetics, those with chronic kidney disease, those with liver disease, those with a condition affecting the brain or nerves and those who are obese.

Previously, environmental factors were hypothesised as being behind the higher risk to men.

This includes the fact men are more likely to be smokers.

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Bald men at higher risk of having severe coronavirus, shocking new research suggests - Express

BOSTON--(BUSINESS WIRE)-- Follica, Inc. (Follica), a biotechnology company developing a regenerative platform designed to treat androgenetic alopecia, epithelial aging and other related conditions, today announced positive feedback from a meeting with the U.S. Food and Drug Administration (FDA) as the company prepares to advance its lead program into Phase 3 development following a successful safety and efficacy optimization study for the treatment of hair loss in male androgenetic alopecia announced in December 2019.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200603005934/en/

Follicas approach, which is designed to stimulate the growth of new follicles and new hair, is being developed as a potential new option for the millions of people seeking treatments to grow new hair. (Graphic: Business Wire)

Follica plans to launch its Phase 3 program this year. Overall, approximately 280 patients will be enrolled, with efficacy assessed against two co-primary endpoints: visible (non-vellus) hair count and patient-reported outcomes on a pre-established scale. The randomized, controlled, double-blinded studies will be conducted in multiple centers across the U.S. A maximal use study to further understand the pharmacokinetics of the treatment will be conducted in parallel. The trial design is consistent with feedback from the FDA during the End of Phase 2 meeting.

In the U.S. alone, 47 million men are affected by progressive hair loss caused by androgenetic alopecia, a condition that is largely unresolved today, leaving many dissatisfied with the current available treatments and looking for a new alternative. Our recent safety and optimization study points to a new level of effect, enabled by our proprietary approach, which stimulates the growth of new follicles and new hair, said Jason Bhardwaj, chief executive officer of Follica. Were grateful to the FDA for their guidance as we prepare for our pivotal program, and we look forward to advancing the development of our treatment regimen, which has demonstrated strong potential to address the current need for those who seek treatment for androgenetic alopecia.

Follicas approach is based on generating an embryonic window in adult scalp cells via a series of short office-based treatments with its proprietary Hair Follicle Neogenesis (HFN) device. The scalp treatments, which last just a few minutes, stimulate stem cells and enable the growth of new hair follicles. A topical drug is then applied to enhance efficacy by growing and thickening new hair follicles and hair on the scalp.

Follica reported topline results from its safety and optimization study in December 2019. That trial was designed to select the optimal treatment regimen using Follicas proprietary HFN device in combination with a topical drug and successfully met its primary endpoint. The selected treatment regimen demonstrated a statistically significant 44% improvement of visible (non-vellus) hair count after three months of treatment compared to baseline (p < 0.001, n = 19). Across all three treatment arms, the overall improvement of visible (non-vellus) hair count after three months of treatment was 29% compared to baseline (p < 0.001, n = 48), reflecting a clinical benefit across the entire trial population and a substantially improved outcome with the optimal treatment regimen. Additionally, a prespecified analysis comparing the 44% change in visible (non-vellus) hair count to a 12% historical benchmark set by approved pharmaceutical products established statistical significance (p = 0.005).

In addition to the safety and optimization study, Follica has validated its approach in prior clinical studies using prototype HFN devices with different treatment parameters and therapeutic compounds. Follicas translational work builds on research by George Cotsarelis, M.D., who isolated and characterized the expression pattern of stem cells from a critical region of the follicle. An expert in epithelial stem cell biology, Dr. Cotsarelis is chair of the department of dermatology at the University of Pennsylvania and a co-founder of Follica.

About Androgenetic Alopecia Androgenetic alopecia represents the most common form of hair loss in men and women, with an estimated 90 million people who are eligible for treatment in the United States alone. Only two drugs, both of which have demonstrated a 12% increase of non-vellus hair count over baseline for their primary endpoints, are currently approved for the treatment of androgenetic alopecia1. The most effective current approach for the treatment of hair loss is hair transplant surgery, comprising a range of invasive, expensive procedures for a subset of patients who have enough donor hair to be eligible. As a result, there remains a significant need for safe, effective, non-surgical treatments to grow new hair.

About Follica Follica is a biotechnology company developing a regenerative platform designed to treat androgenetic alopecia, epithelial aging and other related conditions. Founded by PureTech (LSE:PRTC), a co-inventor of the current platform, and a group of world-renowned experts in hair follicle biology and regenerative medicine, Follicas experimental treatment platform has been shown to stimulate the development of new hair follicles and hair in three previously conducted clinical studies. The companys proprietary treatment is designed to induce an embryonic window via a device with optimized parameters to initiate hair follicle neogenesis, the formation of new hair follicles from epithelial (skin) stem cells. This process is enhanced through the application of a topical compound. Follica completed a safety and efficacy optimization study in 2019, and its Phase 3 program in male androgenetic alopecia is expected to begin in 2020. Follicas technology is based on work originating from the University of Pennsylvania that has been further developed by Follicas internal program. Follicas extensive IP portfolio includes IP exclusively licensed from the University of Pennsylvania as well as Follica-owned IP.

1 Olsen EA et al, J Am Acad Dermatol. 2002 Sep;47(3):377-85Olsen EA et al, J Am Acad Dermatol. 2007 Nov;57(5):767-74. Epub 2007 Aug 29Price VH et al, J Am Acad Dermatol. 2002 Apr;46(4):517-23Kaufman et al, J Am Acad Dermatol. 1998 Oct; 39(4):578-589

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Follica Announces Positive Feedback From End of Phase 2 Meeting With FDA for Its Lead Program to Treat Male Androgenetic Alopecia - BioSpace

Skin is the largest organ of the human body. It is composed of three layers: epidermis-the outermost layer; dermis-contains sweat glands, hair follicles and connective tissue and hypodermis-made up of fat and connective tissue. The main functions of the skin includes protection, sensation and regulation. The skin acts as a barrier and provides protection against harmful chemicals, radiation, microorganism and changing environmental conditions. It also helps regulate body temperature and maintain fluid balance. Skin is an extensive network of nerve cells and contains various receptors to detect changes in the environment such as touch, pain, heat and cold. Damage to skin due to burn or trauma can disrupt all the vital functions performed by the skin.

Currently, topical antibiotics, skin grafting, wound dressings and tissue-engineered substitutes are available in the market that are used to treat skin-related disorders. A skin graft can be done by natural substitute such as amniotic membrane, potato peel or artificial material that includes synthetic polymer sheet, polymer foam or spray. These substitute helps in the healing process. Skin regeneration refers to the regrowth of the damaged skin from the remaining tissue. Stem cell therapy has a vital application in skin regeneration.

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Dermal regeneration matrix device provides an appropriate environment that is necessary for the proliferation and differentiation of skin cells. It helps in triggering the bodys own repair mechanism by cell signaling, that drive the matrix environment in wound healing process. Dermal regeneration matrix device is used to treat skin burns and is also finds application in reconstructive surgery for contractures (scars). The dermal regeneration matrix device is placed over the damaged skin which provides an environment for regeneration of new skin and tissue. The matrix is made of cow collagen, silicone and shark cartilage.

In 1996, the U.S. Food and Drug Administration (FDA) first approved integra dermal regeneration matrix device for treatment of burn injuries. In 2002, dermal regeneration matrix device was approved for use in reconstructive surgery for burn scars. About 30 million people in the U.S. are suffering from diabetes, of which 15% experience a diabetic foot ulcer in their lifetime. In January 2016, FDA approved the use of dermal regeneration matrix for treatment of chronic diabetic foot ulcers (DFU). The usage of dermal regeneration matrix device is expected to expand the growth of dermal regeneration matrix device owing to increase usage in chronic foot ulcer.

Technological advancement and continued research in the development of artificial skin promises to bring more products to the marketplace. Increasing adoption of the device and long-term benefits associated with its application are some of the factors expected to fuel growth of the global dermal regeneration matrix device market over the forecast period. However, less awareness among the consumers and high cost of device are some of the key factors that could hamper growth of the market.

The global dermal regeneration matrix device is segmented on the basis of source, application, end user and geography.

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On the basis of source, the global dermal regeneration matrix device market is segmented into cow collagen, silicone and shark cartilage. On the basis of end user, the global dermal regeneration matrix device market is segmented into hospitals and dermatology centers. The hospital segment is expected to contribute significantly to the total market in terms of market share. According to World Health Organization, over 265,000 deaths are caused due to burns each year. The majority of the burn cases occur in low and middle-income countries. Injuries such as traffic collisions, falls, burns, drowning, poisoning and others are expected to kills around five million people worldwide. Thus, the demand for dermal regeneration growth matrix is expected to be high in the low and middle-income countries over the forecast period.

On the basis of region, the global dermal regeneration matrix device market is segmented into five key regions: North America, Latin America, Europe, Asia Pacific and Middle East & Africa.

Some of the major players in the global dermal regeneration matrix device market include Integra LifeSciences Corporation, Platelet BioGenesis, Avita Medical, Stratatech, Organogenesis Inc., Smith & Nephew, Inc., ACell Inc., Symatese and others.

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Dermal Regeneration Matrix Device Market to Exhibit Increased Demand in the Coming Years - Lake Shore Gazette

Global 3D Cardiac Mapping Systems Market: Overview

Cardiac mapping is a special type of technique which helps in gathering and displaying the information from cardiac electrograms. Such technique is mainly used in the diagnosis of heart rhythms. Therefore, cardiac mapping technique has gained immense popularity in case of arrhythmia. The cardiac mapping procedure involves the percutaneous insertion of catheter into the heart chamber and recording the cardiac electrograms sequentially. Such procedure helps in correlating the cardiac anatomy with the electrograms. The latest 3D cardiac mapping systems provide the three dimensional model of hearts chamber, which further helps in tracking the exact location of the catheter. Such advantages are majorly driving the global 3D cardiac mapping systems market.

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From the perspective of technology, the global 3D cardiac mapping systems market is segmented into basket catheter mapping, electroanatomical mapping, and real-time positional management (Cardiac pathways) EP system. Among these segments, electroanatomical mapping segment accounts for the maximum share in the global 3D cardiac mapping systems market. This mapping are extensively used in several healthcare industry due to its potential in increasing the safety, accuracy, and efficiency of catheter. A research report by TMR Research (TMR) thoroughly explains the new growth opportunities in the global 3D cardiac mapping systems market. Additionally, the report also provides a comprehensive analysis of the markets competitive landscape.

Global 3D Cardiac Mapping Systems Market: Notable Developments

Some of the recent developments are contouring the shape of the global 3D cardiac mapping systems market in a big way:

Key players operating in the global 3D cardiac mapping systems market include BioScience Webster, Boston Scientific Corporation, and Abbott.

Global 3D Cardiac Mapping Systems Market: Key Growth Drivers

Rising Number of Patients with Cardiac Disorders and Arrhythmia Fillips Market

The global 3D cardiac mapping systems market has grown steadily over the years, owing to the convenience it provides to the patients with heart problem. Growing number of people with cardiovascular diseases and rising cases of arrhythmia are the major factors fueling growth in the global 3D cardiac mapping systems market. Along with this, increasing pressure for reducing diagnosis errors and rapidly rising healthcare expenditure are also responsible for boosting the global 3D cardiac mapping systems market. However, above all such factors, the global 3D cardiac mapping systems market is majorly fueled by the accuracy and patient safety provided through real-time monitoring. Such 3D cardiac mapping systems are mainly designed to improve the resolution. This system also helps in gaining prompt of cardiac activation maps. All such advantages are also providing impetus to the growth of the global 3D cardiac mapping systems market.

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Furthermore, rising ageing population who are prone to heart-attack and several chronic heart disorders and increasing diagnosis rate of cardiac illness are the factors stoking demand in the global 3D cardiac mapping systems market. Moreover, this 3D cardiac mapping helps in reducing the diagnosis time. Such factor is also contributing to the growth of the global 3D cardiac mapping systems market.

Global 3D Cardiac Mapping Systems Market: Regional Outlook

On the regional front, North America is leading the global 3D cardiac mapping systems market as the region has seen rapid growth in healthcare industry. Along with this, increasing prevalence of heart attacks, rising healthcare expenditure, and burgeoning population is also responsible for fueling growth in the 3D cardiac mapping systems market in this region.

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3D Cardiac Mapping Systems Market Segmentation Analysis and Global Industry Trends Forecast 2028 - Cole of Duty

The Covid-19 (coronavirus) pandemic is impacting society and the overall economy across the world. The impact of this pandemic is growing day by day as well as affecting the supply chain. The COVID-19 crisis is creating uncertainty in the stock market, massive slowing of supply chain, falling business confidence, and increasing panic among the customer segments. The overall effect of the pandemic is impacting the production process of several industries including Life Science, and many more. Trade barriers are further restraining the demand- supply outlook. As government of different regions have already announced total lockdown and temporarily shutdown of industries, the overall production process being adversely affected; thus, hinder the overall Silicone Foley Catheter Market globally. This report on Silicone Foley Catheter Market provides the analysis on impact on Covid-19 on various business segments and country markets. The report also showcase market trends and forecast to 2027, factoring the impact of Covid -19 Situation.

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Silicone foley catheter is a technique to purify cell populations based on the presence or absence of specific physical characteristics. Silicone foley catheter allows the separation of cells based on their intra- or extracellular properties, including DNA, RNA, and protein interactions, size, and surface protein expression. This is a unique attribute of many stem cell populations, including hematopoietic, embryonic, and cancer stem cells.

The silicone foley catheter market is expected to grow due to the increasing demand from emerging market. However, potential risks associated with the use of Foley catheters and presence of alternative treatments for urinary incontinence is hampering the market growth. Moreover, increasing development in development of medical devices industry, pharmaceutical, and biotechnology industries, increasing prevalence of urologic diseases is boosting the market growth in the upcoming year.

Top Dominating Key Players:

1. AngioDynamics2. B.Braun3. Bard Medical4. Boston Scientific5. Coloplast6. ConvaTec7. Cook Medical Inc.8. Hollister9. Medtronic plc10. Teleflex

The silicone foley catheter market is segmented on the basis of product type and application. Based on product type, the market is segmented as short-term foley catheters and long-term foley catheters. On the basis of application, the market is categorized as prostate gland surgery, urinary retention, urinary incontinence and spinal cord injury.

The study conducts SWOT analysis to evaluate strengths and weaknesses of the key players in the Silicone Foley Catheter Market. Further, the report conducts an intricate examination of drivers and restraints operating in the market. The report also evaluates the trends observed in the parent market, along with the macro-economic indicators, prevailing factors, and market appeal according to different segments. The report also predicts the influence of different industry aspects on the Silicone Foley Catheter Market segments and regions.

Scope of the study:

The research on the Silicone Foley Catheter Market focuses on mining out valuable data on investment pockets, growth opportunities, and major market vendors to help clients understand their competitors methodologies. The research also segments the Silicone Foley Catheter Market on the basis of end user, product type, application, and demography for the forecast period 20202027. Comprehensive analysis of critical aspects such as impacting factors and competitive landscape are showcased with the help of vital resources, such as charts, tables, and infographics.

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Silicone Foley Catheter Market 2027: Which country will show the highest growth? - Cole of Duty

Ample Market Research has recently published a report Human Embryonic Stem Cells Market . The key objective of this report is to highlight various trends and dynamics, new and innovative technology and mergers and acquisitions that are expected to make a positive impact on the overall industry. This report studies the Human Embryonic Stem Cells market size (value and volume) by players, regions, product types and end industries, history data 2014-2018 and forecast data 2019-2025; This report provides a detailed analysis of the prospects for the global Human Embryonic Stem Cells industry up to 2024, including an assessment of the impact of COVID-19.

To know How COVID-19 Pandemic Will Impact This Market/Industry -Request a sample copy of the report: https://www.amplemarketreports.com/sample-request/global-human-embryonic-stem-cells-market-1731516.html

Human Embryonic Stem Cells Market Latest Research Report 2018- 2025 covers a complete market structure across the world with a detailed industry analysis of major key factors. This report provides strategic recommendations consulted by the industrial experts including market forecasts, profit, supply, raw materials, manufacturing expenses, the proportion of manufacturing cost structure, latest market trends, demands and much more.

Global Human Embryonic Stem Cells Market is valued approximately USD XX billion in 2019 and is anticipated to grow with a healthy growth rate of more than XX% over the forecast period 2020-2026. Due to COVID-19 pandemic, the market is facing challenges because of government protocols to stay at home across the world. Human Embryonic Stem Cells (hESCs) are derived from blastocyst and are capable of differentiating into number of cell types that make up the human body as well as it replicates indefinitely and produce non-regenerative tissues such as neural and myocardial cells. They are used in treating a number of blood and genetic disorders related to the immune system, cancers, and disorders as well as used in investigational studies of early human development, genetic diseases and toxicology testing. The technological advancement involving stem cells therapy, rising demand for regenerative medicines, R&D in toxicology testing, technological advancements for the production of embryonic stem cells through alternative methods and increasing prevalence of genetic disorders are the few factors responsible for growth of the market over the forecast period. Furthermore, the introduction of innovative products and other strategic advancements by market players will create lucrative opportunities for the market. For instance, as per companys news release in January 2019, Stemcell Technologies Inc. launched mTeSRl Plus, an enhanced version of mTeSR1. mTeSR Plus is the stabilized feeder-free maintenance medium for human embryonic stem (ES) and induced pluripotent stem (iPS) cells. However, ethical concern related to stem cell research is the major factor restraining the growth of global Vegetable Chips market during the forecast period.

The regional analysis of global Human Embryonic Stem Cells market is considered for the key regions such as Asia Pacific, North America, Europe, Latin America and Rest of the World. Asia Pacific is the leading/significant region across the world due to the presence of several prominent entities incorporated in the U.S. Whereas, Asia-Pacific is also anticipated to exhibit highest growth rate / CAGR over the forecast period 2020-2026.

This report discusses the key drivers influencing Human Embryonic Stem Cells market growth, demand, the challenges and the risks faced by key players and the market as a whole. It also analyzes key emerging trends and their impact on current and future development.

Human Embryonic Stem Cells market report presents the market competitive landscape and a corresponding detailed analysis of the major vendor/manufacturers in the market.

Key players analyzed in the Human Embryonic Stem Cells Insight Report: Astellas Pharma Inc/ Ocata Therapeutics, Stemcell Technologies Inc., Biotime, Inc. / Cell Cure Neurosciences LTD, Thermo Fisher Scientific, Inc., CellGenix GmbH, ESI BIO, PromoCell GmbH, Lonza Group AG, Kite Pharma, Cynata Therapeutics Ltd.

The study was conducted using an objective combination of primary and secondary information including inputs from key participants in the industry. The report contains a comprehensive market and vendor landscape in addition to a SWOT analysis of the key vendors.

Browse Detailed TOC, Tables, Figures, Charts And Companies Mentioned In Human Embryonic Stem Cells Market Research Report At: https://www.amplemarketreports.com/report/global-human-embryonic-stem-cells-market-1731516.html

Strategic Points Covered in Table of Contents

Study Coverage: It includes key manufacturers covered, key market segments, the scope of products offered in the global Conductive Nylon market, years considered, and study objectives. Additionally, it touches the segmentation study provided in the report on the basis of the type of product and application.

Executive Summary: It gives a summary of key studies, viz. production, market growth rate, competitive landscape, market drivers, trends, and issues, and macroscopic indicators.

Production by Region: Here, the report provides information related to import and export, revenue, production, and key players of all regional markets studied.

Profile of Manufacturers: Each player profiled in this section is studied on the basis of SWOT analysis, their products, production, value, capacity, and other vital factors.

Market Size by Manufacturer

Consumption by Region

Market Size by Type,by Application

Production Forecast and Consumption Forecast

Industry Chain, Upstream, and Downstream Customers Analysis

Key Findings, Opportunities and Challenges, Threats, and Affecting Factors

Appendix

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In the end, this report additionally presents product specification, producing method, and product cost structure. Production is separated by regions, technology, and applications. The Human Embryonic Stem Cells Market report includes investment come analysis and development trend analysis. The key rising opportunities of the fastest growing international Human Embryonic Stem Cells industry segments are coated throughout this report. This report provides information about the import, export, consumption and consumption value. The report then provides one of the most crucial aspects of the Human Embryonic Stem Cells Market the forecast for the next five to six years based on the previous as well as current data.

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Excellent growth of Human Embryonic Stem Cells Market- Comprehensive study by key players: Astellas Pharma Inc/ Ocata Therapeutics, Stemcell...

BALTIMORE, June 4, 2020 /PRNewswire/ -- Elixirgen Therapeutics, Inc., a Baltimore-based biotechnology company focused on the discovery, development, and commercialization of therapies for genetic diseases and vaccines, received confirmation from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) application for its lead candidate, EXG34217, was approved on May 23, 2020. EXG34217 is an autologous cell therapy for telomere biology disorders with bone marrow failure.

The FDA's approval allows Elixirgen Therapeutics to proceed with its planned Phase I/II, open label, single center clinical trial to assess the safety and tolerability of EXG34217 at Cincinnati Children's Hospital Medical Center (ClinicalTrials.gov Identifier: NCT04211714). This program's treatment paradigm uses Elixirgen Therapeutics' proprietary ZSCAN4 technology to extend the telomeres of the hematopoietic stem cells of the patients.

About Elixirgen Therapeutics, Inc.Elixirgen Therapeutics, Inc. is a Baltimore-based biotechnology company co-founded by Akihiro Ko and Minoru Ko, MD, PhD, which is focused on curing humanity's ailments through innovations in stem cell biology.The company's experienced team of researchers has a wide variety of specialties, enabling it to use both basic and translational research approaches to developing therapies for genetic diseases and vaccines. For more information visit https://ElixirgenTherapeutics.com

Forward-Looking StatementsThis press release may contain "forward-looking" statements, including statements regarding the effectiveness of EXG34217 to treat telomere biology disorders with bone marrow failure and statements relating to the planned clinical trials of EXG34217. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in drug research and development. In light of these and other uncertainties, the forward-looking statements included in this press release should not be regarded as a representation by Elixirgen Therapeutics that its plans and objectives regarding EXG34217 will be achieved. Any forward-looking statements in this press release speak only as of the date of this press release, and Elixirgen Therapeutics undertakes no obligation to update or revise the statementsin the future, even if new information becomes available.

Contact:Media RelationsElixirgen Therapeutics, Inc.(443) 869-5420Media@ElixirgenTherapeutics.com

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FDA Approves Elixirgen Therapeutics IND Application for Therapy for Telomere Biology Disorders with Bone Marrow Failure - Herald-Mail Media

The current coronavirus pandemic clearly illustrates how dangerous viral infections can become for us. Independent of the present situation, there are people whose bodies are defenseless against infections because their immune systems are unable to combat them - they suffer from immunodeficiency diseases such as ADA-SCID (adenosine deaminase severe combined immunodeficiency) or Wiskott-Aldrich syndrome. Prof. Dr. Alessandro Aiuti, a physician and research scientist based in Milan who works at the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) and at the Vita Salute San Raffaele University, is now being honored with the Else Krner Fresenius Prize for Medical Research 2020 for his groundbreaking successes in the development of gene therapies. The award is coupled to 2.5 million euros in prize money.

In the case of the rare immune disorder ADA-SCID, which exclusively afflicts young children and occurs about 15 times a year in Europe, a defective ADA gene within the genome disrupts lymphocyte development, leaving the young patient's body defenseless against infections. "Without effective therapy, the children rarely survive for more than 2 years because any infection can become perilous for them," Aiuti explains. Standard for this therapy is a bone marrow transplantation from a fully matched sibling. However, a suitable donor is available only for a minority of patients. "Meanwhile children with such a condition benefit from the advances we have made in the field of gene therapy. So far we have treated 36 children from 19 countries using the therapy we developed. In more than 80 percent of the cases, the treatment has had such an impact that no enzyme replacement therapy or transplantation is needed. This achievement has been made possible by the extraordinary effort and dedication of SR-Tiget researchers and clinical team throughout 25 years," Aiuti adds. All of the patients are still alive.

For these successes and his other work in the field of gene therapy, Alessandro Aiuti has now been honored with the Else Krner Fresenius Prize for Medical Research 2020 awarded by the Else Krner-Fresenius-Stiftung (EKFS) foundation. At 2.5 million euros, this award is one of the highest endowed prizes for medical research in the world. "Still young by comparison, this year the prize is being awarded for the third time. It honors research scientists for pioneering contributions in the areas of biomedical science. A major percentage of the prize money flows into the prizewinner's research and is supposed to contribute toward achieving further groundbreaking findings and medical breakthroughs in the future as well," emphasizes Prof. Dr. Michael Madeja, scientific director and member of the management board at EKFS.

The decision regarding the prize recipient was made by a ten-member international jury composed of renowned research scientists in the fields of genome editing and gene therapy along with delegates from the Scientific Commission at EKFS. Prof. Dr. Hildegard Bning, chairwoman of the jury and president of the European Society for Gene and Cell Therapy (ESGCT), substantiates the jury's decision: "Alessandro Aiuti is a truly outstanding physician and scientist. His work has decisively contributed to the development and successful treatment of rare, genetically caused disorders such as SCID. Thanks not least of all to the contributions he has made, even patients with other inheritable illnesses can presumably be treated successfully in the future."

After successful clinical trials, the gene therapy developed for ADA-SCID patients was approved as a pharmaceutical remedy in Europe. It is considered to be one of the key findings in the development of gene therapies worldwide. With this treatment certain blood stem cells (CD34+) are taken from the patient, then the cell DNA is modified. The cells are treated outside the body using a viral vector to accomplish this. The correct version of the gene for the ADA enzyme is introduced into the genome of the cells that were collected. The genetically modified cells are returned to the patient's bloodstream via intravenous infusion. A portion of the modified cells subsequently establish themselves in bone marrow again. The patient now has blood stem cells that function properly and produce lymphocytes to defend against infections - presumably on a life-long basis.

Alessandro Aiuti wants to utilize the prize money from EKFS to set the success story forth, to optimize the therapies further and map out the healing mechanisms involved in a better fashion. The scientist sees another major challenge in conveying the acquired knowledge beyond the successful gene therapies from Milan to as many other genetic disorders as possible. Alongside the therapy for ADA-SCID, the San Raffaele Telethon Institute for Gene Therapy has also developed gene therapies for four more hereditary diseases, among them the Wiskott-Aldrich syndrome and metachromatic leukodystrophy (MLD). To this day a total of more than 100 patients from 35 different countries have been treated.

Biography of Alessandro Aiuti

Alessandro Aiuti was born in Rome in 1966 and studied medicine there at Sapienza University. Following a stay at Harvard Medical School in Boston, Massachusetts in the USA, he received his doctorate in Human Biology in 1996 from Sapienza University. Since 1997 he has been active at the San Raffaele Scientific Institute in Milan, where he meanwhile also teaches as a professor at the Vita Salute San Raffaele University. He is furthermore Deputy Director of Clinical Research at the San Raffaele Telethon Institute for Gene Therapy and Head of the Pediatric Immunohematology Unit at San Raffaele Hospital.

Aiuti is the author of numerous and highly acclaimed publications. Over the course of his career he has received a number of prizes from national and international institutions. Aiuti is a member of the board of the European Society of Gene and Cell Therapy, and a member of the EMA Committee for Advanced Therapies since 2019.

The Else Krner Fresenius Prize for Medical Research

The international Else Krner Fresenius Prize for Medical Research came into existence in 2013 on the occasion of the 25th anniversary of Else Krner's death and is awarded in alternating fields of biomedical science. Endowed with 2.5 million euros, the prize is one of the most highly endowed medical research awards in the world. It honors and supports research scientists who have made significant scientific contributions in their fields and whose work can be expected to yield groundbreaking findings and medical breakthroughs in the future as well.

The Else Krner-Fresenius-Stiftung (EKFS) foundation - Advancing research. Helping people.

The Else Krner-Fresenius-Stiftung, a non-profit foundation, is dedicated to the funding of medical research and supports medical/humanitarian projects. The foundation was established in 1983 by entrepreneur Else Krner and appointed as her sole heir. EKFS receives virtually all of its income in dividends from the Fresenius healthcare group, in which the foundation is the majority shareholder. To date, the foundation has funded around 2,000 projects. With a current annual funding volume around 60 million euros the EKFS is one of the largest foundations for medicine in Germany. More information:www.ekfs.de.

The San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget)

Based in Milan, Italy, the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) is a joint venture between the Ospedale San Raffaele and Fondazione Telethon. SR-Tiget was established in 1995 to perform research on gene transfer and cell transplantation and translate its results into clinical applications of gene and cell therapies for different genetic diseases. Over the years, the Institute has given a pioneering contribution to the field with relevant discoveries in vector design, gene transfer strategies, stem cell biology, identity and mechanism of action of innate immune cells. SR-Tiget has also established the resources and framework for translating these advances into novel experimental therapies and has implemented several successful gene therapy clinical trials for inherited immunodeficiencies, blood and storage disorders, which have already treated >115 patients and have led through collaboration with industrial partners to the filing and approval of novel advanced gene therapy medicines.

Fondazione Telethon

Fondazione Telethon is a non-profit organisation created in 1990 as a response to the appeals of a patient association group of stakeholders, who saw scientific research as the only real opportunity to effectively fight genetic diseases. Thanks to the funds raised through the television marathon, along with other initiatives and a network of partners and volunteers, Telethon finances the best scientific research on rare genetic diseases, evaluated and selected by independent internationally renowned experts, with the ultimate objective of making the treatments developed available to everyone who needs them. Throughout its 30 years of activity, Fondazione Telethon has invested more than EUR 528 million in funding more than 2.630 projects to study more than 570 diseases, involving over 1.600 scientists. Fondazione Telethon has made a significant contribution to the worldwide advancement of knowledge regarding rare genetic diseases and of academic research and drug development with a view to developing treatments. For more information, please visit:www.telethon.it

Issued by news aktuell/ots on behalf of Else Krner-Fresenius-Stiftung

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Groundbreaking Gene Therapies for Hereditary Diseases / Alessandro Aiuti, a physician and research scientist from Milan, receives the Else Krner...

Follica plans to initiate its Phase 3 programme this year

PureTech Health plc (LSE: PRTC) (PureTech), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, is pleased to note that its Founded Entity, Follica, today announced positive feedback from an End of Phase 2 meeting with the US Food and Drug Administration (FDA) for its lead programme to treat male androgenetic alopecia. The company plans to advance the programme into Phase 3 development this year following the successful safety and efficacy optimisation study announced in December 2019.

Bharatt Chowrira, JD, PhD, president and chief of business and strategy at PureTech, said: This positive feedback from FDA enables Follica to move forward with its pivotal trial this year. Current treatments for the progressive hair loss caused by androgenetic alopecia are inadequate, and we are pleased with Follicas progress towards Phase 3 development, bringing us another step closer to a potential new treatment for the millions of people seeking safe, effective, non-surgical treatments to grow new hair.

The full text of the announcement from Follica is as follows:

Follica Announces Positive Feedback from End of Phase 2 Meeting with FDA for its Lead Programme to Treat Male Androgenetic Alopecia

Company plans to initiate its Phase 3 programme this year

BOSTON, June 4, 2020 -- Follica, Inc.(Follica), a biotechnology company developing a regenerative platform designed to treat androgenetic alopecia, epithelial ageing and other related conditions, today announced positive feedback from a meeting with the US Food and Drug Administration (FDA) as the company prepares to advance its lead programme into Phase 3 development following a successful safety and efficacy optimisation study for the treatment of hair loss in male androgenetic alopecia announced in December 2019.

Follica plans to launch its Phase 3 programme this year. Overall, approximately 280 patients will be enroled, with efficacy assessed against two co-primary endpoints: visible (non-vellus) hair count and patient-reported outcomes on a pre-established scale. The randomised, controlled, double-blinded studies will be conducted in multiple centers across the US. A maximal use study to further understand the pharmacokinetics of the treatment will be conducted in parallel. The trial design is consistent with feedback from the FDA during the End of Phase 2 meeting.

In the US alone, 47 million men are affected by progressive hair loss caused by androgenetic alopecia, a condition that is largely unresolved today, leaving many dissatisfied with the current available treatments and looking for a new alternative. Our recent safety and optimisation study points to a new level of effect, enabled by our proprietary approach, which stimulates the growth of new follicles and new hair, said Jason Bhardwaj, chief executive officer of Follica. Were grateful to the FDA for their guidance as we prepare for our pivotal programme, and we look forward to advancing the development of our treatment regimen, which has demonstrated strong potential to address the current need for those who seek treatment for androgenetic alopecia.

Follicas approach is based on generating an embryonic window in adult scalp cells via a series of short office-based treatments with its proprietary Hair Follicle Neogenesis (HFN) device. The scalp treatments, which last just a few minutes, stimulate stem cells and enable the growth of new hair follicles. A topical drug is then applied to enhance efficacy by growing and thickening new hair follicles and hair on the scalp.

Follica reported topline results from its safety and optimisation study in December 2019. That trial was designed to select the optimal treatment regimen using Follicas proprietary HFN device in combination with a topical drug and successfully met its primary endpoint. The selected treatment regimen demonstrated a statistically significant 44% improvement of visible (non-vellus) hair count after three months of treatment compared to baseline (p < 0.001, n = 19). Across all three treatment arms, the overall improvement of visible (non-vellus) hair count after three months of treatment was 29% compared to baseline (p < 0.001, n = 48), reflecting a clinical benefit across the entire trial population and a substantially improved outcome with the optimal treatment regimen. Additionally, a prespecified analysis comparing the 44% change in visible (non-vellus) hair count to a 12% historical benchmark set by approved pharmaceutical productsestablished statistical significance (p = 0.005).

In addition to the safety and optimisation study, Follica has validated its approach in prior clinical studies using prototype HFN devices with different treatment parameters and therapeutic compounds. Follicas translational work builds on research by George Cotsarelis, MD, who isolated and characterised the expression pattern of stem cells from a critical region of the follicle. An expert in epithelial stem cell biology, Dr Cotsarelis is chair of the department of dermatology at the University of Pennsylvania and a co-founder of Follica.

About Androgenetic Alopecia

Androgenetic alopecia represents the most common form of hair loss in men and women, with an estimated 90 million people who are eligible for treatment in the United States alone. Only two drugs, both of which have demonstrated a 12% increase of non-vellus hair count over baseline for their primary endpoints, are currently approved for the treatment of androgenetic alopecia1. The most effective current approach for the treatment of hair loss is hair transplant surgery, comprising a range of invasive, expensive procedures for a subset of patients who have enough donor hair to be eligible. As a result, there remains a significant need for safe, effective, non-surgical treatments to grow new hair.

About Follica

Follica is a biotechnology company developing a regenerative platform designed to treat androgenetic alopecia, epithelial ageing and other related conditions. Founded by PureTech (LSE: PRTC), a co-inventor of the current platform, and a group of world-renowned experts in hair follicle biology and regenerative medicine, Follicas experimental treatment platform has been shown to stimulate the development of new hair follicles and hair in three previously conducted clinical studies. The companys proprietary treatment is designed to induce an embryonic window via a device with optimised parameters to initiate hair follicle neogenesis, the formation of new hair follicles from epithelial (skin) stem cells. This process is enhanced through the application of a topical compound. Follica completed a safety and efficacy optimisation study in 2019, and its Phase 3 programme in male androgenetic alopecia is expected to begin in 2020. Follicas technology is based on work originating from the University of Pennsylvania that has been further developed by Follicas internal programme. Follicas extensive IP portfolio includes IP exclusively licensed from the University of Pennsylvania as well as Follica-owned IP.

About PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, including intractable cancers, lymphatic and gastrointestinal diseases, central nervous system disorders and inflammatory and immunological diseases, among others. The Company has created a broad and deep pipeline through the expertise of its experienced research and development team and its extensive network of scientists, clinicians and industry leaders. This pipeline, which is being advanced both internally and through PureTechs Founded Entities, is comprised of 23 product candidates and one product that has been cleared by the US Food and Drug Administration (FDA). All of the underlying programmes and platforms that resulted in this pipeline of product candidates were initially identified or discovered and then advanced by the PureTech team through key validation points based on the Companys unique insights into the biology of the brain, immune and gut, or BIG, systems and the interface between those systems, referred to as the BIG Axis.

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PureTech Founded Entity Follica Announces Positive Feedback from FDA as it Prepares to Advance its Lead Programme in Male Androgenetic Alopecia into P...

BOSTON--(BUSINESS WIRE)--Follica, Inc. (Follica), a biotechnology company developing a regenerative platform designed to treat androgenetic alopecia, epithelial aging and other related conditions, today announced positive feedback from a meeting with the U.S. Food and Drug Administration (FDA) as the company prepares to advance its lead program into Phase 3 development following a successful safety and efficacy optimization study for the treatment of hair loss in male androgenetic alopecia announced in December 2019.

Follica plans to launch its Phase 3 program this year. Overall, approximately 280 patients will be enrolled, with efficacy assessed against two co-primary endpoints: visible (non-vellus) hair count and patient-reported outcomes on a pre-established scale. The randomized, controlled, double-blinded studies will be conducted in multiple centers across the U.S. A maximal use study to further understand the pharmacokinetics of the treatment will be conducted in parallel. The trial design is consistent with feedback from the FDA during the End of Phase 2 meeting.

In the U.S. alone, 47 million men are affected by progressive hair loss caused by androgenetic alopecia, a condition that is largely unresolved today, leaving many dissatisfied with the current available treatments and looking for a new alternative. Our recent safety and optimization study points to a new level of effect, enabled by our proprietary approach, which stimulates the growth of new follicles and new hair, said Jason Bhardwaj, chief executive officer of Follica. Were grateful to the FDA for their guidance as we prepare for our pivotal program, and we look forward to advancing the development of our treatment regimen, which has demonstrated strong potential to address the current need for those who seek treatment for androgenetic alopecia.

Follicas approach is based on generating an embryonic window in adult scalp cells via a series of short office-based treatments with its proprietary Hair Follicle Neogenesis (HFN) device. The scalp treatments, which last just a few minutes, stimulate stem cells and enable the growth of new hair follicles. A topical drug is then applied to enhance efficacy by growing and thickening new hair follicles and hair on the scalp.

Follica reported topline results from its safety and optimization study in December 2019. That trial was designed to select the optimal treatment regimen using Follicas proprietary HFN device in combination with a topical drug and successfully met its primary endpoint. The selected treatment regimen demonstrated a statistically significant 44% improvement of visible (non-vellus) hair count after three months of treatment compared to baseline (p < 0.001, n = 19). Across all three treatment arms, the overall improvement of visible (non-vellus) hair count after three months of treatment was 29% compared to baseline (p < 0.001, n = 48), reflecting a clinical benefit across the entire trial population and a substantially improved outcome with the optimal treatment regimen. Additionally, a prespecified analysis comparing the 44% change in visible (non-vellus) hair count to a 12% historical benchmark set by approved pharmaceutical products established statistical significance (p = 0.005).

In addition to the safety and optimization study, Follica has validated its approach in prior clinical studies using prototype HFN devices with different treatment parameters and therapeutic compounds. Follicas translational work builds on research by George Cotsarelis, M.D., who isolated and characterized the expression pattern of stem cells from a critical region of the follicle. An expert in epithelial stem cell biology, Dr. Cotsarelis is chair of the department of dermatology at the University of Pennsylvania and a co-founder of Follica.

About Androgenetic AlopeciaAndrogenetic alopecia represents the most common form of hair loss in men and women, with an estimated 90 million people who are eligible for treatment in the United States alone. Only two drugs, both of which have demonstrated a 12% increase of non-vellus hair count over baseline for their primary endpoints, are currently approved for the treatment of androgenetic alopecia1. The most effective current approach for the treatment of hair loss is hair transplant surgery, comprising a range of invasive, expensive procedures for a subset of patients who have enough donor hair to be eligible. As a result, there remains a significant need for safe, effective, non-surgical treatments to grow new hair.

About FollicaFollica is a biotechnology company developing a regenerative platform designed to treat androgenetic alopecia, epithelial aging and other related conditions. Founded by PureTech (LSE:PRTC), a co-inventor of the current platform, and a group of world-renowned experts in hair follicle biology and regenerative medicine, Follicas experimental treatment platform has been shown to stimulate the development of new hair follicles and hair in three previously conducted clinical studies. The companys proprietary treatment is designed to induce an embryonic window via a device with optimized parameters to initiate hair follicle neogenesis, the formation of new hair follicles from epithelial (skin) stem cells. This process is enhanced through the application of a topical compound. Follica completed a safety and efficacy optimization study in 2019, and its Phase 3 program in male androgenetic alopecia is expected to begin in 2020. Follicas technology is based on work originating from the University of Pennsylvania that has been further developed by Follicas internal program. Follicas extensive IP portfolio includes IP exclusively licensed from the University of Pennsylvania as well as Follica-owned IP.

1 Olsen EA et al, J Am Acad Dermatol. 2002 Sep;47(3):377-85Olsen EA et al, J Am Acad Dermatol. 2007 Nov;57(5):767-74. Epub 2007 Aug 29Price VH et al, J Am Acad Dermatol. 2002 Apr;46(4):517-23Kaufman et al, J Am Acad Dermatol. 1998 Oct; 39(4):578-589

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Follica Announces Positive Feedback From End of Phase 2 Meeting With FDA for Its Lead Program to Treat Male Androgenetic Alopecia - Business Wire

For Australias balding community, letting your hair down is just an idiom.

But soon, it may be a reality.

In a breakthrough in the battle against baldness, researchers from the University of Pennsylvania have managed to grow skin that develops distinct layers, including hair follicles,from stem cells.

Scientists were already able to grow skin cells, but recreating the complex, multi-layered skin structure has been a major challenge.

As the largest human organ, the skin has multiple functions including temperature regulation and bodily fluid retention to the sensing of touch and pain that increases the difficulty of synthesising it, researchers say.

But over a four-to-five month period, researchers succeeded in growing complex skin cells and hair follicles, which were grafted onto mice.

More than half of the mice sprouted hair from the process.

Its a development that may also affect those with genetic skin disorders and cancers, as well as those with burns or wounds.

But those who are a little thin on the top shouldnt get excited too fast.

There are several major questions that remain before this approach can become a reality, researchers Leo Wang and George Cotsarelis say.

Several other aspects of the authors approach will also need to be optimised before it can move to the clinic.

The hairs that grew in the current study were small; in future, furtheroptimisation of culture conditions will be needed to form large scalp hairs.

However, the authors conclude: The work holds great promise of clinical translation we are confident that research will eventually see this promise realised.

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Eradicating balding a step closer with new procedure in the cross hairs - The New Daily

Retinol, sometimes referred to collectively as retinoids (the group name for everything in the retinol family) are powerful enough to fade hyper-pigmentation, soften wrinkles and give your skin some of that youthful glow back. Depending on the formulation, retinol formulations might even prevent future wrinkles. Since retinols have a reputation for being strong, some people are scared to actually start using them, or dont know how to begin choosing thebest retinol creamsfor their skin.

But with Google searches for retinol at an all-time high, we have a hunch that people are looking to improve the quality of their skinso weasked Austin-based dermatologist Dr. Adam Mamelak for a primer on all these ingredients starting with r (retinol, retinoids and retinoic acid) which all serve the same purpose.

According to Dr. Mamelak, in its most basic form, retinol is a form of vitamin A and has been used to treat acne, but it has also been shown to help decrease wrinkles and fine lines. More than that, retinol allows the skin to repair any damage already inflicted. And since its all powered by vitamin A, retinol helps turn over the skin, exfoliating it naturally, and also helps stimulate collagen production in the deeper layers.

As you begin your search for the right retinol for your skin, consider starting with one of these 10 options.

Unlike many retinol-based products, First Aid Beauty FAB Skin Lab Retinol Eye Cream With Triple Hyaluronic Acidis a light and creamy formula that doesnt sting. Its active ingredient is microencapsulated retinol, which means its surrounded by a protective layer that helps stimulate natural collagen production to minimize the appearance of crows feet, fine lines and and wrinkles without the irritation. ($42, Sephora.com).

No7 ADVANCED Retinol 1.5% Complex Night Concentrate was so eagerly anticipated in the UK that 100,000 people signed up for the waiting list. In addition to a high concentration of retinol, this product also has a retinol optimizer, which ensures that the product works throughout the night, along with a retinol soother to keep skin calm. ($36.99, us.no7beauty.com)

InstaNaturals Retinol Moisturizercontains a robust blend of ingredients designed to address multiple signs of aging. Combined with vitamin C, Hyaluronic Acid, nourishing oils and extracts, this moisturizer aims to smooth lines and wrinkles while reducing discoloration and blemishes on the skin. It works to fight breakouts by clearing away dead skin cells that can clog the pores, and brightens the appearance of discoloration. For best results, apply this product nightly and follow with an SPF during the day. ($24.00, InstaNaturals Retinol Moisturizer, Amazon.com)

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This past year, Olay launched their Regenerist Retinol24 Night Collection, which hydrates, minimizes pores and evens your skin tone without irritation. The formulation combines retinol and the popular skincare ingredient Niacinamide (vitamin B3), which is used as a soothing ingredient in many acne and rosacea treatments. ($28.99,Olay.com).

If youre looking for a vegan option, Drunk ElephantsA-Passioni Retinol Anti-Wrinkle Creamis a good place to start. It combines 1.0% vegan retinol with other natural, soothing ingredientskale leaf extract and winter cherry juice make the list. ($78, Amazon.com)

If youve tried retinol in the past and had bad side effects including skin irritation,DefenAgemay be a good option for you. Its a clean beauty line, meaning there are no animal or human-originated ingredients, parabens, sulfates, mineral oils, or phthalates. This retinol substitute works by activating dormant LGR6+ stem cells in the body to create fresh new skin, meaning its active ingredients (which include a safe retinol substitute) encourage cell turnover in skin cells that have become sluggish due to the natural aging process. ($28.50 for the 24-Hour Fast Starter Kit, defenage.com)

RoC Skincares new Retinol Correxion Line Smoothing Night Serum Capsules. This overnight renewal treatment comes in single-use capsules (30 per jar), that are sealed for optimal ingredient freshness. Theyre also biodegradable, so you dont have to worry about extra waste. ($33.00, Ulta/Ulta.com)

SeneGence Advanced SenePlex+ Renewal Serum with Retinolcontains incredibly gentle ingredients, including meadowfoam seed oil, aloe vera and hyaluronic acid, so your skin isnt dry or irritated like with typical retinoids. Use two pumps at night for best results. ($75.00, seneweb.senegence.com)

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Recently, theres been a lot of buzz around an ingredient called bakuchiol (pronounced buh-koo-chee-all) which is derived from an Indian plant and is deeply hydrating.Ole Henriksen Goodnight Glow Retin-ALT Sleeping Creme uses bakuchiol, along with other gentle ingredients, that will leave your skin with a glowy look without redness or inflammation. ($55.00, Sephora.com)

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If youre a bit worried about trying retinol, you can always use a product once a week until your skin gets used to it. Or, ease yourself in with a body lotion instead. Advanced Clinicals Retinol Cream is great for elbows, feet, or other rough body parts in need of some extra attention. ($27.95, Walmart.com)

As Dr. Mamelak explains it, the reason retinol works so well is because it increases the blood flow to the skin which will ultimately improve collagen production.

He adds that when retinol is applied directly to the skin, the basal cells (the ones at the lowest level of the skin) will start to divide. This division activates new epidermal cells to migrate to the skin surface, he says. In more basic terms, this means that newer cells appear on the surface of skin, while older cells are shed causing the exfoliation process to occur.

All this improved collagen production and increased exfoliation comes with a bit of a priceyou might notice, for example, that your skin is more sensitive. As Dr. Mamelak explains it, Because the skin cells are rapidly producing, they lack the adhesion and lipid production to protect the skin. Without these layers of protection, your skin becomes more sensitive when using retinol. Your skin also becomes much more sensitive to sunlight, so Dr. Mamelak says using products containing SPF is mandatory when using retinol.

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Best Retinol Creams: Best Retinol Eye Creams, Night Creams and More - Parade