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DNA Editing of Human Embryos: Here’s the Deal with Genetic Modification

Scientists are getting closer to perfecting DNA editing of human embryos, increasing the potential ability to snip out inherited genetic diseases from human offspring. For decades, scientists have been tinkering with the DNA of humans as well as other living things. Previous attempts by Chinese researchers proved unsuccessful because of some safety concerns. These studies, which open the possibility of preventing the transfer of genetic diseases from one generation to another, raised red flags and were initially shut down. Still, DNA editing of human embryos is finally reaching the point where it can be put into action.

More Details on DNA Editing of Human Embryos

Recently, a team of international scientists was able to successfully modify human embryos, removing the genetic mutations responsible for sudden cardiac arrest in healthy individuals. It was said to be a safe and acceptable demonstration of advanced technology for this complicated procedure. Notably, this procedure was the first case of genome editing in human embryos performed outside of China. The research focused on a genetic form of heart disease, which scientists believe could be used for different conditions that are caused by a single gene mutation, including some types of breast cancer and cystic fibrosis.

Scientists hope that if the embryo gene correction method can be proven to be a safe procedure, it can potentially be used to eradicate genetic diseases that have passed on through generations. The procedure of modifying human embryos to remove genetic mutations utilizes the CRISPR-Cas9, a powerful gene-editing tool. It can fix mutations within embryos produced from the sperm of a man who inherited hypertrophic cardiomyopathy. It’s a heart condition that leads to the thickening of the muscular wall of the heart and affects one in 500 individuals. It is the common cause of sudden cardiac arrests among young people.

a photo of a simple diagram in connection to DNA editing of human embryos beside an image of a blue-gloved and laboratory coat-wearing doctor who's looking through a microscope

DNA Editing Corrects Life-Threatening Defects

Every human gene has two copies. Some diseases are the result of the mutation in one copy of the gene. For this particular study, a man who carried a single mutant copy of the MYBPC3 gene—which causes hypertrophic cardiomyopathy—was recruited. Using the man’s sperm and healthy eggs from some donors, the scientists found that about 50 percent of the embryos had the inherited mutant gene. If the embryos were to be implanted into women scheduled to carry them to full term, the offspring would inherit the heart condition of the father. Gene editing significantly reduced the number of embryos that continued to carry the dangerous mutation. When gene editing was performed at the time of fertilization, 72 percent of the embryos were found to be free of the disease-causing mutation.

The result of the demonstration proved to be impressive due to previous attempts at gene editing only partially working, preventing mutations in a few cells but not in the rest. Previous gene editing procedures also resulted in the accidental targeting of wrong genes during the modification process. However, this latest demonstration of gene editing did not show any off-target effects. Richard Hynes, a geneticist at MIT claimed, “they’ve got remarkably good results”—thus bringing the study “closer to clinics, but there’s still a lot of work to do”.

When the procedure becomes established and accepted, people with genetic diseases can opt to reproduce through IVF in order for the embryos to be screened for harmful mutations. Gene editing could increase the number of healthy embryos that will be available for a doctor to implant in women.

The Hurdles DNA Editing of Human Embryos Will Face

There will be more work ahead in order to prove that gene editing is safe. However, even if the question of safety has been resolved, scientists will still face tremendous hurdles especially in terms of government regulations before they can start any clinical trials. As a matter of fact, the U.S. Food and Drug Administration is barred from considering human trials involving edited embryos. In the U.K., it is against the law to implant women with genetically modified embryos.

Genetic modification is a highly controversial issue because it affects not only the child but also future generations of people. Understandably, many have ethical concerns about the procedure and are wary of the results that such practice will yield. However, while the demonstration did not create a new baby, once the procedure is proven successful, there will be no stopping individuals from using the technology to do so. It is indeed a very long road ahead with no clear signs of when scientists will be allowed to move forward.

FDA Offers Digital Health Pre-Certification Program For Technologies

Government is full of regulations for private companies to comply with. These regulations are meant to sift through all the companies which want to do business with the government. Among other things, there are accreditation procedures, which private companies have to follow and/or comply with. This is good for the government as it can expect private firms to deliver on time and within the budget.

The FDA wants to employ an approach of continually updating and upgrading their procedures, which will help improve innovation.

However, one problem with certification is that it takes longer to get certified than it does to comply with requests for a proposal. This can be a disadvantage for those companies who want to compete for government projects, but do not have any experience in government contracting. It can also demotivate new startups from going after government contracts. These companies have to go through accreditation procedures, as well as separate accreditation and certifications for their products and devices.

The FDA has acknowledged this issue with certification, and the need to have streamlined procedures in order to take advantage of advances in technology. Recently, the agency has launched a pilot program for pre-certification specific for innovations in digital health. This would affect tech companies of all types and sizes. It is a bold action that should help unleash new technology that can offer better health care at reduced cost.

Named the Digital Health Innovation Action Plan, the pre-certification program is aimed at a more relaxed set of regulatory requirements for digital health companies who have a proven track record for designing, developing and testing quality health care products. The aim of the program is to shorten the time needed for these companies to take their products to market. It would also result in lesser development costs, savings for the company and ultimately, the public.

FDA Program to Open Competition for Digital Tech

This program is open for software and hardware developers who have proven themselves to be reliable in manufacturing digital devices which are safe, effective and of high quality. It is also necessary that the tech companies have taken appropriate patient safeguards with their products and devices.

Computer tech and digital health pre-certification symbols

The pilot program will only have nine participating companies of various sizes and expertise. The FDA will be evaluating participants beginning in August. The digital tech product companies will be selected according to a specific set of criteria. The company must be currently developing a medical health product. The company must also have a track record in developing and testing their tech products, standing policies and procedures for maintaining the quality of the organizational processes, along with the necessary Key Performance Indicators.

Once accepted into the pilot program, the companies are also expected to provide information and data to confirm that the KPIs are being met, demonstrating a culture of excellence within the organization. The company also has to provide the FDA with actual post-market data, meet with the FDA for monitoring and consultation; along with the availability of onsite-visits, and provide information about the company’s quality assurance and management systems.

The FDA acknowledges that the traditional approach to certifying health products does not fit the current model for novel digital health devices. The FDA wants to employ an approach of continually updating and upgrading their procedures, which will help improve innovation. The framework for such a procedure does not yet exist. Any new regulatory procedure for digital health products should accommodate the distinctive nature of digital health technology as it keeps evolving.

Facebook Fights Fake News

Most people receive at least some form of news from their Facebook feed. That’s great, because it can be posted, read and shared very quickly.

[Facebook will] investigate and flag the story as fake news, if they deem it so. Facebook will also use “updated machine learning” to detect potential hoax stories.

Unfortunately, misinformation, also spreads rapidly through the platform. Due to this ongoing problem, Facebook will now employ a team of fact checkers to search for fake news, and publish their findings online.

This bold move is a response from the social media site after it experienced widespread criticism from around the globe for not doing enough to combat the issue of hoax news stories on its platform.

According to the BBC, the online giant has also recently launched a new feature in four countries that will publish alternative news links beneath problematic articles. Facebook states that their new “related articles” feature will post reliable alternative links beneath potentially fake stories, so the audience can make up their own minds. This feature will be rolled out globally in due course.

Does Facebook Go Far Enough in Fighting Fake News?

However, critics have said that the new measures don’t go far enough to combat the issue of fake news, and still allow these stories to educate the public with false information.

Facebook Fights Fake News and Hoax Stories

“Presenting audiences with context is helpful,” Tom Felle, a senior lecturer in digital journalism at City University, told the BBC.

“But it does nothing to stop the spread of this material, or to stop traffic going to fake news peddlers who are making money out of creating this material.”

Facebook has been cited, by many organizations in the United States, as having part in swaying the 2016 presidential election. Informing the public with realistic fabrications, which they are likely to believe, greatly influences their decision-making process. Experts say the fake news epidemic is a huge issue that will continue to impact major outcomes if not resolved.

In France, during their last presidential elections, users were also bombarded with what many call fake news, and again this was attributed to helping sway the presidential vote.

According to the BBC, Facebook has been reluctant to take down so-called “fake news” stories, arguing that it doesn’t want to be an “arbiter of truth”. Other critics have claimed that what is sometimes classified as fake news, by government organizations, isn’t in fact fake news at all. Instead these groups wish to categorize these stories as such to simply discredit the source. The term has become so widespread that it is being used frequently by both sides.

Facebook’s new system will identify potential false stories through a mixture of user detection and artificial intelligence (AI). The stories are then sent to the fact-checkers who will investigate and flag the story as fake news, if they deem it so. Facebook will also use “updated machine learning” to detect potential hoax stories.

“If an article has been reviewed by fact checkers, we may show the fact-checking stories below the original post,” states Sara Su, product manager of Facebook’s News Feed.

Meanwhile, Tom Felle feels that if Facebook really wants to stop fake news, they will need to back the news industry in a more effective and helpful manner.

“If Facebook wants to help journalism it needs to put its hand in its pocket and support quality, trusted news organizations to better reach audiences, and advertisers,” he concluded.

Stem Cell Hair Growth Cure — Baldness May Now Be a Thing of The Past!

As most men can testify, losing the hair on your head can be a humiliating experience as you age, sometimes causing severe psychological distress. However, experts claim this case could become a thing of the past—as scientists have discovered a cure for baldness by growing hair from stem cells. In a nutshell, a stem cell hair growth cure now exists.

According to Medical News Today, scientists from the University of South Carolina are developing the practice of growing hair from stem cells after “uncovering key molecular events involved in hair growth and stimulating it in adult mice”. The team’s research has become so widely respected that it has even been published in the journal, “Proceedings of the National Academy of Sciences”. Within the journal, the team offers a step-by-step description of the process by which hair grows. It also gives details regarding how they went about their research. Notably, the paper states that the research paves the way for hair growth stimulation in people with alopecia or baldness, which could help prevent the painful and costly practice of hair transplantation.

New Insights Into Hair Growth

“A team of researchers set out to examine how follicles grow out of the skin and how they produce hair by using so-called organoids, which are clusters of stem cells grown in vitro that can self-organize into an organ-like structure. They used the 3-D structure of organoids to gain a better understanding of a certain organ, as they have similar properties to the organ it imitates—which, in this case, is the human skin,” Medical News Today writes.

an image containing a cartoon of a bald man and a cartoon of a guy with hair with the two separated by a DNA strand in the middle as scientist discover a stem cell hair growth cure
Stem cells may be the answer to curing baldness!

Along with the team, Mingxing Lei, a postdoctoral researcher at the University of Southern California’s (USC) Stem Cell laboratory, found there was a six-step process to hair growth. According to reports, the team used skin organoids from newborn and adult skin cells. They focused on progenitor cells, a type of cell that is more differentiated than stem cells. They then “dissociated these from newborn and adult skin and then transplanted them into nude mice”.

The researchers found that “newborn cells formed skin-like organoids in a six-step process that started with the dissociated progenitor cells (step one), which soon aggregated (step two).  These aggregated cells then turned into polarized cysts (step three), which then transformed into so-called coalesced cysts (step four), which went on to form planar skin (step five). In the final step of the process, the skin formed follicles (step six), which were transplanted into a mouse. Here, they produced hair,” the website details.

The Future with Stem Cell Hair Growth

“Our investigation elucidates a relay of molecular events and biophysical processes at the core of the self-organization process during tissue morphogenesis.” The researchers continue by stating: “Molecules are key to the multistage morphological transition, are identified, and can be added or inhibited to restore the stalled process in adult cells.”

These findings on the stem cell hair growth cure surely sent shockwaves through the scientific community, as it provides renewed hope and a more practical solution to those suffering from severe baldness or alopecia. Human testing is yet to take place, but experts claim this significant breakthrough is a major step toward curing baldness in both males and females. This bold idea could even pave the way for further scientific discoveries—as well as improve research and development within the field.

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