StemCell Therapy

PETA Will Call for End to School's Cruel Muscular Dystrophy Tests

For Immediate Release:December 12, 2019

Contact:Tasgola Bruner 202-483-7382

College Station, Texas As veterinary medicine and biomedical sciences students graduate and their families arrive for Texas A&M Universitys (TAMU) commencement on Friday, PETA supporters will be on the scene with signs proclaiming, TAMU Lied: Dogs Were Bred to Die. The protesters will call on TAMU to stop cruel muscular dystrophy (MD) experiments, for which dogs were deliberately bred to develop a crippling and painful form of canine MD that leaves them struggling to walk, swallow, and even breathe.

When: Friday, December 13, 6 p.m.

Where: North entrance of Reed Arena, 730 Olsen Blvd. (at the intersection with Recreation Center Drive), College Station

As Texas A&M students head out into the world, sick, suffering dogs are still locked up in the schools barren laboratory, says PETA Vice President of Laboratory Investigations Dr. Alka Chandna, Ph.D. PETA is calling for these experiments to end and for all surviving dogs to be released for adoption into loving homes.

PETA has released eyewitness video footage showing dogs inside TAMUs laboratory struggling to walk, swallow, and even breathe. The school has recently come under fire for claiming that it didnt breed dogs for experimentationdespite records showing that since PETA launched its campaign in December 2016, as many as 100 puppies had been born in the laboratory. Many of these puppies died shortly after birth, others were left to endure a lifetime with painful, debilitating symptoms, and other puppieswho carried the MD gene but did not exhibit symptomswere condemned to life in a barren cage devoid of the companionship and love that dogs desire.

For more information, please visit PETA.org.

Read more from the original source:
Texas A&M Graduation to Face Protest Over Dog Experiments - PETA

It started with scientific astonishment. Why is there a green glow when looking at an infrared emitting device? "Such a strange phenomenon was observed by my colleagues when they installed an imaging device at the Nicolaus Copernicus University in Torun," says Prof. Wojtkowski. "They came to me sharing this interesting observation that although they use infrared, which should no longer be visible, they still see something; such a weak, greenish light. And why did they look into the assembled device? "Well," laughs the professor, "such human nature and curiosity. Every time you assemble something, you look inside. It's true that it's always risky to look in such device, because the infrared source is the laser, but it's safe to do so while maintaining the laser's power in accordance with the standards.

The scientists' first thought was that the laser was broken and, in addition to infrared (light wavelength similar to that used in old TV remote controls) generated green light. So, they dismantled the laser and meticulously checked what could have broken down. They found nothing. Then someone came up with the simple but ingenious idea to put a filter in front of the eye of the observer, which would cut off visible light. They found the correct filters, put them between the laser and the eye and to their surprise the effect remained. "Our jaws dropped a little because that meant that the device was fine, but something strange was happening in the eye," says the professor. "Fortunately, there was another, very good laser at hand that generated ultra-short pulses of light and could be used to adjust the wavelength, of course in the infrared range. We started to change this length and it turned out that each one evoked a different color effect in the eye - we could perceive various colors! What's more, not weakly, but very clearly." As it happens with such discoveries, it turned out that people had observed it before, but nobody had any idea how to explain it, or they couldn't interpret it correctly.

This unexpected color vision turned out to be two-photon vision. "Luckily, at that time we were being visited by Professor Krzysztof Palczewski, who is a biochemist working in the USA and dealing with vision processes," recalls Professor Wojtkowski. "He was very interested in our discovery. So much so, that he organized a group of experts in various fields (including our team) to explain the mechanism of this vision. Tests were performed on mice, including genetically modified ones. Kasia Komar and Patryk Stremplewski from my team carried out tests on people, because our main expertise is in measurements on living eyes," explains the professor. "After collecting all the results, it turned out that we were dealing with two-photon vision."

This involves the retina receiving a portion of energy half as low as the minimum required for the reaction of photosensitive cells, but very concentrated in time and space; and if the impulse is delivered, then the subject, e.g. a human, sees it as if it were twice as high. It's a bit like throwing small plasticine balls onto a board twice, in the same place and time. The imprint of both balls merges on the board into a larger, visible one. You can also imagine being hit on the head with these sorts of balls. We wouldn't feel any one of them singly, but a double portion could give us a bruise.

This is what happens in the quantum world, the condition being that you have to throw these balls close enough to themselves and appropriately close to one another in time - so that they basically stick together into larger blobs. Physicists call this the optical non-linear effect. Such effects are known for many materials, but it is not obvious that they can occur in doses that are safe, e.g. for the eye. "Until we'd dealt with this ourselves, I myself had thought that two-photon absorption in the eye could occur only once (in principle, once in one eye, once in the fellow eye)," laughs the professor, "After which it wouldn't be possible to see anything. Fortunately, I was wrong."

On the other hand, in the eye there are a lot of intermediaries between what absorbs photon energy (i.e. retinal cells) and what introduces the image in our brain. Photon absorption in itself does not guarantee that we see something. A number of proteins must react. However, it turns out that this process called phototransduction does take place.

And what can it be useful for? For instance, to check if the eye breaks down. With age or at the outset of a disease, say, macular degeneration (AMD), the effect is poorer. Hence the idea for a new generation of machines for microperimetry, i.e. checking whether we see and what we see at various points on the retina. Researchers thought that perhaps thanks to the two-photon effect, the sensitivity of such devices could be improved, or the threshold of infrared light could be measured. "Thanks to AM2M - a company that is a spinout from the Nicolaus Copernicus University in Toru, we have already started to produce new microperimetry machines," the professor says with pride. "There are three in the world right now, and the fourth and fifth and sixth in our country.

What speaks in favor of the new discovery and the devices based on it is also that with age, the human eye becomes more and more turbid and disperses light waves more. Meanwhile, the principle of physics says that the longer the wave, the less it disperses. Infrared will therefore allow for a more thorough examination of the fundus also in people with advanced cataracts or vitreous floaters. Scientists hope that thanks to their device we will detect functional retinal changes, mainly AMD earlier on, but also better understand the process of vision. Indeed, these are the goals of the new MAB (International Research Agenda) working to improve the eyesight of older people.

"As part of our MAB we will try to objectify this process, i.e. move from a little subjective perimetry to objective ophthalmoscopy," the professor advances to the future, "Using holographic optical tomography. We will analyze functional signals on a principle similar as in tympanometry. This will allow us to determine whether the patient sees and what he sees, without feedback from him, even when he is unconscious or unable to communicate, e.g. after a stroke."

"Thanks to the work of Dr. Katarzyna Komar, we have noticed something that we cannot yet explain," adds Professor Wojtkowski. "Namely, infrared vision is different from normal vision. Cones appear to react differently to rods - they seem to be more sensitive. Now we are trying to understand what this results from." We, the potential patients, can only support the researchers, so that thanks to their discoveries our eyes serve us better and for longer.

Reference

Ruminski et al. (2019) Two-photon microperimetry: sensitivity of human photoreceptors to infrared light. Biomedical Optics Express. DOI: https://doi.org/10.1371/journal.pbio.3000524

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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"Invisible Sight" Reveals Secrets of Vision - Technology Networks

Before you went for a sight test, had you experienced any symptoms?

Donald Broughton (DB): My main symptoms were that my eye became tired and painful due to the amount of concentration required for the work that I was doing as a hairdresser.

DB: I knew I had shrapnel in my eye from previous eye examinations. However, Deepak was the first person to consider referring me to have it removed as it was causing a cataract. When I was 16-years-old, I was hunting in Tatton Park in Cheshire and one of the pellets ricocheted from my friends gun and entered my eye.

DB: I was quite unsure if anything could be done. However, I was happy to go along with having it removed. The optometrist was confident and I had nothing to lose.

DB: We are still working on certain aspects of the treatment, but Im pleased with the progress. The surgeon left the pellet in the eye because it had been there for over 60 years but he removed the cataract caused by the pellet. I am awaiting surgery on my other eye because of anisometropia. I have intermittent double vision that I hope will be resolved with surgery.

DB: I have always had regular eye tests. Its important to look after the gift of sight. You dont value what you have until its gone.

DB: After post-operative challenges have settled theres been a dramatic improvement in my vision.

I knew I had shrapnel in my eye from previous eye examinations

Deepak Oberai (DO): Mr Broughton had a dense cataract that was obstructing his vision as a result of a pellet that was stuck in his eye. If removed, it would significantly improve his eyesight. After conducting an optical coherence tomography (OCT) scan it was clear to me that I could help him.

I was very interested in the nature of Mr Broughtons injury and why no treatment or further investigation had been offered in the past. I had to be persistent but referred to him a local eye surgeon. The consultant found the shot gun pellet that was embedded in his lens and was causing a cataract.

DO: We are fortunate enough to have an OCT device, which identified that his retina was still intact. With this information, I was confident that a cataract removal was possible.

DO: My colleague, Claire, took a message saying that the procedure had been successful and how shocked the patient was that the treatment was successful. Since then I have been in contact with both the surgeon and the patient to make sure things are working well.

DO:

Pictured is Mr Oberai and Mr Broughton.

Read more here:
It's important to look after the gift of sight - AOP

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A woman surnamed Peng began leaking from her eyes after working too much at her job. However, she wasnt leaking tears but fluid that had built up under her retina.

According to China Press, the woman from Guangdong, China had frequently worked overtime which resulted in the deterioration of her eyesight.

When she went for medical treatment, she told the doctor that her eyesight was worsening and everything she looked at was blurry. She also said that tears often flowed out.

However, the doctor said this eye-leakage was due to the build-up of fluid under the retina, which is a condition called central serous chorioretinopath.

According to Medical News Today, the retina is responsible for translating light taken into the eye as images the brain can understand. The build-up of liquid can cause the retina to detach, and this can cause vision problems.

In this case, the doctor told the woman that the fluid build-up was caused by overwork of her eye, causing her retina to detach. This condition often happens to people in their mid-40s and is one of the most common retinal diseases.

No treatment is actually required for this condition. Patients only need to rest while the fluid drains out on its own.

In the case where the fluid does not drain out, medication, thermal laser treatment and lifestyle changes are some of the options a patients can consider to treat the condition.

Some lifestyle changes include reducing overall stress levels, sleeping for at least seven hours every night and avoiding alcoholic drinks.

Dont overwork yourself and remember to sleep early, guys! Your health is more important than your job.

Also read: 36yo Collapses & Dies During Job Interview As He Always Work OT in Previous Office

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Woman Has Vision Problems & Starts Leaking Fluid From Eye After Overworking at Her Job - WORLD OF BUZZ

A new international study involving the University of Liverpool reveals how the evolution of powerful vision was shaped by an improved oxygen supply to the eyes.

Keen eyesight in vertebrates from fish to birds and mammals relies on large eyes and thick retinas. Yet the visual process is energetically costly and the high oxygen demand of thick retinas is difficult to meet by the conventional oxygen supply mechanism through blood vessels just behind the retina.

In a study published in eLife, a team of researchers from 15 institutions led by the University of Aarhus and the University of Liverpool has explored the physiological requirements for the evolution of improved eyesight. Their findings uncover a fascinating pattern of mechanisms to improve retinal oxygen supply that evolved in concert with enhanced retinal morphology to improve vision.

The study took advantage of the diversity in form and function among eyes from 87 animal species. By mapping the characteristics of their eyes onto the species tree of life, the researchers unravelled the evolutionary history of the eye from a 425 million-year-old extinct ancestor of modern vertebrates to current day animals. They identified three distinct physiological mechanisms for retinal oxygen supply that are always associated with improved vision.

The first mechanism is present in many fishes and involves mutations in haemoglobin that were associated with the ability to deliver oxygen to the retina at exceptionally high concentrations to overcome the long diffusion distance to the retinal cells. This mechanism was subsequently lost several times, possibly to avoid oxidative damage and gas bubble formation in the eye. Secondly, oxygen delivery could be improved by blood vessels supplying oxygen from the front of the retina or, thirdly, even directly from within the retina, which, however, can obstruct the light path to the retinal photoreceptor cells.

These different trade-offs to retinal oxygen supply appear to be acceptable in the presence of the improved visual power available when the thickness of the retina was allowed to increase.

The study applied state-of-the-art high-frequency ultrasound, micro-computerised tomography (CT), and magnetic resonance imaging (MRI) techniques used in medical research, to unravel the blood supply mechanisms in some very small eyes or in exceptional museum specimens, such as the eye of the living fossil old fourlegs or coealacanth (Latimeria chalumnae).

It was particularly rewarding to be able to collaborate with this team of comparative animal physiologists and medics and help them to reconstruct the evolution of physiological characteristics on the vertebrate family tree, says Liverpools Dr Michael Berenbrink, one of the three senior authors of the study.

Our conclusions are supported by some natural knockouts, such as Antarctic icefishes, which have lost haemoglobin in their blood and evolved a supplemental retinal oxygen supply mechanism of pre-retinal capillaries, or Mexican cavefishes, which have rudimentary eyes and consequently get by with haemoglobins that are less efficient for retinal oxygen supply, Dr Berenbrink continues.

Overall, the study shows that adaptations to ensure oxygen delivery to the retina were a physiological prerequisite for the functional evolution of the eye, illustrating the importance of a thorough knowledge of physiological mechanisms for understanding the evolution of complex structures.

Research reference

The study Retinal oxygen supply shaped the functional evolution of the vertebrate eye is published in eLife. https://doi.org/10.7554/eLife.52153

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How oxygen shaped evolution of better eyesight - Mirage News

After Today Show anchor Savannah Guthries eye injury last week, during which her young son accidentally hit her in the eye with a toy, the anchor is slowly getting better. But it couldve been much worse.

Find out how the 47-year-old is doing and what she has to go through for her treatments to her injury.

According to Guthrie, she was at home with her son when he accidentally jammed her in the eye with one of his toys. The result was a torn retina.

After the incident last week, Guthrie spoke by phone to Today to describe what happened to cause her to stay away from her duties on the morning show.

I got hit Charleythrew a toy train right at my eye and it tore my retina, Guthrieexplained.

It happened last week, actually, and then I lost my vision in my right eye about 24 hours later and then it turned outto be kind of serious. They were afraid my retina was detached.

The vision is getting better every day, but Im still blurry, Guthrie told her co-anchors on Today last week. Right now its like having one contact (lens) in and (one) out. When it first started though, it was like a complete blur. I couldnt have seen anything.

Thankfully, Guthrie was able to avoid surgery on her eye. Shes had five laser treatment sessions to help heal her retina, and especially in order to not have surgery, which can be risky.

The first laser I actually did I had to go under for, it was kind of an emergency, like they rushed me in there, they shot me up with the big laser, and they were actually not sure it had worked at all, and they thought I was going to have to have this surgery, the mom of twoexplained this week.

Its been a traumatizing week for the anchor, with doctors not being completely sure if she would need high-risk retinal surgery. But in the end, it appears the laser treatments have thankfully done the trick.

Basically the eye jiggles, and the retina is like saran wrap, so when you get hit, saran wrap can very easily tear, can get a hole in it, and thats not a good thing, she said. Laser, if you have a small enough tear . . . can basically weld down the outside of the tear to prevent . . . more of the retina detaching. . . you dont actually have to go to the operating room.

Despite the discomfort and pain she was in, the mother of two still managed to power through it all and co-host the Thanksgiving Day Parade with a big smile on her face.

Im actuallystill hoping I can do the parade tomorrow.Im not supposed to, like, jump up and down or anything because itskind of like literally hanging by a thread, Guthrie said. But Imvery positivebecause I think its going to be OK.

As it turned out, she was in wonderful spirits and did a great job with her Today co-hosts at fronting the parade. Guthrie clearly isnt going to let a little thing like a torn retina stop her from celebrating the holidays!

Read more: Al Roker Reveals What Used To Cause Him to Overeat and Why Hes Never Going Back to Fat

See more here:
Savannah Guthrie Has to Go Through This Treatment After Her Scary Eye Injury - Showbiz Cheat Sheet

Dec. 11, 2019 06:30 UTC

PARIS--(BUSINESS WIRE)-- Regulatory News:

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191210006078/en/

Figure 1. LHON Natural History from Interim Analysis of REALITY vs. Time Course of Visual Acuity from REVERSE and RESCUE - Note: BCVA = best-corrected visual acuity. The LOWESS line for REALITY (n=15 subjects) is based on a series of polynomial regressions around each data point. The regressions use a limited look back and look forward and give distant points less weight. The time course of BCVA for REVERSE and RESCUE uses the least-squares mean based on a mixed model ANCOVA analysis. The starting points of the curves are set to the average time from onset to time of treatment (16 weeks for RESCUE, 39 weeks for REVERSE). (Photo: Business Wire)

GenSight Biologics (Paris:SIGHT) (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today reported results from the REALITY registry study and an analysis of REVERSE and RESCUE Phase III data, which further highlight the poor prognosis for patients with loss of vision due to Leber Hereditary Optic Neuropathy (LHON) associated with the ND4 mutation. The results confirm LHON experts observations from their clinical practice and contrast sharply against the bilateral improvement observed in LUMEVOQ (GS010)s Phase III studies.

Natural history studies in LHON have been difficult to conduct, so these results add to the body of knowledge and firm up the conventional wisdom that with rare exceptions, LHON is marked by precipitous loss of vision with little chance of improvement in the first few years, commented Mark Moster, MD, Neuro-Ophthalmology, Wills Eye Hospital and Professor of Neurology and Ophthalmology at Thomas Jefferson University, Philadelphia, United-States, and investigator in the REVERSE and RESCUE trials. The lack of improvement in the REALITY subjects is in stark contrast to the improvements seen in our REVERSE and RESCUE patients.

REALITY is a retrospective and cross-sectional observational study of subjects with LHON, conducted in centers across Spain, Italy, France, United Kingdom, and the United States. The objective is to generate insights about the natural history of the disease based on an approach that would facilitate comparisons with REVERSE and RESCUE. The study seeks to enroll 50 subjects by the second quarter of 2020.

Interim analysis of REALITY, based on the fifteen subjects with the ND4 mutation who were at least 15 years old at onset and who had enrolled in the study as of September 2019, shows the dramatic and usually irreversible decline in visual acuity that is the typical outcome for ND4 LHON patients. Unlike in subjects enrolled in REVERSE and RESCUE, who all received a unilateral injection of LUMEVOQ, mean visual acuity in REALITY subjects did not recover after the initial decline.

These findings highlight just how remarkable the visual trends in REVERSE and RESCUE are, commented Bernard Gilly, Co-founder and Chief Executive Officer of GenSight. The findings will support our effort to provide regulatory authorities with the most robust insights about the natural history of the disease, so that we can convincingly demonstrate the therapeutic benefit delivered by LUMEVOQ.

A second set of results, derived from a pooled dataset of baseline readings from the REVERSE and RESCUE patient populations, shows that eyes farther along the progression of the disease, as measured by time since onset, had worse visual acuity.

The picture of visual decline is based on cross-sectional data, yet remains consistent with the pattern revealed by the interim analysis for REALITY.

About GenSight Biologics

GenSight Biologics S.A. is a clinical-stage biopharma company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics lead product candidate, GS010, is in Phase III trials in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. Using its gene therapy-based approach, GenSight Biologics product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery.

About LUMEVOQ (GS010)

LUMEVOQ (GS010) targets Leber Hereditary Optic Neuropathy (LHON) by leveraging a mitochondrial targeting sequence (MTS) proprietary technology platform, arising from research conducted at the Institut de la Vision in Paris, which, when associated with the gene of interest, allows the platform to specifically address defects inside the mitochondria using an AAV vector (Adeno-Associated Virus). The gene of interest is transferred into the cell to be expressed and produces the functional protein, which will then be shuttled to the mitochondria through specific nucleotidic sequences in order to restore the missing or deficient mitochondrial function. LUMEVOQ was accepted as the invented name for GS010 (lenadogene nolparvovec) by the European Medicines Agency (EMA) in October 2018.

About Leber Hereditary Optic Neuropathy (LHON)

Leber Hereditary Optic Neuropathy (LHON) is a rare maternally inherited mitochondrial genetic disease, characterized by the degeneration of retinal ganglion cells that results in brutal and irreversible vision loss that can lead to legal blindness, and mainly affects adolescents and young adults. LHON is associated with painless, sudden loss of central vision in the 1st eye, with the 2nd eye sequentially impaired. It is a symmetric disease with poor functional visual recovery. 97% of patients have bilateral involvement at less than one year of onset of vision loss, and in 25% of cases, vision loss occurs in both eyes simultaneously. The estimated incidence of LHON is approximately 1,400 to 1,500 new patients who lose their sight every year in the United States and Europe.

About RESCUE and REVERSE

RESCUE and REVERSE are two separate randomized, double-masked, sham-controlled Phase III trials designed to evaluate the efficacy of a single intravitreal injection of GS010 (rAAV2/2-ND4) in subjects affected by LHON due to the G11778A mutation in the mitochondrial ND4 gene.

The primary endpoint will measure the difference in efficacy of GS010 in treated eyes compared to sham-treated eyes based on BestCorrected Visual Acuity (BCVA), as measured with the ETDRS at 48 weeks post-injection. The patients LogMAR (Logarithm of the Minimal Angle of Resolution) scores, which are derived from the number of letters patients read on the ETDRS chart, will be used for statistical purposes. Both trials have been adequately powered to evaluate a clinically relevant difference of at least 15 ETDRS letters between treated and untreated eyes adjusted to baseline.

The secondary endpoints will involve the application of the primary analysis to bestseeing eyes that received GS010 compared to those receiving sham, and to worseseeing eyes that received GS010 compared to those that received sham. Additionally, a categorical evaluation with a responder analysis will be evaluated, including the proportion of patients who maintain vision (< ETDRS 15L loss), the proportion of patients who gain 15 ETDRS letters from baseline and the proportion of patients with Snellen acuity of >20/200. Complementary vision metrics will include automated visual fields, optical coherence tomography, and color and contrast sensitivity, in addition to quality of life scales, biodissemination and the time course of immune response. Readouts for these endpoints are at 48, 72 and 96 weeks after injection.

The trials are conducted in parallel, in 37 subjects for REVERSE and 39 subjects for RESCUE, in 7 centers across the United States, the UK, France, Germany and Italy. Week 96 results were reported in 2019 for both trials, after which patients were transferred to a long-term follow-up study that will last for three years.

ClinicalTrials.gov Identifiers: REVERSE: NCT02652780RESCUE: NCT02652767

About REFLECT

REFLECT is a multi-center, randomized, double-masked, placebo-controlled study to evaluate the safety and efficacy of bilateral injections of GS010 in subjects with LHON due to the NADH dehydrogenase 4 (ND4) mutation.

The trial planned to enroll 90 patients with vision loss up to 1 year in duration and will be conducted in multiple centers in Europe and in the US.

In the active arm, GS010 will be administered as a single intravitreal injection to both eyes of each subject. In the placebo arm, GS010 will be administered as a single intravitreal injection to the first affected eye, while the fellow eye will receive a placebo injection.

The primary endpoint for the REFLECT trial is the BCVA reported in LogMAR at 1.5-Year post-treatment in the secondaffected/notyetaffected eye. The change from baseline in secondaffected/notyetaffected eyes receiving GS010 and placebo will be the primary response of interest. The secondary efficacy endpoints include: BCVA reported in LogMAR at 2-Years post-treatment in the secondaffected/notyetaffected eye compared to both placebo and the firstaffected eye receiving GS010, OCT and contrast sensitivity and quality of life scales. The first subject was treated in March 2018, and enrolment was completed in July 2019, ahead of schedule.

ClinicalTrials.gov Identifiers: REFLECT: NCT03293524

About REALITY

REALITY is a multi-country retrospective and cross-sectional observational study of affected LHON subjects, based on subjects medical charts and the administration of surveys on Health-Related Quality of Life (HRQoL) and direct and indirect costs associated with the disease.

The study will recruit at least 50 subjects (both adult and pediatric) chiefly in the following countries: Spain, Italy, France, United Kingdom, and the United States.

The primary objectives for the REALITY study are: to describe the evolution of visual functional and structural changes and other associated symptoms in patients with LHON; understand the impact of LHON-related vision loss on the HRQoL; and understand the economic burden for patients and their families arising from direct and indirect costs associated with the disease. The secondary objective is to describe the relationship between genetic, lifestyle and/or environmental factors and the expression of the LHON phenotype.

The first subject was enrolled on 3 January 2018, and enrollment is targeted to be completed in early Q2 2020.

ClinicalTrials.gov Identifiers: REALITY LHON Registry: NCT03295071

View source version on businesswire.com: https://www.businesswire.com/news/home/20191210006078/en/

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GenSight Biologics reports findings from REALITY study and REVERSE-RESCUE analysis highlighting positive benefits from LUMEVOQ (GS010) compared to...

A SCOTTISH Santa Claus has amazingly had his vision saved - after discovering he couldn't read names of children on his list anymore.

Veteran Father Christmas James Marshall couldn't believe he wasn't on the nice list after discovering he was struggling to see the names of the kids visiting his grotto.

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The 55-year-old from Bellshill, Lanarkshire, has been warming the hearts of many for the past ten years by attending events across Scotland as Santa and raising money for charity.

But he was stunned when he was diagnosed with Glaucoma after he decided to pay the opticians a visit - which could've resulted in him losing his sight.

The Scot booked his Specsavers appointment after thinking he would need a new pair of glasses because of his struggles to carry out his Santa duties.

It was during the visit, that optometrist director Douglas Waugh spotted something unusual during Mr Marshalls sight test and referred him to University Hospital Wishaw where he was diagnosed with an advanced form of Glaucoma in both eyes.

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James said: "The whole situation was a shock to the system. Ive worn glasses for more than 30 years but I had no idea there was anything really problematic with my sight.

"I suffered a stroke when I was 32 so whenever Ive experienced a blind spot, Id always put it down to that. There wasnt any symptoms or pain, just an occasional blurriness.

"I only began to notice it more when trying to read the names of children aloud during one of my grotto visits.

"I even remember asking one of my elves to help out at one point so just thought I needed to get a new pair of glasses.

"However, the visit to Specsavers and the test carried out by Douglas just showed me how much sight I had lost due to the condition."

The condition also impacted James other job as a hospital catering manager which he was unable to continue working at due to the potential hazards caused by his reduced sight.

He added: "The whole experience was life-changing and the damage done to my eyes was irreversible.

"I need to regularly take eye drops to prevent the glaucoma from getting any worse and need to visit the hospital so they can monitor the condition, but its a price Im willing to pay.

"Im incredibly grateful to the prompt and professional care I received from the team at Specsavers, things could have been monumentally worse.

"If the condition hadnt been spotted, theres a chance I would have lost sight in both of my eyes."

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In the spirit of the Christmas season, James is now hoping to share his story and give others an opportunity to get their eyes checked to check vision and other health conditions.

Often symptomless in its early stages, glaucoma is one of the leading causes of irreversible sight loss.

Mr Waugh, Store director in Specsavers Bellshill, said: "Jamess case, although rare, is an example of just how vital it is to go for a regular eye test.

"We recommend getting your eyes checked every two years as they can detect various health conditions, not just changes in prescription.

"We are very glad to hear that Jamess is doing well and were thrilled to have invited him along to our big Christmas light switch on to truly make our towns Christmas feel magical."

We pay for your stories and videos! Do you have a story or video for The Scottish Sun? Email us atscoop@thesun.co.ukor call0141 420 5300

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Bellshill Santa has his eyesight saved after struggling to read kids names on his list - The Scottish Sun

Liz Bonnin natural history, science and environmental TV presenter has announced Specsavers Carlows investment in hospital-quality equipment that can help detect treatable eye conditions sooner.

Specsavers Carlow has rolled out theOptical Coherence Tomography (OCT) scanner in store - acutting-edgepiece of equipment that allows opticians to view the eye in more detail than ever before.

It is all part of its commitment to providing its customers with access to the very latest optical technology, helping to detect a number of eye conditions, such as age-related macular degeneration and diabetic retinopathy, sooner.

OCT can also help to detect glaucoma up to four years in advance.

Given that nearly half of all sight loss is preventable, an OCT scanmeans conditions can be managed before they get worse and can help prevent potential sight loss.

An OCT scan, which only takes a few seconds, uses light to take more than 1,000 images of the back of your eye and beyond, looking right back to the optic nerve and creating a cross-section view.

Imagine it like a cake you can see the top of the cake and the icing, but the image produced from an OCT scan slices the cake in half and turns it on its side, so you can see all the layers inside.

It gives your optician an incredibly accurate picture of your eye and its structures.

Speaking at the launch of the OCT campaign, Liz said: "I am short sighted and have always relied on regular eye checks, so I was keen to help raise awareness about their importance, especially as early detection is vital in the fight against preventable sight loss.

"The OCT scan can detect eye health conditions before physical symptoms are presented.

"Specsavers Carlow is leading the way in terms of the advanced technology on offer in store. An OCT scan would have previously required a hospital visit, but now there really is no excuse to not keep on top of our eye health."

Speaking about the state-of-the-art optical technology, store director at Specsavers Carlow, Mary McGinley, said: "This innovative technology gives our opticians the ability to enhance the offering for customersby identifying and helping to detect or manage conditions.

"OCT technology produces such a detailed picture of the structures in the eye that it allows us to identify signs of diseases years earlier than traditional methods.

"Given that 75% of vision impairment and blindness can be prevented, the sooner we can detect these conditions, the sooner we can help manage them or refer people for treatment."

The scan is in addition to a thorough eye test, during which the optometrist uses a range of clinical tests and procedures to measure the quality of someones vision and the health of their eyes.

A customers OCT images are stored on file, so Specsavers optometrists can note any changes over time a real benefit when monitoring someones overall eye health.

OCT is now available in Specsavers Carlow. For more information on the services available or to make an appointment, please visitwww.specsavers.ie/stores/carlow

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Specsavers Carlow taking a deeper look into your eyes with new state-of-the-art tech - Carlow Live

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LAWRENCE, Kan. -- University of Kansas sophomore piano performance major, Luther Fuller doesn't read music like most students, but he doesn't exactly play by ear either.

Instead he relies on memory and Braille to bring his music to life.

"I memorize it as I go," Fuller said. "I learn a few measures of right hand, then get the left hand for that. By the time I finished learning all the notes, I also have it memorized."

Fuller has Retinoschis. It's a genetic disorder that caused him to lose most of his vision at a young age.

"I have a tiny bit of light perception in my left eye. I have no usable vision. So pretty much my whole life, I have no memory of sight," Fuller said.

But Fuller said he doesn't need his sight when he sits down to tickle the ivories. His professor says his talent is amazing.

"He has to just memorize the music right away. I think that's an extraordinary gift and something that's very special," Michael Kirkendoll said.

Fuller said he finds freedom through his music. It's been that way as long as he can remember.

"I needed help with a lot of things. so I liked being able to improvise on that toy piano at first. Then this spinet that we got, being able to improvise on there and do it unassisted, it brought me joy," Fuller said.

Fuller relies on that freedom to get him where he wants to go.

"I think that people, when they first see Luther play or talk to Luther, the first thing that strikes them is that he's a blind pianist," Kirkendoll said. "I think of him first as a pianist, and then he also just happens to be blind,"

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Ever since becoming a part of the Marvel Cinematic Universe in 2o11, Thor has had a rough go of it. Over his MCU history, he's lost both of his parents before his very eyes, along with his adopted brother, his lifelong home andto add insult to injuryhis right eye. That's a lot to endure over the course of seven years for someone who lives for millennia. And while Thor may have gotten a replacement eye in Avengers: Infinity War, with his luck, he is liable to lose it again in Thor: Love and Thunder.

Here's a quick look how Thor lost and gained an eye over the course of two films, how he may lose it again and how it compares to recent developments in the comic books.

RELATED:Wonder Woman & Superman Just Appeared in the Marvel Universe... as Thors?

Thor: Ragnarok had the Asgardians lose heavily right from the outset, with tragedy befalling them steadily throughout the film. Odin's death frees his secret daughter Hela, the Norse Goddess of Death, who immediately lays waste to Asgard, completely decimating its armies and killing the Warriors Three. After a brief period of exile on the faraway world of Sakaar, Thor returns to reclaim his throne from his evil sister, with Loki, Bruce Banner and Valkyrie in tow.

As the others assisted in rescuing the refugees hiding on the outskirts of Asgard from Hela and her undead army, Thor battled his long-lost sister in the Asgardian throne room. Despite putting up a valiant effort, Hela slashed out Thor's right eye, fulfillinghis arc in the movie and completing his transformation into the more mature king his father once needed him to be. Help is shortlydefeated, along with Asgard's prophesied destruction at the hands of Surtur. As Thor led his people into an uncertain future, he was seen wearing an eyepatch similar to his father.

RELATED: Thor's Eyepatch is CGI in Avengers: Infinity War

The Asgardians were the first casualties seen in Avengers: Infinity War, their ship laid waste as Thanos and the Black Order recovered the Tesseract secretly kept by Loki who was killed personally by Thanos. Responding to the ship's distress call after its destruction, the spacefaring team found Thor within the ship's wreckage and miraculously still alive. To replace Mjolnir, his mythical hammer destroyed by Hela during Ragnarok, Thor left for the dwarven forge of Nidavellir with Rocket and Groot.

RELATED:Thor: The Worthy #1 Is an Electric Dose of Thunderous Nostalgia

As the trio approach Nidavellir, located within the heart of a dying star, Rocket consoled Thor as he reflected over his recent losses. To raise his spirits, Rocket gave Thor a functioning, artificial eye he had stole from a hapless mark sometime earlier, heavily implying that he had smuggled the prosthetic in his anus. While Rocket cautioned Thor should wash the eye first, the God of Thunder instead promptly inserted it. He immediately regained his full sight through his new eyevisibly brown instead of natural blue.

The loss of Thor's eye has been hinted at in the comics in recentyears. Toward the start of Jason Aaron's acclaimed run on the character, a vision of the future incarnation of Thor is seen lacking his left eye. However, it was the recent crossover event War of the Realms that revealed what had actually occurred. The final issue of the series had Thor nailed to the World Tree Yggdrasil so he could gain the greatness of the All-Father. The fiery process proved excruciatingly painful itburned out his eye, but gave Thor the resolve he needed to defeat the villainous Malekith and take the Asgardian throne.

Thor may have regained his sight, but with Taika Waititi returning to helm Thor: Love and Thunder and the acclaimed filmmaker's proclaimed appreciation for Aaron's comic book run on the character, this may be fleeting. After all, the MCU Thor has been a hard-luck case since his debut and, even with Jane Foster back in tow, the Asgardian Avenger still stands to lose much.

KEEP READING: Avengers Just Introduced the Most Dangerous Version of Thor

Godzilla vs. Kong Footage Reveals King Kongs New Titan-Beating Height

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Avengers: How Thor Got His Eye Back (and Why He Might Lose It Again) - CBR - Comic Book Resources

Why James Chen is a man on mission to restore eyesight for all by 2035 | The Independent Independent Premium

The Hong-Kong businessman is using the wealth generated by his familys business for greater good. He tells Zlata Rodionovathat philanthropy is not about writing big cheques

Chen wants to sort the worlds eyesight out before humans are sent to Mars ( James Chen )

Futurist and inventor Elon Musk wants to send humans to Mars by the 2030s but James Chen has a no less ambitious mission:making sure the whole world can see the landing clearly when it happens.

For the past 15 years the philanthropist has been trying to tackle poor vision. According to Chen, the pace of innovation can be overwhelming when compared with the lack of progress in technology designed to tackle the most basic challenges still facing the developing world,from access to food and clean water to a simple pair of corrective glasses.

We really want to solve the vision issue before Nasa or Elon Musk put a man or a woman on Mars because we want everyone on Earth to be able to see it, he says.

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Charitable campaigns include everything from rescuing homeless dogs and planting trees to funding eye surgeries and donating tech skills.

WELL employees picked mandarin oranges for a food bank in Santa Barbara. Workers at Aadya bought Healthy Roots dolls for kids in Detroit from a startup toy company. Omintracs employees will place wreaths on the graves of military veterans on Wreaths Across America Day on Dec. 14.

Starting in November and stretching through this month, tech companies are marking the holiday season with donation drives, financial contributions, and volunteer projects.Salesforce has some of the biggest global ambitions to make a difference. At Dreamforce, Salesforce kicked off a Year of Action for the Sustainable Development Goals from the United Nations 17 global goals that measure collective progress against the world's biggest challenges.

Over the next year, Salesforce will donate $17 million to advance the SDGs through grants to its nonprofit partners and company matches to employee donations.

According to Deloitte, millennials, baby boomers, retirees, and Gen Xers want to support social impact work in the corporate sector, which could offer a competitive edge in hiring.

Tech companies can strengthen local communities and build a more loyal workforce by establishing meaningful social impact programs. Here are a few of the ways employees and executives are giving back this season.

Many companies stick with go-to holiday projects such as food and toy drives. Others find ways to support people and animals in need.

The cybersecurity company ReliaQuest sponsors Bike Build, an event that assembles bikes for foster kids in Tampa. The nonprofit onbikes holds the annual event to provide kids with their very first bike. ReliaQuest employees will help out at the event as well.

Sigstr employees are supporting a dog rescue group with the "Dogs First, Sigstr Second" campaign. Justin Keller, vice president of marketing for the email signature marketing platform, said that team members meet clients on a target account list, and the company makes a donation to rescue a homeless dog on the employee's behalf.

The software development company Chetu supported a tree-planting initiative in India last month. Team members volunteered with Mission 100 Crore Tree Plantation to add trees in a region that has poor air quality.

Chetu said its employees donated over 30 hours to the initiative last month and would continue to invest in this initiative in the future.

Many companies use their particular technical skillset to support causes.

DataRobot, an artificial intelligence company, has an AI for Good program that works with educational institutes, hospitals, and environmental nonprofits.

The company shares technology, time, and resources with the organizations to make sure their machine learning applications generate real, long-term value.

Legacybox will help families in Southern California preserve memories from the holidays and throughout the year by donating $100,000 in digitizing kits to residents in communities at risk of wildfires. Residents can get slides, films, and audio recordings converted to digital format as a download, on a zip drive, or a DVD.

Ada, a marketing automation firm, partnered with a tech-centric nonprofit to develop the Chalmers chatbot designed for Toronto's homeless community. This service provides 24/7 access to information about where to get free meals and clothing as well as open shelter space.

"At Ada, we're inspired by our namesake Ada Lovelace, whose legacy reminds us to challenge norms and bring new thinking to helping solving important social problems," said Ruth Zive, Ada's head of marketing.

The digital banking company Quontic is addressing homelessness in the Dominican Republic.

The company is sending a group of 35 employees to the island for four days to build two homes for two homeless families. Quontic CIO Patrick Sells said service project fits with the company's corporate mission to provide mortgages to low-income families and immigrants.

"This trip will also serve as a time to do team building and corporate strategy work but most importantly remind all of us the critical work we do everyday in our offices to help families like those we served on the trip," he said.

Volunteers from SE2 help with website maintenance for United Way of Greater Topeka Christmas Bureau, a nonprofit that connects donor families with people in need during the holiday season.

Back in 2011, SE2 built a responsive web application to tackle the administrative processes that the community adoptions required.

Today, the United Way leverages the web-based system to scan and index paper applications, capture adopter/adoptee data, match families and share information between all the involved parties.

SE2 employees make improvements to the system each year and donate volunteer time as well.

"This has been a great opportunity for us to support United Way Christmas Bureau over the last several years using our skills to simplify and automate the family adoption process," said Ambrish Patel, an enterprise architect at SE2.

Many companies match donations of time and money made by employees through the Pledge 1% initiative. Led by Salesforce, this initiative builds corporate philanthropy by asking companies to make annual donations of 1% of product, equity, profit, or time to charitable organizations.

The cloud communications platform Twilio is a Pledge 1% company. To date, 232 Twilio employees have donated to or volunteered for the Pledge 1% program, which has resulted in $56,333.00 in donations to 145 charities.

"Through our Pledge 1% initiative, we match employees' donations and volunteer time to nonprofits of their choice, and we add in an additional boost between November 18 to December 18," said Erin Reilly, the company's chief social impact officer.

Advertising tech company Media Math is also a member of the Pledge 1% movement. The company's philanthropic division focuses on the 13% of people living on less than $2 per day through a Campaigns Count project.

"For every 20 campaigns in our platform, MediaMath.org funds an eyesight-saving surgery for individuals who suffer from low vision or whose blindness is treatable," said Michael Quinn, founder and director of the company's philanthropic arm.

In September, the company reached a milestone: funding surgeries for 5,000 people in some of the poorest regions of the world.

Our editors highlight the TechRepublic articles, galleries, and videos that you absolutely cannot miss to stay current on the latest IT news, innovations, and tips. Fridays

Each December on National Wreaths Across America Day, Wreaths Across America coordinates wreath-laying ceremonies at Arlington National Cemetery, as well as at more than 1,600 additional locations in all 50 U.S. states, at sea, and abroad.

Image: Wreaths Across America

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Tech companies find creative ways to give back - TechRepublic

A method of machine learning has proven capable of turning 2D images into 3D models. Created by researchers at multi-million-dollar GPU manufacturer NVIDIA, the framework shows that it is possible to infer shape, texture, and light from a single image, in a similar way to the workings of the human eye.

Close your left eye as you look at this screen. Now close your right eye and open your left, writes NVIDIA PR specialistLauren Finkle on the company blog, youll notice that your field of vision shifts depending on which eye youre using. Thats because while we see in two dimensions, the images captured by your retinas are combined to provide depth and produce a sense of three-dimensionality.

Termeda differentiable interpolation-based renderer, or DIB-R, the NVIDIA rendering framework has the potential to aid, and accelerate various areas of 3D design and robotics, rendering 3D models in a matter of seconds.

Making 3D from 2D

As explained by Finkle, the 3D world we live in is actually seen through a 2D lens otherwise deemed stereoscopic vision. Depth is created in the brain by combining images seen through each eye, creating the sense of a 3D image.

Based on a similar principle, DIB-R is capable of transforming input from a 2D image into a map, predicting shape, color, texture and lighting of an image. This map is then used to shape a polygon sphere, creating a 3D model representing the object in the original 2D image.

To achieve high 3D modeling speeds, DIB-R must be trained first with a wide dataset of images. One of the tests the team has performed so far is with a series of bird photos. All of the photos areRGBA modeled. After two days of training the framework using a singleNVIDIA V100 GPU, it could produce a 3D object from a 2D image in less than 100 milliseconds. The results can be seen below.

Giving sight to autonomous robots

One of the potential applications of such a framework is in the development of autonomous robots, capable of understanding the environment around them and perceiving depth. Another application is in the creation of rapid 3D mockups based on 2D sketches, i.e. for architecture and product design.

For Jonathan Beck, founder of 3D art heritage projectScan the World, the process also has certain implications in photogrammetry a method commonly used for the rendering of real-world 3D objects into digital, 3D models. Ive seen something similar before made by independentdevelopers but this is the first time its been released by a big organization, Beck states. It would be interestingto see how this leads into photogrammetry, where an AI can assume parts of a missing sculpture from other images. Much like how the Artec 3D scanner can calculate the form of an object if there are gaps in the scan data.

AI can help create a bridge where 3D scanning cannot currently deliver.

More details of the NVIDIA project can be found in this dedicated microsite, and in the paper Learning to Predict 3D Objects with an Interpolation-based Differentiable Renderer. The research is conducted and authored byWenzheng Chen, Jun Gao, Huan Ling, Edward J. Smith, Jaakko Lehtinen, Alec Jacobson, and Sanja Fidler.

Subscribe to thefree 3D Printing Industry newsletterfor the latest researchdevelopments. You can also stay connected by following us onTwitterand liking us onFacebook.

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Featured image shows3D models of cars created from 2D source images. Image via NVIDIA

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NVIDIA proposes way of teaching robots depth perception, and how to turn 2D images into 3D models - 3D Printing Industry

WASHINGTON, D.C., Dec. 11, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- The Alliance for Regenerative Medicine (ARM), the international advocacy organization representing the cell and gene therapy and broader regenerative medicine sector, announced its 2020 Cell & Gene Therapies State of the Industry briefing will take place January 13, 2020 in San Francisco, held in conjunction with Biotech Showcase 2020.

ARMs State of the Industry briefing is the largest cell and gene therapy-focused annual event taking place during the week of the 2020 J.P. Morgan Healthcare Conference. The briefing is expected to attract more than 500 of the fields leading executives, investors, life science media, patient advocates, and academic leaders.

This briefing offers a comprehensive industry overview, including insights into key sector trends and metrics, the financial and partnering outlook, recent advances, the clinical pipeline and potential product approvals, commercialization challenges, and a preview of the coming year.

Preliminary Agenda:

8:00 8:20am | Introduction & Industry UpdateJanet Lambert,CEO, Alliance for Regenerative Medicine

8:20am 9:05am | Emerging Cell Therapies for CancerPascal Touchon,CEO, Atara BiotherapeuticsMatthew Kane,Co-Founder and CEO, Precision BioSciencesSamarth Kulkarni,CEO, CRISPR Therapeutics

9:05am 9:50am | Next Generation Gene and Cell TechnologiesShelia Mikhail,CEO, AskBioLaurence Cooper,CEO, ZiopharmTimothy Miller,Co-Founder, President, & Chief Scientific Officer, Abeona Therapeutics

Registration is complimentary and open to the public; however,RSVP is required. The event will be broadcast live via streaming webcast,available on ARMs website.

The briefing will take place at the Parc 55 Hilton, 55 Cyril Magnin Street in San Francisco, California from 8:00 9:50am and is held in conjunction with Biotech Showcase, organized by EBD Group and Demy Colton. Please note that attendance at this briefing is separate from registering to attend the Biotech Showcase conference, which requires paid registration.

About The Alliance for Regenerative MedicineThe Alliance for Regenerative Medicine (ARM) is an international multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine worldwide. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, D.C. to specifically represent the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. Today, ARM has more than 350 members and is the leading global advocacy organization in this field. To learn more about ARM or to become a member, visithttp://www.alliancerm.org.

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The Alliance for Regenerative Medicine Announces 2020 Cell & Gene Therapies State of the Industry Briefing - GlobeNewswire

When embryonic Stem Cell therapy was first discovered in 1998, it changed the face of medicine. The idea of being able to regenerate and replace damaged cells seemed futuristic at the time, yet today such treatments are commonplace. Now, science has taken another quantum leap this time into the nano-sized world of exosomes, tiny bubbles that grow out of cell walls and contain much of the information contained within the cell including Growth factors, microRNA and messenger RNA. Mesenchymal stem cell (MSC) exosome therapy is currently one of the hottest trends in regenerative medicine, one that patients at AM Medical in Yelm can now experience.

Everyone has heard of stem cell therapy, but it turns out that its not the stem cells that are doing the work, says Dr. Ana Mihalcea, President of AM Medical. Its the exosomes that carry the information of regeneration. Infused stem cells, attach to blood vessel walls, and then give off exosomes.

Exosomes have several key differences from stem cells; they do not get removed from the circulation like stem cells, which are in the body for less than 72 hours before they get destroyed by the immune system; they do not produce a rejection reaction because they are not a cell and contain no DNA, and they pass the blood brain barrier, Mihalcea notes. In a study on stroke scientists fluorescently tagged exosomes, and the infused exosomes went exactly to the region where the stroke had occurred, she adds. The same was not true of stem cells as they do not cross the blood brain barrier.

As a result of their powerful cargo, exosomes can be used to address a multitude of conditions, including arthritis, autoimmune disorders, cardiovascular and neurogenerative diseases like Parkinsons and Alzheimers. Old cells can be reprogrammed by MSC exosomes as the target cells can transcribe the microRNA into functional proteins. Just like a virus, the exosome information of the young stem cells can infect the old cells with Youth, explains Mihalcea.

Spinal cord injuries are an area in which exosomes have produced dramatic results. Mihalcea cites the example of Dr. Douglas J. Spiels Interventional Pain Specialty Practice in NJ. Dr. Spiel has been able to rehabilitate spinal cord injuries with Exosome infusions into the spine and intravenously, she says. After several weeks, hes had patients regain muscle strength and sensation. These are prolonged, ongoing regenerative effects that continued to improve for months after the infusion.

When it comes to autoimmune diseases, inflammation plays a key role. Again, exosomes are able to reduce the problem by downregulating inflammation. TGF Beta 3 [Transforming growth factor beta-3] is the most important anti-inflammatory protein in the body and is abundant in MSC exosomes says Mihalcea. Many more Growth factors for blood vessel growth, neuronal and other tissue growth are present, allowing regenerative effects in all organ systems including skin wounds and burns.

The exosomes at AM Medical come from a laboratory in Florida that conducted pioneering research in the field. They come from perinatal mesenchymal stem cells and are scanned for any possible viruses to ensure their safety. Once harvested, the exosomes are concentrated so they can be infused in large doses.

For patients who qualify, the infusion process takes 10 to 15 minutes. Already, its been producing results for AM Medical patients. Weve had people with arthritis and chronic pain who had great responses, Mihalcea notes. There is an overall increase in wellbeing and sense of rejuvenation that is definitely noticeable.

Perhaps one of the largest sources of excitement over exosomes has to do with their anti-aging effects. Recently, ideas about the root causes of aging have been evolving, according to Mihalcea. Its been thought that aging occurs due to multiple different reasons like stem cell exhaustion, epigenetic changes, telomere shortening and others, she explains. It turns out that exosomes can modify almost all the hallmarks of aging. Theyre changing epigenetic expression to youthful function, and there are many potential applications. This is a new frontier in regenerative medicine that can help many people.

Learn more by watching Dr. Ana Mihalceas video on Exosomes The New Frontier Part 1: Longevity and Age reversal or reading further on the AM Medical website.

Sponsored

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Cutting Edge Exosome Regenerative Therapy Comes to Yelm's AM Medical - ThurstonTalk

WASHINGTON, Dec. 10, 2019 /PRNewswire/ -- A new report released by the independent, non-profit Alliance for Cell Therapy Now, highlights the need for a national effort to measure outcomes related to regenerative cell therapies, as well as increased federal funding for research at the National Institutes for Health (NIH) and expanded capacity at the Food and Drug Administration (FDA) to support this rapidly growing field. The report is based on insights shared by several leaders during a September 2019 event on Capitol Hill hosted by Alliance for Cell Therapy Now in collaboration with the Regenerative Medicine Foundation and the Cord Blood Association.

Regenerative cell therapies represent the next generation of treatments that are showing great promise in cardiology, neurology, oncology, orthopedics, osteoarthritis, and wound healing. Several well-designed clinical trials are now being conducted under FDA-approved investigational new drug protocols. At the same time, some clinics have caused patient harm or made questionable claims, taking advantage of vulnerable patients and casting a negative light on this promising field.

The 21st Century Cures Act contained several provisions to make safe and effective regenerative cellular therapies available to patients, and the FDA and the NIH have taken several steps to advance and support the field. However, additional actions are needed to help bring safe and effective therapies to patients.

Leaders representing FDA, NIH, the Duke University School of Medicine and Cord Blood Association, the Georgia Institute of Technology, the Marcus Foundation, the Regenerative Medicine Foundation, Sanford Health, the Wake Forest Institute of Regenerative Medicine, and Alliance for Cell Therapy Now, participated in the event.

To read the entire report, go to http://allianceforcelltherapynow.org/wp-content/uploads/2019/12/Regenerative-Cell-Therapies-Alliance-for-Cell-Therapy-Capitol-Hill-Briefing-Sept-2019-1.pdf

To view speaker slides and a webcast of the event, visit http://allianceforcelltherapynow.org/events/.

SOURCE Alliance for Cell Therapy Now

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New Report Calls for Measurement of Outcomes and Federal Funding for Research and Increased Capacity at FDA to Advance Safe and Effective Regenerative...

Based on promising results in an early clinical trial, Mayo Clinic has formed a new joint venture with materials engineering firm W.L. Gore & Associates to spearhead a new therapy using stem cells to repair a painful tissue problem stemming from Crohn's disease.

Mayo and Gore on Tuesday announced the formation of a for-profit company called Avobis Bio ("a vobis" is Latin for "by you"), based in Delaware, where Gore is also based. The privately held company will draw on the expertise of scientists at Mayo and Gore to launch a second-phase clinical trial in the hopes of eventually offering the treatment commercially.

A laboratory director at Mayo Clinic said Avobis Bio's therapy, if successful, may be a first-of-its-kind in health care, involving the delivery of a person's own mesenchymal stem cells on a synthetic "scaffold" that biodegrades over time, eventually leaving behind only native tissue sealing a wound. The first application of the technology is treatment of a health problem called perianal fistulae. But if successful, Avobis Bio may one day offer a variety of tissue and organ-repair therapies combining Mayo's stem cell expertise and Gore's medical materials.

"This is a completely new approach, where we are trying to leverage what the body can do for itself," said Allan Dietz, co-director of the Human Cell Therapy Lab in Mayo's Center for Regenerative Medicine.

Mesenchymal stem cells can naturally convert into other kinds of tissue, like muscle or bone. For the Avobis Bio therapy, the cells are harvested from a biopsy of a person's body fat and cultivated at a Mayo laboratory to high purity. No one knows whether the cells deposited into the wound directly convert into scar tissue, or if the stem cells trigger genetic signals that cause other cells in the surrounding tissue to begin the healing process.

"We provide stem cells in the right frame, at the right time, for the body to recognize the signals that it should begin the healing process," Dietz said. "I think in some ways, it was a required simple first step but it appears to be a major step."

Gore is perhaps best known to the public for its Gore-Tex outerwear, but the privately held $3.7 billion engineering and manufacturing firm sells products in an array of industries, including a line of medical devices designed to repair nonnatural holes in body organs. Mayo has used Gore-made devices for many years.

Several years ago, physician-researchers at the not-for-profit Mayo Clinic in Rochester grew keenly interested in a Gore device called the Bio-A Fistula Plug, a flexible bioabsorbable plug made from a material similar to dissolving stitches.

The plug can be used to repair unnatural canals that form between a person's anal canal and their outer skin, after Crohn's disease weakens surrounding tissues. These canals, also known as perianal fistulae, are painful, disruptive and difficult to treat, doctors said. For patients with Crohn's disease, lifetime incidence of perianal fistulae ranges between 23% and 38%, according to past studies.

In 2017, Mayo announced first-in-human results of their experimental therapy treating Crohn's patients' perianal fistulae using a Gore Bio-A Fistula Plug coated with the patient's own stem cells. The study, run in consultation with the Food and Drug Administration, provided the open-label treatment to a small group of patients whose fistulae had not responded to treatment for a median time of six years.

After initial results proved encouraging, the trial eventually enrolled 20 people. Of the 19 who remained in the trial for at least a year, 76% experienced healing of their fistulae, according to results announced by researchers but not yet published in a journal. If validated in a larger clinical trial, that rate of healing would be dramatically better than outcomes under existing treatments, the companies said.

"We have done work in the past looking at combining cells and materials. For us, the clinical trial results from Mayo were incredibly compelling," said Tiffany Brown, a Gore employee and general manager of Avobis Bio. "It is a challenge to translate how cells behave in the lab to how they will behave in patients. So having that proof in real patients really got the conversation going on how we could work together."

If the therapy is proved safe and effective in larger trials, Brown said about 50,000 Crohn's patients per year could be eligible to get it for perianal fistulae. Although Gore is phasing out general sales of its Bio-A Fistula Plug, the device will be supplied exclusively to Avobis Bio.

Mayo and Gore declined to reveal financial details for Avobis Bio, except to note that both parties are contributing to the limited-liability joint venture. The company has a five-member board of managers, with Mayo appointing two members and Gore appointing three.

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Mayo Clinic, maker of Gore-Tex outerwear are teaming up in Crohn's fight - Minneapolis Star Tribune

(Reuters) - Privately held drug developer Enzyvant said on Thursday the U.S. Food and Drug Administration declined to approve its regenerative tissue therapy for a rare immunodeficiency disorder and raised concerns about its manufacturing.

The company was hoping to win its first approval for the therapy, RVT-802, aimed at treating congenital athymia, a disorder affecting babies born without a small gland called thymus, which produces T-cells needed to regulate the immune system.

The health regulator in a letter to Enzyvant raised questions about the manufacturing process for the treatment as well other issues based on its inspection of the manufacturing site, the company said.

Many of these are topics that we are very aware of and we anticipated those to be post-marketing commitments, not approval requirements, Chief Executive Officer Rachelle Jacques told Reuters on a phone call.

The good news is theres no requirement for us to foresee any additional animal studies or any additional clinical trials.

The company said it had planned to manufacture its treatment through a third-party manufacturer.

If approved, RVT-802 would have been the first to win an FDA nod under the agencys Regenerative Medicine Advanced Therapy (RMAT) designation, granted to drug developers making regenerative therapies for conditions lacking treatment options.

Babies born with congenital athymia - about 17 to 24 cases in the United States every year - usually do not survive beyond the age of two.

RVT-802 is a tissue-based therapy, manufactured by sourcing thymus tissue from infants undergoing heart surgeries unrelated to congenital athymia, and administered only once.

Ten clinical studies spanning over two decades and 85 patients were conducted at North Carolinas Duke University, where the treatment was developed.

Enzyvant is currently owned and entirely funded by Swiss drug developer Roivant, but will become here a subsidiary of Japan-based Sumitomo Dainippon in a deal expected to close next year.

We would anticipate that the deal would close before we could fully address the issues in the (FDA letter), Jacques said.

Reporting by Vishwadha Chander and Tamara Mathias; Editing by Maju Samuel and Shinjini Ganguli

Original post:
FDA declines to approve Enzyvant regenerative therapy on manufacturing concerns - Reuters

Circularity Healthcare, LLC Joins Forces with "Behind The Scenes" with Host Laurence Fishburne

MIAMI (PRWEB) December 11, 2019

Circularity is partnering with Telly Award-Winning "Behind the Scenes" to provide regular, ongoing, high-quality content from leading experts in a variety of fields with an initial focus on microcirculation science, regenerative medicine, and advanced wound healing and related symptoms.

"Behind The Scenes with Host Laurence Fishburne" is a public television series that has won numerous awards and delivers precision idea-telling at its best. Circularity is an innovative healthcare organization that is health-bent on their trademarked slogan: "Improving Lives by Improving Blood Flow." Their coming together to bring forward the ideas of modern health science on a stellar entertainment platform can only make for riveting content going forward. Viewers will find themselves in a win-win situation.

Watching informative content via this stylized venue will leave viewers feeling quite satisfied with their television watching experience. It is time well spent and information precisely delivered.

A Little More About Circularity

Circularity is concerned with bringing the very best in healthcare innovation to the public. In so doing, they have manufactured a product called D'OXYVA. This product has a two-pronged approach to health. First, it can be quite effective in reducing the debilitative effects of many of the diseases that are affecting the world today, such as COPD, diabetes, and cardiovascular illnesses. Secondly, Circularity's D'OXYVA can be used in a preventative capacity to improve microcirculation. The concept of microcirculation has far-reaching implications in neurology, oncology, endocrinology, cardiovascular health, respiratory health, dermatology, diabetic wound healing or diabetic wound care and other major fields.

Circularity Healthcare, LLC is the power behind D'OXYVA. This noninvasive trans-dermal and circulatory health technology is just the first product to be offered. Circularity is invested in revolutionizing the healthcare space. They plan to do this by creating cutting edge medical products and procedures that are both patient and physician friendly while being effective in minimizing and eradicating diseases.

What "Behind The Scenes with Host Laurence Fishburne" Will Bring to the Table

Behind The Scenes has been an innovator in bringing information to the forefront in the public television space. The award-winning series features segments on the newest technologies, as well as fresh takes on existing entities, phenomenon, and natural occurrences. The show's website boasts that the television series "highlights the evolution of education, medicine, science, technology and industry through inspiring stories."

Aside from the Emmy-winning and Academy Award nominated actor Lawrence Fishburne as host, the program has an award-winning creative development team. Viewers walk away with a rich knowledge of the subject. Viewers may have known about this subject their whole lives, or it may be about something completely new. Viewers learn an evolving aspect of the topic which keeps the perspective fresh.

The dawning of a new age has appeared with this collaboration. Individuals who want to know more about what the health science field is bringing into our hospitals and doctors' offices will not be disappointed. In today's world, it is imperative that we are advocates for our own health.

Coming Soon: Miami ReLife's Dr. Steven Gelbard

The first series is with Dr. Steven Gelbard, a nationally-famed authority with his ReLife Miami Institute on stem cells. Dr. Gelbard presents D'OXYVA's Nobel Prize-winning science as a regenerative medicine. Dr. Gelbard is involving his direct contacts with top NFL players and other top sports celebrities in the monthly series, along with 2540 top neurosurgeons and other experts working under ReLife.

Consumers might imagine having the ability to receive D'OXYVA and other innovative treatments and non-invasive procedures for chronic wound care amid the luxury of a five-star hotel. Behind The Scenes guest, Dr. Gelbard, a Tufts School of Medicine educated neurosurgeon, makes it happen right now. Medicine has left the hospital building and has become the proactive choice of the health conscious. Viewers can all look forward to learning more about how to live a healthier and more informed lifestyle from this awe-inspiring episode.

According to Norbert Kiss, President and CEO of Circularity Healthcare, this collaboration is door busting. Mr. Kiss tells us, "[We] can offer unprecedented access to this amazing Emmy-winning show called Behind the Scenes with very competitive terms due to our strategic involvement. We welcome any expert."

Don't miss the evolution. It's being televised. Circularity and Behind The Scenes viewers can stay tuned for a mind-fortifying experience!

Circularity Values:

Circularity believes in a long-sought-after goal in health care; people should have access to one health application that solves most of their short and long term health issues without compromising other aspects of their health while doing this quickly, affordably, and without pain.

Circularity develops, manufactures and markets advanced technologies that significantly improve quality of life by improving some of the most essential physiological functions in the body.

About Behind The Scenes With Laurence Fishburne

Behind The Scenes is an award-winning program that highlights new stories and innovative concepts through groundbreaking short-form and long-form documentary presentation. The program, which is anchored by a veteran production team with decades of industry experience, is able to effectively communicate the most critical stories to a wide and diverse audience.

Behind The Scenes with Laurence Fishburne, has established an impressive and heralded career, amassing over one-hundred credits across the varied platforms of stage, television and film. He's well known for major for roles in such films as; John Wick 2, Fantastic 4 Rise of the Silver Surfer, Mission Impossible III, Mystic River, Boyz n the Hood, What's Love Got to Do With It, and Apocalypse Now. On the small screen, the award-winning and versatile actor played compelling roles in shows such as CSI: Crime Scene Investigation, CSI: Miami, CSI: New York and Hannibal. The Behind The Scenes Actor currently stars as Pops on the hit TV comedy Black-ish.

About Circularity Healthcare, LLC

Circularity Healthcare, LLC, located in Los Angeles, CA is a private biotech and medtech products and services company that designs, makes, markets, sells, distributes and licenses its own patented and patent pending technologies, such as its flagship non-invasive deoxyhemoglobin vasodilator product line, D'OXYVA. One of the main mechanisms underlying D'OXYVA's science received the Nobel Prize for Medicine in 2019. Circularity enters into exclusive agreements with manufacturers to launch products and with large and small clinics and hospitals in order to help them enhance their profits and credit profiles with a wide variety of advanced products and services. In addition, Circularity Healthcare assists in the financing of equipment, working capital and also patient financing at industry-leading terms and speed.

For more information, please visit http://www.circularityhealthcare.com, or doctors (Rx only) visit http://wound.doxyva.com and send your general inquiries via the Contact Us page. For specific inquiries contact Circularity Customer Care by phone toll free at 1-855-5DOXYVA or at 1-626-240-0956.

Forward-Looking Information

This press release may contain forward-looking information. This includes, or may be based upon, estimates, forecasts and statements as to management's expectations with respect to, among other things, the quality of the products of Circularity Healthcare, LLC, its resources, progress in development, demand, and market outlook for non-invasive transdermal delivery medical devices. Forward-looking information is based on the opinions and estimates of management at the date the information is given and is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those initially projected. These factors include the inherent risks involved in the launch of a new medical device, innovation and market acceptance uncertainties, fluctuating components and other advanced material prices, new federal or state governmental regulations, the possibility of project cost overruns or unanticipated costs and expenses, uncertainties relating to the availability and costs of financing needed in the future and other factors. The forward-looking information contained herein is given as of the date hereof and Circularity Healthcare, LLC assumes no responsibility to update or revise such information to reflect new events or circumstances, except as required by law. Circularity Healthcare, LLC makes no representations or warranties as to the accuracy or completeness of this press release and shall have no liability for any representations (expressed or implied) for any statement made herein, or for any omission from this press release.

For the original version on PRWeb visit: https://www.prweb.com/releases/innovative_collaboration_the_cutting_edge_of_medicine_goes_behind_the_scenes/prweb16783651.htm

Read the rest here:
Innovative Collaboration: The Cutting Edge of Medicine Goes - Benzinga