BREAKTHROUGH: Her vision was getting worse, then animal research made things clear – Speaking of Research

By Justin A. Varholick, Ph.D.

As we grow older theres an impending fear that we will slowly, but surely, begin to lose our vision. This slow loss of vision is clinically dubbed low vision and impacts more than 39 million Americans, costs $68 billion annually in direct health care costs, and is only growing in our population as baby boomers enter the at-risk age of 65 and older. Magnifiers can often be used to help people with acute issues of low vision, but are often inconvenient and frustrating. More serious issues of low vision such as cataracts, age-related macular degeneration, glaucoma, and diabetic retinopathy require advanced treatment and surgery. For example, cataracts can be improved or reversed by removing the cloudy lens and replacing it with an artificial one. Such surgeries are not always ideal, or convenient, and further contribute to the already hefty direct health care costs. But, a recent breakthrough by Japanese scientists, in correcting blurry vision, might reverse this bleak future.

Old cells can become new againOur story begins around the mid-20th century, in 1958. A young and aspiring scientist, named John Gurdon, was studying frogs at the University of Oxford in England. Not everyone thought Gurdon would end up actually becoming a scientist. In his early days his school master thought such a career was far-fetched for Gurdon. Indeed, he ranked last in his Biology class out of 250 students. Yet despite such poor grades, Gurdon found himself studying frogs at Oxford and earning a doctoral degree in Biology. And his studies would surprisingly lead to a breakthrough in vision, and likely many other issues in human health, like Parkinsons Disease, heart disease, and spinal cord injury.

At the time Gurdon was trying to test an age-old theory on cell development. Many scientists before him discovered that cells the smallest unit of life begin without a clear fate in the early stages of an embryo. Then as the cell develops, their fate becomes more clear. They become cells of the heart, of the brain, the kidneys, the stomach, the spinal cord, or the eyes. But they cannot go back to a time when they had no fate, or specialization. The cells can only develop in one direction, from no destiny, to a clear path, then to a mature adult cell; like one found in the heart. But you just cant take a heart cell and start the process over, maybe turning it into a brain cell.

In disagreement with this theory, Gurdon did a simple experiment. He knew that a tadpole has more adult cells than a frog egg. A tadpole has gills, a heart, eyes, etc., while a frog egg simply does not. So, he cut open the tadpole and removed a single cell from the intestine; an intestinal cell. He then cut open the intestinal cell and removed its nucleus; the seed of the cell carrying all the DNA. Very carefully, he did the same with the frog egg, and finally replaced the nucleus of the frog egg with the nucleus of the intestinal cell. According to the age-old theory, the intestinal nucleus should stop normal development of the frog egg. But thats not what happened.

Instead, the new frog egg continued to develop normally, becoming a tadpole that later became an adult frog. Gurdon thought this was unbelievably odd, and so did everyone else in science. After many more experiments doing the exact same procedure (i.e., replication), it seemed that what he saw was a real, replicable fact. For some reason the nucleus of the intestinal cell was able to reverse itself to have no fate and slowly develop into any other adult cell. The seed from the intestine somehow could become the seed of a heart, brain, kidney, or even an eye cell and of course, an intestinal cell too.

After many more experiments testing the same theory, on many more animals, it seemed the theory was true, but it just didnt work for mammals. Given that the same effect could not be repeated in a mammal, some believed this discovery did not apply to humans. But they were wrong.

The discovery of induced pluripotent stem cellsAlmost 45 years later, around the start of the millennium, Shinya Yamanaka and Kazutoshi Takahashi began running experiments that would translate Gurdons findings to humans. Born after Gurdons findings were already published and well known, Yamanaka and Takahashi grew up in a world in which the fact that old cells can become new again was widely knowna solid foundation for further hypotheses, experiments, and discovery. So, the scientists set out to do what no one had before: turn adult skin cells of mice into new cells without a clear fate.

Yamanaka, the lead investigator of the study, shared a similar early history with Gurdon. He first became a medical doctor in Japan but was frustrated by his inability to quickly remove small human tumors taking over an hour rather than the typical 10 minutes. Senior doctors gave him the nickname Jamanaka, a Japanese pun for the word jama meaning obstacle. He then found himself earning a PhD in pharmacology and becoming a post-doctoral scientist, but spent more time caring for mice than doing actual research. Frustrated again, his wife suggested he just become a practicing physician. Despite her advice, Yamanaka applied to become an Assistant Professor at Nara Institute of Science and Technology, in Japan, and won everyone over with his fantastical ideas of investigating embryonic stem cells; the cells without a clear fate.

Then the persistence paid off when Yamanaka with his assistant, Takahashi discovered how to induce adult skin cells from mice to return to an embryonic, or stem cell, state without a clear fate. They began their experiments knowing that gene transcription factors proteins that turn genes on and off were responsible for keeping embryonic cells in a state without a clear fate. They thought that by turning specific genes on and off with these factors, they could turn back time and make an adult cell embryonic again. So, they tried many different combinations of gene transcription factors and ultimately discovered that 4 specific ones were enough to induce an adult skin cell to a mouse to become an embryonic cell. Because these re-newed embryonic cells, or stem cells, originally came from adult cells they came up with a new name, induced pluripotent stem cell. Broken down, induced pluripotent stem cells means that the cell was induced to become pluripotent pluri meaning several, like plural, and potent meaning very powerful (and stem meaning to have the ability to turn into any cell in the body).

These induced pluripotent cells were thought to be very powerful indeed and scientists across the globe were excited by this great discovery. They had visions of taking a persons skin or blood, forming them into induced pluripotent cells, and then using them to grow a new liver or new parts of the brain. Laboratories across the world confirmed the results by repeating the experiment.

Human stem cells Just repeating the experiments in mice, or frogs, was not enough. They needed to begin making induced pluripotent stem cells from humans. Enter scientists from the University of Wisconsin-Madison. The lead scientist, James Thomson was already well known for deriving primate embryonic cells from rhesus monkeys in 1995 and the first human embryonic cell line in 1998. In fact, Thomsons accomplishment of isolating embryonic cells from monkeys was the first sound evidence that it was possible to do the same for humans. Such discoveries placed him on the forefront in ethical considerations for research using human embryos and the most obvious scientist to lead the path toward making induced pluripotent stem cells from humans.

Thomsons team made the first human derived induced pluripotent stem cells from adult skin, with Yamanaka as a co-scientist. They followed the same general principles set by Yamanaka, who did the procedure with mouse skin cells. Importantly to Thomson, this discovery helped to relieve some ethical controversy with using human embryos to make human stem cells. By being able to induce adult human skin to become pluripotent stem cells, much research on human stem cells could be done without human embryos albeit research with human embryos remains necessary.

Yet more important to the discussion at hand, the ability to induce human skin to become pluripotent stem cells placed us on the edge of a breakthrough. With some clinical trials in humans, the fantasy of growing a new liver, heart, or eye was more a reality than ever before.

The start of human trials In 2012, around the time both Gurdon and Yamanaka were presented with the Nobel Prize in Physiology and Medicine for their work leading to induced pluripotent stem cells, human clinical trials were beginning in Japan. The first clinical trial was for age-related macular degeneration, an eye condition leading to blindness. Unfortunately, this trial was quickly terminated when Yamanaka and his team identified small gene mutations in the transplanted induced pluripotent stem cells from the first patient. Although the procedure did cure the patient of macular degeneration, these small gene mutations worried the scientists because they could lead to tumor development.

But recently with the introduction of an inducible suicide gene that can signal cells with abnormal growth to die, human trials are starting up again. In October of 2018, Japanese scientists began trials with Parkinsons disease, a brain disease related to a shortage of neurons producing dopamine. Scientists took cells from the patients, made them into induced pluripotent stem cells, guided them to develop into dopamine producing cells, and then deposited them in the dopamine centers of the brain through surgery. The outcome is promising since similar procedures in monkeys have been successful.

Other trials in Japan have also started, including spinal cord injury and one for replacing the cornea of the eye. Early results replacing damaged corneas with induced pluripotent stem cells, thereby correcting blurry vision, were just announced at the end of August. Although it will take more patients and safety checks before all humans can get induced pluripotent cells to correct their damaged eyes, malfunctioning brains, or broken spinal cords, Takahashi the post-doctoral scientist working with Yamanaka thinks it might happen as early as 2023. So, it looks like that in our lifetime we just might be able to stay young and enjoy retirement because of great breakthroughs in animal research.Note, EuroStemCell is a great resource for learning more about the ethics and research currently being done with stem cells derived from human embryos.

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BREAKTHROUGH: Her vision was getting worse, then animal research made things clear - Speaking of Research

Stem Cell Therapy Market To Increase Exponentially During 2018 2025 – Downey Magazine

Stem cells are most vital cells found in both humans and non-human animals. Stem cells are also known as centerpiece of regenerative medicine. Regenerative medicines have capability to grow new cells and replace damaged and dead cells. Stem cell is the precursors of all cells in the human body. It has the ability to replicate itself and repair and replace other damaged tissues in the human body. In addition, stem cell based therapies are used in the treatment of several chronic diseases such as cancer and blood disorders.

The globalstem cell therapy marketis categorized based on various modes of treatment and by therapeutic applications. The treatment segment is further sub-segmented into autologous stem cell therapy and allogeneic stem cell therapy. The application segment includes metabolic diseases, eye diseases, immune system diseases, musculoskeletal disorders, central nervous system disorders, cardiovascular diseases and wounds and injuries.

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Stem Cell Therapy Market, By Treatments:

Allogeneic Stem Cell TherapyAutologous Stem Cell Therapy

Stem Cell Therapy Market, By End Users:

HospitalsAmbulatory Surgical Centers

Stem Cell Therapy Market, By Application:

OncologyCentral Nervous System DiseasesEye DiseasesMusculoskeletal DiseasesWound & InjuriesMetabolic DisordersCardiovascular DisordersImmune System Disorders

Stem Cell Therapy Market, By Geography:

North AmericaEuropeAsia PacificMiddle East & AfricaLatin America

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In terms of geographic, North America dominates the global stem cell therapy market due to increased research activities on stem cells. The U.S. represents the largest market for stem cell therapy followed by Canada in North America. However, Asia is expected to show high growth rates in the next five years in global stem cell therapy market due to increasing population. In addition, increasing government support by providing funds is also supporting in growth of the stem cell therapy market in Asia. China and India are expected to be the fastest growing stem cell therapy markets in Asia.

Key Players in the Stem Cell Therapy Market are:

Chiesi Farmaceutici S.P.A Are:Gamida CellReNeuron Group, plcOsiris Therapeutics, Inc.Stem Cells, Inc.Vericel Corporation.Mesoblast, Ltd.

Full View of Report Analysis:http://www.marketgrowthanalysis.com/stem-cell-therapy-market

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Stem Cell Therapy Market To Increase Exponentially During 2018 2025 - Downey Magazine

Stem Cell Transplants Used to Grow Fully Functional Lungs in Mice – Technology Networks

Researchers at Columbia University were able to grow fully functional lungs in mouse embryos using transplanted stem cells. The findings suggest that it may be ultimately possible to use the technique to grow human lungs in animals for patients who need transplants and to study new lung treatments.

Millions of people worldwide who suffer from incurable lung diseases die without treatment due to the limited supply of donor lungs for transplantation, said co-senior author Wellington V. Cardoso, MD, PhD, professor of medicine and of genetics & development at Columbia University Vagelos College of Physicians and Surgeons. Our study shows that it may eventually be possible to develop new strategies for generating human lungs in animals for transplantation as an alternative to waiting for donor lungs.

Researchers have dedicated major efforts to bioengineer lungs by growing stem cells on synthetic scaffolds or in lungs that have been stripped of their original cells. Though substantial progress has been made, researchers have been unable to generate a fully functional lung capable of maintaining survival in animal models.

We thought it might be simpler to grow new lungs in a developing animal, so that we could take advantage of the animals natural signals for lung development, says first author Munemasa Mori, MD, PhD, instructor of medicine at Columbia University Vagelos College of Physicians and Surgeons.

The researchers first challenge was to create tissue culture conditions that would allow the donor stem cells to expand proliferate and maintain their ability to transform into many different cell types.

Next, the researchers implanted these stem cells in two types of engineered mouse embryos. One type lacked the stem cells that develop into mature lung cells and another could not produce enough of the cells to make a lung. This procedure created a chimeric embryo that was a mix of donor and host cells.

The implanted stem cells outcompeted the host cells for growth-promoting molecules present in the embryo, leading to the formation of functional lungs that allowed the mice to live well into adulthood. A variety of lung function tests confirmed that the chimeric lungs worked as well as normal mouse lungs, with no signs of rejection.

The stem cells were implanted before the embryos immunological system was turned on, which may explain why the organs were not rejected, says Mori, who will later test his approach in larger animals and in interspecies organ transplants.

Many of the signals for lung development are conserved across species, from frogs to mice to humans, so the idea of using animals to grow human lungs is not out of the question, Cardoso says.

The research was performed in collaboration with Hiromitsu Nakauchi, PhD, a professor at Stanford University School of Medicine and the University of Tokyo, a co-senior author of the paper.

Reference:Mori, M., Furuhashi, K., Danielsson, J. A., Hirata, Y., Kakiuchi, M., Lin, C.-S., Cardoso, W. V. (2019). Generation of functional lungs via conditional blastocyst complementation using pluripotent stem cells. Nature Medicine. https://doi.org/10.1038/s41591-019-0635-8

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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Stem Cell Transplants Used to Grow Fully Functional Lungs in Mice - Technology Networks

Human Heart Cells Transform in Space; Return to Normal on Earth: Study – The Weather Channel

Representational image

Heart cells are altered in space, but return to normal within 10 days on Earth, say researchers who examined cell-level cardiac function and gene expression in human heart cells cultured aboard the International Space Station (ISS) for 5.5 weeks.

Exposure to microgravity altered the expression of thousands of genes, but largely normal patterns of gene expression reappeared within 10 days after returning to Earth, according to the study published in the journal Stem Cell Reports.

"We're surprised about how quickly human heart muscle cells are able to adapt to the environment in which they are placed, including microgravity," said senior study author Joseph C. Wu from Stanford University.

These studies may not only provide insight into cellular mechanisms that could benefit astronaut health during long-duration spaceflight, but also potentially lay the foundation for new insights into improving heart health on Earth.

Past studies have shown that spaceflight induces physiological changes in cardiac function, including reduced heart rate, lowered arterial pressure, and increased cardiac output.

But to date, most cardiovascular microgravity physiology studies have been conducted either in non-human models or at tissue, organ, or systemic levels.

Relatively little is known about the role of microgravity in influencing human cardiac function at the cellular level.

To address this question, the research team studied human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs). They generated hiPSC lines from three individuals by reprogramming blood cells, and then differentiated them into heart cells.

Beating heart cells were then sent to the ISS aboard a SpaceX spacecraft as part of a commercial resupply service mission. Simultaneously, ground control heart cells were cultured on Earth for comparison purposes.

Upon return to Earth, space-flown heart cells showed normal structure and morphology. However, they did adapt by modifying their beating pattern and calcium recycling patterns.

In addition, the researchers performed RNA sequencing of heart cells harvested at 4.5 weeks aboard the ISS, and 10 days after returning to Earth.

These results showed that 2,635 genes were differentially expressed among flight, post-flight, and ground control samples.

Most notably, gene pathways related to mitochondrial function were expressed more in space-flown heart cells.

A comparison of the samples revealed that heart cells adopt a unique gene expression pattern during spaceflight, which reverts to one that is similar to ground-side controls upon return to normal gravity, the study noted.

According to Wu, limitations of the study include its short duration and the use of 2D cell culture.

In future studies, the researchers plan to examine the effects of spaceflight and microgravity using more physiologically relevant hiPSC-derived 3D heart tissues with various cell types, including blood vessel cells.

"We also plan to test different treatments on the human heart cells to determine if we can prevent some of the changes the heart cells undergo during spaceflight," Wu said.

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Human Heart Cells Transform in Space; Return to Normal on Earth: Study - The Weather Channel

Serving those who serve us – The Hub at Johns Hopkins

ByKristin Hanson

This article was originally published on Nov. 8 on giving.jhu.edu

Between 2001 and the beginning of 2018, more than 1,500 U.S. military service members lost limbs in the line of duty. Although technology has improved the prosthetic devices these people can use, a stubborn obstacle remains: the fragility of human skin.

"Skin was never meant to hold this kind of pressure," says Lee Childers, the senior scientist for the Extremity Trauma and Amputation Center of Excellence at Brooke Army Medical Center in San Antonio, Texas.

"Think about it like a blister on your foot. It's painful, but you can still get by," he continues. "In an amputation, it's a blister on your residual limb. You can't use your prosthesis until the blister is completely healed. If it's your leg [that is affected], you can't walk for two or three weeks. Think about how that would impact your life."

What if there were a way to make the skin at an amputation site tougher, like the palm of your hand or the sole of your foot? Luis Garza, an associate professor of dermatology at Johns Hopkins and leader of the Veteran Amputee Skin Regeneration Program, is developing a cell therapy that could enable prosthetics wearers to use their devices longer.

"This is an example of personalized medicine," Garza says. "We're taking each person's own cells, growing them up, and inserting them back in."

Garza's postdoctoral research focused on skin stem cells. In 2009, he and his department chair, Sewon Kang, began having conversations about how that work could help the increasing numbers of veterans coming back from war with amputations. Garza and his team received grants from the U.S. Department of Defense, National Institutes of Health, and Maryland Stem Cell Fund that have moved the program forward in the past decade.

Garza's team spent the summer of 2019 testing "normal" subjectsthose without amputationsto perfect the procedure, including the dose, content, method, and frequency of the injections. During one appointment, members of Garza's team took biopsies of skin from a subject's scalp and sole. The cells went to a lab where they were grown under an FDA-approved protocol and passed through quality control tests.

In a second appointment, subjects completed a questionnaire and underwent baseline measurements of their skin's thickness and strength. Garza's team then injected a site on the subjects' skin with the stem cells grown from their cells in the lab.

Image caption: Luis Garza, associate professor of dermatology at Johns Hopkins, leads the Veteran Amputee Skin Regeneration Program.

"We're hoping that these stem cell populations will engraft in the new skin," Garza says.

The subjects returned to Hopkins several months later to go through the questionnaire and measurements once more, and Garza's team documented changes.

Confident in the results they gleaned from the normal subjects, Garza's team enrolled its first subject with an amputation in August. Moving from the normal population to the amputation-affected population quickly unearthed some aspects of the therapy Garza didn't anticipate.

"When we talked with him, he said 'I don't want to mess with my one remaining footdo you have to take skin from there?' And we said, 'Actually, no, we could do your palm,'" Garza says.

His team then tested the biopsy and growth of palm cells from subjects in the normal population. "We're moving away from having our product informed purely by biology to letting our therapy development be shaped by the user."

Although federal grants have supported much of the program's progress, private philanthropy has played a role, too. Corporations like Northrop Grumman, foundations like the Alliance for Veteran Support, and grateful patients with and without ties to the armed forces have contributed nearly $300,000. Those gifts have enabled the program to persevere through gaps between federal grants.

A man sits at a desk, speaking with another man who sits beside him. A large microscope sits on the desk, and a brightly colored image of a skin biopsy appears on a computer screen.

Private funds will be increasingly important as the project enters its next phase: extension to military medical centers around the country. Garza's team must prove that the safeguards to protect cells on their round-trip voyage from a test site to Hopkins are effective. They also must secure approval by local institutional review boards for clinical studies.

"Soldiers are used to getting orders, but you can't order someone to be part of a [medical] study," Garza says. "There are hard medical ethics questions around how to make this open to them but ensure they don't feel obligated. We've been working on that for a year, and we probably have another six months or so to go."

Childers stands ready for whenever the program's extension is a go. He will lead the study at Brooke Army Medical Center and feels motivated by the prospect of helping many of the veterans he works with every day.

"We do everything we can to serve those who serve us. This can enable people to return to duty and be redeployed if they choose," he says. "This is game-changing technology that will have an impact for our service members, but also others who live with amputation."

That population includes the hundreds of thousands of Americans who've undergone amputations for complications of diabetes, who must use a wheelchair, or who wear ankle or foot orthoses for help with walking, among others.

"Having the ability to transform skin anywhere you want to target on the body will have gigantic implications across the entire spectrum of our society in many ways," Childers says.

There's a lot of work to be done before such benefits reach the public, Garza cautions. With continued support from donors and the military community, though, he's optimistic about the program's future.

"The challenges are pretty big, but I think within five years, it could happen," he says. "That's the hope."

Disclaimer: The view(s) expressed herein are those of the author(s) and do not reflect the official policy or position of the Brooke Army Medical Center, the U.S. Army Medical Department, the U.S. Army Office of the Surgeon General, the Department of the Army, the Department of the Air Force and Department of Defense or the U.S. Government.

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Serving those who serve us - The Hub at Johns Hopkins

Kadimastem to Present Interim Results of Cohort A of Its Phase 1/2a Clinical Trial in ALS at the 7th International Stem Cell Meeting, in Tel-Aviv,…

NESS ZIONA, Israel, Nov. 11, 2019 /PRNewswire/ --Kadimastem Ltd.(TASE: KDST),a clinical stage cell therapy company, today announced that it will present the interim results of Cohort A of its ongoing Phase 1/2a Clinical Trial in ALS (as published in Company's press release) at the 7th International Stem Cell Meeting, to be held on November 12-13 at the Dan Panorama Hotel in Tel Aviv, Israel.

The International Stem Cell Meeting, hosted by the Israel Stem Cell Society, is a highly reputed conference, participated by international world leaders in stem cell research.

Presentation Details:

Title: "FIRST IN HUMAN CLINICAL TRIALS WITH HUMAN ASTROCYTES AS A NOVEL CELL THERAPY FOR THE TREATMENT OF ALS"

Session:ONGOING CLINICAL TRIALS WITH CELL THERAPY

Presenter:Arik Hasson, PhD, Executive VP, Research and Development, Kadimastem

Date:Wednesday, November 13, 2019

Time:1:50 pm Israel

Location: Dan Panorama Hotel, Tel Aviv, Israel

Rami Epstein, CEO of Kadimastem, stated: "We are pleased to share these results with global leaders in the cell therapy and stem cells industry,demonstrating the potential of AstroRx, our astrocyte-based cell therapy product,to bring treatment to ALS patients, and possibly other neurodegenerative diseases. We look forward to further share data of this ongoing trial, with final results of cohort A expected by year-end 2019and results of cohort B expected in Q3, 2020."

About the Phase 1/2a ALS Clinical Trial

The Phase 1/2a trial is an open label, dose escalating clinical study to evaluate the safety, tolerability and preliminary efficacy of AstroRxcells in patients with ALS. The trial is expected to include 21 patients and is being conducted at the Hadassah Medical Center, Jerusalem, Israel. The primary endpoints of the trial are safety evaluation and tolerability of a single administration of allogeneic astrocytes derived from human Embryonic Stem Cells (hESC), administered in escalating low, medium and high doses (100x106, 250x106, and 500x106 cells, respectively). The medium dose will also be administered in 2 consecutive injections separated by an interval of ~60 days. Secondary end points include efficacy evaluation and measurements. Treatment is administered in addition to the appropriate standard-of-care.

About AstroRx

AstroRx is a clinical grade cell therapy product developed and manufactured by Kadimastem in its GMP-compliant facility, containing functional healthy astrocytes (nervous system support cells) derived from human Embryonic Stem Cells (hESC) that aim to protect diseased motor neurons through several mechanisms of action. The Company's technology enables the injection of AstroRxcells into the spinal cord fluid of patients suffering from Amyotrophic Lateral Sclerosis (ALS) with the goal of supporting the malfunctioning cells in the brain and spinal cord, in order to slow the progression of the disease and improve patients' quality of life and life expectancy. AstroRxhas been shown to be safe and effective in preclinical studies. AstroRxhas been granted orphan drug designation by the FDA.

About ALS

Amyotrophic Lateral Sclerosis (ALS) is a rapidly progressive fatal neurodegenerative disease causing disfunction in the upper and lower motor nerves that control muscle function. ALS leads to muscle weakness, loss of motor function, paralysis, breathing problems, and eventually death. The average life expectancy of ALS patients is 2-5 years. According to the ALS Therapy Development Institute, it is estimated that there are approximately 450,000 ALS patients worldwide of which 30,000 reside in the US. According to the ALS Foundation for Life, the annual average healthcare costs of an ALS patient in the US are estimated at US$ 200,000. Thus, the annual healthcare costs of ALS patients in the US alone amount to US$ 6 Billion.

About Kadimastem

Kadimastem is a clinical stage cell therapy company, developing and manufacturing "off-the-shelf" allogeneic proprietary cell products based on its platform technology for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into clinical grade functional cells. AstroRx, the Company's lead program, is a clinical-grade astrocyte cell therapy for the treatment of ALS, currently undergoing a Phase 1/2a clinical trial. In addition, preclinical trials are ongoing with the Company's IsletRx pancreatic functional islet cells for the treatment of insulin dependent diabetes. Kadimastem was founded by Prof. Michel Revel, CSO of the Companyand Professor Emeritus of Molecular Genetics at the Weizmann Institute of Science. Prof. Revel received the Israel Prize for the invention and development of Rebif, a multiple sclerosis blockbuster drug sold worldwide. Kadimastem is traded on the Tel Aviv Stock Exchange (TASE: KDST).

Company Contacts:Yossi Nizhar, CFOy.nizhar@kadimastem.com+972-73-797-1613

Investor and Media Contact:Meirav Gomeh-Bauermeirav@bauerg.com+972-54-476-4979

Global Media Contact:Dasy (Hadas) MandelDirector of Business Development, Kadimastemd.mandel@kadimastem.com+972-73-797-1613

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Kadimastem to Present Interim Results of Cohort A of Its Phase 1/2a Clinical Trial in ALS at the 7th International Stem Cell Meeting, in Tel-Aviv,...

The Value and Versatility of Clinical Flow Cytometry – Technology Networks

What is flow cytometry and how does it work?Flow cytometry(FCM) is a scientific technique used to measure the physical and biochemical characteristics of cells.1The sample is injected into the flow cytometer instrument, where it is typically focused to flow one cell at a time past light sources and detectors. Tens of thousands of cells can be examined in seconds to determine their morphology, granularity, scattering and transmission of light, or fluorescence of biomarkers, depending on the variation of FCM used.

The first conventional fluorescence-based flow cytometer was developed and commercialized in the late 60s/early 70s in Germany.2 Over the last five decades, FCM has developed rapidly in terms of the number of its applications and the quantity and dimensionality of the data it generates.1,3 Dr. Minh Doan, formerly of the Imaging Platform of the Broad Institute (USA) and now head of Bioimaging Analytics at GlaxoSmithKline in the USA, states, There have been significant advances in all three Vs of flow cytometry data: velocity (throughput/speed of data acquisition), volume (data content), and variety (sample types and signal acquisition technology).

Michael Parsons, manager of the Flow Cytometry Core of the Lunenfeld-Tanenbaum Research Institute in Toronto, Canada, agrees. The two biggest trends in flow cytometry are high content data and the merging of technologies from separate disciplines. For example, the last five years or so have seen the emergence of mass cytometry, which merges the disciplines of flow cytometry and mass spectrometry. In its latest iteration, an image cytometry module has been incorporated to generate unprecedented amounts of content (number of measured parameters) from relatively small amounts of patient tissue. Spectral flow cytometry has also established itself as an important emerging technology. Indeed, mass cytometry can now measure up to 50 features on a single cell simultaneously using antibodies tagged with rare earth metals,4 and imaging flow cytometry allows for 1000s of morphological features and multiple fluorescence markers to be analyzed per cell.3Flow cytometry, therefore, has inarguable potential as a clinical tool for disease diagnosis, prognosis, and therapeutic monitoring. However, some challenges remain in translating the full promise of FCM into clinical practice. Here, some of the current clinical applications of FCM will be discussed, as well as some of the compelling new applications being researched.

Similarly, FCM of liquid biopsies could be used to detect circulating tumor cells in the bloodstream.3 These cells are extremely rare, and with its high sensitivity, FCM is perfectly poised to make a significant impact in this area. This approach has potential for the clinical detection of early-stage cancer as well as the detection of circulating metastatic or drug-resistant cancer cells. For example, a study published earlier this year described label-free liquid biopsy with very high throughput (> 1 million cells/second) for drug-susceptibility testing during leukemia treatment.8

Prior to an organ transplant, FCM can be used to crossmatch the patient's serum with donor lymphocytes to detect antibodies that could result in organ rejection.1 Postoperatively, the analysis of various cell markers on the peripheral blood lymphocytes can indicate early transplant rejection, detect bone marrow toxicity arising from immunosuppressive therapies, and help differentiate infections from organ rejection. For blood transfusions, FCM can be used to detect contamination of blood with residual white blood cells, which can have adverse effects such as pulmonary edema.9Groups such as Dr. Roshini Abrahams at Nationwide Childrens Hospital in Ohio, USA, are using FCM to diagnose primary immunodeficiency disorders with the use of immunophenotyping and functional assays.10 These disorders are caused by genetic mutations that result in defects in the immune system, such as X-linked (Brutons) agammaglobulinemia and X-linked hyper-IgM syndrome. Over 300 of these disorders have been identified thus far, and the causative mutations lower immune defense against the attack of infections.

HIV is, of course, an example of a secondary (acquired) immunodeficiency disorder. FCM analysis of CD4 and other markers on lymphocytes in the peripheral blood is used to monitor the treatment of HIV patients, and a CD4 count <200 cells/mL together with a positive antibody test for HIV is used as a diagnostic for AIDS.1 Secondary immunodeficiencies can also be caused by e.g., substance abuse, malnutrition, other medical conditions, and certain medical treatments. FCM of a panel of markers can be used to confirm suspected cases.1In pregnancy, when a Rhesus blood group D-negative mother carries a D-positive fetus, fetal-maternal bleeding can sensitize the mother to the D-positive blood cells from the fetus and this can be fatal to subsequent D-positive newborns.11 FCM is used to measure the degree of fetal-maternal hemorrhage to determine the correct dose of prophylactics to be administered shortly after delivery.

In addition to oncology and immunology applications, FCM is also used to diagnose a variety of rare hematologic disorders12 as well as autoimmune/autoinflammatory disorders such as spondylarthritis (arthritis of the spine).13 Another area of research that is likely to give rise to increasing clinical applications in the future is that of platelet activity, which is important in many clinical conditions.1,14

Experts suggest that it may be possible to overcome this data analysis hurdle by applying machine learning approaches coupled with further standardization of FCM workflows.3,15 The most exciting applications of high content data revolve around the use of machine learning, in particular, deep learning, to extract relevant meaning from large data sets. Machine learning, coupled with big data, has the potential for driving diagnosis and treatment options tailored to the patients disease in a timely manner, says Dr. Parsons. In addition, Prof. Sadao Ota of RCAST at the University of Tokyo, Japan, points out, We still need to figure out how to design a workflow that convincingly validates diagnostic results, especially if the diagnosis employs the power of machine learning. Such developments are necessary before the rich information content of advanced FCM technology can be fully applied in the clinic.

In terms of other future advances in the field, Prof. Ota specifically makes mention of the potential of cell sorters combined with FCM.16 There are exciting and unique applications of sorters in fields such as cell therapy and regenerative medicine. Also, creating key applications of imaging cell sorters in pharmaceutical fields may accelerate global drug discovery. Dr. Doan concurs, Disease heterogeneity makes it hard to validate findings. Perhaps the use of flow cytometry with sorting capability can help such validation, where events-of-interest collected by flow cytometry can be validated with other downstream assays. Finally, as Dr. Doan notes, With multiple layers of data(types) incorporated altogether, there are now possibilities to do more with less, i.e., label-free sample measurement, which could lead to more direct, faster, and smarter diagnoses. Rare events (e.g., metastatic cancer cells) may soon be detected better than before.References1.Bakke A.C. Clinical Applications of Flow Cytometry. Laboratory Medicine. 2000; 31(2): 97104. doi: 10.1309/FC96-DDY4-2CRA-71FK.2.Herzenberg L.A., Parks D., Sahaf B., Perez O., Roederer M., Herzenberg L.A. The history and future of the fluorescence activated cell sorter and flow cytometry: a view from Stanford. Clinical Chemistry. 2002;48(10):181918273.Doan M., Vorobjev I., Rees P., Filby A., Wolkenhauer O., Goldfeld A.E., Lieberman J., Barteneva N., Carpenter A.E., Hennig H. Diagnostic potential of imaging flow cytometry. Trends in Biotechnology. 2018;36(7):649652. doi: 10.1016/j.tibtech.2017.12.008.4.Olsen L.R, Leipold M.D., Pedersen C.B., Maecker H.T. The anatomy of single cell mass cytometry data. Cytometry Part A. 2019;95(2):156172. doi: 10.1002/cyto.a.23621.5.Laerum O.D., Farsund T. Clinical application of flow cytometry: a review. Cytometry. 1981;2(1):113. doi: 10.1002/cyto.990020102.6.Li J., Wertheim G., Paessler M., Pillai V. Flow cytometry in pediatric hematopoietic malignancies. Clinics in Laboratory Medicine. 2017;37(4):879893. doi: 10.1016/j.cll.2017.07.009.7.Gupta S., Devidas M., Loh M.L., Raetz E.A., Chen S., Wang C., Brown P., Carroll A.J., Heerema N.A., Gastier-Foster J.M., Dunsmore K.P., Larsen E.C., Maloney K.W., Mattano L.A. Jr., Winter S.S., Winick N.J., Carroll W.L., Hunger S.P., Borowitz M.J., Wood B.L. Flow-cytometric vs. -morphologic assessment of remission in childhood acute lymphoblastic leukemia: a report from the Childrens Oncology Group (COG). Leukemia. 2018;32(6):13701379. doi: 10.1038/s41375-018-0039-7.8.Kobayashi H., Lei C., Wu Y., Huang C-J., Yasumoto A., Jona M., Li W., Wu Y., Yalikun Y., Jiang Y., Guo B., Sun C-W., Tanaka Y., Yamada M., Yatomi Y., Goda K. Intelligent whole-blood imaging flow cytometry for simple, rapid, and cost-effective drug-susceptibility testing of leukemia. Lab on a Chip. 2019;19(16):26882698. doi: 10.1039/c8lc01370e.9.Castegnaro S., Dragone P., Chieregato K., Alghisi A., Rodeghiero F., Astori G. Enumeration of residual white blood cells in leukoreduced blood products: Comparing flow cytometry with a portable microscopic cell counter. Transfusion and Apheresis Science. 2016;54(2):266270. doi: 10.1016/j.transci.2015.10.001.10.Abraham R.S., Aubert G. Flow cytometry, a versatile tool for diagnosis and monitoring of primary immunodeficiencies. Clinical and Vaccine Immunology. 2016;23(4):254271. doi: 10.1128/CVI.00001-16.11.Kim Y.A., Makar R.S. Detection of fetomaternal hemorrhage. American Journal of Hematology. 2012;87(4):417423. doi: 10.1002/ajh.22255.12.Bn M.C., Le Bris Y., Robillard N., Wuillme S., Fouassier M., Eveillard M. Flow cytometry in hematological nonmalignant disorders. International Journal of Laboratory Hematology. 2016;38(1):516. doi: 10.1111/ijlh.12438.13.Duan Z., Gui Y., Li C., Lin J., Gober H.J., Qin J., Li D., Wang L. The immune dysfunction in ankylosing spondylitis patients. Bioscience Trends. 2017;11(1):6976. doi: 10.5582/bst.2016.01171.14.Pasalic L. Assessment of platelet function in whole blood by flow cytometry. Methods in Molecular Biology. 2017;1646:349367. doi: 10.1007/978-1-4939-7196-1_27.15.Doan M., Carpenter A.E. Leveraging machine vision in cell-based diagnostics to do more with less. Nature Materials. 2019;18(5):414418. doi: 10.1038/s41563-019-0339-y.16.Ota S., Horisaki R., Kawamura Y., Ugawa M., Sato I., Hashimoto K., Kamesawa R., Setoyama K., Yamaguchi S., Fujiu K., Waki K., Noji H. Ghost cytometry. Science. 2018;360(6394):12461251. doi: 10.1126/science.aan0096.

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The Value and Versatility of Clinical Flow Cytometry - Technology Networks

Global Cell Harvesting Industry Research: Key Companies Profile with Sales, Revenue, Market Share, Price and Competitive Situation Analysis – Inquiry…

Cell harvesting usually for use in cancer or other treatment. Usually the cells are removed from the patients own bone marrow. Stem cells can be harvested from the blood or bone marrow. Umbilical cords have been saved as a future source of stem cells for the baby.

Access Report Details at: https://www.themarketreports.com/report/global-cell-harvesting-market-by-manufacturers-regions-type-and-application-forecast

Market share of global Cell Harvesting industry is dominate by companies like PerkinElmer (US), Brandel (US), TOMTEC (US), Cox Scientific (UK), Connectorate (Switzerland), Scinomix (US), ADSTEC (Japan), Sartorius, Terumo Corporation and others which are profiled in this report as well in terms of Sales, Price, Revenue, Gross Margin and Market Share (2017-2018).

With the help of 15 chapters spread over 100 pages this report describe Cell Harvesting Introduction, product scope, market overview, market opportunities, market risk, and market driving force. Later it provide top manufacturers sales, revenue, and price of Cell Harvesting, in 2017 and 2018 followed by regional and country wise analysis of sales, revenue and market share. Added to above, the important forecasting information by regions, type and application, with sales and revenue from 2019 to 2024 is provided in this research report. At last information about Cell Harvesting sales channel, distributors, traders, dealers, and research findings completes the global Cell Harvesting market research report.

Market Segment by Regions, regional analysis covers:

North America (USA, Canada and Mexico)

Europe (Germany, France, UK, Russia and Italy)

Asia-Pacific (China, Japan, Korea, India and Southeast Asia)

South America (Brazil, Argentina, Columbia, etc.)

Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)

Market Segment by Type, covers:

Manual

Automated

Market Segment by Applications, can be divided into

Biopharmaceutical

Stem Cell Research

Purchase this premium research report at: https://www.themarketreports.com/report/buy-now/1496763

Table of Contents

1 Market Overview

2 Manufacturers Profiles

3 Global Cell Harvesting Market Competitions, by Manufacturer

4 Global Cell Harvesting Market Analysis by Regions

5 North America Cell Harvesting by Countries

6 Europe Cell Harvesting by Countries

7 Asia-Pacific Cell Harvesting by Countries

8 South America Cell Harvesting by Countries

9 Middle East and Africa Cell Harvesting by Countries

10 Global Cell Harvesting Market Segment by Type

11 Global Cell Harvesting Market Segment by Application

12 Cell Harvesting Market Forecast (2019-2024)

13 Sales Channel, Distributors, Traders and Dealers

14 Research Findings and Conclusion

15 Appendix

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Global Cell Harvesting Industry Research: Key Companies Profile with Sales, Revenue, Market Share, Price and Competitive Situation Analysis - Inquiry...

Jennifer OConnell: President Kanye in 2024? Be very afraid America – The Irish Times

I realised I was listening to one of the most important cultural messages we need at this moment in American history. Kanyes counter-cultural voice is desperately needed, goes one rapturous review of Kanye Wests new album, Jesus is King.

Every second I spend listening to it, my mind is focused on the Holy One. I see Jesus glorified throughout every track.

That second line is a clue that the review didnt come from Rolling Stone or NME. Instead, it emerged on that somewhat less well-known rap-lovers bible, the website of the organisation Concerned Women for America.

As its name might hint, this is an evangelical Christian non-profit, normally associated with its stands against feminism, same-sex marriage, stem cell research, pornography, cloning, gambling, sex education and sure, why not while theyre at it evolution. And now its reviews of rap albums.

The reinvention of Kanye West rapper, tweet-happy pseudo-philosopher, purveyor of such wisdoms as slavery is a choice, husband of a Kardashian, and more recently, icon of the alt-right is complete. He has stopped hinting that he might run for president of the United States in 2024 (in January this year, he tweeted simply 2024), and has started just declaring it outright.

There will be a time when I will be the president of the US, he confidently predicted in an interview with an Apple Music show, Beats 1, while sitting overlooking his private lake surrounded by a herd of gambolling deers on his multithousand acre property in Wyoming. He also reveals in the interview that he didnt like the property when he first saw it, but then noticed that it matched his colour palette. I was like, these are the Yeezy tones right here, Yeezy being the brand of 300 footwear he flogs with Adidas. The right to own land matching your expensive runners could make for a compelling election promise.

So Kanye 2024 is happening. And why not? If property salesman, charmless reality TV star, unhinged tweeter, reader of no books without his name in the title, malignant narcissist and performative misogynist Donald Trump can do it, why not rapper and shoe salesman, husband of a reality TV star, unhinged tweeter, reader of no books without his name in the title, malignant narcissist and performative misogynist Kanye West?

Well, lets see. Kanye might be the darling of everyone from Conservative Women for American to Donald Trump jnr (who tweeted that he was the epitome of fearless creativity and dangerous, unapprovedideas), but there is the question of his not exactly on-brand past his porn addiction, his sex addiction, his opioid addiction, his liking for the word bitch. If his newfound fanbase appears surprisingly untroubled by all of this, its because they are able to suggest it was all just a scene-setting prelude to his current, more wholesome incarnation.

And he has been obliging them with plenty of evidence of this reinvention. He recently said he tried to ban premarital sex among people working on the album. He also denounced abortion and the morning-after pill, accused Democrats of brainwashing black people, and said that God had given him a $68 million tax refund. Its astonishing how many extremely rich people subscribe to the belief that the richer you are, the more God loves you. Or perhaps its not astonishing at all.

Kanye pretended to be who he wasnt to show you who he really is, explains Mike Cernovich, the alt-right, anti-feminist conspiracy theorist, predicting that Kanye could bring the races together.

The idea of the rapper putting himself forward for nomination seems ridiculous, surreal, daft and, simultaneously, sort of inevitable. What could be a more natural conclusion to a decade in which the global news agenda dissolved into a dark, Dadaist comedy, a time when charlatan/joker/narcissist/no political experience or identifiable policies whatsoever became part of the job description for any sort of serious run at high-profile high office?

Troublingly, the mainstream US media is falling into exactly the same trap with West that it fell into with Trump. Its alternately ignoring him, and treating him like the punchline to a grim, postmodern joke, while clinging to the hope that something shiny will come along before 2024 to distract him before the country embarrasses itself any further. Because nobody is actually all that sure America will be ready to put a grown-up in charge by then.

Is this all just a publicity stunt for Kanye? I wouldnt count on it, any more than it was all just a publicity stunt for Trump. As in: it may just be a publicity stunt, but that doesnt mean it wont happen anyway.

On the subject of his own greatness, unlimited messianic potential and his belief in the direct line his creator has to his bank balance, Kanye is deadly serious. With his pseudo-philosophical, self-help musings; his disregard for facts, history or science; his love of conspiracy theories; his paranoia; his parasitic relationship with the media and the astonishing depths of his own self-belief, its hard to imagine, in fact, a more appropriate emblem for this age were in. I suspect his ambitions dont stop at being the next Donald Trump. He fancies himself as the next Jesus Christ.

joconnell@irishtimes.com

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Jennifer OConnell: President Kanye in 2024? Be very afraid America - The Irish Times

Human heart cells are altered by spaceflight, but return mostly to normal on Earth – Space Daily

Heart muscle cells derived from stem cells show remarkable adaptability to their environment during and after spaceflight, according to a study publishing November 7 in the journal Stem Cell Reports.

The researchers examined cell-level cardiac function and gene expression in human heart cells cultured aboard the International Space Station for 5.5 weeks. Exposure to microgravity altered the expression of thousands of genes, but largely normal patterns of gene expression reappeared within 10 days after returning to Earth.

"Our study is novel because it is the first to use human induced pluripotent stem cells to study the effects of spaceflight on human heart function," says senior study author Joseph C. Wu of Stanford University School of Medicine.

"Microgravity is an environment that is not very well understood, in terms of its overall effect on the human body, and studies like this could help shed light on how the cells of the body behave in space, especially as the world embarks on more and longer space missions such as going to the moon and Mars."

Past studies have shown that spaceflight induces physiological changes in cardiac function, including reduced heart rate, lowered arterial pressure, and increased cardiac output. But to date, most cardiovascular microgravity physiology studies have been conducted either in non-human models or at tissue, organ, or systemic levels. Relatively little is known about the role of microgravity in influencing human cardiac function at the cellular level.

To address this question, Wu and his collaborators (including graduate student Alexa Wnorowski, former Stanford graduate student Arun Sharma, now a research fellow at Cedars-Sinai in Los Angeles, and former Stanford graduate student turned astronaut Kathleen Rubins) studied human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs). They generated hiPSC lines from three individuals by reprogramming blood cells, and then differentiated them into hiPSC-CMs.

Beating hiPSC-CMs were then launched to the International Space Station aboard a SpaceX spacecraft as part of a commercial resupply service mission. Simultaneously, ground control hiPSC-CMs were cultured on Earth for comparison purposes.

Upon return to Earth, space-flown hiPSC-CMs showed normal structure and morphology. However, they did adapt by modifying their beating pattern and calcium recycling patterns.

In addition, the researchers performed RNA sequencing of hiPSC-CMs harvested at 4.5 weeks aboard the International Space Station, and 10 days after returning to Earth. These results showed that 2,635 genes were differentially expressed among flight, post-flight, and ground control samples.

Most notably, gene pathways related to mitochondrial function were expressed more in space-flown hiPSC-CMs. A comparison of the samples revealed that hiPSC-CMs adopt a unique gene expression pattern during spaceflight, which reverts to one that is similar to groundside controls upon return to normal gravity.

"We're surprised about how quickly human heart muscle cells are able to adapt to the environment in which they are placed, including microgravity," Wu says. "These studies may provide insight into cellular mechanisms that could benefit astronaut health during long-duration spaceflight, or potentially lay the foundation for new insights into improving heart health on Earth."

According to Wu, limitations of the study include its short duration and the use of 2D cell culture. In future studies, the researchers plan to examine the effects of spaceflight and microgravity using more physiologically relevant hiPSC-derived 3D heart tissues with various cell types, including blood vessel cells. "We also plan to test different treatments on the human heart cells to determine if we can prevent some of the changes the heart cells undergo during spaceflight," Wu says.

Research Report: "Effects of Spaceflight on Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Structure and Function"

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Human heart cells are altered by spaceflight, but return mostly to normal on Earth - Space Daily