Stem Cell Clinic

Stem Cell Therapy Global Market to Reach $18.17 Billion by 2031 – GlobeNewswire

Dublin, Aug. 11, 2022 (GLOBE NEWSWIRE) -- The "Stem Cell Therapy Global Market Opportunities And Strategies To 2031" report has been added to ResearchAndMarkets.com's offering.

The global stem cell therapy market reached a value of nearly $4,019.6 million in 2021, having increased at a compound annual growth rate (CAGR) of 70.9% since 2016. The market is expected to grow from $4,019.6 million in 2021 to $10,600.2 million in 2026 at a rate of 21.4%. The market is then expected to grow at a CAGR of 11.4% from 2026 and reach $18,175.4 million in 2031.

Growth in the historic period in the stem cell therapy market resulted from rising prevalence of chronic diseases, a rise in funding from governments and private organizations, rapid growth in emerging markets, an increase in investments in cell and gene therapies, surge in healthcare expenditure, and an increase in pharmaceutical R&D expenditure. The market was restrained by low healthcare access in developing countries, limited reimbursements, and ethical concerns related to the use of embryonic stem cells in the research and development.

Going forward, increasing government support, rapid increase in the aging population, rising research and development spending, and increasing healthcare expenditure will drive market growth. Factors that could hinder the growth of the market in the future include high cost of stem cell therapy, stringent regulations imposed by regulators, and high cost of storage of stem cells.

The stem cell therapy market is segmented by type into allogeneic stem cell therapy and autologous stem cell therapy. The autologous stem cell therapy segment was the largest segment of the stem cell therapy market segmented by type, accounting for 100% of the total in 2021.

The stem cell therapy market is also segmented by cell source into adult stem cells, induced pluripotent stem cells, and embryonic stem cells. The induced pluripotent stem cells was the largest segment of the stem cell therapy market segmented by cell source, accounting for 77.2% of the total in 2021. Going forward, the adult stem cells segment is expected to be the fastest growing segment in the stem cell therapy market segmented by cell source, at a CAGR of 21.7% during 2021-2026.

The stem cell therapy market is also segmented by application into musculoskeletal disorders and wounds & injuries, cancer, autoimmune disorders, and others. The cancer segment was the largest segment of the stem cell therapy market segmented by application, accounting for 49.7% of the total in 2021. Going forward, musculoskeletal disorders and wounds & injuries segment is expected to be the fastest growing segment in the stem cell therapy market segmented by application, at a CAGR of 22.1% during 2021-2026.

The stem cell therapy market is also segmented by end-users into hospitals and clinics, research centers, and others. The hospitals and clinics segment was the largest segment of the stem cell therapy market segmented by end-users, accounting for 66.0% of the total in 2021. Going forward, hospitals and clinics segment is expected to be the fastest growing segment in the stem cell therapy market segmented by end-users, at a CAGR of 22.0% during 2021-2026.

Scope: Markets Covered:

Key Topics Covered:

1. Stem Cell Therapy Market Executive Summary

2. Table of Contents

3. List of Figures

4. List of Tables

5. Report Structure

6. Introduction

7. Stem Cell Therapy Market Characteristics

8. Stem Cell Therapy Trends And Strategies

9. Impact Of Covid-19 On Stem Cell Therapy Market

10. Global Stem Cell Therapy Market Size And Growth

11. Global Stem Cell Therapy Market Segmentation

12. Stem Cell Therapy Market, Regional And Country Analysis

13. Asia-Pacific Stem Cell Therapy Market

14. Western Europe Stem Cell Therapy Market

15. Eastern Europe Stem Cell Therapy Market

16. North America Stem Cell Therapy Market

17. South America Stem Cell Therapy Market

18. Middle East Stem Cell Therapy Market

19. Africa Stem Cell Therapy Market

20. Stem Cell Therapy Global Market Competitive Landscape

21. Stem Cell Therapy Market Pipeline Analysis

22. Key Mergers And Acquisitions In The Stem Cell Therapy Market

23. Stem Cell Therapy Market Opportunities And Strategies

24. Stem Cell Therapy Market, Conclusions And Recommendations

25. Appendix

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/o4adwl

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Stem Cell Therapy Global Market to Reach $18.17 Billion by 2031 - GlobeNewswire

Scientists say they have created ’embryos’ without sperm or eggs – Medical News Today

Creating an embryo from cells other than sperm and egg cells and then growing them outside the uterus is an area of study that has developed significantly over the past 5 years. How long until we unlock the black box of human embryology?

This month, researchers announced that they have been culturing a mouse embryo model made entirely out of embryonic stem cells and without the use of a sperm and egg, or a uterus, for 8.5 days, about 2 days longer than previous experiments had achieved.

Genetic analysis revealed that the structures and cell activity in these embryo models were 95% similar to real mouse embryos and functional. This suggests that these models were similar enough to natural embryos that they could be studied to gain insight into how they work.

Research on both mice and human embryos can offer insight into the mechanisms that allow them to divide, implant, and develop. However, being able to build them from scratch helps researchers bypass potentially expensive and unethical experiments on embryos and also helps them verify if assumptions about how they work are correct.

A paper recently published in Cell outlines the achievement by researchers in Prof. Jacob Hannas laboratory at the Weizmann Institute of Science in Rehovot, Israel.

This is the latest step in a long line of incremental steps in recent years to create an embryo from scratch in the lab.

Prof. Hannas team had already published details of one particularly important part of the puzzle last year in Nature, when they outlined the process they had used to grow embryo models outside of a uterus.

The system they developed uses bottles filled with liquids that act as a culture for the cells, which can rotate or remain static at different points of development.

In an email to Medical News Today, Prof. Hanna noted: Since we know what it takes to support the growth of [natural mouse embryos] outside the uterus (device and conditions), we can finally test whether and which stem cells can generate an embryo ab initio [from the start] only from stem cells.

We couldnt do that before because how are you going to grow a synthetic embryo if you dont know how to grow a natural embryo? Low and behold indeed, the same device, the same media conditions, and the same parameters allowed aggregates of 27 cells of pluripotent stem cells to reach day 8.5-stage embryos when placed in this device after 8 days.

Prof. Jacob Hanna

The device and the media were critical. These embryos are whole embryos they have [a] yolk sac and placenta. But remarkably, we did not use placenta stem cells and yolk sac stem cells, but showed that everything can be made exclusively from naive pluripotent embryonic stem or induced pluripotent stem cell lines that are routinely expanded in labs around the world, he explained.

This was remarkable because previously, researchers had made embryo models that began to form the placenta, egg yolk, and amnion using a mixture of embryonic stem cells and stem cells taken from the trophoblast layer. This is the layer that normally differentiates into the placenta in embryos.

However, the failure rate in this latest set of experiments was high, with just 50 of 10,000 of these cell mixtures forming first into spheres and then into more egg-shaped structures such as an embryo.

Not only did these embryo models start to produce the structures that would support a pregnancy, but by the end of the 8.5 days in which they grew, they had formed a beating heart, blood stem cell circulation, a head region with folds, a neural tube and the beginnings of a gut tube.

The same week this paper appeared in Cell, the University of Cambridge-based laboratory of Prof. Magdalena Zernicka-Goetz published two papers on a preprint server: shared here and here. In fact, Prof. Zernicka-Goetzs team shared the latter on the same day the Cell study was published.

This paper outlines how the researchers from the Cambridge lab had observed similar organ structures start to form in their own research using embryo models.

Prof. Zernicka-Goetz told MNT in an interview that these papers would appear in peer-reviewed journals in the coming weeks and that their final versions were currently under embargo.

So it is [a] step by step [process] [] our paper is going to show even further developments, she told us.

This latest finding builds on the previous work of other laboratories and teams, both those of Prof. Zernicka-Goetz and others, said Prof. David Glover, her husband.

Profs. Glover and Zernicka-Goetz have teams at Cambridge and CalTech. They have carried out research together and appear as co-authors on one of the papers due to be published soon.

He told MNT in an interview: I think you have to go back to Magdas paper published in 2017, [whose] senior author was Sarah Harrison, which establishes the principle of being able to make an embryo-like structure using a mixture of extraembryonic cells and embryonic cells.

Extraembryonic cells include key components forming extraembryonic tissues, which are crucial to maintaining embryo survival. Extraembryonic tissues include the placenta, yolk sac, and amnion.

Being able to produce embryo models that feature the start of development of these tissues is so important because they help initiate the signaling that helps the embryo model develop and self-assemble much as a naturally developing embryo would, Prof. Glover noted.

The fact is that, because our own embryos develop inside the womb, they require extraembryonic tissues to develop properly. And those extraembryonic tissues have two functions. They provide, of course, a structural basis, they provide a yolk sac, [and] they provide the placenta, he explained.

But before they get to that stage, they also provide signals to the embryo to tell it how to properly develop. And if you dont have those signals there, then the embryo doesnt develop properly, the researcher added.

These particular models were just one type of embryo model currently being developed, said Prof. Glover.

Researchers have also developed other models, such as blastoids, which attempt to recreate the pre-implantation blastocyst stage of the embryo, and gastruloids, which do not have any extraembryonic tissues, and as a result, tend not to have a brain region.

Dr. Nicholas Rivrons laboratory at the Institute of Molecular Biotechnology at the Austrian Academy of Sciences, Vienna, Austria, has worked on developing embryo models to gain greater insight into the pre-implantation stage.

His group published a 2018 key paper in Nature. It outlined how they developed mouse embryo models using embryonic stem cells and stem cells from the trophoblast layer to create blastoids that could be implanted into the uterus of a mouse for a couple of days.

Then, in December 2021, the same team published another paper in Nature. This time, they outlined how they had created embryo models to the blastocyst stage made from human pluripotent stem cells, which they had induced to become able to differentiate into different types of cells.

Speaking to MNT, Dr. Rivron said: For the next stages of investigation, we need to actually understand how those embryos can be combined with the uterine cells in order to understand the processes of implantation into the uterus and how this can develop our knowledge to solve various health challenges of family planning, fertility decline, also the origin of diseases.

While the embryo models described in the latest paper demonstrated they had self-organized to form some structures that would go on to form the placenta, these embryo models were limited by how much further they could grow without one, said Dr. Rivron.

The limitation is the placenta the placenta is extremely important, he noted, due to the fact that it provides the nutrients and oxygen to the embryo that are essential for it to grow and develop further.

The latest paper also confirmed that the very first stages of organ development, known as organogenesis, could be observed in these model embryos.

This has typically been difficult to observe, as it typically occurs in the uterus. However, by establishing a process to develop these embryo models in the laboratory, the differentiation of the cells, the genetic control of this differentiation, and the environment needed for typical development can all be studied.

The latest paper used mouse embryonic stem cells to develop the model embryos, which will require ethical approval. By contrast, human embryo research is extensively regulated.

Guidelines for this regulation are released by the International Society for Stem Cell Research (ISSCR) approximately every 5 years, with the last set of guidelines released last year. This guidance addressed the existence of stem cell-derived embryo models and the possibility of chimeric embryo models built using cells from different species alongside human cells.

While it may prove technically possible to grow organs using embryo models, Dr. Rivron pointed out that this may not be necessary or, indeed, ethically desirable.

He pointed instead to the development of organoids, stem cell-derived models of organ tissues that can be used to investigate cellular behavior, and perhaps the development, of organs too.

In fact, a paper outlining how researchers at Harvard Unversity had bioengineered structures of the human heart appeared in Science in the same week as the latest article on embryo models.

Dr. Rivron contributed to the latest set of ISSCR guidelines and told MNT: If you want to study organogenesis or create organs, the political principle is that you have to use, morally, the least problematic way of studying these, and organoids offer a way to do this.

Both the development of organoids and embryo models have come in leaps and bounds in the past 5 years, and their basis, new genomic approaches we can use to understand and recreate mammalian structures, are similar.

It will be interesting to see how the disciplines converge in years to come, to give us an even greater set of tools to unlock the black box of our development.

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Scientists say they have created 'embryos' without sperm or eggs - Medical News Today

CD19/22 CAR T Cells in Children & Young Adults with B-ALL – Physician’s Weekly

Antigen modulation places a limit on the longevity of remission after single-antigen focused chimeric antigen receptor (CAR) T-cell therapy, although combinatorial targeting can get around it. For a study, researchers reported on phase 1 dose-escalation research of a new murine stem cell virus (MSCV)-CD19/CD22-4-1BB bivalent CAR T-cell (CD19.22.BB) for children and young adults (CAYA) with B-cell malignancies, building on the experiences targeting CD19 and CD22 in B-cell acute lymphoblastic leukemia (B-ALL).

Finding the appropriate dosage and toxicity were the main goals. Response rates and relapse-free survival (RFS) were secondary goals. Laboratory studies, CAR T-cell growth, and cytokine profiling were used as biologic correlates. Twenty B-ALL patients, ranging in age from 5.4 to 34.6 years, received CD19.22.BB.

Among the entire cohort, the complete response (CR) rate was 60% (12 of 20), and in CAR-naive patients, it was 71.4% (10 of 14). About 10 (50%) people had cytokine release syndrome (CRS), with only 1 developing neurotoxicity (grade 3) and 3 (15%) having grade 3 CRS. The 6-month RFS and 12-month RFS for those attaining CR were 80.8% (95% CI: 42.4%-94.9%) and 57.7% (95% CI: 22.1%-81.9%), respectively. MSCV-CD19.22.BB had less CAR T-cell growth and persistence than EF1-CD22.BB. Laboratory comparisons of EF1 and MSCV promoters were sparked by BB, but they did not turn up any significant differences.

As shown by ex vivo cytokine secretion and the elimination of leukemia, CD19.22.BB limited CD22 targeting resulted in the creation of a new bicistronic CD19.28/CD22.BB constructs with increased cytokine production against CD22. Further modification of combinatorial antigen targeting helped to address noted drawbacks with the use of CD19.22.BB, which has shown to be safe and effective in a substantially pretreated CAYA B-ALL cohort.

Reference: ashpublications.org/blood/article-abstract/140/5/451/485318/CD19-22-CAR-T-cells-in-children-and-young-adults?redirectedFrom=fulltext

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CD19/22 CAR T Cells in Children & Young Adults with B-ALL - Physician's Weekly

Froma Harrop: What about embryos that were getting thrown out anyway? – Lincoln Journal Star

Such is the state of the Republican Party that only eight of its 210 House members voted "yes" on a bill to protect the right to contraceptives. We're talking birth control.

Rep. Cathy McMorris Rodgers, R-Wash, denounced the bill as a "Trojan horse for more abortions."

Start with the obvious. Contraceptives prevent the unwanted pregnancies that lead to abortions. Also, the number of abortions in this country has steadily declined over the last 40 years, the reason being increased contraceptive use.

Other Republicans complained that Democrats pushed the birth control protection bill just for show. After all, no state currently bans contraceptives. One might agree, except that Justice Clarence Thomas just wrote that the thinking behind the Supreme Court's overturning of Roe v. Wade could apply to contraceptives as well.

Some have opposed Roe on the grounds that Congress, not the courts, should have enshrined any national right to abortion. Well, that's the approach just taken by the Democrat-controlled House concerning contraceptives. It passed a law guaranteeing a right to birth control.

Since Republicans are going down that path, one must ask, "What about embryos?" As a law professor, Supreme Court Justice Amy Coney Barrett signed a statement that life began at fertilization. An embryo is a fertilized egg.

Fertility clinics discard thousands upon thousands of abandoned embryos every year. That's because a single round of in vitro fertilization treatment typically involves collecting 10 or more eggs with only one or two being implanted in the mother. Many countries actually require that these surplus embryos be destroyed after a certain period.

Shouldn't states declaring embryos to be people require the clinics to preserve all unused embryos or close down? The cost of storing frozen embryos can exceed $1,000 a year.

In the opinion overturning Roe, Justice Samuel Alito wrote that abortion destroys "potential life" and the life of an "unborn human being." Foes of contraception make the same argument, that sperm and eggs are potential life, even before they meet.

Then there is embryonic stem cell research, which holds great promise for defeating such medical scourges as Alzheimer's and heart disease. The procedures require destroying embryos (many of them donated by IVF patients who didn't need them).

Thanks to a new embryonic stem cell-derived therapy, a man ravaged by formerly incurable Type 1 diabetes seems to have been cured of this terrible condition. The overjoyed 57-year-old patient, Brian Shelton of Ohio, exclaimed: "This is a whole new life. It's like a miracle."

One of the developers was Dr. Doug Melton. In 2001, Melton had to cut his lab's ties to Harvard University after President George W. Bush barred federal funding for research involving the destruction of embryos. Fortunately for humankind, private money was found to help Melton establish a separate lab.

By the way, Bush never did anything about the IVF clinics that were discarding unused embryos. But in 2005, he put on a bizarre show at one of them where he said, "There is no such thing as a spare embryo." He noted that 81 embryos had already been "adopted" under a special program run by a pro-life group.

Well, that left only about 399,982 unused embryos then stored at IVF clinics -- embryos that could have helped lead to cures for deadly diseases. We can only wonder how many lives might have been saved had medical research not been hobbled over two decades by an obsession over embryos that were getting thrown out anyway.

As the midterms approach, voters might ask themselves whether they want to empower a Republican Party that thinks like this -- that couldn't get even one out of 27 members to support something as basic as birth control.

Harrop writes for Creators: @FromaHarrop.

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Froma Harrop: What about embryos that were getting thrown out anyway? - Lincoln Journal Star

Stress can throw off circadian rhythms and lead to weight gain – Medical News Today

Scientists at Weill Cornell Medicine in New York say that stress-induced circadian clock disruptions may influence weight gain.

A study published in June showed that mice with artificially increased stress levels and interrupted hormone releases experienced an increase in fat cell growth. Its results appear in Cell Reports.

The second study, published in August, found that fat cell precursors commit to becoming fat cells only within a few hours at night. This work appears in the Proceedings of the National Academies of Sciences (PNAS).

Mary Teruel, PhD, associate professor of biochemistry at Weill Cornell Medicine, was the senior author of both studies.

A lot of forces are working against a healthy metabolism when we are out of circadian rhythm, Dr. Teruel said in a press release. The more we understand, the more likely we will be able to do something about it.

In the Cell Reports study, Dr. Teruel and her team implanted pellets with glucocorticoids, a type of stress-related hormone, in mice. This was to mimic the effects of chronic stress or Cushings disease.

Cushings disease triggers elevated levels of cortisol, the bodys stress hormone.

The pellets released glucocorticoids under the skin of the mice at a steady rate over three weeks. The researchers also observed control mice with typical daily stress hormone fluctuations.

Although all the mice ate the same healthy diet, the mice with pellets ended up weighing over 9% more than the control mice.

The researchers observed whether the weight gain was from fat expansion and found that the brown and white fat of the pellet mice had more than doubled. Their insulin levels spiked as well.

To the teams surprise, the metabolic disturbances kept blood glucose levels low. Further, the disruptions prevented fat from accumulating in the blood or liver.

When the researchers removed the pellets, these changes reversed immediately.

Dr. Teruel explained to MNT: We saw this in our paper, basically, once we stopped flattening the corticoids, [the mice] started reversing [the fat mass gain] and the hyperinsulinemia went away so that increased insulin that seems to be causing the fat mass gains that went away when the restored rhythm.

She added that this study indicates that chronic stress can make weight gain more likely, even with a healthy, low fat diet.

If you stress the animals at the wrong time, it has a dramatic effect. The mice arent eating differently, but a big shift in metabolism causes weight gain, Dr. Teruel said in the release.

Dr. Teruels research team hopes that their findings lead to developing drugs that could help reset circadian rhythms to help people with obesity.

We dont know enough [yet], but one would think cortisol receptor antagonists or [] things that restore the cortisol rhythms would probably help a lot.

Dr. Mary Teruel

Experts understand that flaws in circadian clock genes can alter cell differentiation in fat, immune, skin, and muscle cells.

The PNAS study revealed that even though differentiation happens over a few days, differentiation commitment happens within only a few hours. The findings also show that daily bursts of cell differentiation seem to be limited to evening phases when people are normally resting.

The decision to become a fat cell happens rapidly over 4 hours. It is like a switch, Dr. Teruel said.

Medical News Today discussed this with Dr. Mir Ali, bariatric surgeon and medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in Fountain Valley, California.

Dr. Ali explained how fat cells come to be: Fat cells form from [an] adipocyte progenitor cell or a type of cell that has not differentiated into its final form. The form it takes [to become] a fat cell depends on the hormonal and chemical stimulation it receives.

In the study, Dr. Teruel and her partners used fluorescent markers to observe daily fluctuations of fat cell production.

The researchers attached a red fluorescent protein to a protein that regulates circadian clock genes. They also attached a yellow fluorescent protein to peroxisome proliferator-activated receptor gamma (PPARG), a protein that controls fat cell production.

They discovered that during the rest period of the day, a certain circadian protein CCAAT enhancer binding protein alpha induces a rapid increase in the protein that regulates fat cell production.

The researchers also found that when PPARG levels hit a certain threshold, individual fat precursor cells irreversibly commit to differentiate within only a few hours, which is much faster than the rest phase and the overall multiday differentiation process.

Dr. Teruel and her team believe that working with this time window may open therapeutic strategies to use timed treatment relative to the [circadian] clock to promote tissue regeneration.

Dr. Ali said: These studies are interesting in that they show the timing and length of stimulation affect the formation and growth of fat cells. The implications of this are that if we can find a way to safely influence the cell to grow or not grow, it may affect obesity in humans.

However, he believed that more extensive research is needed to make the studies findings applicable to humans.

Dr. Teruel told MNT that she and her co-authors were just trying to work on basic mechanisms [] Right now, we need to show this is really a mechanism that happens []

The researchers do plan to replicate the studies with people. We are looking at protein ribbons and humans using saliva samples, Dr. Teruel shared with MNT. Were planning to do those kinds of experiments.

Their main objective, she said, is to figure out ways to restore circadian [rhythms].

Dr. Teruel mentioned that currently known strategies, such as meditation and regular sleep in the dark may help.

She expressed hope that there could be some pharmacological ways [to] fix this in the future as well.

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Stress can throw off circadian rhythms and lead to weight gain - Medical News Today

Is Oxygen the Answer to Long Covid? – WIRED

She was dead tired but couldnt sleep, couldnt think straight, and could barely walk. The muscle pain in her arms and legs was so bad that she spent days in bed. When she did get up, she used a wheelchair. And she couldnt focus on even the most trivial tasks, let alone work. But doctors couldnt agree on what was wrong with 41-year-old Maya Doari.

The sac-like tissues surrounding her heart were inflamed, of that they were sure, so she was diagnosed with pericarditis. But when her left hand turned blueon and off for monthsher physicians told her dont try to understand, because they no longer could.

Neither could a vocal cord specialist, who mocked her when she tried to speak, hardly able to muster a soft whisper. And when she attempted physical therapy to relearn how to walk, she experienced seizures. I asked, Dont you think it could be connected to the Covid I had? They said no and sent me home, saying its psychological.

But her condition was real. And it may not be as unique as it sounds.

Three months earlier, Doaria homeopath who lives in a small village near Jerusalemhad come down with a 24-hour fever and strong bone pain. It was Covid. But after these initial symptoms passed, days later the real symptoms began. My doctors said my case was the worst long Covid they had ever seen.

Covid can have many lingering effects, and for now at least, long Covid is the catch-all phrase used to describe them. Over 200 symptoms have been gathered under this umbrella term, ranging from the commontiredness, fever, and brain fog, or difficulty thinkingto the more striking, like Doaris seizures and speech problems. The exact prevalence of long Covid is debated, but millions around the world have reported having lasting symptoms.

Yet today, a year after her long Covid symptoms arrived, Doari says they are 98 percent gone, a turnaround tied to new research that may have uncovered a promising long-Covid treatment.

Its called hyperbaric oxygen therapy, and in July Israeli researchers published a studywhich Doari participated inthat showed using this technique to deliver massive amounts of oxygen to the body appears to alleviate many of Covids cognitive and physical after-effects.

Hyperbaric oxygen therapy has been around for decades and typically entails getting into a hard-shell, pressurized tube where the air pressure is up to three times that of our atmosphere, and then breathing in concentrated oxygen. Originally intended to treat the bends, a dangerous condition that can result from deep-sea diving or high-altitude mountaineering, its now used to promote healing in cancer patients and burn victims and is even used by athletes eager for a performance boost or people looking to remove plastic surgery scars.

Breathing in concentrated oxygen under pressure raises the amount of it that dissolves in the blood, meaning that more oxygen gets delivered throughout the bodys tissues. This can then boost the power of the immune system and stimulate the release of stem cells and substances called growth factors, which help tissues heal.

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Is Oxygen the Answer to Long Covid? - WIRED

GlyNAC supplementation reverses aging hallmarks in aging humans – Baylor College of Medicine News

A randomized, double blind human clinical trial conducted by researchers at Baylor College of Medicine reveals that supplementation with GlyNAC a combination of glycine and N-acetylcysteine improves many age-associated defects in older humans and powerfully promotes healthy aging. This is relevant because until now, there have been no solutions toward improving many of these age-related declines in people. Published in the Journal of Gerontology: Medical Sciences, the study shows that older humans taking GlyNAC for 16-weeks improved many characteristic defects of aging. This includes oxidative stress, glutathione deficiency and multiple aging hallmarks affecting mitochondrial dysfunction, mitophagy, inflammation, insulin resistance, endothelial dysfunction, genomic damage, stem cell fatigue and cellular senescence. These were associated with improvements in muscle strength, gait speed, exercise capacity, waist circumference and blood pressure.

This is the first randomized clinical trial of GlyNAC supplementation in older humans, and it found that a wide variety of age-associated abnormalities improved in older adults supplemented with GlyNAC, while no improvements were seen in those receiving placebo, said corresponding author Dr. Rajagopal Sekhar, professor of medicine - endocrinology, diabetes and metabolism at Baylor.

The improvements in oxidative stress, glutathione levels and mitochondrial function in the muscle tissue of older humans taking GlyNAC were similar to the improvements in organs such as the heart, liver and kidneys of aged mice supplemented with GlyNAC as reported in the researchers recent publication. Taken together, the results of these studies show that GlyNAC supplementation can improve these defects in many different organs of the body. GlyNAC supplementation in aging mice increased their length of life mice by 24%, said Sekhar. Gait speed is reported to be associated with survival in older humans. Our randomized clinical trial found a significant improvement in gait speed in older humans supplemented with GlyNAC. This raises the interesting question of whether GlyNAC supplementation could have implications for survival in people. For the last 20 years, Sekhar has been studying natural aging in humans and animal models to understand why age-related declines occur and how to correct them. His work brings mitochondria, known as the batteries of the cell, as well as free radicals and glutathione to discussions about how they are connected. Sekhars work and discoveries could also help explain why we age and how to improve health while aging.

Mitochondria dysfunction, oxidative stress and aging

Mitochondria generate energy needed for supporting cellular functions. Therefore, normal mitochondrial function is critically important for a healthy life. Sekhar believes that improving the health of malfunctioning mitochondria in aging is the key to healthy aging. Energy supports life and mitochondria provide energy. I believe that mitochondrial health is vitally important to our well-being, and maintaining mitochondrial health as we age should be a high priority in our efforts to improve overall health, said Sekhar.

However, the ability of mitochondria to work well declines as we age. How to improve the ability of these failing mitochondria to work is not well understood, and therefore no solutions have been available. Sekhars group discovered earlier that supplementing GlyNAC in aged mice corrected malfunctioning mitochondria. However, to definitively determine whether GlyNAC supplementation benefited people, a placebo-controlled randomized clinical trial was required.

Sekhar and his team conducted and completed such a randomized clinical trial which found that older people have widespread mitochondrial damage and other age-associated defects compared to young people. After 16-weeks of GlyNAC supplementation, mitochondrial function of older people improve toward levels found in young people. This was accompanied by improvements in multiple additional outcomes as reported in the publication. Analysis of the molecular data from the trial suggests that the GlyNAC supplementation is able to fill cells with younger and more efficient mitochondria. Collectively these exciting new discoveries hold great promise for improving our mitochondrial and general health as we age, Sekhar said.

A second vital benefit offered by supplementing GlyNAC is that it also helps protect the body from an important problem called oxidative stress. Oxidative stress is caused by high levels of toxic waste products known as reactive oxygen species or free-radicals. Oxidative stress can damage our cells, membranes, lipids, proteins and DNA, and is very common in aging. Glutathione is a natural antioxidant. Glutathione is made every day inside our cells and it works by protecting cells from harmful oxidative stress. However, in older people, glutathione levels are very low and the harmful oxidative stress is very high. GlyNAC supplementation corrects glutathione deficiency and lowers oxidative stress in older humans back to youthful levels, thereby solving both problems.

Sekhar believes that the restoration of mitochondrial health and correction of oxidative stress with GlyNAC supplementation are two powerful reasons which help explain why so many other age-related defects improve. It also accounts for the wide spectrum of health benefits.

Taking GlyNAC is not the same as taking glutathione: Introducing the Power of 3

It is really important to understand that this trial supplemented GlyNAC, and did not supplement glutathione, says Sekhar. This is because our body does not get its glutathione from food, but the body has to make its own glutathione every day. All our organs maintain different levels of glutathione in a delicate balance that favors health. Too little glutathione cannot fight the harmful oxidative stress, and too much glutathione could lead to harmful reductive stress, said Sekhar. This is why GlyNAC is a natural solution for correcting glutathione deficiency, because it provides the raw materials to help cells to make their own glutathione in just the right amount. We have seen that this repeatedly in all our prior studies supplementing GlyNAC, including this trial.

One of the intriguing questions from this trial is why so many improvements occur toward promoting health. We believe that this is due to the combined effort of three separate components glycine, cysteine (from NAC) and glutathione, and not just due to glutathione itself. Glycine and cysteine are both very important for cellular health on their own, and GlyNAC provides both. Glycine and cysteine are building blocks to form glutathione, which also has health benefits. We believe that the improvements in this trial and in our previous studies are the result of the combined effects of glycine and NAC and glutathione, and we refer to this combination as the Power of 3, said Sekhar.

GlyNAC improves several aging hallmarks in aging

The population of older adults is expected to exceed 2.1 billion by 2050, according to the World Health Organization. This predicted increase in the older human population will result in a rise of the need for healthcare and will intensify the stress on healthcare systems around the world. To understand what causes unhealthy aging, scientific research has identified nine aging hallmarks that represent specific defects that are believed to contribute to health decline while aging.

It is believed that correcting aging hallmarks could help people age in a healthier way, Sekhar said. However, we do not fully understand why these aging hallmarks occur in the first place, and therefore there have been no proven solutions via human randomized clinical trials to improve or correct aging hallmarks in aging humans.

The aging hallmarks that improved are mitochondrial dysfunction, altered intercellular communication, nutrient sensing, loss of proteostasis, genomic instability, cellular senescence and stem cell fatigue. The study participants were instructed not to change their usual diet or physical activity; therefore, nothing changed except for the GlyNAC supplementation. This tells us that benefits were due to GlyNAC supplementation. But we were really surprised to see so many aging hallmarks improve. This level of improvement offers clues as to how and why these aging hallmarks may be connected to one another, says Sekhar.

GlyNAC improves muscle strength in aging

GlyNAC supplementation improved muscle strength in the upper and lower extremity and a trend toward increased exercise capacity. These findings could have additional implications for improving the health of older humans, especially in terms of being able to be more physically active, said Sekhar.

This study was effort intensive and took many years to complete. I take this opportunity to thank all my co-investigators, nursing staff, and everyone who helped with this trial. I especially thank all the trial participants who volunteered to participate in this research, Sekhar said.

Sekhar led the study team consisting of Premranjan Kumar, Chun Liu, James Suliburk, Jean W. Hsu, Raja Muthupillai, Farook Jahoor, Charles G. Minard and George E. Taffet, all at Baylor College of Medicine. For this trial, Sekhar received funding support from the National Institutes of Health/National Institute of Aging, and philanthropic support from the McNair Medical Institute at the Robert and Janice McNair Foundation in Houston, TX.

Baylor College of Medicine holds a patent on GlyNAC, which has been licensed to Nestl Health Science. GlyNAC is marketed in the United States by Nestl Health Science under the name CelltrientTM Cellular Protect. Nestl Health Science did not provide financial or material support for this research work.

As he moves forward, Sekhar plans to expand on his work to understand more about the health benefits of GlyNAC supplementation on cells, tissues and organs of the body. He plans on seeking funding to conduct larger clinical trials in more typical older humans to increase our understanding of how GlyNAC could improve health in aging. Additionally, as reported in their previously published exploratory study, Sekhars group found that GlyNAC supplementation in older humans could improve memory and cognition. He has studied this further in aged mice and found that GlyNAC supplementation appears to correct multiple age-related declines directly in the brain, and was associated with improvements in memory and brain health a report on these emerging new and exciting findings is in development.

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GlyNAC supplementation reverses aging hallmarks in aging humans - Baylor College of Medicine News

Bluebird Bios first gene therapy for rare blood disease wins FDA approval – The Boston Globe

Zynteglo could change that by providing a healthy copy of the essential beta-globin gene to blood stem cells, allowing their bodies to make healthy blood cells and eliminate the need for regular transfusions. In clinical trials, about 90 percent of patients who got the one-time therapy no longer needed transfusions to treat their disease.

Dr. David A. Williams, chief of hematology/oncology at Boston Childrens Hospital, was impressed with the effectiveness of the therapy. This is clearly very clinically meaningful for the patients, he said.

Before Zynteglos approval, stem cell transplants were the only potentially curative options for people with beta thalassemia, but many people with the condition are unable to find a genetically-matched donor. Doctors who treat people with the condition were excited by the approval of Zynteglo.

This is really huge. The idea that now you have the option of a curative therapy for all patients is enormous, said Dr. Sujit Sheth, chief of the division of pediatric hematology/oncology at Weill Cornell Medicine.

Sheth noted that stem cell transplants carry the risk of immune rejection, which can be deadly. You have a far lower risk of complications from getting your own cells back than if youre getting it from someone else, he said.

Bluebird estimates that there are as many as 1,500 people with transfusion-dependent beta thalassemia in the United States. Thomas Klima, the firms chief commercial officer, told the Globe that as many as 850 of them may qualify for Zynteglo.

The firm expects about one-third of those patients to be pretty eager to get therapy, Klima added. Another third may need more information and time to think it over, and the final third may consider their current transfusion treatments fine.

Despite the relatively modest numbers of patients who may get the therapy, the approval is a major win for Bluebird, which has faced a series of troubles over the past few years that brought its stock falling about 98 percent from its peak in 2018. The firm said it would lay off 30 percent of its employees in April and warned investors it only had enough cash to last until the first half of 2023.

Over the last year we faced so many challenges, Klima said. But the group thats here now and the group thats getting ready to launch our gene therapies couldnt be more thrilled.

The therapy is made from a patients own blood stem cells collected during a hospital visit and shipped to the contract manufacturing firm Lonza, just south of Houston, TX. Once there, scientists will treat the cells with Bluebirds gene therapy, made from a lentivirus that shuttles the beta-globin gene into the cells.

After a quality check, cells are shipped back to the hospital. Before getting the altered cells infused, a patient must undergo chemotherapy to clear out space in their bone marrow for the new cells to engraft. Once they take hold, they will make new healthy red blood cells for years, potentially indefinitely.

Craig Butler, national executive director of the Cooleys Anemia Foundation a nonprofit patient organization for thalassemia is excited for people to have an alternative to time-consuming transfusions.

Its usually a full day process for someone, which means that theyre missing a day of work or a day of school, he said. The approval of Zynteglo means that they will no longer have to be bound to transfusions for the rest of their lives.

Wanda Sihanath, 26, was one of the first people to get the therapy in a clinical trial in 2014. She hasnt needed a transfusion in over eight years. It feels like really great not to be tethered to hospital and having to check in at least once a month, she said.

Sihanath, who lives in San Jose, was excited to hear that Zynteglo is approved. I am super stoked, she said, and is hopeful that the therapy will help untether people from regular hospital visits.

But the chemotherapy Sihanath got to prepare her body for the gene therapy may have affected her fertility, and she wishes she would have sought a little more counseling about getting the procedure at a young age. Doctors say that some young people may wish to hold off on getting the therapy.

The therapy will only be offered at a small number of centers across the United States, including at Boston Childrens Hospital.

Colleen Dansereau, the hospitals director of clinical operations of the gene therapy program, anticipates that the hospital will be ready to start the treatment procedure for a patient by September. But she anticipates it could take longer for Bluebird to get ready and for insurers to guarantee payment for the therapy.

Boston Childrens regularly provides transfusions for about 45 people with the condition, plus additional patients referred from other centers, Dansereau said.

The hospital may end up treating additional patients with beta thalassemia from other parts of the world where the disease is more prevalent, including the Middle East and Southeast Asia, Dansereau added. We anticipate that we could have an increase in our international services for this particular product.

Zynteglo is the third gene therapy approved by the FDA. The Roche gene therapy Luxturna, which treats a genetic eye disease, was approved in 2017 with a price tag of $850,000. The Novartis gene therapy Zolgensma, which treats spinal muscular atrophy, was approved in 2019 with a cost of $2.1 million. The FDA could approve a fourth gene therapy, also made by Bluebird, in September.

Ryan Cross can be reached at ryan.cross@globe.com. Follow him on Twitter @RLCscienceboss.

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Bluebird Bios first gene therapy for rare blood disease wins FDA approval - The Boston Globe

Molecular Map Reveals Insights Into the Genetic Drivers of CLL – The ASCO Post

By The ASCO Post Staff Posted: 8/16/2022 2:43:00 PM Last Updated: 8/16/2022 3:15:33 PM

A newly constructed map of the landscape of genetic changes in chronic lymphocytic leukemia (CLL) may provide a better understanding of this complex malignancy that could lead to more accurate prognoses for patients, improved diagnostics, and novel treatments. These research findings were published by Knisbacher et al in Nature Genetics, and the study was conducted by an international collaboration of investigators, including teams from the Mass General Cancer Center, the Dana-Farber Cancer Institute, and the Broad Institute of MIT and Harvard.

CLL exists as either a slowly or rapidly growing cancer and has been linked to certain genetic mutations, but it has yet to be fully characterized. Previous analyses have provided only fragments of a CLL map, each focusing on particular types of patients or limited data. To provide a more thorough understanding of the biological underpinnings of CLL and its molecular subtypes, scientists set out to construct a map from the largest CLL data set to date. To build the CLL map, the team analyzed variations in genetic sequences, gene-expression patterns, and chemical modifications to DNAor genomic, transcriptomic, and epigenomic datafrom 1,148 patients.

Such a CLL map could eventually be leveraged in the clinic, wherein the genomic features of new patients can be compared with the treatments and outcomes of patients with similar genetic profiles, said co-senior and co-corresponding author Catherine Wu, MD, Chief of the Division of Stem Cell Transplantation and Cellular Therapies at Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. This profiling could potentially help more accurately tailor prognosis and treatment of a new patient based on their particular molecular features, getting closer to precision medicine.

Key Findings

The scientists identified 202 genes109 of which were novelthat when mutated, could potentially drive CLL, and they refined the characterization of subtypes of CLL with distinct genomic characteristics and prognoses. Beyond genetic sequences, the expression patterns of certain genes further subcategorized CLL and provided valuable prognostic information.

Our study has revealed that the genetic and biologic landscape of CLL is more complex than previously appreciated, said co-senior and co-corresponding author Gad Getz, PhD, Director of Bioinformatics at the Mass General Cancer Center and Director of the Cancer Genome Computational Analysis group at the Broad Institute. Patients clinical outcomes were associated with a combination of genomic, transcriptomic, and epigenomic featuresintegrating these data could predict a patients likelihood of experiencing remission vs developing more advanced cancer.

We are releasing a CLL map portal that is based on the CLL map and will be an interactive website for translational researchers to use as a resource for further investigationsuch as learning more about the different drivers and subtypes of CLL, said Dr. Getz.

Disclosure: This work was supported by the National Institutes of Health and the Broad/IBM Cancer Resistance Research Project. For full disclosures of the study authors, visit nature.com.

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Molecular Map Reveals Insights Into the Genetic Drivers of CLL - The ASCO Post

MESO NUMISMATICS, INC. Management’s Discussion and Analysis of Financial Condition and Results of Operations (form 10-Q) – Marketscreener.com

Forward-Looking Statements

Certain statements, other than purely historical information, including estimates, projections, statements relating to our business plans, objectives, and expected operating results, and the assumptions upon which those statements are based, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements generally are identified by the words "believes," "project," "expects," "anticipates," "estimates," "intends," "strategy," "plan," "may," "will," "would," "will be," "will continue," "will likely result," and similar expressions. We intend such forward-looking statements to be covered by the safe-harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995, and are including this statement for purposes of complying with those safe-harbor provisions. Forward-looking statements are based on current expectations and assumptions that are subject to risks and uncertainties which may cause actual results to differ materially from the forward-looking statements. Our ability to predict results or the actual effect of future plans or strategies is inherently uncertain. Factors which could have a material adverse effect on our operations and future prospects on a consolidated basis include, but are not limited to: changes in economic conditions, legislative/regulatory changes, availability of capital, interest rates, competition, cybersecurity, and generally accepted accounting principles. These risks and uncertainties should also be considered in evaluating forward-looking statements and undue reliance should not be placed on such statements. We undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Further, information concerning our business, including additional factors that could materially affect our financial results, is included herein and in our other filings with the SEC.

Since the acquisition of Global Stem Cell Group in August last year, our focus has been mainly dedicated to its operations serving the markets in the regenerative medicine industry. We still have numismatics operation, but the overall plan for the company is too move from the sale of coins, paper currency, bullion and medals into what we believe is a more lucrative opportunity for our company.

We work with doctors and their staff to provide products, solutions, equipment, services, and training to help them be successful in the application of Stem Cell Therapies. Our team combines solutions from extensive clinical research with the manufacturing and commercialization of viable cell therapy and immune support related products that we believe will change the course of traditional medicine around the world forever. Our strategy allows us the ability to create immediate revenue streams through product sales, distribution, and clinical applications, driven by our extensive education platform. Our revenue comes directly from the training and the seminars, from the resale of these kits, products, and equipment, services, and from the reoccurring application of our process using the kits and solutions we provide.

Global Stem Cells Group is a leader in the Stem Cell and Regenerative Medicine fields, covering clinical research, patient applications, along with physician training through our state-of-the-art global network of companies. The Company's mission is to enable physicians to make the benefits of stem cell medicine a reality for patients around the world. They have been educating doctors on the science and application of cell-based therapeutics for the past 10 years. Our professional trademarked association "ISCCA" INTERNATIONAL SOCIETY FOR STEM CELL APPLICATION is a global network of medical professionals that leverages these multinational relationships to build best practices and further our mission.

The Company envisions the ability to improve "health-span" through the discovery and developments of new cellular therapy products, and cutting-edge technology.

Global Stem Cells Group, as almost everyone else in the world, was severely affected by the covid 19 pandemic. As we look to recover in 2022, we are integrating every aspect of the regenerative medicine industry. During 2022, we plan to add manufacturing and commercialization of viable cell therapy and immune support related products that we believe will change the course of traditional medicine around the world forever.

We believe this strategy will allow us the ability to increase our current revenues and create immediate revenue streams through product sales, distribution, and clinical applications, driven by our extensive education platform here are our main projects and revenue generators for 2022 and beyond.

Results of Operations for the Three Months Ended June 30, 2022 and 2021.

Revenue increased by 1,831% in the amount of $288,752 for the three months ended June 30, 2022, compared to the same period in 2021. The key reason for the increase in revenue was a result of the acquisition of Global Stem Cells Group, Inc. on August 18, 2021. Revenue from viable cell therapy and immune support related products along with physician training was $297,521 and a decrease in sale of coins, metals and paper money of $8,769 for the three months ended June 30, 2022, compared to the same period in 2021.

Listed below are the revenues, cost of revenues and gross profits by Company for the three months ended June 30, 2022:

We expect to increase our revenues in future quarters from our operations associated with Global Stem Cells with less expected revenues in future quarters associated with our numismatic operations.

Operating expenses increased by 99% in the amount of $255,634 for the three months ended June 30, 2022, compared to the same period in 2021. Listed below are the major changes to operating expenses:

Advertising and marketing fees increased by $80,817 for the three months ended June 30, 2022, compared to the same period in 2021, primarily due to the acquisition of Global Stem Cells Group, Inc. on August 18, 2021.

Depreciation and amortization increased by $35,125 for the three months ended June 30, 2022, compared to the same period in 2021, primarily due to completion of Cancun lab in May 2022.

General and administrative expense increase by $125,359 for the three months ended June 30, 2022, compared to the same period in 2021, primarily due to the acquisition of Global Stem Cells Group, Inc. on August 18, 2021.

Other expense increased by $456,085 for the three months ended June 30, 2022, compared to the same period in 2021, primarily as a result of the increase in interest on promissory notes. During the six months ended June 30, 2021, we received $11,400,000 in proceeds received from the issuance of promissory notes. We expect other expense to increase in future quarters as a result of the interest on the new debt.

We recorded a net loss of $1,493,065 for the three months ended June 30, 2022, as compared with a net loss of $926,077 for the same in 2021.

Results of Operations for the Six Months Ended June 30, 2022 and 2021.

Revenue increased by 2,941% in the amount of $594,387 for the six months ended June 30, 2022, compared to the same period in 2021. The key reason for the increase in revenue was a result of the acquisition of Global Stem Cells Group, Inc. on August 18, 2021. Revenue from viable cell therapy and immune support related products along with physician training was $596,270 and a decrease in sale of coins, metals and paper money of $1,883 for the six months ended June 30, 2022, compared to the same period in 2021.

Listed below are the revenues, cost of revenues and gross profits by Company for the six months ended June 30, 2022:

We expect to increase our revenues in future quarters from our operations associated with Global Stem Cells with less expected revenues in future quarters associated with our numismatic operations.

Operating expenses increased by 190% in the amount of $761,900 for the six months ended June 30, 2022, compared to the same period in 2021. Listed below are the major changes to operating expenses:

Advertising and marketing fees increased by $135,194 for the six months ended June 30, 2022, compared to the same period in 2021, primarily due to the acquisition of Global Stem Cells Group, Inc. on August 18, 2021.

Professional fees increased by $262,824 for the six months ended June 30, 2022, compared to the same period in 2021, primarily due to audit and accounting expenses.

Depreciation and amortization increased by $61,902 for the six months ended June 30, 2022, compared to the same period in 2021, primarily due to completion of Cancun lab in May 2022.

General and administrative expense increase by $216,667 for the six months ended June 30, 2022, compared to the same period in 2021, primarily due to the acquisition of Global Stem Cells Group, Inc. on August 18, 2021.

Other expense increased by $1,271,308 for the six months ended June 30, 2022, compared to the same period in 2021, primarily as a result of the increase in interest on promissory notes. During the six months ended June 30, 2021, we received $11,400,000 in proceeds received from the issuance of promissory notes. We expect other expense to increase in future quarters as a result of the interest on the new debt.

We recorded a net loss of $3,170,029 for the six months ended June 30, 2022, as compared with a net loss of $1,398,384 for the same in 2021.

Liquidity and Capital Resources

Since inception, the Company has financed its operations through private placements and convertible notes. The following is a summary of the cash and cash equivalents as of June 30, 2022 and December 31, 2021.

Edgar Online, source Glimpses

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MESO NUMISMATICS, INC. Management's Discussion and Analysis of Financial Condition and Results of Operations (form 10-Q) - Marketscreener.com