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Is Regen BioPharma a Good Investment? – Value the Markets

Regen BioPharma recently filed a patent related to a mRNA cancer immunotherapeutic vaccine. Does the market growth potential make RGBP a good investment opportunity?

Oncology stock Regen BioPharma (OTCMKTS: RGBP) is a penny stock listed on the OTC pink market.

Regen BioPharma, Inc focuses on the development of translational medicine platforms for the commercialization of stem cell therapies. The company aims to obtain regulatory approval and execute clinical trials in cell therapy. Regen BioPharma develops medicines for diabetes, heart-related illness, circulatory issues, and Chronic Obstructive Pulmonary Disease (COPD).

The company actively identifies small molecules that inhibit or express NR2F6 leading to immune cell activation for oncology applications and immune cell suppression for autoimmune diseases.

Regen BioPharma is in the early stages of developing its products and therapies. The business was incorporated in 2012 and is based in La Mesa, California.

Regen has identified and filed patents on small molecules that activate and inhibit a novel gene (NR2F6) which controls how the immune system reacts to cancer cells and inflammatory responses.

Its progress is currently pre-clinical, so commercialization is a long way off.

The conditions Regen hopes its investigations will eventually be able to address include:

Initial indications (inhibitor): bladder cancer, myelodysplastic syndrome, lung cancer

Initial indications (activator): rheumatoid arthritis, inflammatory bowel disease, psoriasis

Additional indications include solid tumors, acute leukemia and GVHD

Regen currently has the following products in its pipeline:

HemaXellerate: Cleared to proceed to Phase I/II clinical trials (stimulates blood production in patients whose bone marrow is not correctly functioning)

dCellVax: a breast cancer therapy (a dendritic cell-based immunotherapy that stimulates the patient's immune system)

DiffronC: a novel form of therapy called differentiation therapy that is expected to have much milder toxicity than chemotherapy.

For the quarterly period ended June 30, 2022

Revenues: $31.2k (up 6.8% Y/Y)

Total Revenues: $58.7k (up 3.7% Y/Y)

Operating Loss: -$58.9k (from -$42.4k Y/Y)

Between September 2021 and June 2022, Regen saw its cash decline by 85%. This is primarily due to paying off debts and using cash to fund the business.

Regen BioPharma is expected to report its Fiscal Year 2022 results on December 22, 2022.

RGBP stock has five billion shares outstanding.

On July 19, 2022, Regen BioPharma issued 54.5 million shares to Coventry Enterprises LLC to settle $180.5k in convertible debt.

On August 9, 2022, KCL Therapeutics, Inc. (a wholly owned subsidiary of Regen BioPharma) filed a provisional patent application with the US Patent and Trademark Office covering Regen's novel approach for enabling chimeric antigen receptor (CAR)-T cell-based therapies to kill solid tumors through prevention of a process called "T cell exhaustion." T cells are part of the immune system and develop from stem cells in the bone marrow.

Regen BioPharma's patent application protects the use of its patented survivin mRNA both as a stand-alone vaccine and as an immunotherapy.

David Koos, Chairman and CEO of Regen BioPharma, commented:

The currently filed application discloses means of significantly increasing efficacy by combining modified-mRNA with unique cellular immunotherapy as well as adjuvant approaches,

CAR-T cells have been in the clinic for 6 years, but they have hardly made a dent in treating solid tumors,

We hope that through the diligent work of our scientists and collaborators that advancements such as what we announced today will pave the way to bring this incredible cellular immunotherapy to patients suffering from solid tumors such as lung, colon, prostate and others.

Regen BioPharma is not profitable but makes a small income from royalties and anniversary fees under license agreements.

The company holds shares in Oncology Pharma (OTCMKTS: ONPH) and Zander Therapeutics.

Zander Therapeutic has been granted an exclusive license to develop and commercialize IP controlled by Regen BioPharma for non-human veterinary therapeutic use.

Meanwhile, Regen has granted an exclusive license to Oncology Pharma, Inc. to develop and commercialize "Antigen specific mRNA cellular cancer vaccines" for treating pancreatic cancer.

And KCL Therapeutics, Inc. has granted an exclusive license to Oncology Pharma, Inc. to develop and commercialize certain intellectual property for the treatment of colon cancer.

David Koos, Chairman and CEO of Regen BioPharma, said:

We are very proud of our broad, deep and cutting-edge patent portfolio,

We are continuing to develop additional IP focused on immunotherapy of cancer and look forward to developing some of these technologies in-house and some of them via outlicensing.

RGBP stock has a price-to-earnings ratio (P/E) of 48.7. Its price-to-book-value (P/BV) is negative, which means it owes more than it owns. RGBP stock does not come with a shareholder dividend.

Over the past year, Regen BioPharma Inc (RGBP) has traded between $0 and $0.08. Today the stock trades at $0.0096 and has a market cap of $48m.

Year-to-date, the RGBP stock price is down by -50%, while the S&P 500 is down -13.73% over the same period.

Furthermore, on August 22, 2022, Regen BioPharma (RGBP-US) closed down -86.3% off its 52-week high vs. the subsector average change of -39.4%.

Regen BioPharma plans to rapidly advance novel technologies through pre-clinical and Phase I/ II clinical trials. If it can successfully advance its small molecule therapies for treating cancer and autoimmune disorders, the addressable market is significant, and it could potentially make money.

Immunotherapy of cancer represents a vast market currently being led by the class of drugs called "checkpoint inhibitors" and "CAR-T" cells. To date, there is no mRNA immunotherapy available for treating cancer.

A stock with a beta higher than 1.0 is expected to be more volatile than the S&P 500. RGBP stock has a beta of 3.75, which accurately reflects its volatile nature.

Its price-to-book-value (P/BV) is negative, meaning it owes more than it owns.

RGBP common stock is a "penny stock," and therefore comes with the associated risk in dealing in penny stocks, such as lack of liquidity.

The economy is experiencing a period of high inflation, which could lead to interest rate rises and/or a recession. This is not conducive to raising funds at favorable rates and could adversely affect the company's ability to raise the money needed to conduct its research and trials.

There is a lack of liquidity in trading a stock such as Regen BioPharma. Therefore, there will probably be a large spread between the bid and ask price of RGBP shares. This means if you want to sell your shares in a hurry, you may not get a reasonable price for them.

Furthermore, the company has a history of issuing additional stock, which dilutes existing shareholder value.

Regen BioPharma stock seems like a hugely speculative investment with a lot of shareholder risk in the current investing environment.

Author: Kirsteen Mackay

This article does not provide any financial advice and is not a recommendation to deal in any securities or product. Investments may fall in value and an investor may lose some or all of their investment. Past performance is not an indicator of future performance.

Kirsteen Mackay does not hold any position in the stock(s) and/or financial instrument(s) mentioned in the above article.

Kirsteen Mackay has not been paid to produce this piece by the company or companies mentioned above.

Digitonic Ltd, the owner of ValueTheMarkets.com, does not hold a position or positions in the stock(s) and/or financial instrument(s) mentioned in the above article.

Digitonic Ltd, the owner of ValueTheMarkets.com, has not been paid for the production of this piece by the company or companies mentioned above.

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Is Regen BioPharma a Good Investment? - Value the Markets

Scientists use stem cells to create synthetic mouse embryos – ABC News

Scientists have created synthetic mouse embryos from stem cells without a dad's sperm or a mom's egg and womb

ByLAURA UNGAR AP Science Writer

Scientists have created synthetic mouse embryos from stem cells without a dad's sperm or a mom's egg or womb.

The lab-created embryos mirror a natural mouse embryo up to 8 days after fertilization, containing the same structures, including one like a beating heart.

In the near term, researchers hope to use these so-called embryoids to better understand early stages of development and study mechanisms behind disease without the need for as many lab animals. The feat could also lay the foundation for creating synthetic human embryos for research in the future.

We are undoubtedly facing a new technological revolution, still very inefficient but with enormous potential, said Llus Montoliu, a research professor at the National Biotechnology Centre in Spain who is not part of the research. It is reminiscent of such spectacular scientific advances as the birth of Dolly the sheep and others.

A study published Thursday in the journal Nature, by Magdalena Zernicka-Goetz at the California Institute of Technology and her colleagues, was the latest to describe the synthetic mouse embryos. A similar study, by Jacob Hanna at the Weizmann Institute of Science in Israel and his colleagues, was published earlier this month in the journal Cell. Hanna was also a coauthor on the Nature paper.

Zernicka-Goetz, an expert in stem cell biology, said one reason to study the early stages of development is to get more insight into why the majority of human pregnancies are lost at an early stage and embryos created for in vitro fertilization fail to implant and develop in up to 70% of cases. Studying natural development is difficult for many reasons, she said, including the fact that very few human embryos are donated for research and scientists face ethical constraints.

Building embryo models is an alternative way to study these issues.

To create the synthetic embryos, or embryoids, described in the Nature paper, scientists combined embryonic stem cells and two other types of stem cells all from mice. They did this in the lab, using a particular type of dish that allowed the three types of cells to come together. While the embryoids they created werent all perfect, Zernicka-Goetz said, the best ones were indistinguishable from natural mouse embryos. Besides the heart-like structure, they also develop head-like structures.

This is really the first model that allows you to study brain development in the context of the whole developing mouse embryo, she said.

The roots of this work go back decades, and both Zernicka-Goetz and Hanna said their groups were working on this line of research for many years. Zernicka-Goetz said her group submitted its study to Nature in November.

Scientists said next steps include trying to coax the synthetic mouse embryos to develop past 8 days with the eventual goal of getting them to term, which is 20 days for a mouse.

At this point, they struggle to go past the 8 1/2-day mark, said Gianluca Amadei, a coauthor on the Nature paper based at the University of Cambridge. We think that we will be able to get them over the hump, so to speak, so they can continue developing.

The scientists expect that after about 11 days of development the embryo will fail without a placenta, but they hope researchers can someday also find a way to create a synthetic placenta. At this point, they don't know if they will be able to get the synthetic embryos all the way to term without a mouse womb.

Researchers said they dont see creating human versions of these synthetic embryos soon but do see it happening in time. Hanna called it the next obvious thing.

Other scientists have already used human stem cells to create a blastoid, a structure mimicking a pre-embryo, that can serve as a research alternative to a real one.

Such work is subject to ethical concerns. For decades, a 14-day rule on growing human embryos in the lab has guided researchers. Last year, the International Society for Stem Cell Research recommended relaxing the rule under limited circumstances.

Scientists stress that growing a baby from a synthetic human embryo is neither possible nor under consideration.

Perspective on this report is important since, without it, the headline that a mammalian embryo has been built in vitro can lead to the thought that the same can be done with humans soon, said developmental biologist Alfonso Martinez Arias of the Universitat Pompeu Fabra in Spain, whose group has developed alternative stem cell based models of animal development.

"In the future, similar experiments will be done with human cells and that, at some point, will yield similar results," he said. "This should encourage considerations of the ethics and societal impact of these experiments before they happen.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Department of Science Education. The AP is solely responsible for all content.

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Scientists use stem cells to create synthetic mouse embryos - ABC News

Dr. Lin on Patient Eligibility for CAR T-cell Therapy in Hematologic Caners – OncLive

Yi Lin, MD, PhD, discusses patient eligibility for CAR T-cell therapy in hematologic cancers.

Yi Lin, MD, PhD, hematologist, oncologist, Department of Hematology, CAR T-Cell Therapy Program, Mayo Clinic, discusses patient eligibility for CAR T-cell therapy in hematologic cancers.

Many oncologists have experience referring patients for stem cell transplant, and referring patients for CAR T-cell therapy can work in a similar fashion, though it may be more beneficial since CAR T-cell therapy can be effective in patients with active disease, Lin explains. When referring patients to CAR T-cell therapy, it is important to consider a patients number of prior lines of therapy, their comorbidities, and organ function, Lin adds.

Though clinical trials evaluating CAR T-cell therapies in hematologic malignancies have strict parameters, it can be difficult for many patients to fall inside all of those parameters in real-world practice, Lin continues. In reports on real-world data for patients with leukemia or lymphoma who received CAR T-cell therapy, approximately half of patients treated fall outside of at least 1 parameter that was used for CAR T-cell therapies in clinical trials, Lin notes.

Through coordination between clinicians and the CAR T-cell therapy team, patients who fall outside the parameters used in clinical trials can still have comparable outcomes from CAR T-cell therapy, Lin concludes.

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Dr. Lin on Patient Eligibility for CAR T-cell Therapy in Hematologic Caners - OncLive

Higher Doses of CAR T-Cell Therapy May Improve Survival for Young Patients With B-Cell ALL – The ASCO Post

By The ASCO Post Staff Posted: 8/16/2022 10:52:00 AM Last Updated: 8/16/2022 3:13:09 PM

Young people with B-cell acute lymphoblastic leukemia (ALL) who received doses of tisagenlecleucel, a chimeric antigen receptor (CAR) T-cell therapy, at the higher end of the approved dosing range had significantly better survival rates at 1 year compared with those who received lower doses within this range, according to research published by Stefanski et al inBlood Advances.

Since its approval as the first gene therapy available in the United States in 2017, tisagenlecleucel has offered a welcome treatment option for pediatric patients with B-cell ALL whose cancer does not respond to chemotherapy or recurs after prior response. However, the wide dosing range approved for the therapy can pose a conundrum for doctors who sometimes must choose whether to use a higher or lower dose with little evidence to guide these decisions. This new study offers the first insights into optimal dosing based on real-world data.

In the past, we did not have data to guide clinical decisions around commercial CAR T-cell dosing and didnt know if higher doses would affect toxicity and compromise outcomes, or support enhanced antileukemia effect, said Liora Schultz, MD, a pediatric oncologist at the Stanford Children's HealthLucile Packard Children's Hospital and the studys lead author. [These data have] direct clinical applicability, as it supports use of higher dosing, as available, within the approved tisagenlecleucel dose range.

More About B-Cell ALL and Tisagenlecleucel

ALL is the most common type of cancer in children, and B-cell ALL is its most common subtype. It is often treatable with chemotherapy, but about 20% of patients either do not respond to chemotherapy or subsequently relapse. CAR T-cell therapy is becoming an integral part of standard care as an alternative or supplement to stem cell transplantation for pediatric patients with relapsed or refractory B-cell ALL.

Tisagenlecleucel is approved at a dosing range of 0.2 to 5 million CAR T cells/kg for patients weighing 50 kg or less, or 10 to 250 million CAR T cells for patients weighing over 50 kg. In practice, the number of CAR T cells that are manufactured for each patient varies substantially based on the number of T cells that are obtained initially and the rate at which the modified cells grow in the laboratory.

Any amount of CAR T cells within the approved range is considered an acceptable dose, but if more than the minimum number of cells are available within the approved range, doctors can decide whether to use a higher amount or a lower amount. Clinical trials for tisagenlecleucel provided guidance on dosing leading to the therapys approval, but real-world data are useful to fine-tune dosing and inform decision-making when there are multiple options available.

Study Details

For the study, researchers analyzed rates of overall survival, event-free survival, and relapse-free survival at 1 year among 185 patients aged 26 years or younger who received tisagenlecleucel for relapsed or refractory B-cell ALL. They found that patients who received a dose at the higher end of the approved range (between 2.4 and 5.1 million cells/kg) had significantly higher survival rates according to all three measures compared with patients who received a dose at the lower end (between 0 and 1.3 million cells/kg). In the highest-dose group, 86% of patients were alive at 1 year, compared to 59% in the lowest-dose group. Researchers did not observe any signs of increased toxicity or safety concerns with higher doses.

The findings suggest that administering doses of tisagenlecleucel at the higher end of the approved range could help to achieve a more effective and long-term responsewithout raising the toxicity risk.

A lot of effort is focused on complex engineering and development of next-generation CAR T-cell therapies, said Dr. Schultz. This study aims to explore if clinical manipulations using our current approved construct, tisagenlecleucel, can achieve even incremental advances in the field.

The researchers plan to further examine the data to determine how additional clinical variables might influence outcomes following CAR T-cell therapy.

Disclosure: For full disclosures of the study authors, visit ashpublications.org/bloodadvances.

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Higher Doses of CAR T-Cell Therapy May Improve Survival for Young Patients With B-Cell ALL - The ASCO Post

Haematopoietic Stem Cell Gene Therapy in IEM – Physician’s Weekly

Due to donor-derived cells capacity to deliver enzymes to enzyme-deficient tissues and organs for the rest of ones life, allogeneic hematopoietic stem cell transplantation (allo-HSCT) has become widely used as a therapeutic approach for many inborn errors of metabolism (IEM) over the past 30 years. However, patients who have IEM were the only ones who could clinically benefit from allo-HSCT, patients still had a large burden from their residual illness, and allo-HSCT was still linked to severe short- and long-term toxicities as well as transplant-related death.

In the 1990s, hematopoietic stem/progenitor cell gene therapy (HSPC-GT) was developed for the treatment of a few monogenic primary immunodeficiencies, and in recent years, its use has expanded to include a number of IEM. Gene-corrected hematopoietic progenitors could provide supra-physiological enzyme levels to hard-to-reach regions, such as the brain and skeleton, with a possible improved therapeutic effect. This made HSPC-GT particularly appealing in neurodegenerative IEM.

Furthermore, HSPC-GT had lower rates of morbidity and death than allo-HSCT, albeit it must be weighed against the chance of insertional mutagenesis. Clinical trials in the IEM sector were multiplying quickly, and certain HSPC-GT items had just lately been given the go-ahead. In contrast to tried-and-true treatment approaches like allo-HSCT, the review discussed the development of ex vivo HSPC-GT in a variety of IEM with an emphasis on current findings from GT clinical trials and risks vs. benefits considerations.

Reference: onlinelibrary.wiley.com/doi/10.1111/bjh.18179

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Haematopoietic Stem Cell Gene Therapy in IEM - Physician's Weekly

Reprogramming the Brain’s Cleaning Crew to Mop Up Alzheimer’s Disease – Weill Cornell Medicine Newsroom

The discovery of how to shift damaged brain cells from a diseased state into a healthy one poses a new potential path to treating Alzheimers and other forms of dementia, according to a new collaborative study from researchers at UC San Francisco and Weill Cornell Medicine.

The research focuses on microglia, cells that stabilize the brain by clearing out damaged neurons and the protein plaques often associated with dementia and other brain diseases.

These cells are understudied, despite the fact that changes in them are known to play a significant role Alzheimer's and other brains diseases, said Dr. Martin Kampmann, associate professor at the Institute for Neurodegenerative Diseases in the UCSF Weill Institute for Neurosciences and co-senior author on the study, which appears Aug. 11 in Nature Neuroscience.

We were able to overcome limitations in microglia research by building a new platform to generate microglia in the lab using inducible stem cells, said co-senior author Dr. Li Gan, director of the Helen and Robert Appel Alzheimers Disease Research Institute and the Burton P. and Judith B. Resnick Distinguished Professor in Neurodegenerative Diseases in the Feil Family Brain and Mind Research Institute at Weill Cornell Medicine.

Now, using a new CRISPR method we developed, we can uncover how to actually control these microglia, to get them to stop doing toxic things and go back to carrying out their vitally important cleaning jobs, Dr. Kampmann said. This capability presents the opportunity for an entirely new type of therapeutic approach.

Most of the genes known to increase risk for Alzheimers disease act through microglial cells, making it clear that they can have a big effect on how such neurodegenerative diseases play out, said Dr. Kampmann.

This makes sense because microglia act as the brains immune system. Ordinary immune cells cant cross the blood-brain barrier, so its the task of healthy microglia to clear out waste and toxins, keeping neurons functioning at their best. When microglia start losing their way, the result can be brain inflammation and damage to neurons and the networks they form.

Under some conditions, for example, microglia will start removing synapses between neurons. While this is a normal part of brain development in a persons childhood and adolescent years, it can have disastrous effects in the adult brain.

Over the past five years or so, many studies have observed and profiled these varying microglial states but havent been able to characterize the genetics behind them.

Dr. Kampmann and his team wanted to identify exactly which genes are involved in specific states of microglial activity, and how each of those states are regulated. With that knowledge, they could then flip genes on and off, setting wayward cells back on the right track.

Accomplishing that task required getting around some fundamental obstacles that have prevented researchers from being able to control gene expression in these cells. For example, microglia are very resistant to the most common CRISPR technique, which involves getting the desired genetic material into the cell by using a virus to deliver it.

To overcome this obstacle, Dr. Gan and Dr. Kampmann teamed up to coax stem cells donated by human volunteers to become microglia and confirmed that these cells function like their ordinary human counterparts.

By providing the stem cells with a road map, we gave them a fast track to become microglia in a week, a process that usually takes over a month, said Dr. Gan.

The team then developed a new platform that combines a form of CRISPR that enables researchers to turn individual genes on and off (which Kampmann had a significant hand in developing), with readouts of data that indicate functions and states of individual microglia cells.

Through this analysis, the team was able to pinpoint genes that effect the cells ability to survive and proliferate, how actively a cell produces inflammatory substances, and how aggressively a cell prunes synapses.

Beyond that, because the scientists had determined which genes control those activities, they were able to reset genes, flipping the cell from a diseased state to a healthy one.

Armed with this new technique, the next step is to investigate how to control the relevant states of microglia, targeting the cells with existing pharmaceutical molecules and testing them in preclinical models. The ultimate goal is to identify specific molecules that act on the genes necessary to nudge diseased cells back to healthy states.

Many Weill Cornell Medicine physicians and scientists maintain relationships and collaborate with external organizations to foster scientific innovation and provide expert guidance. The institution makes these disclosurespublic to ensure transparency. For this information, see profile for Dr. Li Gan.

The original version of this story appeared in the UCSF newsroom.

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Reprogramming the Brain's Cleaning Crew to Mop Up Alzheimer's Disease - Weill Cornell Medicine Newsroom

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