Monthly Archives: July 2022

Researchers lift the veil on stubborn probiot – EurekAlert

Posted: July 19, 2022 at 2:46 am

image:Rodolphe Barrangou and Echo Pan manipulate good bacteria using CRISPR systems. view more

Credit: Marc Hall, NC State University

New North Carolina State University research shows progress in gathering information on an important yet difficult to characterize human gut bacterium called Bifidobacterium, which is used in many probiotics that help maintain healthy microbiomes. The findings hold promise to help make so-called good bacteria even better.

As our lab expands and diversifies the types of good bacteria that we work with, we turn to more finicky bacteria, like Bifidobacterium, said Rodolphe Barrangou, the Todd R. Klaenhammer Distinguished Professor of Food, Bioprocessing and Nutrition Sciences at NC State and corresponding author of a paper describing the research published today in Proceedings of the National Academy of Sciences. This bacterium is harder to grow and harder to work with than others, but we were able to make some important discoveries and understand more about the bacteriums genetic basis for its health-promoting functionalities.

Bifidobacterium is one of the two main players in the probiotic industry along with Lactobacillus and is particularly dominant in the colon of infants, said Meichen (Echo) Pan, an NC State Ph.D. student and first author of the paper. But it is much more difficult to manipulate compared to Lactobacillus.

NC State researchers used both the bacteriums internal CRISPR-Cas system as well as a portable engineered CRISPR effector to make their findings. CRISPR-Cas systems are adaptive immune systems that allow bacteria to withstand attacks from enemies like viruses. These systems have been adapted by scientists to remove or cut and replace specific genetic code sequences.

Bifidobacterium, it turns out, has an abundance of native CRISPR-Cas systems, and one of them is a relatively understudied type I-G system.

In separate experiments, the researchers used this internal system and a portable Cas effector called a cytosine base editor to resensitize a Bifidobacterium strain to a common antibiotic tetracycline. Many bacteria carry natural resistance to antibiotics.

Restoring antibiotic sensitivity is conceptually and practically important because bacteria can potentially transfer antibacterial resistance to other bacteria in the gut, Pan said.

The researchers also found tiny changes in different strains of the bacterium, so-called single nucleotide polymorphisms or SNPs, that seemed to reflect large differences in the phenotypes, or characteristics, of the strains.

This was a surprising lesson: One letter difference in strains with genetic codes that are over 99% similar can make huge differences, Barrangou said. What genes turn on and how they behave due to their environment can make a huge difference and will require researchers to customize the CRISPR tool to adapt the editing strategy accordingly.

NC State and the North Carolina Agricultural Foundation supported the work, in a collaborative effort with IFF. Co-authors of the paper include former NC State post-doctoral researcher Claudio Hidalgo-Cantabrana, NC State graduate student Avery Roberts, and former NC State staff scientist Yong Jun Goh, Wesley Morovic of IFF Health and Biosciences, and Kimberly K.O. Walden at the University of Illinois Urbana Champaign.

-kulikowski-

Note to editors: An abstract of the paper follows. Genomic and Epigenetic Landscapes Drive CRISPR-based Genome Editing in BifidobacteriumAuthors: Meichen Pan, Claudio Hidalgo-Cantabrana, Avery Roberts, Yong Jun Goh, Rodolphe Barrangou, NC State University; Wesley Morovic, IFF Health and Biosciences; Kimberly K.O. Walden, University of Illinois Urbana Champaign

Published: July 18, 2022 in Proceedings of the National Academy of Sciences

DOI: 10.1073/pnas.2205068119

Abstract: Bifidobacterium is a commensal bacterial genus ubiquitous in the human gastrointestinal tract, which is associated with a range of health benefits. The advent of CRISPR-based genome editing technologies provides opportunities to investigate the genetics of important bacteria, and transcend the lack of genetic tools in bifidobacteria to study the basis for their health-promoting attributes. Here, we repurpose the endogenous type I-G CRISPR-Cas system and adopt an exogenous CRISPR base editor for genome engineering in B. animalis subsp. lactis, demonstrating that both genomic and epigenetic contexts drive editing outcomes across strains. We reprogrammed the endogenous type I-G system to screen for naturally occurring large deletions up to 27 kb, and to generate a 500 bp deletion in tetW to abolish tetracycline resistance. A CRISPR-cytosine base editor was optimized to install CG-to-TA amber mutations to re-sensitize multiple B. lactis strains to tetracycline. Remarkably, we uncovered new epigenetic patterns that are distributed unevenly among B. lactis strains, despite their genomic homogeneity, that may contribute to editing efficiency variability. Insights were also expanded to Bifidobacterium longum subsp. infantis to emphasize the broad relevance of these findings. This study highlights the need to develop individualized CRISPR-based genome engineering approaches for distinct bacterial strains and opens new avenues for engineering of next generation probiotics.

Proceedings of the National Academy of Sciences

Experimental study

Cells

Genomic and Epigenetic Landscapes Drive CRISPR-based Genome Editing in Bifidobacterium

18-Jul-2022

R.B., C.H.-C. and Y.J.G are inventors on several patents related to CRISPR-Cas systems and their uses. R.B. is a cofounder of Intellia Therapeutics, Locus Biosciences, TreeCo, CRISPR Biotechnologies and Ancilia Biosciences, and a shareholder of Caribou Biosciences, Inari Ag, Felix Biotechnologies, and Provaxus.C.H.-C. is a cofounder of Microviable Therapeutics and shareholder of CRISPR Biotechnologies. W.M. is employed by IFF Health & Biosciences, International Flavors and Fragrances, Inc., which commercializes probiotic products.

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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Immunoglobin Products Market to Witness Comprehensive Growth by 2031 – BioSpace

Posted: July 19, 2022 at 2:45 am

Wilmington, Delaware, United States, Transparency Market Research Inc.: Immunoglobulin, likewise alluded to as antibody is a protein delivered by plasma cells and different lymphocytes. It is a complicated element that applies its immunomodulatory impact on various parts of the insusceptible system. It is acquired from the blood through the course of fractionation and is refined for remedial and non-helpful applications. Various classes of immunoglobulin, IgE, IgG, IgA, IgM, and IgD, are utilized for the treatment of different immunological and neurological illnesses. These immunoglobulins are regulated through intravenous and subcutaneous methods of conveyance.

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Immunoglobulin's likewise called antibodies are huge Y-formed proteins created by B-cell. These are the glycoprotein atom delivered by plasma cells because of the section of unfamiliar elements, for example, infections and microbes into the body. The creation of antibodies is a significant function of the immune system. Antibodies utilize a limiting instrument for killing the movement of an unfamiliar particle called an antigen. These are comprised of fundamental primary units to be specific weighty chains and light chains.

Events of circumstances where individuals are brought into the world with low or no amount of immunoglobulin, or with an immune system that doesn't function as expected are extremely normal. In such condition battling with germs and different infections become very troublesome. In this manner, immunoglobulin treatment assumes a significant part in making up for the inadequate amount of immunoglobulin in the body.

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The report on the global immunoglobin products market offers both qualitative and quantitative analysis of the market and its key growth trajectories such as drivers, restraints, challenges, and new opportunities of growth. The report also focuses on the impact of the novel COVID19 pandemic prevalent on this market and the key strategies that can be adopted by players to attract significant revenues during the forecast period. Furthermore, the list of all players and their chief contributions to the market are listed in the report as well. The report is available for sale on the company website.

Immunoglobin Products Market Competitive Landscape

The nature of the global market is significantly competitive on account of the presence of notable players. Some of them are indulging in joint ventures, major collaborations, and merger and acquisition strategies for attracting significant revenues during the forecast period. The rest of the players are investing in expansion of their product portfolio across geographies to stand out in the crowd of the market competition.

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Some of the key players of the global immunoglobin products market include:

Immunoglobin Products Market List of Innovations

The commercial shipping and distribution of an immunoglobin produced by Kamada in collaboration with Kedrion called KEDRAB was declared on May 2018. The KEDRAB is aimed at treating rabies.

In April 2019, the commercial sales of BIVIGAM manufactured by ADMA Biologics were declared to be approved by the Food and Drug Administration.

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Immunoglobin Products Market Growth Drivers

The main considerations that fuel the market development during the figure time frame remember an expansion for the geriatric populace and the number of hemophilic patients, further developed immunoglobulin creation inferable from the rise of cutting edge innovations and improved purging strategies (with better plasma yield).

Besides, the flood in the predominance of sicknesses, for example, ongoing fiery demyelinating polyneuropathy (CIDP), hypogammaglobulinemia, and others is relied upon to support the market development. Despite this, severe unofficial laws toward immunoglobulin items and the high gamble of side effects inferable from the utilization of immunoglobulin are relied upon to hamper the development of the market.

Immunoglobin Products Market Regional Insights

North America held the largest share in the overall immunoglobin products market accountable to the availability of first line treatment in well-established healthcare centers of the developed nations. Besides this, the rising number of patients, increasing adoption of subcutaneous immunoglobin, and other advanced immunotherapies will also augment the regional growth of the market.

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Posted in Delaware Stem Cells | Comments Off

Antibody Therapy Market Propels at a Robust CAGR of 13.2% due to Rising Cancer and Other Chronic Disease Prevalence Future Market Insights, Inc. -…

Posted: July 19, 2022 at 2:45 am

Future Market Insights Global and Consulting Pvt. Ltd.

Rising governmental spending in cancer research and technology development may open up new potential for the worldwide antibody therapy market to expand. North America Antibody Therapy Market is growing at the highest CAGR during the forecast period 2022-2032

NEWARK, Del, July 15, 2022 (GLOBE NEWSWIRE) -- The global antibody therapy market is expected to reach US$ 727.78 Bn in 2032, with a favorable rate of 13.2% during the forecast period. The availability of a robust antibody therapy pipeline increases the company's chances of achieving higher market revenue.

As novel medicines and pharmaceuticals for treating diseases are licensed, the market for antibody therapy is growing. The increasing need for targeted pharmacological therapy and technological advancements are boosting the antibody therapy market.

FMI presents a comparative analysis of the market growth rates and development prospects in the global antibody therapy market. According to the Future Market Insights analysis, demand in the global organic spices market is expected to rise with a robust CAGR of 13.2% during the forecast years of 2022-2032.

Get Sample PDF Of the Report @ https://www.futuremarketinsights.com/reports/sample/rep-gb-14362

Key Takeaways

The worldwide antibodies market will be driven by rising cancer and other chronic disease prevalence, rising regulatory approvals and launch of medicines, and rising research partnerships to create a robust therapeutic pipeline.

COVID-19 significantly influenced the global economy, affecting all nations by disrupting activities in every industry, regardless of size. The rising prevalence of COVID-19 patients influenced the healthcare industry.

The antibody therapy industry has gained significant traction due to a surge in demand for COVID-19 therapeutic development.

Strong market growth is projected due to government backing for the launch of new treatments. The rising frequency of cancer and other chronic diseases is one of the primary factors driving the global monoclonal antibodies market.

Increasing regulatory approvals and the debut of new medicines are complementing market growth. The global cancer risk is rapidly increasing, and more secure clinical treatment is being sought over traditional methods.

The North American antibody therapy market maintained a 49.1% share in 2021. As a result of the rising need for targeted medications in the region.

Story continues

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Competitive Landscape Bristol-Myers Squibb, GlaxoSmithKline plc, Takeda Pharmaceuticals, Eli Lilly and Company, Merck & Co, Inc., Seagen, Johnson & Johnson, Novartis AG, Regeneron Pharmaceuticals, and F. Hoffmann-La Roche Ltd. are some of the key companies profiled in the full version of the report.

Key players who have exited the market are implementing cost-cutting measures. In the coming years, antibody therapy is projected to become more affordable and accessible. In addition, the comprehensive research projects will result in new monoclonal antibody therapy product introductions. Antibodies have a robust therapeutic pipeline, resulting in a rapid growth rate.

More Insights into the Antibody Therapy Market

Due to increased investment in innovative antibody treatment developed the North America antibody therapy market maintaining a 49.1% share in 2021. As a result of the rising need for targeted medications in the region, clinical studies have increased, contributing to the market's overall growth.

The market is anticipated to continue to be dominated by North America. Demand for antibody therapy is likely to be high, resulting in surging growth.Many patients are drawn to the therapy by low-cost treatments. In addition, the high prevalence of cancer fuels a massive demand for monoclonal antibody therapy. Antibody treatment is in high demand in this area. With the highest share, Asia Pacific is the next largest region.

The growth of aging populations increases chronic illness rates. This ultimately creates a positive impact on the antibody therapy market. In addition, Europe is a fast-growing key participant with a lot of potential. Europe has a high rate of investment, research, and expansion.

Key Segments Covered in Antibody Therapy Industry Research

By Type:

Monoclonal Antibodies

Antibody Drug Conjugates

By End User:

Hospitals

Speciality Centers

Others

By Region:

North America

Latin America

Europe

Asia Pacific

Middle East and Africa

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About antibody therapy market - Healthcare Market

In the latest study, FMI offers a detailed study of the global antibody therapy market for the forecast period of 2022 to 2032. This study also highlights key drivers promoting the sales of the antibody therapy market through detailed segmentation. Our research studies serve as referencing market guidelines for key industry manufacturers, channel partners, and government bodies for developing the way forward.

Table of Content1. Executive Summary

1.1. Global Market Outlook

1.2. Summary of Statistics

1.3. Key Market Characteristics & Attributes

1.4. FMI Analysis and Recommendations

2. Market Overview

2.1. Market Coverage / Taxonomy

2.2. Market Definition / Scope / Limitations

3. Market Risks and Trends Assessment

3.1. Risk Assessment

3.1.1. COVID-19 Crisis and Impact on Antibody Therapy Demand

3.1.2. COVID-19 Impact Benchmark with Previous Crisis

3.1.3. Impact on Market Value (US$ Mn)

3.1.4. Assessment by Key Countries

3.1.5. Assessment by Key Market Segments

3.1.6. Action Points and Recommendation for Suppliers

3.2. Key Trends Impacting the Market

3.3. Formulation and Product Development Trends

4. Market Background and Foundation Data Points

TOC continued..!

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About the Healthcare Division at Future Market Insights

The Healthcare team at Future Market Insights offers expert analysis, time-efficient research, and strategic recommendations with an objective to provide authentic insights and accurate results to help clients worldwide. With a repertoire of over 100+ reports and 1 million+ data points, the team has been analysing the industry lucidly in 50+ countries for over a decade. The team provides a brief analysis of key trends including competitive landscape, profit margin, and research development efforts.

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About Future Market Insights (FMI)

Future Market Insights (ESOMAR certified market research organization and a member of Greater New York Chamber of Commerce) provides in-depth insights into governing factors elevating the demand in the market. It discloses opportunities that will favour the market growth in various segments on the basis of Source, Application, Sales Channel and End Use over the next 10-years.

Contact:

Future Market Insights Inc.Christiana Corporate, 200 Continental Drive,Suite 401, Newark, Delaware - 19713, USAT: +1-845-579-5705For Sales Enquiries:sales@futuremarketinsights.comWebsite:https://www.futuremarketinsights.com Report:https://www.futuremarketinsights.com/reports/antibody-therapy-marketLinkedIn|Twitter|Blogs

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Posted in Delaware Stem Cells | Comments Off

I Have Cancer And I’m Thankful For The Life Science Industry – Clinical Leader

Posted: July 19, 2022 at 2:44 am

By Ed Miseta, Chief Editor, Clinical LeaderFollow Me On Twitter @EdClinical

Most folks know that your life can change in an instant. For example, the moment you meet someone that you just know is meant to be your soul mate, the moment you found out you would be a parent, or the day you started a new job that you wanted your entire life. But other times your life can change in unpleasant ways, and that happened to me last year.

It started innocently enough. It was a nice spring day in May 2021. I remember it well because I am from Erie, Pennsylvania and we do not get many nice spring days in May. The previous fall I had cut down a couple bushes in my yard and that day I hoped to dig out the stumps. I had my saw, shovel, and pick, and used them to chop, dig, and cut through the roots. It took about two hours, but I managed to get them out.

The next day I was in a lot of pain, which I expected. It was the first yard work I had done in seven months, and I know I am not getting any younger. I decided to take it easy for a few days and assumed the pain would go away.

Unfortunately, it did not go away. And it did not get better. In fact, after a few weeks, I could tell the pains were getting worse. I had pain in my left shoulder that I was convinced was a torn rotator cuff muscle. I also had pain in my left side and severe pain in my lower back. The pain in my back got so bad I could barely sit for more than a few minutes. I also had pain in my right leg that worsened until I was forced to walk with a noticeable limp.

After a few weeks I did go to see my primary care provider. I was convinced the pain was muscle related, although my doctor felt it was bone related. When x-rays showed no bone damage, he sent me for a scan to see what might be causing the leg pain. I went to the hospital on Friday July 2nd to get the scan done, but on that day, I looked really bad. In fact, when I was checking out, the nurse I spoke to was so concerned about my condition she sent me to the emergency room to be checked out.

Tests Lead To More Tests

They put me in a bed, started an IV, and began the requisite blood work. The first thing they noticed was that my kidney function was almost non-existent. I had started taking NSAIDs for the pain. When they did not help, I started taking more. What I did not realize is that even when those medications are not helping with your pain, they can be damaging your kidneys. They also found that my calcium levels were sky high. A doctor decided they would admit me to the hospital. So much for my 4th of July plans.

They needed to run a lot more tests, but a holiday weekend is not the best time to do that. Over the weekend they focused on getting my kidneys back on track, and on Tuesday they were back to running tests.

On Thursday, a cancer doctor came in and told me he saw spots on one of the scans. Those spots, coupled with the pain I was experiencing, led him to believe they might be lytic lesions that are associated with a blood cancer called multiple myeloma. The physician stated he would have to perform a bone marrow biopsy, which he did later that afternoon. The next day he came into my room and told my wife and I that the biopsy confirmed his diagnosis.

To say that was a shocking moment in my life would be a huge understatement. There was no history of multiple myeloma in my family. I tried to eat healthy, and I spent a lot of my free time running and biking. There was no way I could have cancer. But I did, and that evening I received my first chemo treatment. I continued to receive them at the cancer center in Erie for the next five months. During that time, my pain levels improved until I was able to walk and move with little discomfort. The pain in my lower back did not improve but after eight radiation treatments that pain subsided as well.

In December I went to the Roswell Cancer Center in Buffalo to have some stem cells removed. I went back in January to have a blast of chemo that would wipe out my bone marrow and to receive the stem cells they removed. That was followed by the four worst weeks of my life.

Thanks to the wonderful folks at Roswell, I recovered from that treatment as well. After a few months I began working from home and on June 6, 2022, I returned to working in the office for the first time since my diagnosis. I feel better than I have in a year and one week after returning to the office I also ran my first 5k in more than 15 months.

Why I Feel Thankful

By now you might be wondering why I have decided to share this story. I have been covering clinical trials for almost 10 years. In that time, I have developed a growing respect for everyone who works in this industry.

I have had the opportunity to speak to hundreds of clinical executives from sponsor companies. I have also seen and heard the passion they bring to their jobs every day. A few years ago, I interviewed an executive whose company was working on a treatment for a rare disease. During the interview she became emotional and at one point I could tell she was crying. Why the tears? Did they discover a cure for the disease? No. Were they able to improve the condition of patients? No. In fact, the condition of patients in the trial continued to decline.

However, the trial did cause the condition of patients to deteriorate at a slower rate than patients who did not receive the treatment. That is what caused her to be so emotional.

Some may not have understood her reaction, considering the results of the study. However, I am sure she knew that when you extend the life of a patient by one year, one month, or even one week, that is extra time the patient can spend with loved ones, take in a concert or sporting event, walk their dogs, or just sit outside and enjoy the sun. And I am sure that executive also knew that cures do not happen overnight. Drug discovery is a long and tedious process. A small advancement made by one company can lead to advancements by other companies that can eventually lead to an effective treatment or a cure. She knew the discoveries that had just been made were the first steps towards that treatment. That is why she was so emotional, and that is the passion that pharma folks bring to drug discovery every day.

Contributions of Partners

Pharma does amazing work to help patients, but they do not perform the work alone. Several partners assist them with the work. First, there are the sites. Without clinical sites and their qualified staff, trials could not be conducted. Sites know their patients and they recruit those individuals, treat them, and gather the data required to gain a regulatory approval.

Then there are the heroes we call patients. When it was time for me to start my chemo drugs, my oncologist was able to tell me they were FDA approved, how they would help my condition, and what side effects I was likely to experience. But as I was receiving those treatments, I thought about the patients who came before me. At one time, a group of patients were told they had multiple myeloma and there was no effective treatment. They were told a pharma company had a drug that might help their condition. The treatment was not FDA approved, we were not sure what the side effects would be, and in fact we were not even sure it would improve their condition. But we needed them to take part in a clinical trial to evaluate the drugs and see if they worked. Many of those patients thought about it and said, Sure, Ill do it. That is my definition of a hero.

Today I feel better because of their efforts. One of the chemo drugs I took, Velcade, did not exist 20 years ago. Another chemo treatment I received, and my current maintenance medication, is Revlimid, which has only been available to patients for five years. I feel thankful to those patients who helped make these treatments available for me.

There is one group I have not mentioned yet, and that is the contract research organizations (CROs). Everyone involved in drug development knows that drug discovery is not possible without the efforts of those partners. In todays clinical trials, CROs do most of the heavy lifting. A sponsor company can take a drug so far, and then hand it over to a CRO that will take it through a difficult Phase 3 trial and produce the package of information needed for regulatory approval. Drugs would not be approved for patients without their efforts, and I am thankful to those partners as well, who I suspect will rarely get the recognition they deserve.

Pharma does not have the best reputation, and much of the criticism the industry receives in not deserved. So, on behalf of myself and the millions of patients whose lives you have saved or improved, thank you. We appreciate the work you do.

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I Have Cancer And I'm Thankful For The Life Science Industry - Clinical Leader

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Whitmer to veto adoption, abortion alternative funds from Michigan budget – Bridge Michigan

Posted: July 19, 2022 at 2:44 am

That includes $10 million Republicans had included for marketing programs that promote adoption as an alternative to abortion, $2 million in tax credits for adoptive parents and $3 million for a maternal navigator pilot program that would be run by a nonprofit that promotes childbirth and alternatives to abortion.

Whitmer will also veto $1.5 million Republicans included for "pregnancy resource centers" and $700,000 for Real Alternatives, a Pennsylvania-based nonprofit that expanded into Michigan several years ago, according to her office.

Whitmer spokesperson Bobby Leddy accused such centers of using deceptive advertising that target young women and women with low incomes who are seeking abortion care, painting themselves as comprehensive, licensed health care clinics that provide all options, and then lie to women about medical facts.

Gov. Whitmer supports legislation that provides every possible resource to women who are pregnant, seeking to start a family, or those who arent ready yet, but she cannot support aspects of a bill that sends millions in taxpayer dollars to fake health centers that intentionally withhold information from women about their health, bodies, and full reproductive freedom, Leddy wrote in a statement.

Genevieve Marnon, who lobbied for the funding for Right to Life of Michigan, said she is not surprised by the expective vetoes but bristled at the governors rejection of what the Legislature envisioned as a $2 million tax credit program for adoptive parents.

We have the largest budget in history, and we want to throw a bone to adoptive parents, and she's vetoing that? Wow, she's for women alright, said Marnon, who is legislative director of the states Right to Life.

Marnon declined further comment until Whitmer explains her decision in an official veto letter.

The expected vetoes come as Whitmer continues to ask the Michigan Supreme Court to declare unconstitutional a 1931 law that would ban most abortions in the state. The Republican-led Legislature is defending the law, which was temporarily suspended in May but could be reactivated following the U.S. Supreme Court decision to strike down Roe v. Wade.

In signing the education portion of the state budget last week, Whitmer line-item vetoed $1 million for pregnant and parenting student support services at Michigan colleges that would be prohibited from referring students to abortion providers, along with $5 million for research grants prohibiting universities from using stem cells derived from aborted fetal tissue.

House Appropriations Chair Thomas Albert, who could not immediately be reached for comment Monday, responded to last weeks education vetoes by suggesting Whitmer is only interested in promoting the deadly choice that ends a human life."

"Its inexplicable that the governor would refuse to support pregnant community college students who choose to become parents," Albert told the Detroit Free Press.

Whitmer is expected to sign the second part of the state budget a nearly $55 billion general government spending plan later this week, minus the abortion and adoption-related provisions.

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Whitmer to veto adoption, abortion alternative funds from Michigan budget - Bridge Michigan

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Therapeutic Solutions International Granted Emergency IND by FDA for Expanded Patient Access to JadiCell Universal Donor Stem Cell for COVID-19 ARDS…

Posted: July 19, 2022 at 2:43 am

ELK CITY, Idaho--(BUSINESS WIRE)--Therapeutic Solutions International announced today granting of Emergency IND # 28685 and a May Proceed Notification from the Food and Drug Administration (FDA) for the treatment of advanced COVID-19 ARDS outside of the currently ongoing Double Blind Placebo Controlled Phase III clinical trial for the same indication. The Company previously announced treatment of 15 "no option patients under both eIND and Right to Try Law1.

Based on my clinical experience with the JadiCells, their therapeutic effects are unparalleled in comparison to any other stem cell therapy, said Dr. James Veltmeyer, Chief Medical Officer of Therapeutic Solutions International. With the increase in COVID-19 cases, as well as the anticipated deluge of COVID-19 long hauler patients, it is imperative that we have mechanisms to provide these cells to patients who desperately need them, even if it is outside of the clinical trial. Our number one mission as a Company is to accelerate development of these cells as rapidly as possible and to save peoples lives.

Previously the Company has demonstrated superior activity of JadiCells to other stem cells, as well as identifying mechanisms of action2,3. The JadiCell is currently in Phase III for COVID-19 ARDS4, has been granted IND numbers for COPD5, and Chronic Traumatic Encephalopathy6, and is in late preclinical development for Idiopathic Pulmonary Fibrosis7.

We are thankful for the brave doctors that approach us and work with us to provide accelerated access to potentially life-saving cell therapies such as JadiCells to their patients, said Timothy Dixon, President, and CEO of Therapeutic Solutions International. We are blessed to have very positive relations with the FDA which has allowed for rapid movement through the various regulatory hurdles involved in development and commercialization of stem cell therapies.

About Therapeutic Solutions International, Inc.

Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is http://www.therapeuticsolutionsint.com.

1 Therapeutic Solutions International Successfully Treats "No Option" Patients with its JadiCell Stem Cell Therapy While Advancing Preparations for Phase III COVID-19 Clinical Trial (yahoo.com) 2 Therapeutic Solutions International Identifies and Files Patent on Novel Mechanism of Action of Its FDA Phase III Cleared JadiCell Treatment of COVID-19 and Delta Variant (prnewswire.com) 3 Therapeutic Solutions International Identifies Novel Biological Pathway Utilized by its Phase III Adult Stem Cell Product JadiCell to Stimulate Healing of Injured Lung Tissue | Business Wire 4 Therapeutic Solutions International Announces Launching of Phase III Clinical Trial for Treating COVID-19 Lung Damage Using its JadiCell Universal Donor Stem Cell Drug | BioSpace 5 Review of TSOIs COPD Therapy Moves Forward With IND Designation (copdnewstoday.com) 6 Therapeutic Solutions International Files Investigational New Drug Application (IND) with FDA for Treatment of Chronic Traumatic Encephalopathy Using Clinically Validated JadiCell Universal Donor Stem Cell (prnewswire.com) 7 Therapeutic Solutions International Develops Novel Stem Cell Based Therapy to Reduce Lung Scarring: Potential Solution to Post COVID-19 Lung Deterioration (prnewswire.com)

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Therapeutic Solutions International Granted Emergency IND by FDA for Expanded Patient Access to JadiCell Universal Donor Stem Cell for COVID-19 ARDS...

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Hayden resident family determined to keep the fight against multiple sclerosis at home – KREM.com

Posted: July 19, 2022 at 2:43 am

Robin and Paula Bates are determined to beat the odds, and to keep the fight at home.

HAYDEN, Idaho Hayden resident Robin Bates greets each day with a positive attitude and a grateful heart.

Keeping his chin up has been difficult lately. His secondary progressive multiple sclerosis has taken a toll on him and his wife of 23 years, Paula, who is his full-time caregiver.

Robin, 52, is facing the distressing possibility of having to move into an assisted living facility away from the love of his life, away from his friends and family, away from the home he knows, our partners at the Coeur d'Alene Press report.

As his condition deteriorates, he is running out of time.

"It's getting so much worse so much quicker," Robin said Friday. "I just started to lose the ability to use my hands. I cant even open my hands anymore."

Robin is in the process of qualifying for a hematopoietic stem cell transplant, a procedure that involves the intravenous infusion of stem cells that help reestablish blood cell production in people whose bone marrow or immune systems are not properly functioning.

It's not possible in the United States, and it's not cheap or covered by insurance.

Robin is working to raise $50,000 to cover the cost of the transplant, hospital stay, rehabilitation time, travel, lodging, food and other expenditures that will come with traveling outside of the country.

"I'm confident I'm going to get approved by Mexico, probably South Africa," said Robin, who is originally from South Africa. "Getting it done is going to be easy. It comes down to how soon I can raise the money and move forward."

Robin came to the U.S. when he was 27. He met Paula and the two were soon married.

Just three months into their marriage, he was diagnosed with multiple sclerosis, a disease that impacts the brain and spinal cord, which make up the central nervous system. It causes an array of symptoms, including numbness and tingling in the arms and legs, trouble walking, dizziness, vision problems and emotional and cognitive changes.

Robin has spent the last 13 years in a wheelchair. He's tried to participate in clinical trials, only to be told he is not able to because of his age and the advanced stage of his condition. He said he has tried countless conventional disease-modifying drugs to treat multiple sclerosis, as well as loads of alternative therapies, including diet and exercise programs.

But it keeps getting worse. Without some change of course, he fears life as he knows it will end.

"Its all going to go away if I cant stop this. I'm going to have to go to a home, my marriage will pretty much end, Robin said. "Its heartbreaking. It's frustrating. Its scary, and thats kind of where I am. If I had the money I would get the stem cell transplant tomorrow. They cant guarantee that I'm going to get better, but they can guarantee I wont get worse."

Email Robin at robinmbates@hotmail.com or visit https://bit.ly/3z9YYcz to donate.

The Coeur d'Alene Press is a KREM 2 news partner. For more from our partners,click here.

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Hayden resident family determined to keep the fight against multiple sclerosis at home - KREM.com

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Whitmer axes stem cell research, pregnancy center funding over abortion access concerns – MLive.com

Posted: July 19, 2022 at 2:43 am

Gov. Gretchen Whitmer used her veto pen on the states education budget Thursday to strike funding for pregnancy centers and stem cell research, saying that wording within the bill tried to create a gag rule concerning abortion.

Whitmer gave the final OK to a $19.6 billion K-12 education budget which contained an additional roughly $2 billion to universities and $530.3 million to community colleges, bringing the overall amount of the education budget to $22.2 billion July 14 at Mott Community College in Flint.

Word of her vetoes, however, came not too long after signing the budget and were targeted in two specific areas: stem cell research and crisis pregnancy centers.

RELATED: Whitmer signs $19.6B historic education budget, contains highest ever per-pupil investment

In a letter sent to lawmakers detailing the status of the final budget bill, Whitmer wrote that she was striking the items from the document as they harm womens health care.

These line items would create a gag rule preventing reproductive health-service providers from even mentioning abortion and otherwise make it harder for women to get the health care they need, she wrote. Any efforts to undermine a womans ability to make her own medical decisions with her trusted health-care provider will earn my disapproval. Women and doctors should be making health-care decisions not politicians.

Comprising her three vetoes were two $500,000 funding pots for pregnant and parenting student services, the wording for which put an explicit bar on mentioning abortion as a form of family planning, and $5 million in funding for stem cell/fetal tissue research.

Similar to the pregnancy service centers, wording surrounding the stem cell research grants would require universities agree to not conduct any research on aborted fetal tissue in order to make use of those funds.

On Friday, her administration again defended the move, with Whitmers Communication Director Bobby Leddy saying: While politicians in other states rush to restrict womens health care rights, even in instances of rape or incest, Michigan must remain a place where a womans ability to make her own medical decisions with her trusted health-care provider is respected.

The education budget signed earlier this week possesses the highest amount of per-pupil funding the state has ever allocated at $9,150 a child. Its a $450 increase per child, equaling a total cost increase of $630.5 million from the year prior. Theres also $214 in additional per-pupil funding for mental health and school safety for every child enrolled in a public school district.

Melanoma Kills Nearly Twice The Number Of Men Than Women: Study – Kaiser Health News

Posted: July 19, 2022 at 2:40 am

Researchers in London found that male skin cancer deaths increased by 219% since 1973, compared to 76% for women in the same period. Meanwhile, a separate study found that Black and Latino cancer patients experienced more delays in care than white patients. Other research covers covid, menstruation, Alzheimer's, and more.

Fox News:Men's Skin Cancer Deaths Are Higher Than Women's: New AnalysisCancer Research UK an independent cancer research organization in London examined skin cancer fatality records.The group found that male melanoma skin cancer deaths have increased by 219% since 1973.(Moore, 7/17)

CIDRAP:Cancer Treatment Delays Spotlighted In Minority Groups Amid COVID-19A higher proportion of Black (75.6%) and Latino (80.2%) participants and those of other races (75.9%) experienced care modifications, including delayed clinic visits, lab tests, and imaging, as well as a change in care location than White participants (57.1%). A higher proportion of Black (98.0%) than White respondents (84.1%) who had care modifications said their clinic or physician requested the modifications. (7/15)

On covid research news

The New York Times:Covid-19 Vaccines Temporarily Changed Menstrual Cycles, Study ShowsNearly half of the participants of a recent study who were menstruating regularly at the time of the survey reported heavier bleeding during their periods after receiving the Covid-19 vaccine. Others who did not typically menstruate including transgender men, people on long-acting contraceptives, and post-menopausal women also experienced unusual bleeding. (Sheikh, 7/15)

CBS News:Studying The Effects Of Long COVIDSince contracting COVID-19 back in January 2021, Ken Todd has never made a full recovery, making him one of the millions who suffer from "long COVID." (7/17)

CIDRAP:More (Mostly Mild) Side Effects When Flu Vaccine Given With COVID BoosterSelf-reported data from nearly 1 million Americans show an 8% to 11% higher rate of mostly mild systemic adverse events after simultaneous seasonal flu vaccine and mRNA COVID-19 booster (third) doses than with the COVID-19 booster alone. (Van Beusekom, 7/15)

In news about other research

CIDRAP:Study Shows Global Rise In Macrolide-Resistant Mycoplasma PneumoniaeAntibiotic resistance, one of the most common causes of community-acquired pneumonia (CAP) in children, has risen dramatically over the past two decades, according to a study published this week in JAMA Network Open. To analyze global patterns, temporal trends, and regional variations in macrolide-resistant Mycoplasma pneumoniae (MRMP) infections, a team of South Korean researchers conducted a systematic review and meta-analysis of 153 studies from 150 articles published prior to Sep 10, 2021. (7/15)

Zenger News:Glass Of Wine A Day May Lead To Alzheimer's, Research SuggestsJust one small glass of wine a day could give you Alzheimer's or Parkinson's, according to new research. Consuming just seven units of alcohol a week - half the recommended maximum - fuels iron in the brain. (Kitanovska, 7/16)

AP:High-Flying Experiment: Do Stem Cells Grow Better In Space?Researcher Dhruv Sareens own stem cells are now orbiting the Earth. The mission? To test whether theyll grow better in zero gravity. Scientists at Cedars-Sinai Medical Center in Los Angeles are trying to find new ways to produce huge batches of a type of stem cell that can generate nearly any other type of cell in the body and potentially be used to make treatments for many diseases. The cells arrived over the weekend at the International Space Station on a supply ship. (Ungar, 7/17)

Also, in innovations

The Wall Street Journal:High-Tech Smell Sensors Aim To Sniff Out Disease, ExplosivesAnd Even MoodsBut now scientists and entrepreneurs are redoubling their efforts to recreate the sense of smell in compact devices that detect and analyze odors similar to the way cameras now recognize our faces and microphones our words. In pursuit of these high-tech deviceswhich could use odors to detect disease like cancer or Covid-19, locate hidden explosives or decipher our moods and behaviorssome companies are leveraging advances in synthetic biology and genetic engineering. Others are harnessing advances in artificial intelligence. (Hernandez, 7/16)

Reuters:Roche Launches Dual Antigen And Antibody Diagnostic Test For Hepatitis CRoche (ROG.S) has launched an new dual antigen and antibody diagnostic test for hepatitis C, the Swiss pharmaceuticals company said on Monday, which it says will give an earlier diagnosis of the virus. The Elecsys HCV Duo is the first commercially available immunoassay that allows the simultaneous and independent determination of the hepatitis C virus status from a single human plasma or serum sample. (7/18)

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Patients have turned to pricey ‘blood washing’ to treat long COVID – New York Post

Posted: July 19, 2022 at 2:40 am

Desperate to have their lives back, long COVID patients are turning to an expensive last resort therapy to cure the mysterious illness.

Apheresis, or blood washing, is a process in which a component of blood, such as plasma, is separated and then filtered back into your body via giant needles inserted into a vein.

Gitte Boumeester, who found out about blood washing through a Facebook support group, spent more than $15,000 to have the treatment, BMJ and ITV News reported, in a joint investigation out Tuesday.

I thought, whats the worst thing Ive got to lose? the Dutch psychiatrist-in-training told reporters. Money was the only thing.

And that she did once Boumeester concluded, two months after the procedure, that the blood washing didnt work.

The process is typically used in cases where its necessary to remove specific components of blood, such as the treatment of blood cancers, plasma and platelet donation or to collect stem cells.

But in Germany, doctors consider it one of the last resorts for the treatment of some lipid disorders, which are marked by abnormal levels of lipids, or fats, in the blood the effects of which some have theorized are similar to long-term COVID infection.

Boumeesters battery of tests revealed nothing about her condition, which developed soon after she caught the SARS-CoV-2 virus in November 2020, despite her debilitating exhaustion.

Yet some researchers, namely Dr. Beate Jaeger, have hypothesized that long COVID may be caused by small clots in the blood that get in the way of the flow of oxygen, leading to the telltale extreme fatigue and muscle aches. Thus, washing the blood of unnecessary lipids and proteins, in combination with the use of anticoagulants, blood thinners such as clopidogrel, apixaban and heparin, could help clear the capillaries for better blood circulation.

Jaeger, a cardiovascular specialist in Mlheim, Germany, fought to see apheresis used on COVID patients in the ICU and to publish a paper on her approach, attempts of which were denied. Finally, a pair of her patients agreed to undergo the treatment free of charge. Then, 60 more opted-in. Shes since seen extremely successful results in thousands of patients, she said.

In one of her reports, Jaeger claimed that a long COVID patient who used a wheelchair could miraculously walk again following treatment. Another improved their stride from a labored walk to a jog.

Beverley Hunt, medical director of the charity Thrombosis UK, told BMJ, I am worried these patients have been offered therapies which have not been assessed by modern scientific methods: well-designed clinical trials. In this situation the treatment may or may not benefit them but, worryingly, also has the risk of harm.

The process of apheresis is safe if properly performed, but there are potentially dire consequences to having overly-thin blood, particularly if hemorrhage occurs.

Even under the safest conditions, patients also risk financial ruin. Boumeester traveled some 1,700 air miles to the Long Covid Center in Larnaca, Cyprus. For two months, she rented an apartment on the beach while making weekly appointments for apheresis, and more unproven add-on therapies, such as hyperbaric oxygen and intravenous vitamin infusions.

Six rounds of blood washing cost her more than $1,600 per session, while additional treatments came with price tags up to about $150, which she did on the recommendation of the clinicians.

I was a little ambivalent about all the extra treatment, but I promised myself if I was there I would do anything, to just try, she said.

Experimental treatments are generally permitted throughout Europe as long as theres clear patient consent, but experts fear that clinics like the Long Covid Center may be overpromising.

People could potentially go bankrupt accessing these treatments, for which there is limited to no evidence of effectiveness, said University of Birmingham researcher Shamil Haroon, whose work on the Therapies for Long Covid in Non-hospitalized Patients trial will eventually go on to inform how doctors approach the disease.

Like Boumeester, British businessman Chris Witham, from Bournemouth, traveled across the continent, toKempten, Germany, for a $7,000 course of apheresis that didnt work.

Id have sold my house and given it away to get better, without a second thought, he told BMJ and ITV News.

The outlets spoke to just six long COVID patients who said the procedure improved some of their condition, though symptoms lingered.

Their reporting flies in the face of claims made by Austrian entrepreneur and long COVID sufferer Markus Klotz, who founded the clinic in Cyprus and claims it worked for him after having the treatment with Jaegar in Mlheim. Over 80% of patients report to keep their gains permanently, read one post on the Facebook page for the Apheresis Association, also led by Klotz.

I realized before I started that the outcome was uncertain, but everyone at the clinic is so positive that you start to believe it too and get your hopes up, Boumeester said.

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Monthly Archives: July 2022

Researchers lift the veil on stubborn probiot – EurekAlert

Immunoglobin Products Market to Witness Comprehensive Growth by 2031 – BioSpace

Antibody Therapy Market Propels at a Robust CAGR of 13.2% due to Rising Cancer and Other Chronic Disease Prevalence Future Market Insights, Inc. -…

I Have Cancer And I’m Thankful For The Life Science Industry – Clinical Leader

Whitmer to veto adoption, abortion alternative funds from Michigan budget – Bridge Michigan

Therapeutic Solutions International Granted Emergency IND by FDA for Expanded Patient Access to JadiCell Universal Donor Stem Cell for COVID-19 ARDS…

Hayden resident family determined to keep the fight against multiple sclerosis at home – KREM.com

Whitmer axes stem cell research, pregnancy center funding over abortion access concerns – MLive.com

Melanoma Kills Nearly Twice The Number Of Men Than Women: Study – Kaiser Health News

Patients have turned to pricey ‘blood washing’ to treat long COVID – New York Post

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