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Mayo Clinic Q and A: Stem cell therapy for arthritis …

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DEAR MAYO CLINIC: Whats the latest information on using stem cell therapy to treat an arthritic shoulder that causes excessive pain?

ANSWER: New efforts in regenerative medicine, including stem cell therapy, could dramatically affect orthopedic surgery over the coming years. Much of this hope is pinned on using stem cells to treat degenerative conditions such as shoulder arthritis. Although it shows promise, stem cell treatment for arthritis isnt widely available at this time, as its still being researched.

Stem cells are the basic building blocks of all human tissue. Stem cells hold potential as treatment, in part, because they can communicate valuable information about tissue growth and healing to other cells in the body. Arthritis involves joint degeneration due to loss of the cartilage that cushions bones. Recently researchers have begun to look to stem cells for orthopedic conditions such as shoulder arthritis. Progress using stem cells to treat arthritis already has been reported, with the ultimate goal of using stem cells to regrow cartilage.

When discussing stem cell therapy, its important to understand that pure stem cells are not currently available to U.S. patients outside of a clinical research study. A handful of clinical research trials, monitored by the U.S. Food and Drug Administration (FDA), are ongoing at this time to study stem cell treatment for arthritis. The early findings from these trials are encouraging.

Unfortunately, the excitement surrounding emerging stem cell therapy has led some patients and health care providers to overlook the lack of scientific evidence to support its use at this time. Stem cell therapies currently used outside clinical studies do not contain pure stem cells. Instead, they are a mix of a variety of cells, of which only a very small percentage are stem cells. It is possible that many of these treatments do not contain enough stem cells to help.

It is also important to recognize that many stem cell therapies now marketed directly to patients are conducted without the required biologics license from the FDA. Also, some forms of mislabeled stem cell therapies do not contain any living stem cells. Such practices are cause for concern, as these treatments can mislead patients and the public, and delay the scientific progress needed to turn stem cell therapies into cures.

What the research into stem cells and arthritis shows is that there are opportunities for stem cell treatment to be used as injection therapy alone and in addition to orthopedic surgical procedures. Successful stem cell therapies thus far have resulted mostly in pain relief and improvement in function or quality of life. Only a few limited early studies have demonstrated improvement in new cartilage or bone formation needed to cure arthritis. Exactly how that cartilage regrowth occurs, or even how pain relief is achieved, is still unknown. That means if you have a stem cell procedure, it will be used to treat the symptoms of arthritis only. The ability to cure the disease entirely is not yet available.

No major research studies have specifically investigated stem cell treatment for shoulder arthritis. Much of what is known about stem cells in arthritis comes from research into knee degeneration. Its not known if the successes treating knee arthritis will prove to be similarly beneficial when used for the shoulder. Therefore, current recommendations to treat shoulder arthritis remain the judicious use of gentle pain relievers, exercise and occasional steroid injections. In severe cases, shoulder replacement can provide long-lasting pain relief.

With demonstrable safety and mounting evidence of the effectiveness of stem cell therapy for some orthopedic conditions, potentially all orthopedic disease could be treated with stem cell therapy in the future. But, first, doctors and patients will have to wait until the scientific evidence catches up to the excitement around this promising option. Dr. Shane Shapiro, Orthopedic Surgery and Center for Regenerative Medicine, Mayo Clinic, Jacksonville, Florida

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Mayo Clinic Q and A: Stem cell therapy for arthritis ...

Cell Therapy Markets, 2030 – ResearchAndMarkets.com – Business Wire

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DUBLIN--(BUSINESS WIRE)--The "Cell Therapy - Technologies, Markets and Companies" report from Jain PharmaBiotech has been added to ResearchAndMarkets.com's offering.

This report describes and evaluates cell therapy technologies and methods, which have already started to play an important role in the practice of medicine. Hematopoietic stem cell transplantation is replacing the old fashioned bone marrow transplants. The role of cells in drug discovery is also described. Cell therapy is bound to become a part of medical practice.

Stem cells are discussed in detail in one chapter. Some light is thrown on the current controversy of embryonic sources of stem cells and comparison with adult sources. Other sources of stem cells such as the placenta, cord blood and fat removed by liposuction are also discussed. Stem cells can also be genetically modified prior to transplantation.

Cell therapy technologies overlap with those of gene therapy, cancer vaccines, drug delivery, tissue engineering, and regenerative medicine. Pharmaceutical applications of stem cells including those in drug discovery are also described. Various types of cells used, methods of preparation and culture, encapsulation, and genetic engineering of cells are discussed. Sources of cells, both human and animal (xenotransplantation) are discussed. Methods of delivery of cell therapy range from injections to surgical implantation using special devices.

Cell therapy has applications in a large number of disorders. The most important are diseases of the nervous system and cancer which are the topics for separate chapters. Other applications include cardiac disorders (myocardial infarction and heart failure), diabetes mellitus, diseases of bones and joints, genetic disorders, and wounds of the skin and soft tissues.

Regulatory and ethical issues involving cell therapy are important and are discussed. The current political debate on the use of stem cells from embryonic sources (hESCs) is also presented. Safety is an essential consideration of any new therapy and regulations for cell therapy are those for biological preparations.

The cell-based markets was analyzed for 2020, and projected to 2030. The markets are analyzed according to therapeutic categories, technologies and geographical areas. The largest expansion will be in diseases of the central nervous system, cancer and cardiovascular disorders. Skin and soft tissue repair, as well as diabetes mellitus, will be other major markets.

The number of companies involved in cell therapy has increased remarkably during the past few years. More than 500 companies have been identified to be involved in cell therapy and 317 of these are profiled in part II of the report along with tabulation of 306 alliances. Of these companies, 171 are involved in stem cells.

Profiles of 73 academic institutions in the US involved in cell therapy are also included in part II along with their commercial collaborations. The text is supplemented with 67 Tables and 26 Figures. The bibliography contains 1,200 selected references, which are cited in the text.

Markets and Future Prospects for Cell Therapy

Key Topics Covered:

Part I: Technologies, Ethics & Regulations

Executive Summary

1. Introduction to Cell Therapy

2. Cell Therapy Technologies

3. Stem Cells

4. Clinical Applications of Cell Therapy

5. Cell Therapy for Cardiovascular Disorders

6. Cell Therapy for Cancer

7. Cell Therapy for Neurological Disorders

8. Ethical, Legal and Political Aspects of Cell therapy

9. Safety and Regulatory Aspects of Cell Therapy

Part II: Markets, Companies & Academic Institutions

10. Markets and Future Prospects for Cell Therapy

11. Companies Involved in Cell Therapy

12. Academic Institutions

13. References

For more information about this report visit https://www.researchandmarkets.com/r/jqee92

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Cell Therapy Markets, 2030 - ResearchAndMarkets.com - Business Wire

A Cure for Type 1 Diabetes? For One Man, It Seems to Have Worked. – The New York Times

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Brian Sheltons life was ruled by Type 1 diabetes.

When his blood sugar plummeted, he would lose consciousness without warning. He crashed his motorcycle into a wall. He passed out in a customers yard while delivering mail. Following that episode, his supervisor told him to retire, after a quarter century in the Postal Service. He was 57.

His ex-wife, Cindy Shelton, took him into her home in Elyria, Ohio. I was afraid to leave him alone all day, she said.

Early this year, she spotted a call for people with Type 1 diabetes to participate in a clinical trial by Vertex Pharmaceuticals. The company was testing a treatment developed over decades by a scientist who vowed to find a cure after his baby son and then his teenage daughter got the devastating disease.

Mr. Shelton was the first patient. On June 29, he got an infusion of cells, grown from stem cells but just like the insulin-producing pancreas cells his body lacked.

Now his body automatically controls its insulin and blood sugar levels.

Mr. Shelton, now 64, may be the first person cured of the disease with a new treatment that has experts daring to hope that help may be coming for many of the 1.5 million Americans suffering from Type 1 diabetes.

Its a whole new life, Mr. Shelton said. Its like a miracle.

Diabetes experts were astonished but urged caution. The study is continuing and will take five years, involving 17 people with severe cases of Type 1 diabetes. It is not intended as a treatment for the more common Type 2 diabetes.

Weve been looking for something like this to happen literally for decades, said Dr. Irl Hirsch, a diabetes expert at the University of Washington who was not involved in the research. He wants to see the result, not yet published in a peer-reviewed journal, replicated in many more people. He also wants to know if there will be unanticipated adverse effects and if the cells will last for a lifetime or if the treatment would have to be repeated.

But, he said, bottom line, it is an amazing result.

Dr. Peter Butler, a diabetes expert at U.C.L.A. who also was not involved with the research, agreed while offering the same caveats.

It is a remarkable result, Dr. Butler said. To be able to reverse diabetes by giving them back the cells they are missing is comparable to the miracle when insulin was first available 100 years ago.

And it all started with the 30-year quest of a Harvard University biologist, Doug Melton.

Dr. Melton had never thought much about diabetes until 1991 when his 6-month-old baby boy, Sam, began shaking, vomiting and panting.

He was so sick, and the pediatrician didnt know what it was, Dr. Melton said. He and his wife Gail OKeefe rushed their baby to Boston Childrens Hospital. Sams urine was brimming with sugar a sign of diabetes.

The disease, which occurs when the bodys immune system destroys the insulin-secreting islet cells of the pancreas, often starts around age 13 or 14. Unlike the more common and milder Type 2 diabetes, Type 1 is quickly lethal unless patients get injections of insulin. No one spontaneously gets better.

Its a terrible, terrible disease, said Dr. Butler at U.C.L.A.

Patients are at risk of going blind diabetes is the leading cause of blindness in this country. It is also the leading cause of kidney failure. People with Type 1 diabetes are at risk of having their legs amputated and of death in the night because their blood sugar plummets during sleep. Diabetes greatly increases their likelihood of having a heart attack or stroke. It weakens the immune system one of Dr. Butlers fully vaccinated diabetes patients recently died from Covid-19.

Added to the burden of the disease is the high cost of insulin, whose price has risen each year.

The only cure that has ever worked is a pancreas transplant or a transplant of the insulin-producing cell clusters of the pancreas, known as islet cells, from an organ donors pancreas. But a shortage of organs makes such an approach an impossibility for the vast majority with the disease.

Even if we were in utopia, we would never have enough pancreases, said Dr. Ali Naji, a transplant surgeon at the University of Pennsylvania who pioneered islet cell transplants and is now a principal investigator for the trial that treated Mr. Shelton.

For Dr. Melton and Ms. OKeefe, caring for an infant with the disease was terrifying. Ms. OKeefe had to prick Sams fingers and feet to check his blood sugar four times a day. Then she had to inject him with insulin. For a baby that young, insulin was not even sold in the proper dose. His parents had to dilute it.

Gail said to me, If Im doing this you have to figure out this damn disease, Dr. Melton recalled. In time, their daughter Emma, four years older than Sam, would develop the disease too, when she was 14.

Dr. Melton had been studying frog development but abandoned that work, determined to find a cure for diabetes. He turned to embryonic stem cells, which have the potential to become any cell in the body. His goal was to turn them into islet cells to treat patients.

One problem was the source of the cells they came from unused fertilized eggs from a fertility clinic. But in August 2001, President George W. Bush barred using federal money for research with human embryos. Dr. Melton had to sever his stem cell lab from everything else at Harvard. He got private funding from the Howard Hughes Medical Institute, Harvard and philanthropists to set up a completely separate lab with an accountant who kept all its expenses separate, down to the light bulbs.

Over the 20 years it took the lab of 15 or so people to successfully convert stem cells into islet cells, Dr. Melton estimates the project cost about $50 million.

The challenge was to figure out what sequence of chemical messages would turn stem cells into insulin-secreting islet cells. The work involved unraveling normal pancreatic development, figuring out how islets are made in the pancreas and conducting endless experiments to steer embryonic stem cells to becoming islets. It was slow going.

After years when nothing worked, a small team of researchers, including Felicia Pagliuca, a postdoctoral researcher, was in the lab one night in 2014, doing one more experiment.

We werent very optimistic, she said. They had put a dye into the liquid where the stem cells were growing. The liquid would turn blue if the cells made insulin.

Her husband had already called asking when was she coming home. Then she saw a faint blue tinge that got darker and darker. She and the others were ecstatic. For the first time, they had made functioning pancreatic islet cells from embryonic stem cells.

The lab celebrated with a little party and a cake. Then they had bright blue wool caps made for themselves with five circles colored red, yellow, green, blue and purple to represent the stages the stem cells had to pass through to become functioning islet cells. Theyd always hoped for purple but had until then kept getting stuck at green.

The next step for Dr. Melton, knowing hed need more resources to make a drug that could get to market, was starting a company.

His company Semma was founded in 2014, a mix of Sam and Emmas names.

One challenge was to figure out how to grow islet cells in large quantities with a method others could repeat. That took five years.

The company, led by Bastiano Sanna, a cell and gene therapy expert, tested its cells in mice and rats, showing they functioned well and cured diabetes in rodents.

At that point, the next step a clinical trial in patients needed a large, well financed and experienced company with hundreds of employees. Everything had to be done to the exacting standards of the Food and Drug Administration thousands of pages of documents prepared, and clinical trials planned.

Chance intervened. In April 2019, at a meeting at Massachusetts General Hospital, Dr. Melton ran into a former colleague, Dr. David Altshuler, who had been a professor of genetics and medicine at Harvard and the deputy director of the Broad Institute. Over lunch, Dr. Altshuler, who had become the chief scientific officer at Vertex Pharmaceuticals, asked Dr. Melton what was new.

Dr. Melton took out a small glass vial with a bright purple pellet at the bottom.

These are islet cells that we made at Semma, he told Dr. Altshuler.

Vertex focuses on human diseases whose biology is understood. I think there might be an opportunity, Dr. Altshuler told him.

Meetings followed and eight weeks later, Vertex acquired Semma for $950 million. With the acquisition, Dr. Sanna became an executive vice president at Vertex.

The company will not announce a price for its diabetes treatment until it is approved. But it is likely to be expensive. Like other companies, Vertex has enraged patients with high prices for drugs that are difficult and expensive to make.

Vertexs challenge was to make sure the production process worked every time and that the cells would be safe if injected into patients. Employees working under scrupulously sterile conditions monitored vessels of solutions containing nutrients and biochemical signals where stem cells were turning into islet cells.

Less than two years after Semma was acquired, the F.D.A. allowed Vertex to begin a clinical trial with Mr. Shelton as its initial patient.

Like patients who get pancreas transplants, Mr. Shelton has to take drugs that suppress his immune system. He says they cause him no side effects, and he finds them far less onerous or risky than constantly monitoring his blood sugar and taking insulin. He will have to continue taking them to prevent his body from rejecting the infused cells.

But Dr. John Buse, a diabetes expert at the University of North Carolina who has no connection to Vertex, said the immunosuppression gives him pause. We need to carefully evaluate the trade-off between the burdens of diabetes and the potential complications from immunosuppressive medications.

Mr. Sheltons treatment, known as an early phase safety trial, called for careful follow-up and required starting with half the dose that would be used later in the trial, noted Dr. James Markmann, Mr. Sheltons surgeon at Mass General who is working with Vertex on the trial. No one expected the cells to function so well, he said.

The result is so striking, Dr. Markmann said, Its a real leap forward for the field.

Last month, Vertex was ready to reveal the results to Dr. Melton. He did not expect much.

I was prepared to give them a pep talk, he said.

Dr. Melton, normally a calm man, was jittery during what felt like a moment of truth. He had spent decades and all of his passion on this project. By the end of the Vertex teams presentation, a huge smile broke out on his face; the data were for real.

He left Vertex and went home for dinner with Sam, Emma and Ms. OKeefe. When they sat down to eat, Dr. Melton told them the results.

Lets just say there were a lot of tears and hugs.

For Mr. Shelton the moment of truth came a few days after the procedure, when he left the hospital. He measured his blood sugar. It was perfect. He and Ms. Shelton had a meal. His blood sugar remained in the normal range.

Mr. Shelton wept when he saw the measurement.

The only thing I can say is thank you.

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A Cure for Type 1 Diabetes? For One Man, It Seems to Have Worked. - The New York Times

FDA Warns About Stem Cell Therapies | FDA

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Researchers hope stem cells will one day be effective in the treatment of many medical conditions and diseases. But unproven stem cell treatments can be unsafeso get all of the facts if youre considering any treatment.

Stem cells have been called everything from cure-alls to miracle treatments. But dont believe the hype. Some unscrupulous providers offer stem cell products that are both unapproved and unproven. So beware of potentially dangerous proceduresand confirm whats really being offered before you consider any treatment.

The facts: Stem cell therapies may offer the potential to treat diseases or conditions for which few treatments exist. Sometimes called the bodys master cells, stem cells are the cells that develop into blood, brain, bones, and all of the bodys organs. They have the potential to repair, restore, replace, and regenerate cells, and could possibly be used to treat many medical conditions and diseases.

But the U.S. Food and Drug Administration is concerned that some patients seeking cures and remedies are vulnerable to stem cell treatments that are illegal and potentially harmful. And the FDA is increasing its oversight and enforcement to protect people from dishonest and unscrupulous stem cell clinics, while continuing to encourage innovation so that the medical industry can properly harness the potential of stem cell products.

To do your part to stay safe, make sure that any stem cell treatment you are considering is either:

And see the boxed section below for more advice.

The FDA has the authority to regulate stem cell products in the United States.

Today, doctors routinely use stem cells that come from bone marrow or blood in transplant procedures to treat patients with cancer and disorders of the blood and immune system.

With limited exceptions, investigational products must also go through a thorough FDA review process as investigators prepare to determine the safety and effectiveness of products in well-controlled human studies, called clinical trials. The FDA has reviewed many stem cell products for use in these studies.

As part of the FDAs review, investigators must show how each product will be manufactured so the FDA can make sure appropriate steps are being taken to help assure the products safety, purity, and strength (potency). The FDA also requires sufficient data from animal studies to help evaluate any potential risks associated with product use. (You can learn more about clinical trials on the FDAs website.)

That said, some clinics may inappropriately advertise stem cell clinical trials without submitting an IND. Some clinics also may falsely advertise that FDA review and approval of the stem cell therapy is unnecessary. But when clinical trials are not conducted under an IND, it means that the FDA has not reviewed the experimental therapy to help make sure it is reasonably safe. So be cautious about these treatments.

About FDA-approved Products Derived from Stem Cells

The only stem cell-based products that are FDA-approved for use in the United States consist of blood-forming stem cells (hematopoietic progenitor cells) derived from cord blood.

These products are approved for limited use in patients with disorders that affect the body system that is involved in the production of blood (called the hematopoietic system). These FDA-approved stem cell products are listed on the FDA website. Bone marrow also is used for these treatments but is generally not regulated by the FDA for this use.

All medical treatments have benefits and risks. But unproven stem cell therapies can be particularly unsafe.

For instance, attendees at a 2016 FDA public workshop discussed several cases of severe adverse events. One patient became blind due to an injection of stem cells into the eye. Another patient received a spinal cord injection that caused the growth of a spinal tumor.

Other potential safety concerns for unproven treatments include:

Note: Even if stem cells are your own cells, there are still safety risks such as those noted above. In addition, if cells are manipulated after removal, there is a risk of contamination of the cells.

When stem cell products are used in unapproved waysor when they are processed in ways that are more than minimally manipulated, which relates to the nature and degree of processingthe FDA may take (and has already taken) a variety of administrative and judicial actions, including criminal enforcement, depending on the violations involved.

In August 2017, the FDA announced increased enforcement of regulations and oversight of stem cell clinics. To learn more, see the statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA website.

And in March 2017, to further clarify the benefits and risks of stem cell therapy, the FDA published a perspective article in the New England Journal of Medicine.

The FDA will continue to help with the development and licensing of new stem cell therapies where the scientific evidence supports the products safety and effectiveness.

Know that the FDA plays a role in stem cell treatment oversight. You may be told that because these are your cells, the FDA does not need to review or approve the treatment. That is not true.

Stem cell products have the potential to treat many medical conditions and diseases. But for almost all of these products, it is not yet known whether the product has any benefitor if the product is safe to use.

If you're considering treatment in the United States:

If you're considering treatment in another country:

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FDA Warns About Stem Cell Therapies | FDA

Neuroplast secures 10 million in funding to boost clinical development of stem cell therapy for traumatic spinal cord injuries – Spinal News…

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Neuroplast has raised a total of 10 million in a Series B funding round, the money of which will be used to obtain conditional European Medicines Agency (EMA) market approval for its Neuro-Cells stem cell therapy to treat patients with traumatic spinal cord injuries (TSCIs).

Neuro-Cells is a treatment that is designed to use the patients own stem cells to prevent further loss of function during the acute phase after sustaining damage to the spinal cord, in an effort to save mobility and independence.

The funding round included investment from Lumana Invest, Brightlands Venture Partners, LIOF, and from the Innovation Credit from the Netherlands Enterprise Agency.

Neuroplast has already completed a clinical Phase I trialin collaboration with Hospital Nacional de Parapljicos (Toledo, Spain)that it says confirmed safety and tolerability, without product-related adverse events. The firm is currently preparing for an international multicentre randomised placebo-controlled Phase II study.

This latest funding will help finance the next steps towards EMA market approval for TSCI, which includes running Phase II and III trials, consulting the EMA and executing a Health Technology Assessment.

Vincent The, chief financial officer at Neuroplast, said: This funding enables us to complete the Neuro-Cells development pathway for TSCI. With the recent successful completion of our Phase I study, we now have both a good clinical as well as a solid financial foundation in place.

This puts us in a great position to start exploring the broader potential of the Neuro-Cells technology platform for other primarily inflammation-driven neurological disorders. For these activities, we are seeking complementary investment.

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Neuroplast secures 10 million in funding to boost clinical development of stem cell therapy for traumatic spinal cord injuries - Spinal News...

Innovating Reversible Cell Therapies With RNA – Technology Networks

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In recent years, the field of DNA-modified cell therapies has experienced clinical advancements in patient outcomes specifically in late-stage cancer patients. Permanent changes to the genetic compositions in patients cells may lead to toxicities such as cytokine release syndrome, or the uncontrollable proliferation of DNA-modified cells. To address the irreversibility and lack of predictability of DNA-modified cell therapies, Cartesian Therapeutics is developing a range of RNA-modified allogeneic and autologous cell therapies in autoimmune, oncologic and respiratory disorders.

In this interview, Murat Kalayoglu, MD, PhD, president and CEO of Cartesian Therapeutics discusses the companys efforts to develop RNA-modified cell therapies that expand past oncology. Dr. Kalayoglu also provides his predictions for the nascent field of cell therapy, and clinical milestones we can expect to see in the coming years.

Q: Can you tell us about the history and origins of Cartesian Therapeutics and its technology?A: Cartesian was founded in 2016 with a mission to develop potent, yet safer, cell therapies initially for the treatment of multiple myeloma. The motivation to innovate novel cell therapies for this rare form of blood cancer was born out of shared experiences between myself and the other founders, chief scientific officer Dr. Mike Singer and chief operating officer Dr. Metin Kurtoglu. Several of our friends and family members have been diagnosed with multiple myeloma, and we recognized first-hand the need for treatment for this incurable disease.

We originally licensed chimeric antigen receptor technology (CAR) T-cell therapy from the National Institutes of Health (NIH) as a unique way of targeting B-cell maturation antigens (BCMA), a critical part of the disease pathway of multiple myeloma. CAR T-cell therapy is a form of immunotherapy in which a patients own T cells, a type of immune cell, are modified in a laboratory to bind to cancerous cells. We investigated the potential to engineer these cells with RNA instead of DNA to overcome the limitations of conventional DNA-engineered CAR T-cell therapies.

What began as a focused effort exclusively on multiple myeloma has morphed into a technology platform that we recognize has broad applications beyond oncology. Currently, Cartesian is a fully integrated RNA cell therapy company with multiple cell therapy candidates in clinical trials. Our cell therapies target not just cancer, but also autoimmune disease and respiratory disease. We plan to move forward into additional disease categories in 2022.

Q: How is RNA cell therapy different from DNA cell therapy? What benefits does this bring?A: In conventional cell therapy, scientists modify the DNA in cells with irreversible, permanent changes at the level of the gene. Each daughter cell produced from a DNA-modified cell is identical to the parent cell, and genetic coding errors may result in the replication of cancerous cells.

DNA-modified cell therapies raise other safety concerns when introduced into the patient. They begin to proliferate when encountering a target antigen and can often proliferate out of control if any semblance of the target antigen is detected. They may cause toxicity and an unwanted inflammatory immune response known as cytokine release syndrome. These adverse effects of DNA cell therapy are harmful for patients already suffering from the debilitating effects of their disease. And while it often makes sense for a patient with an advanced, late-stage cancer to take the risk of encountering these toxicities, it often doesnt make sense to do so with earlier-stage cancers or conditions outside of oncology.

Our philosophy is to expand cell therapy beyond the most advanced cancers, and we believe using RNA instead of DNA will allow us to make reversible, controllable changes inside cells. Because RNA has a defined half-life, RNA-modified cells are more predictable in the bodies of patients. The changes reflected in RNA-modified cells do not integrate irreversibly into the genome but may last long enough to produce therapeutic proteins without the toxicities common to conventional cell therapy.

In addition, conventional cell therapies require difficult-to-source laboratory equipment or biologically active products such as GMP-grade viral vectors to produce the DNA-modified cells. RNA cell therapy does not require as complex of equipment and allows us to enter the clinic more quickly at a lower cost.

Q: Can you tell me a bit about Cartesians RNA Armory technology and the work being done at the companys GMP manufacturing facility?A: At Cartesian, we are developing an entirely new manufacturing platform that weve now coined the RNA Armory. The RNA Armory is a cell-based combination therapy platform that allows us to use a cell as both a vehicle for delivering as well as a factory for producing a combination of RNA therapeutics. Through the RNA Armory, we can simultaneously engineer multiple RNAs directly into the cell, enabling us to accurately target the site of disease. These cells are then able to secrete not just one, but multiple RNA therapeutics in the form of secreted proteins right at the site of disease. Because RNA-modified cells lose functionality over time, we can control their effectiveness against the target antigen more precisely than DNA-modified cells that can proliferate unpredictably.

We integrated our manufacturing in-house at our headquarters in Gaithersburg, Maryland, to optimize research, development and supply chain and manufacturing. We believe the platform itself can work with various types of cells, but there are two main areas of focus right now in the clinic: T cells and mesenchymal stem cells (MSCs).

Q: Cartesian is taking cell therapy beyond oncology. Tell me more about the programs in myasthenia gravis and acute respiratory distress syndrome (ARDS).

Myasthenia gravis is a chronic autoimmune disorder in which autoantibodies destroy the communication between nerves and muscles, resulting in neuromuscular weakness. We are developing Descartes-08, a T-cell therapy that targets BCMA. Our rationale for targeting BCMA stems from the fact that long-lived, diseased plasma cells, along with the autoantibodies they produce, typically express BCMA in myasthenia gravis patients.

Descartes-08 is our first-generation autologous cell therapy to combat myasthenia gravis. Our scientists collect and modify a patients own T cells using the RNA Armory to produce redirected (CAR-T) cells. Clinicians then reinfuse the T cells back into the patients body over the course of several treatments. Our hope is that Descartes-08 may destroy the very cells that produce the autoantibodies. We recently reported positive results in the first cohort of myasthenia gravis patients dosed with Descartes-08 and have escalated the treatment to an expansion cohort.

We are also developing Descartes-30, our targeted second-generation MSC therapy for patients with moderate-to-severe ARDS. Descartes-30 is an allogeneic (i.e., off-the-shelf) cell therapy currently in Phase 1/2a clinical trials. Our team of scientists harvests stem cells from healthy donors and engineers two different enzymes into them that work synergistically to degrade neutrophil extracellular traps (NETs), a key driver of inflammation and clotting in patients with ARDS. RNA-modified cells are then infused into patients. Our belief is that the degradation of NETs using Descartes-30 may alleviate the burden of ARDS by clearing alveoli and vessels in the lungs.

Q: The company also has a clinical program in multiple myeloma can you tell me more about this drug candidate and the ongoing clinical study? How does this compare to conventional treatments for multiple myeloma?

A:We are currently testing two different CAR T-cell therapies, Descartes-08 and Descartes-11, to target BCMA-expressing cancer cells in patients with multiple myeloma. Descartes-08 and Descartes-11 vary in their activations and the way in which they bind to BCMAs. We plan to test both Descartes-08 and Descartes-11 in the clinic to determine which one produces more efficacious results in patients with multiple myeloma, advancing the better performing therapy into late-stage clinical trials.

While other cell therapies investigate the potency of treatments in later stage multiple myeloma patients, Descartes-08 and -11 are focused on patients with newly diagnosed multiple myeloma. Multiple myeloma is an incurable disease characterized by relapses that are treated with effective drugs until the patient is in remission. As the disease progresses, the remission period becomes shorter and shorter after each relapse.

Our hypothesis is to develop potent yet safer RNA-modified CAR T-cell therapy for use in the early stages of multiple myeloma. We hope our RNA cell therapy candidates may be combined with other effective drugs at the beginning of a patients treatment regimen to eliminate any remnant of the disease during the first line of therapy. Both Descartes-08 and Descartes-11 have been well-tolerated from a safety perspective in Phase 1 clinical trials and are both being tested in Phase 2a studies in patients with high-risk, newly-diagnosed multiple myeloma.

Q: What can we expect for the future of RNA cell therapy in the industry and for Cartesian?A: We are hopeful for the future of RNA cell therapy. We do not foresee extensive limitations in the kinds of combinations of therapeutics that RNA cell therapy can provide to patients, a challenge that plagues conventional DNA-modified cells. RNA-modified cells have the potential to integrate complex therapeutic combinations. The potential synergistic efficacy and sheer number of combinations may allow clinicians to target the disease precisely and through multiple mechanisms simultaneously.Q: Why do you think there has not been greater interest in the development of RNA therapy so far? Is this set to change?A: The main limitation for investigating RNA cell therapies occurs when institutions do not have the capacity to manufacture high quality products at large quantities. Since cells lose function over multiple rounds of proliferation, patients must be dosed with a larger number of cells, and often with repeat-dosing. Institutions and companies must have the capability to scale up high-quality cells, and efforts have failed in the past due to limited manufacturing capabilities that inhibit the quantity of cells produced. We hope more laboratories streamline their manufacturing processes to investigate RNA cell therapies and their potential to help patients across a variety of disease states.

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Innovating Reversible Cell Therapies With RNA - Technology Networks

InGeneron Publishes Significant Support for the Existence of Naturally Pluripotent Stem Cells in All Organs in the Adult Body – Galveston County Daily…

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InGeneron Publishes Significant Support for the Existence of Naturally Pluripotent Stem Cells in All Organs in the Adult Body - Galveston County Daily...

US Stem Cell Therapy Market size and analysis by leading manufacturers, application and types 2021-2027 Energy Siren – Energy Siren

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Stem Cell Therapy Market 2021-2027:

The Global Stem Cell Therapy market exhibits comprehensive information that is a valuable source of insightful data for business strategists during the decade 2015-2027. On the basis of historical data, Stem Cell Therapy market report provides key segments and their sub-segments, revenue and demand & supply data. Considering technological breakthroughs of the market Stem Cell Therapy industry is likely to appear as a commendable platform for emerging Stem Cell Therapy market investors.

The complete value chain and downstream and upstream essentials are scrutinized in this report. Essential trends like globalization, growth progress boost fragmentation regulation & ecological concerns. This Market report covers technical data, manufacturing plants analysis, and raw material sources analysis of Stem Cell Therapy Industry as well as explains which product has the highest penetration, their profit margins, and R & D status. The report makes future projections based on the analysis of the subdivision of the market which includes the global market size by product category, end-user application, and various regions.

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This Stem Cell Therapy Market Report covers the manufacturers data, including shipment, price, revenue, gross profit, interview record, business distribution, etc., these data help the consumer know about the competitors better.

Topmost Leading Manufacturer Covered in this report:Osiris Therapeutics, NuVasive, Chiesi Pharmaceuticals, JCRPharmaceutical, Pharmicell, Medi-post, Anterogen, Molmed, Takeda (TiGenix)

Product Segment Analysis: AutologousAllogeneic

On the Basis of Application:Musculoskeletal DisorderWounds & InjuriesCorneaCardiovascular DiseasesOthers

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Regional Analysis For Stem Cell TherapyMarket

North America(the United States, Canada, and Mexico)Europe(Germany, France, UK, Russia, and Italy)Asia-Pacific(China, Japan, Korea, India, and Southeast Asia)South America(Brazil, Argentina, Colombia, etc.)The Middle East and Africa(Saudi Arabia, UAE, Egypt, Nigeria, and South Africa)

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To analyze and forecast the market size of Stem Cell TherapyIndustry in theglobal market. To study the global key players, SWOT analysis, value and global market share for leading players. To determine, explain and forecast the market by type, end use, and region. To analyze the market potential and advantage, opportunity and challenge, restraints and risks of global key regions. To find out significant trends and factors driving or restraining the market growth. To analyze the opportunities in the market for stakeholders by identifying the high growth segments. To critically analyze each submarket in terms of individual growth trend and their contribution to the market. To understand competitive developments such as agreements, expansions, new product launches, and possessions in the market. To strategically outline the key players and comprehensively analyze their growth strategies.

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At last, the study gives out details about the major challenges that are going to impact market growth. They also report provides comprehensive details about the business opportunities to key stakeholders to grow their business and raise revenues in the precise verticals. The report will aid the companys existing or intend to join in this market to analyze the various aspects of this domain before investing or expanding their business in the Stem Cell Therapy markets.

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US Stem Cell Therapy Market size and analysis by leading manufacturers, application and types 2021-2027 Energy Siren - Energy Siren

Susanna Park inducted as holder of Roth Endowed Chair for Discovery, Education and Patient Care – UC Davis Health

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Susanna Soon-Chun Park, a vitreoretinal surgery specialist, was inducted Nov. 6 as the inaugural holder of the Barbara A. and Alan M. Roth, M.D. Endowed Chair for Discovery, Education and Patient Care.

The special ceremony was at the new SMUD Museum of Science and Curiosity.

Speakers included Allison Brashear, now former dean of the School of Medicine, and Mark J. Mannis, professor and chair of the Department of Ophthalmology & Vision Science.

Dr. Park is a brilliant clinician-scientist, and her dedication to discovery that leads to treatments and cures for patients with vision loss or no vision, is inspiring. We are honored that she is a member of our distinguished faculty, Mannis said.

In the clinic, Park provides surgical and medical therapies for retinal disorders and treats patients with intraocular tumors. Park is also is the director of the Retina Division and director of the vitreoretinal fellowship program at UC Davis.

Parks colleagues Paul Sieving, the Neil and MJ Kelly Presidential Chair in Vitreoretinal Science, Ala Moshiri, an associate professor of ophthalmology, and Glenn Yiu, associate professor of ophthalmology, also gave remarks.

Parks research has focused on developing novel therapies for retinal disorders through translational and clinical research, including exploring the use of stem cells for retinal regenerative therapy.

Park was one of the first investigators in the U.S. to receive FDA-clearance to conduct NIH-funded clinical trials using stem cells for vision loss. She is the principal investigator for currently enrolling clinical trials investigating stem cell treatment for vision loss from retinal problems, central retinal vein occlusion, and retinitis pigmentosa.

The ceremony also included a video celebrating the accomplishments of Alan M. Roth, a former UC Davis faculty member who established the endowed chair in 2017. Roth was in attendance at the event.

I am humbled and honored to be the first recipient of this endowed chair and would like to thank Dr. Roth for his generous contribution to the department, Park said. With the funds that become available with this endowed chair, I will be able to continue the research exploring stem cells in our bone marrow as a potential therapy for retinal regeneration.

Park noted in her remarks that Roth was an important collaborator in the early phase of stem cell research in the Department of Ophthalmology. His detailed analysis of the histology slides of animals that were treated with stem cells made it possible for us to get FDA clearance to conduct clinical trials to treat patients with the stem cell therapy, Park said.

Roth joined the then-new Department of Ophthalmology in 1972 and went on to distinguish himself as a clinician, pathologist and teacher. Roth initiated Ophthalmic Pathology at UC Davis, helping to determine the causes of eye disease at the microscopic level.

Roth officially retired from UC Davis in 1997 but continued to work part-time, seeing patients and serving as a pathologist and teacher. His late wife, Barbara, a trained orthoptist, passed away in 2014.

In addition to the endowed chair, Roth established the Alan and Barbara Roth Ophthalmic Pathology Laboratory in the new UC Davis Eye Center facility.

A video of the full investiture ceremony is available on the Eye Centers YouTube channel.

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Susanna Park inducted as holder of Roth Endowed Chair for Discovery, Education and Patient Care - UC Davis Health

Immunomic Therapeutics Announces Collaboration With iOncologi – BioSpace

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- Potential to bring in-house cell-based therapies that potentiate checkpoint inhibitors

ROCKVILLE, Md.--(BUSINESS WIRE)-- Immunomic Therapeutics, Inc., (ITI) a privately held clinical-stage biotechnology company focused on advancing its proprietary nucleic acid immunotherapy platform, announced today an exclusive option to license or acquire a series of innovative technologies in the immuno-oncology space from iOncologi, Inc., (iOi).

Preclinical studies led by iOi Co-Founders, Drs. Duane Mitchell and Catherine Flores, have demonstrated that resistance to immune checkpoint inhibitors (ICIs) can be overcome by iOis novel, intravenously delivered stem cell-based therapeutic. Rapid translation of this possible breakthrough discovery into first-in-human clinical trials is underway. ITIs option offers potential opportunities for both companies to further facilitate clinical and commercial development in the field of cell therapy and for collaboration in the development of nucleic acid vaccines that complements ITIs own UNITE technology. The option agreement contemplates additional investment by ITI dependent upon iOi achieving certain clinical trial milestones.

We are pleased to expand our collaboration with Dr. Duane Mitchell, both in his role as Founder & President of iOncologi, and as a leading academic researcher in the immuno-oncology field. Dr. Mitchell has been instrumental in the development and leadership of our ATTAC-II clinical trial for patients with Glioblastoma, said Dr. William Hearl, CEO of Immunomic Therapeutics. His determination to bring innovative treatments to patients is what compounds the complementary technologies in both companies.

We are very excited to have iOncologi and Immunomic Therapeutics bring together complementary expertise in the advancement of new treatments for patients with refractory cancers, said Dr. Mitchell. This agreement expands upon a longstanding and very fruitful collaboration with Dr. Hearl and the team at ITI in bringing forward novel immunotherapy treatments for patients with Glioblastoma. I look forward to the advances that will come from this agreement between the two companies.

About Immunomic Therapeutics, Inc.

Immunomic Therapeutics, Inc. (ITI) is a privately-held, clinical stage biotechnology company pioneering the development of vaccines through its proprietary technology platform, UNiversal Intracellular Targeted Expression (UNITE), which is designed to utilize the bodys natural biochemistry to develop vaccines that generate broad immune responses. UNITE has a robust history of applications in various therapeutic areas, including infectious diseases, oncology, allergy and autoimmune diseases. ITI is primarily focused on applying the UNITE platform to oncology, where it could potentially have broad applications, including antigen-derived antibodies as biologics. The Company has built a pipeline leveraging UNITE with programs in oncology, animal health, infectious disease and allergy. ITI has entered into a significant allergy partnership with Astellas Pharma and has formed several academic collaborations with leading Immuno-oncology researchers at Fred Hutchinson Cancer Research Institute, Johns Hopkins University of Medicine, and Duke University School of Medicine. ITI maintains its headquarters in Rockville, Maryland. For more information, please visit http://www.immunomix.com.

About iOncologi, Inc.

iOncologi, Inc. (iOi) is a privately held biotechnology company focused on the advancement of novel immunotherapies for the treatment of refractory cancers and infectious diseases. iOis core platform technology involves the proprietary use of intravenously delivered stem cells to overcome resistance to immune checkpoint inhibitors (ICIs) in a variety cancers. iOi holds particular expertise in the treatment of malignant brain tumors and is focused on advancing its immunomodulatory stem cell therapy for adult and pediatric patients with malignant gliomas, as well as for patients with brain metastasis. iOis stem cell therapy has also demonstrated a capacity to enhance the effectiveness of adoptive T cell therapy and holds significant potential in the treatment of severe infectious diseases and sepsis. iOi maintains its headquarters at The Hub at Innovation Square in Gainesville, Florida.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211123006210/en/

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Immunomic Therapeutics Announces Collaboration With iOncologi - BioSpace

Covid vaccine: Stem cell transplant patients who must be completely re-vaccinated struggling to book jabs – iNews

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Stem cell transplant patients are being denied vital Covid vaccines despite guidelines stating they must be given an additional jab after their treatment wipes out pre-existing protection from life-threatening illnesses.

People who receive stem cell transplants effectively have their immune system replaced, meaning they need to get all their vaccinations again, including childhood immunisations and Covid-19 jabs.

The Covid-19 Green Book, which features the latest information on vaccination procedures, states: Individuals who have received a bone marrow transplant after vaccination should be considered for a re-immunisation programme for all routine vaccinations and for Covid-19.

For example, a stem cell transplant patient who received both their Covid jabs before their treatment would need a further two or three jabs followed by a booster to protect them against the virus.

Some patients who are immunosuppressed were told to have a third vaccine following their initial first two doses, followed by a booster jab and stem cell patients will need the same level of protection after their treatment.

But despite the official guidance, patients are reporting difficulties in getting the life-saving jabs because their medical records wrongly state that they are ineligible.

Mark Davies, 54, who had a stem cell transplant as part of his treatment for myeloma, a type of blood cancer, earlier this year, received two doses of the Covid vaccine before the procedure.

His consultant advised him to get vaccinated against Covid again once he had recovered from the transplant as his condition means he is at high risk of getting seriously ill from the coronavirus.

But when Mr Davies tried explaining the situation to his GP, they would not schedule him in to be re-vaccinated.They were just sort of adamant that the computer says no, Mr Davies told i.

After numerous phone calls and emails, he was able to book an appointment for another jab, but only because he had become eligible for a booster at the time.

Research shows that people with compromised immune systems may not mount a full response to Covid-19 vaccination and therefore are likely to be less protected than the general population.

Bone marrow transplant patient Tony Capon, 72, needs to get all his Covid-19 jabs again. But despite a letter from his consultant, getting re-vaccinated has been a challenge.

He says: I was completely frustrated by this whole process and reaching the point where it was quite clear to me that people that were supposedly trying to sort this out were going to get to the end of the road.

The GP practice suggested that I walk into the big vaccination centre. I didnt really want to go there because being so vulnerable, I didnt really want to walk through the whole shopping centre and go into this place. But I thought this may be the only way Im going to get vaccinated, so I telephoned them on Sunday and booked an appointment for a booster vaccine.

Together with my wife, we have now been in some form of self isolation for 21 months. There were just two small periods when we did venture out in the summer of 2020 when we all thought things were so much better. Id already had two vaccines at that point.

We havent seen our grandchildren, aged four and eight, in the flesh for two years. Just three weeks ago, when we were doing a FaceTime call, my four-year-old grandson turned to his dad and said he didnt know who I was.

We want to go out, we want to see our grandchildren but weve been stuck at home all this time.

As a result, the need to get vaccinated is of even greater importance for people like Mr Davies, who was among those initially prioritised for the first Covid-19 jabs.He said he fears he may have to shield again if he is unable to get re-vaccinated.Its really scary. Inevitably, you feel extremely vulnerable.

I absolutely took the view that Im not going anywhere, not seeing people outside. And I think its exhausting. Youve been through a fairly big and quite traumatic procedure and, fortunately, seem to be recovering from that, but youve then got this challenge.

Myeloma information nurse specialist at Myeloma UK, Ellen Watters, said the situation people like Mr Davies were facing was truly devastating and unacceptable.

She said: These patients have extremely weakened immune systems and any protection they may have received from previous COVID-19 vaccines is now gone. The people were speaking to feel theyve exhausted every possible avenue and are now being forced to self-isolate indefinitely.

In addition to myeloma, stem cell transplants, also known as bone marrow transplants, are used to treat a range of conditions. These include:

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Covid vaccine: Stem cell transplant patients who must be completely re-vaccinated struggling to book jabs - iNews

Calls for stem cell donation to change in Australia to reduce reliance on overseas donors – ABC News

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Shelley Garvie had beenthrough three rounds of chemotherapy to treat acute myeloid leukaemia when she was told her best hopewasa stem cell transplant.

For that to happenshe needed to find a match from within her own family or from a registry of donors.

Also referred to as a bone marrow transplant, the procedureitself ismuch like a blood transfusion.

In preparation, Ms Garvie's own immune system needed to be shut down.

Aftermonths of living in cancer accommodation in Adelaide,away from her home and two teenage children in Loxtonin the Riverland of South Australia,Ms Garvie likened the processto facing a steep hill at the end of a marathon.

"Cancer takes everything you have and I felt like I had just done so much hard work, I had been in this really good mindset and hoping that chemo would do the job," she said.

"Being told I had to go to transplant was another level of scary."

But a donor was found and the stem cell transplant was a success.

Ms Garvie's own stem cells were replaced with those of her donor to rebuild her blood and immune systems.

"It's the most harrowing thing I've ever been through, but it saved my life," Ms Garvie said.

"I'm back home now, I'm able to be with my loved ones, to be present in their lives.

"It's the greatest gift anyone could give you."

Ms Garvie needed an allogeneic hematopoietic progenitor stem cell (HPC) transplant, during whichhealthy stem cells from a matching donor are infused into a patient's bloodstream.

It can offer the best chance of a cure for blood and bone marrow cancers and other diseases.

About 30 per cent of all patientscan find a donor within their family, with siblings usually offering the best chance of a match.

But Ms Garvie'ssister Jodie was not a match and her onlyhope was to be matched with an unrelated donor.

That process was conducted by the Australian Bone Marrow Donor Registry (ABMDR)by searching the Australian and overseasdonor registries.

Like 80 per cent of the 400 Australian patients needing a bone marrow transplant each year, Ms Garvie's donor was found overseas.

The ABMDR has been calling on the government to change the way Australia recruits and tests donors toimprove the domestic donor pool and avoid the delays, supply issues and the financial impacts of importing stem cells,especially during a pandemic.

Chief executive Lisa Smith said while Australia would always need to use overseas donors, an 80 per cent dependency was well in excess of global norms.

"Australian clinicians are selecting an overseas donor 60 per cent more often than their overseas counterparts," she said.

Thefederal government funded areview of the HPC sector in 2018and released aNational HPC Frameworkin November 2021, which identified reducing reliance on overseas donors and improved recruitment model as long-term objectives.

But without a concrete time frame progress hadstalled, Ms Smith said.

"The framework says nothing about life after June 30 next year and leaves all the old questions unanswered," she said.

People aged 18-35 can register to be a stem cell donor when they give blood through the Australian Red Cross Lifeblood program.

There are about 180,000 people registered and the procedure for donating stem cells is similar to donating plasma.

But Ms Smith said some of the restrictions on blooddid not apply to stem cell donation and called for Australia to adopt the international model of allowing donors to register online and conduct a home cheek swab for tissue testing.

This model has been piloted in Australia twice through the ABMDR's Strength to Give campaign, launched in 2018.

Those campaigns recruitedabout 12,000donors, butthe program has now closed and needs government approvalto continue.

"That would put us in a position where we start to see more Australian patients receiving donations from Australian donors and we don't have to deal with the risk, the complexity and the time delay involved with importing products from overseas, particularly during a pandemic," Ms Smithsaid.

"Obviously we need funding for this model there is a pool of funds sitting there.

"Government needs to make the decision to let us spend the money on the recruitment of donors in this way.

"We need to repair Australia's donor pool to bring it in line with the kinds of donor pools we see and depend on overseas."

The Leukaemia Foundation has supported the push for Australia to reduce its dependence on overseas stem cell donors and to better service patient needs.

"We have been monitoring this issue for a number of years and are generally concerned about the ability to serve the needs of the Australian population in a timely manner here," the foundation's Blood Cancer Partnerships general manager Tim Murphy said.

"People aren't necessarily missing out on the transplant itself, but what is happening is it takes a bit longer to happen and with the challenges around COVID the supply of stem cells became very acute.

"We are over-reliant on things that are outside of our control.

"If we had more secure supply within Australia some of those challenges wouldn't be so challenging."

Increasing the ethnic diversity of the Australian registry has been identified by the HPC review as a priority, as patients are most likely to be a match with a donor from the same ethnic background.

Professor David Ritchie, the head of theallogeneic bone marrow transplant service at the Royal Melbourne Hospital and Peter McCallum Cancer Centre, says recruitment needs to better reflect Australian multiculturalism.

"Indigenous Australians are one, but equally included are people from Pacific Islands, Melanesia, southern Mediterranean and African extractionthat are currently very significantly under-represented on donor registries internationally, let alone in Australia," he said.

"In order to be able to deliver care to people we look after here in Australia it makes sense to have the registry representative of the ethnic groups currently in Australia."

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Calls for stem cell donation to change in Australia to reduce reliance on overseas donors - ABC News

An Against-the-Odds Cancer Story Can Be Yours – Curetoday.com

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I had it all, or thought I did. At 55 happy in my marriage and at the top of my career I awoke one morning in damp, tangled sheets. Turning to dislodge my leg, a searing pain shot up my back. I moaned, gasped, then slowly sat. My husband had already left for work in San Francisco. Wincing as I stood, I made my way downstairs holding tight onto the bannister and walked to my home office. At my computer, I typed in back pain and my other oddball symptoms: shortness of breath, weight loss and night sweats. In a nanosecond, Google diagnosed a kidney infection. A quick appointment, a bottle of antibiotics, and Id be fine. In my internet search, I failed to include the lump on my neck.

Mid-morning, when I mentioned the persistent knot to my internist, she ordered emergency blood tests and X-rays. Twenty minutes later, my chest X-ray blazing with cancerous nodes filled her computer screen.

Likely lymphoma, she mumbled. Im sorry.

There was a heart, lungs and stomach, but also filling the screen were bright spots that resembled glistening hailstones scattered on a sidewalk after a storm.

Lymphoma? No. Cancer happened to other people.

Without immediate transfusions, a heart attack was imminent. Within two hours I became an inpatient in a faded hospital gown. Vulnerable and weak, Id been changed from the woman I am one who tries to be kind, has good taste (or thinks she does), doesnt eat meat, reads a lot, drinks a little too much and wishes she werent so ambivalent about sex into a medical record number, lab values, a diagnosis and a course of treatment.

Tests revealed mantle cell lymphoma (MCL), a rare and aggressive disease. Ninety-eight percent of my bone marrow was a cancerous mush.

Inpatient Chemotherapy Was Full of Surprises

During treatment, I had to pee in a pink plastic hat to measure the number of dead cancer cells in my urine. I was as soggy as a sea cucumber from the fluids that dripped into me around the clock. I endured a psychotic drug reaction where I learned what crawling out of ones skin means. And a near-fatal blood poisoning made me wonder about the shape, size, and sound of death. After an onslaught of chemo, I was emaciated, bald, and against all odds in remission.

But MCL has a nasty habit of coming right back, and to prevent a quick recurrence, I needed a stem cell transplant. But neither of my brothers were a match, nor was there anyone in the international database of donors.

Without a transplant my survival was unlikely. The only possible donor was Johnny, my brilliant, off-the-grid brother who had vanished 30 years earlier.

Finding him was nothing short of miraculous. That he was a genetic match and agreed to donate his stem cells was profoundly amazing.

I was admitted to Stanford Advanced Cancer Center for a tortuous 10 days where my immune system was chemically eradicated and I endured daily doses of radiation.

After the stem cell transplant, I was released to begin 100 days of recovery with my husband, Dan, as my trusty caregiver.

My Hideous Body

I couldnt cook, clean, do laundry, drive, exercise or have sex. Dan had to do all of this well, except for the sex part. He didnt reach for me. I didnt blame him. Plastic tubes a Hickman catheter for taking blood and giving meds, sprouted from my chest, and my hairless, emaciated body was hideous. Wed had sex only once in the eight months since my diagnosis.

Every drop of water I drank (three liters a day) had to be boiled. Dan did this graciously, reliably and without complaint for 100 days. Also, with his meticulous attention to detail, he flushed my catheter tubes daily and cleaned them twice a week.

So many heroes came into my life during my year of treatment, and, because of them, I am now a 16-year survivor of a lymphoma that would have almost certainly taken my life in less than three.

Cancer is a great teacher and helped me rebuild my family. Johnny is now back in my life, and while the 30 years we were apart and our significantly divergent paths in life created two people who are profoundly different, I can now help him financially, love him from a distance and express sincere gratitude for his great gift of a second chance at life.

I am hopeful that my story will convince others who have faced cancer themselves or love someone who has that miracles do happen. An against-the-odds story can be everyones.

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The Expanding Role of Interferons in Myeloproliferative Neoplasms – Targeted Oncology

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In the treatment of myeloproliferative neoplasms (MPNs), 1 interferon agent is FDA approved in the United States. Ropeginterferon alfa-2b-njft (Besremi) is indicated for adults with polycythemia vera (PV), but as research continues to support the use of these agents, oncologists have more questions.

To better understand the underlying mechanisms of action associated with interferons, as well as efficacy, safety, and mechanism of resistance, the MPN Research Foundation (MPNRF) launched a 3-year global initiative.

"It is unusual that we have been effectively using interferon for the treatment of MPNs for more than 30 years without fully understanding how it works," said Richard T. Silver, MD, in a press release about the initiative. "That is why the MPNRF's Interferon Initiative is so important. Interferon appears to uniquely affect the MPN stem cells and has other valuable attributes.

In an interview with Targeted Oncology, Silver, professor emeritus of Medicineat Weill Cornell Medicine, discussed the role of interferon in the treatment of MPNs as well as the importance of the 3-year global MPN initiative being conducted by the MPNRF.

TARGETED ONCOLOGY: Can you discuss which patients benefit from recombinant IFN alpha. What agents are showing promise right now?

Silver: Interferon can be effective in a number of hematologic disease but currently, its primarily used to treat myeloproliferative neoplasms. It was first used to chronic myeloid leukemia [CML] before we had very specific treatment for it. I happen to be very interested in chronic myeloid leukemia, But now, we have much better therapy than interferon, because of the similar for CML because of the similarities of CML to other disease is of the myeloproliferative group.

In 1988, I had the idea of using it in PV and some investigators in Austria have used interferon to treat essential thrombocytopenia [ET]. So, of the 3 MPNs, interferon is most commonly used in PV because many patients with ET do not require therapy at all, when they do interferon is very effective.

We and others have evaluated interferon in very myelofibrosis and find it to be effective in about 80% of cases. Overall, Interferon is more was effective PV because it's been shown that it affects the PV stem cell leading to its exhaustion.

Resistance and intolerance to interferons has been shown. Can you explain how common this is?

Most patients with PV and ET, develop intolerance rather than resistance to interferons, and mostly, it's in the form of peripheral neuralgia. It can be autoimmune disease, and sometimes people get thinking disorders or depressed on interferon. Sometimes they develop liver abnormalities.

It's not a benign drug. If you look at the total of patients who become intolerant to interferon, it's about 15% to 20%. When the drug is used properly, that is to say we're using low doses of interferon, it's about the same number of patients in our series of 470 patients with PV who have developed intolerance to hydroxyurea, which is a commonly used drug in PV treatment. So, all these drugs have side effects, which must be evaluated very carefully.

Resistance to interferon is a very complex issue. Presumably, there are biologic effects in the stem cells that occur that make the stem cell not responsive to interferon. That is being worked on now in the research setting. But we don't know why some patients develop resistance per se to interferon, but that is not as common as intolerance.

Can you talk about the key goals of the 3-Year Global MPN Interferon Initiative?

The Myeloproliferative Neoplasm Research Foundation thats very active in raising funds for research around this disease. They organized an initiative to determine how interferon works or what is the mechanism of action accounting for success. It should be noted parenthetically that interferon was first used in viral diseases, and particularly in hepatitis. Its effect rheumatologically and its use in hematologic disease is really a secondary manifestation of its broad physiologic potential.

To determine how interferon works, a combination of laboratory studies were conducted in 4 different laboratories around the world. The goal was to determining the effectiveness and reason why interferon works in hematological disorders. Based on mouse models, they have demonstrated that interferon is effective, because it affects PV stem cell, and probably is most active in affecting the megakaryocytic stem cell, which is sort of the mother cell of all stem cells. There are other proteins that affect this phenomenon, and these were part of the research that was generated by the MPN Research Foundation.

There are many unanswered questions and many detailed questions that need to be answered before we really have a full understanding of how this drug works hematologically. But, I should also note that many drugs have been used therapeutically before we could really understand the basis for its use. The best example is penicillin. You know, the observation that penicillin was an antibacterial agent was made long before the basis for understanding why it was effective. So, this is very encouraging. At Weill Cornell, where I have the privilege of being a professor, we have just completed a retrospective study of 470 patients who have been treated with phlebotomy only or hydroxyurea or interferon. The study has demonstrated that patients treated with interferon have a much better survival than those treated with hydroxyurea and that hydroxyurea is superior to phlebotomy.

What is your key takeaway from the report published around this initiative?

I think the all the laboratory investigators would agree that we have ways to go before we fully understand the mechanism action of interferon and why it works is most effective, as I said, PV and ET. It works in early phases of myelofibrosis. When myelofibrosis for example, becomes advanced in the bone marrow, it becomes very sclerotic or fibrotic, interferon is not effective. So, there are many questions to be answered. This is the beginning and like all research, when you conduct research, it often opens more questions that are answered. And I think this has been true in this MPN Research Foundation. As I said, I think the most important aspect of this has been to focus the effect of interferon on the MPN stem cell and show that is, in fact, very active on that cell.

What interferon research has been most impressive for the treatment of MPNs?

Ropeginterferon alfa-2b is one that has very long action. That is to say that you can give an injection on day 1 and you wont have to give another injection for another 2 to 4 weeks. This agent has just been FDA approved for the treatment of polycythemia vera in the United States. It was already approved in Europe, so there will be more and more patients being treated with interferon soon.

In your expert opinion, how should interferon be used in the clinical setting? What does the future look like for these agents?

Our goal in using interferon in hematologic malignancies is obviously to keep the patients with a very good quality of life, so they can maintain their professional, social, and family lives with minimal adverse events. That's our goal. And I think we can achieve it with these new forms of interferons. So, I'm very positive.

Reference:

3-Year Global MPN interferon initiative report released by MPN Research Foundation. News release. MPN Research Foundation. November 1,,2021. Accessed November 23, 2021. https://bit.ly/3DLkeW5

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The Expanding Role of Interferons in Myeloproliferative Neoplasms - Targeted Oncology

Michael B. Jordan spends Thanksgiving with Lori Harvey’s …

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These lovebirds went all out for Turkey Day.

Michael B. Jordan joined his girlfriend, Lori Harvey, for her familys Thanksgiving celebration on Thursday.

Extremely thankful , Harvey, 24, captioned a Boomerang selfie with Jordan, 34, on Instagram as he raised a glass of white wine.

She also shared photos of other family members at the get-together, including stepfather Steve Harvey and brothers Wynton and Broderick. Some of the Harveys were seen napping, while others enjoyed a game of billiards on a Louis Vuitton-printed pool table.

The model uploaded pictures of their delicious-looking Thanksgiving feast as well, showing off their traditional turkey dish, a plethora of pies, baked macaroni and cheese, bread pudding and spaghetti with meatballs.

We start eating early in the Harvey household, Lori captioned a video of their food on her Instagram Story.

Lori and the Black Panther actor celebrated their one-year dating anniversary last week with a fancy dinner together.

Its been a year crazy!! Jordan wrote on Instagram at the time, to which Lori echoed, Happy anniversary my love.

The pair, who initially kept their love life private, first sparked romance rumors when they were spotted together in Atlanta ahead of Thanksgiving last year.

Jordan and Lori then confirmed their relationship by going Instagram-officialin January.

The Family Feud host, 64, has sincegiven Jordan his stamp of approval, telling Ellen DeGeneres in March, I have tried not to like him. I have tried to find something wrong with him that I can dig in cause I done got rid of all of them.

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Michael Jordan Once Completely Clowned a Famous Rappers Shoe Idea, but They Still Ignored His Advice: No Ones Trying to Wear Some Christmas Shoes -…

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Over the years, Michael Jordans shoe brand has become as popular as one of its kind can get. Due to its significant success, many basketball and sneaker fans dream of designing their own Air Jordans one day. However, most people would probably like MJ himself to actually approve of the kicks.

Macklemore, though, didnt get that nod from His Airness.

While the famous rapper did, in fact, get to design his own Jordans a few years back, the experience took somewhat of a turn when the Hall of Famer clowned his idea.

Michael Jordans shoes have become about as popular as any sneaker on the market. Since signing with Nike in 1984, MJ has earned over an estimated $1 billion from the company (per Forbes), and he even launched his own extension of it called Jordan Brand in 1997.

Because of its significant popularity, many Air Jordan player exclusives (PEs) have come out over the years. If youre unfamiliar with PEs, they are made specifically for players, and they dont typically go on the market to consumers.

According to Complexs Sole Collector, athletes to get custom Air Jordan PEs have included: Kobe Bryant, Gary Payton, Derek Jeter, Penny Hardaway, Shaquille ONeal, Ray Allen, Russell Westbrook, Deion Sanders, and many more.

In fact, while hes not a player, Macklemore is actually included on that list.

In 2015, Macklemore revealed to Complex Magazine that he got to design his own Air Jordans for performing at the Jordan Brand Classic. They ended up being the Air Jordan 6s.

The rapper said he then got to meet MJ at one point, and their interaction came when his shoe was still in the design phase. But the six-time NBA champ quickly let him know his real thoughts on the sneaker.

I showed him the shoe, Macklemore said to Complex. He was like I dont like green. He was like, F*** green. It reminds me of some Christmas s***. No ones trying to wear some Christmas shoes. Just completely discarded my colorway. I was like, OK, Ima still do it. You f***ed the game up. But I hear you.

Getting your idea clowned by Jordan probably didnt feel too good. But the green shoes make sense for Macklemore, given his Seattle Mariners and Seattle Seahawks fandoms.

He shouldnt feel too bad, though, as the Chicago Bulls legend also hates another type of shoe.

In addition to green shoes, Michael Jordan apparently hates black kicks as well.

Hes not a fan of black shoes ever, former VP of Footwear for Jordan Brand, Gentry Humphrey, stated to The Complex Sneakers Podcast in 2021. He does not like black shoes. Youll probably rarely see him wear black shoes. Every time he wore them in the playoffs, it was a mentality. He wanted to wear black shoes based on how he wanted to take his game to the next level when he was in an opponents arena. So, he felt this notion of being stealth-like was important. That would be the only time. Casually, though, youll never see him wearing black shoes.

So, since he has a distinct taste in sneakers, you can absolutely bet that His Airness is involved in Jordan Brand meetings, specifically when it comes to recreating retro Air Jordans.

The one thing about Michael that Ive always said is hes, to me, the secret weapon of the brand, Humphrey also said when talking to Complex. People really underestimate how astute he is to the game. From a business standpoint, he can tell you the numbers of whats going on in the brand. And he loves footwear. I think that if he wasnt a professional athlete, hed probably want to do something in it.

Michael Jordan may be known as the NBA GOAT, but his influence on the sneaker world has been just as impactful.

RELATED:Bradley Beal Admits He Was Surprised When Michael Jordan Wanted Him on Jordan Brand: Mike Dont Like Nobody

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Michael Jordan Once Completely Clowned a Famous Rappers Shoe Idea, but They Still Ignored His Advice: No Ones Trying to Wear Some Christmas Shoes -...

The Womens Air Jordan 1 Low LV8D Appears In Grey And White – Sneaker News

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Throughout its 36-year-old history, Jordan Brand has been criticized for not offering women-exclusive footwear. Over the last five years, the NIKE, Inc. subsidiary has made strides on this front, while also modifying classics like the Air Jordan 1 Low with design cues catered to female sneaker enthusiasts.

Yet to be officially announced by the brand, a platform sole-donning iteration of the aforementioned pair named the LV8D (read: elevated) variant has recently appeared in a neutral white and grey colorway. Construction across the upper remains true to Peter Moores 36-year-old design including the placement of the Wings logo. The biggest deviation from the inaugural low-top Air Jordan 1, then, arrives via the exaggerated, fashion-forward midsole and outsole combination underfoot. Tread pattern has been updated on the womens retro, although its likely not meant for the hardwood. Nevertheless, the platform sole help the muted color palette make a statement.

A firm Nike.com release date hasnt been disclosed by the brand, but thats likely to change as 2022 inches closer. In any case, enjoy early images of the pair.

For more from under the Team Jumpman banner, check out the Cool Grey 11 arriving for the whole family on December 11th.

Where to Buy

Make sure to follow @kicksfinder for live tweets during the release date.

Womens: N/AStyle Code: DH7004-100

Images: Foot Locker

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WATCH: Rookie TE Brevin Jordan Puts Texans Up, 14-3 – State of The Texans

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HOUSTON -- When the Houston Texans selected University of Miami tight end Brevin Jordan in the fifth round, universal praise was handed to new general manager Nick Caserio for finding a high-upside talent. But fans eventually began to ponder why he was limited in playing time.

It's hard to imagine the rookie missing more reps in the future after his surge since becoming a more prominent figure in the passing attack.

Jordan scored a 13-yard touchdown to begin the second quarter as Houston (2-8) takes the 14-3 lead over the New York Jets. On third down, quarterback Tyrod Taylor connected with the 6-5 tight end across the middle of the field in man-to-man coverage.

Jordan bullied a pair of defenders to push his way across the goal-line for his second touchdown of the season. It would also mark his seventh catch since Week 8 against the Los Angeles Rams.

Hes growing, Texans coach David Culley said of Jordan last week. Hes growing into that role. If youve noticed, hes getting a few targets where hes been one-on-one and weve moved him outside. We feel like thats a good matchup because hes a very good athlete out there."

Jordan has begun to see more significant play over fourth-year pro Jordan Akins. A former third-round pick in 2018 and Texas Rangers outfielder turned tight end at UCF, Akins enters a contract season and was at the plight of trade rumors during the NFL deadline last month.

This season, Akins has recorded21 receptions for 184 yards on 28 targets in nine games in three starts. He was listed as inactive for Sunday's game against the Jets, allowing Jordan to play a similar role.

The Texans will begin on defense to begin the second half.

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WATCH: Rookie TE Brevin Jordan Puts Texans Up, 14-3 - State of The Texans

The Air Jordan 1 Low Crater Returns With University Blue Hits – Sneaker News

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The Air Jordan 1 Low may not have the cachet of its tallest counterpart, but its allowed NIKE, Inc. to promote some of its more experimental designs to the masses. For its latest ensemble, the low-top silhouette has indulged in recycled Nike Grind materials.

At a glance, the newly-surfaced pair boasts Air Jordan heritage, but closer inspection reveals a number of details rooted in Jordan Brands future, not past. The mix of materials throughout the upper deliver a predominantly-muted aesthetic, but collars, branding on the tongue and haphazard stitching at the profiles introduce vibrant University Blue flair to the mix. Yet, the retros most eye-catching details are arguably those constructed with up-cycled factory floor scraps as part of the companys Move to Zero initiative: everything from the fabric found at the toe box and heel to the sidewall logos feature a grey and multi-color look made possible by the grinding down of excess materials collected throughout Jordan Brand and Nikes manufacturing processes. Nike Dunk-reminiscent sole units also partake in the sustainability efforts, with midsoles opting for a Crater Foam build, while tread uses the aforementioned Nike Grind solution.

Enjoy images of the low-top Jordan 1 ahead, and anticipate a Nike.com launch soon.

In other news, the Cool Grey 11s officially release on December 11th.

Where to Buy

Make sure to follow @kicksfinder for live tweets during the release date.

Mens: $110Style Code: DM4657-004

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The Air Jordan 1 Low Crater Returns With University Blue Hits - Sneaker News