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What is the difference between ventilation and respiration? – EMS1.com

By Stem Cell Clinic

By Chris Ebright

You were taught from day one of taking vital signs to countrespirations. However, I am here to say that your stellar EMT instructor let you down because thats wrong. The same incorrect terminology is also written in numerous textbooks, on run reports, and spoken everyday between medical professionals. So now youre asking: OK, smartypants, then what is the proper term? The appropriate term, my fellow professionals, is, you count ventilations.

Arent these terms essentially the same? The easy answer is no. The harder question is: Well, why not? This installment of Back to the Basics discusses these physiological processes and how they differ. So please, read on.

Simply put, ventilation is breathing the physical movement of air between the outside environment and the lungs. Air travels through the mouth and nasal passages, then down the pharynx. Upon reaching the vocal cords, air flows into the trachea, transitioning from the upper airway into the lower airway. Here, it continues distally to the carina, then through the primary bronchi, various branches of bronchioles, and eventually arriving in the alveoli. This is inhalation. Air movement in a reverse pathway from alveoli to mouth and nose, is exhalation. Inhalation, followed by exhalation, equals one ventilation. This is what you observe (chest rise and fall) when determining the breathing rate.

A ventilation can only take place if the brainstem, cranial and associated peripheral nerves, the diaphragm, intercostal musculature and lungs are all functional. Combining the function of all these structures, the pulmonary ventilation mechanism establishes two gas pressure gradients. One, in which the pressure within the alveoli is lower than atmospheric pressure this produces inhalation. The other, in which the pressure in the alveoli is higher than atmospheric pressure this produces exhalation. These necessary changes in intrapulmonary pressure occur because of changes in lung volume.

So, how does the lung volume change? Quite simply, it is a combination of muscle contractions stimulated by the central nervous system, and the movement of a serous membrane within the thorax called the pleura. The pleura is made of two layers: a parietal layer that lines the inside of the thorax and a visceral layer that covers the lungs and adjoining structures (blood vessels, bronchi, and nerves). Between the visceral and parietal layers is a small, fluid-filled space, called the pleural cavity.

The initiation of ventilation begins with the brainstem, where impulses (action potentials) generate within the medulla oblongata, then travel distally within the spinal cord. The impulse traverses individually through cervical nerves three, four and five until just above the clavicle. Here, the three cervical nerves merge into one large nerve called the phrenic nerve, which attaches distally to the diaphragm. Imagine these two nerves resembling a pair of suspenders on the anterior chest. The delivered impulse from the phrenic nerve initiates diaphragm contraction.

The intercostal muscles are a group of intrinsic chest wall muscles occupying the intercostal spaces. They are arranged separately in three distinct layers (external intercostal muscles, internal intercostal muscles, and innermost intercostal muscles). The intercostal nerves that stimulate these muscles originate from the spinal cord thoracic nerves 1-11.

Inhalation is initiated as the dome-shaped diaphragm is stimulated. As it contracts and flattens, the thorax expands inferiorly. The internal and innermost intercostal muscles relax, while the external intercostal muscles contract from stimulus by the thoracic nerves. This produces an upward and outward movement of the ribs (similar to the movement of a bucket handle), and the sternum (similar to when pulling upward on a handle of a water pump). The fluid in the pleural cavity acts like glue, adhering the thorax to the lungs. Hence, as the thorax expands vertically and laterally, the parietal layer drags the visceral layer along with it, causing the lungs to expand. Adequate expansion of the lungs results in a decreased pressure within the alveoli. Therefore, when the alveolar pressure drops below atmospheric pressure, air rushes into the lungs.

Remember, inhalation requires a stimulus initiated from the central nervous system. Think of it like turning on a light. The light stays unlit until you flip a switch (CNS), releasing electricity and stimulating the components of the light bulb. As long as the switch is on and there is an impulse, the light stays lit. However, if you turn off the switch, the stimulus ceases, and the light shuts down. Exhalation is akin to turning off the switch, so to speak.

Thoracic stretch receptors constantly monitor chest expansion. Once an acceptable limit of expansion develops, they send a message to the central nervous system to turn off the switch. All the nerves stimulating diaphragmatic and external intercostal muscle contraction temporarily stop conducting. Consequently, the diaphragm and the external intercostal muscles relax, decreasing the thoracic volume like letting air out of a balloon. Assisting with this passive process, the internal and innermost intercostal muscles are stimulated. Their contraction pulls the ribcage and attached pleura further downward and inward, compressing the lungs and increasing the air pressure within the alveoli. Once the alveolar pressure exceeds the atmospheric pressure, air moves out of the lungs.

That is all there is to it simple, right? Adults normally ventilate between 12 to 20 times per minute, thanks to the autonomic nervous system. We do not even have to think about it! Nonetheless, what becomes a problem (and why EMS gets a call) is when the nervous system, the thoracic musculature, or the lungs become diseased or disabled. Here is a partial list of pathologies that impair ventilation:

Respiration is the movement of gas across a membrane. The gas exchange in the lungs is referred to as external respiration. The very thin membrane gas crosses is called the respiratory membrane, separating the air within the alveoli from the blood within pulmonary capillaries. Its structure consists of the alveolar wall, the capillary wall, and eachs respective basement membrane. A basement membrane is a thin, fibrous structure that separates the lining of an internal or external body surface from underlying connective tissue. Think of it like Christmas wrapping paper around a box.

Recall that adequate ventilation enables air to reach the alveoli and establish a pressure gradient. The alveolar pressure of oxygen typically ranges from 80 to 100 mmHg, whereas the alveolar pressure of inspired carbon dioxide is very low (typically 40 mmHg). Oxygen-depleted blood, transported from the bodys cells and back to the right side of the heart, is pumped into the pulmonary trunk and through the pulmonary arteries. Eventually, the blood makes its way through the distal pulmonary capillaries surrounding the alveoli. Oxygen within the pulmonary bloodstream typically has a pressure of 40 mmHg, and carbon dioxide has a pressure of 45 mmHg. These differences in pressure allow for diffusion of oxygen from alveolar air, across the respiratory membrane and onto the hemoglobin of red blood cells. Carbon dioxide diffuses off hemoglobin, crosses the respiratory membrane, and enters the alveolar space.

The result of external respiration establishes a hemoglobin oxygen pressure in excess of 100 mmHg, and a decreased pressure of carbon dioxide of 40 mmHg. The exchange of oxygen and carbon dioxide continues across the respiratory membrane until the equilibrium of each gas is established. Oxygen-rich blood then flows from the lungs via the pulmonary veins back to the left side of the heart. Here, it is pumped out through the aorta to all body tissues.

Blood flows from the systemic circulation, down through arteries, arterioles, and eventually to the capillaries. Capillaries are only large enough to accommodate one red blood cell at a time, and blood flow at this level is very slow. This maximizes the time for the release of oxygen and reabsorption of carbon dioxide. Cells require high concentration oxygen to function correctly. Thus, another membrane exchange of gas must take place between individual body cells and the systemic capillaries.

This transaction occurs with gas already within the body, so it is termed internal respiration. Organelles within a cell take oxygen and combine it with glucose, fat, or protein, and make energy (ATP) through a series of complex chemical reactions. The resultant waste product is a high concentration of carbon dioxide. So, as arterial blood flows into capillaries, an awaiting cell has low oxygen pressure (40 mmHg, typically) and a high carbon dioxide pressure (45 mmHg).

Oxygen that is attached to hemoglobin maintains a pressure of around 100 mmHg, and carbon dioxide a pressure of 40 mmHg. A diffusion gradient is established once again, only this time in the opposite direction that occurred in the lungs. At the cellular level, the exchange of oxygen and carbon dioxide commences across the cellular/capillary membrane until an equilibrium of each gas is established. Blood flow continues through the venules, veins, vena cava, heart, and back into the lungs with a hemoglobin oxygen pressure of 40 mmHg and a carbon dioxide pressure of 45 mmHg. Rinse and repeat, every minute, of every day, for life.

Unfortunately, external and internal respiration can also be negatively influenced and inhibited by various disease processes. At the time of this article, the most notable respiratory pathology is caused by COVID-19, the coronavirus. View the YouTube video from the Cleveland Clinics Dr. Sanjay Mukhopadhyay (found in the reference listings) to get a first-hand view of what COVID-19 does to the alveolar-capillary membrane.

Additionally, here are some other common respiration pathologies:

Hopefully, now you understand the difference between ventilation and respiration. Even though these are independent physiological processes, they are also mutually dependent to ensure the survival of the human body. So, the next time someone misuses one of these terms set them straight with a smile. Tell em Chris told you.

Chris Ebright is an EMS education specialist with ProMedica Air and Mobile in Toledo, Ohio, managing all aspects of internal continuing EMS education as well as for numerous EMS systems in northwest Ohio and southeast Michigan. He has been a nationally registered paramedic for 25 years, providing primary EMS response, land and air critical care transportation. Chris has educated hundreds of first responders, EMTs, paramedics, and nurses for 24 years with his trademark whiteboard artistry sessions, including natives from the Cayman Islands and Australia. Chris passion for education is also currently featured as a monthly article contributor, published on the Limmer Education website. He has been a featured presenter at numerous local, state and national EMS conferences over the past 13 years, and enjoys traveling annually throughout the United States meeting EMS professionals from all walks of life. Chris is a self-proclaimed sports, movie and rollercoaster junkie and holds Bachelor of Education degree from the University of Toledo in Toledo, Ohio. He can be contacted via email at c.ebrightnremtp@gmail.com or through his website http://www.christopherebright.com.

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What is the difference between ventilation and respiration? - EMS1.com

Cytovia Therapeutics partners with Inserm to develop selective CD38 NK therapeutics and offer new treatment options for Multiple Myeloma patients |…

By Induced Pluripotent Stem Cells

Details Category: DNA RNA and Cells Published on Thursday, 08 October 2020 15:15 Hits: 194

NEW YORK, NY, USA and PARIS, France I October 08, 2020 I Cytovia Therapeutics ("Cytovia"), an emerging biopharmaceutical company, announces today that it has entered a research and licensing agreement with Inserm to develop NK engager bi-specific antibodies and iPSC CAR NK cell therapy targeting CD38, a key marker of multiple myeloma. The licensing agreement has been negotiated and signed by Inserm Transfert, the private subsidiary of Inserm, on behalf of Inserm (the French National Institute of Health and Medical Research) and its academic partners. Cytovia is licensing Inserm's CD38 antibody and Chimeric Antigen Receptor (CAR) patent and applying its proprietary NK engager bispecific antibody and iPSC CAR NK technology platforms. The research agreement will include evaluation of the therapeutic candidates at Hpital Saint-Louis Research Institute (Inserm Unit 976) under the leadership of Professors Armand Bensussan and Jean-Christophe Bories.

Dr Daniel Teper, Cytovia's Chairman and CEO commented: "We are delighted to partner with one of the top centers of excellence in the world for research and treatment in hematology. CD38 is a validated target and Natural Killer cells have significant cytotoxicity to Myeloma cells. We are looking forward to bringing promising new options to address the unmet needs of patients with Multiple Myeloma and aim for a cure."

Professor Armand Bensussan, Director of The Immuno-Oncology Research Institute at Hpital Saint-Louis added: "We have demonstrated the selectivity of our novel CD38 antibody in killing myeloma cells but not normal cells such as NK, T, and B cells. The activation of NK cells through NKp46 may enhance the efficacy of the bispecific antibody in patients not responsive to CD38 monoclonal antibody therapy. CD38 CAR NK is a promising approach forrelapsed/refractory patients and an alternative to CAR T therapies."

About Multiple Myeloma Multiple Myeloma is a currently incurable cancer, affecting a type of white blood cell known as plasma cells. It leads to an accumulation of tumor cells in the bone marrow, rapidly outnumbering healthy blood cells. Instead of producing beneficial antibodies, cancerous cells release abnormal proteins causing several complications. While symptoms are not always present, the majority of patients are diagnosed due to symptoms such as bone pain or fracture, low red blood cell counts, fatigue, high calcium levels, kidney problems, and infections. According to the World Cancer Research Fund, Multiple Myeloma is the second most common blood cancer, with nearly 160,000 new annual cases worldwide, including close to 50,000 in Europe. 32,000 in the US, and 30,000 in Eastern Asia. Over 95% of cases are diagnosed late, with a 5-year survival rate of 51%. Initial treatment comprises of a combination of different therapies, including biological and targeted therapies, corticosteroids, and chemotherapy, with the option for bone marrow transplants for eligible patients. Immunotherapy and cell therapy are the most promising new treatment option for Multiple Myeloma, with the potential for long term cancer remission.

About CAR NK cells Chimeric Antigen Receptors (CAR) are fusion proteins that combine an extracellular antigen recognition domain with an intracellular co-stimulatory signaling domain. Natural Killer (NK) cells are modified genetically to allow insertion of a CAR. CAR-NK cell therapy has demonstrated initial clinical relevance without the limitations of CAR-T, such as Cytokine Release Syndrome, neurotoxicity or Graft vs Host Disease (GVHD). Induced Pluripotent Stem Cells (iPSC) - derived CAR-NKs are naturally allogeneic, available off-the-shelf and may be able to be administered on an outpatient basis. Recent innovative developments with the iPSC, an innovative technology, allow large quantities of homogeneous genetically modified CAR NK cells to be produced from a master cell bank, and thus hold promise to expand access to cell therapy for many patients.

About Cytovia Cytovia Therapeutics Inc is an emerging biotechnology company that aims to accelerate patient access to transformational immunotherapies, addressing several of the most challenging unmet medical needs in cancer and severe acute infectious diseases. Cytovia focuses on Natural Killer (NK) cell biology and is leveraging multiple advanced patented technologies, including an induced pluripotent stem cell (iPSC) platform for CAR (Chimeric Antigen Receptors) NK cell therapy, next-generation precision gene-editing to enhance targeting of NK cells, and NK engager multi-functional antibodies. Our initial product portfolio focuses on both hematological malignancies such as multiple myeloma and solid tumors including hepatocellular carcinoma and glioblastoma. The company partners with the University of California San Francisco (UCSF), the New York Stem Cell Foundation (NYSCF), the Hebrew University of Jerusalem, and CytoImmune Therapeutics. Learn more at http://www.cytoviatx.com

About Inserm Founded in 1964, the French National Institute of Health and Medical Research (Inserm) is a public science and technology institute, jointly supervised by the French Ministry of National Education, Higher Education and Research, and the Ministry of Social Affairs, Health and Womens Rights. Inserm is the only French public research institute to focus entirely on human health and position itself on the pathway from the research laboratory to the patients bedside. The mission of its scientists is to study all diseases, from the most common to the rarest. With an initial 2020 budget of 927.28 million, Inserm supports nearly 350 laboratories throughout France, with a team of nearly 14,000 researchers, engineers, technicians, and post-doctoral students. http://www.inserm.fr

SOURCE: Cytovia Therapeutics

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Cytovia Therapeutics partners with Inserm to develop selective CD38 NK therapeutics and offer new treatment options for Multiple Myeloma patients |...

Dolly the Sheep: ’90s Media Sensation – Mental Floss

By Induced Pluripotent Stem Cells

It was Saturday, February 22, 1997, and Scottish researchers Ian Wilmut and Keith Campbell were expecting a final moment of calm before the results of their unprecedented scientific experiment were announced to the world.

The team had kept the breakthrough under wraps for seven months while they waited for their paper to be published in the prestigious journal Nature. Confidential press releases had gone out to journalists with the strict instruction not to leak the news before February 27.

But that night, the team was tipped off that journalist Robin McKie was going to break the story the very next day in the British newspaper The Observer.

Wilmut and Campbell raced to the lab at the Roslin Institute on Sunday morning as McKie's story hit the media like a thunderbolt. International news outlets had already started swarming at the institute for access to Wilmut and Campbell's creation: Dolly the sheep, the world's first mammal successfully cloned from a single adult cell. Shielded from the general public, she stuck her nose through the fence and munched calmly on the hay in her pen, unperturbed by the horde of news photographers. Dolly, a woolly, bleating scientific miracle, looked much like other sheep, but with a remarkable genetic difference.

By the end of that Sunday, February 23, nearly every major newspaper in the world carried headlines about Dolly the sheep.

Born on July 5, 1996, Dolly was cloned by Wilmut and Campbell's team at the Roslin Institute, a part of the University of Edinburgh, and Scottish biotechnology company PPL Therapeutics. The scientists cloned Dolly by inserting DNA from a single sheep mammary gland cell into an egg of another sheep, and then implanting it into a surrogate mother sheep. Dolly thus had three mothersone that provided the DNA from the cell, the second that provided the egg, and the third that carried the cloned embryo to term. Technically, though, Dolly was an exact genetic replica of only the sheep from which the cell was taken.

Following the announcement, the Roslin Institute received 3000 phone calls from around the world. Dolly's birth was heralded as one of the most important scientific advances of the decade.

But Dolly wasn't science's first attempt at cloning. Researchers had been exploring the intricacies of cloning for almost a century. In 1902, German embryologists Hans Spemann and Hilda Mangold, his student, successfully grew two salamanders from a single embryo split with a noose made up of a strand of hair. Since then, cloning experiments continued to become more sophisticated and nuanced. Several laboratory animal clones, including frogs and cows, were created before Dolly. But all of them had been cloned from embryos. Dolly was the first mammal to be cloned from a specialized adult cell.

Embryonic stem cells, which form right after fertilization, can turn into any kind of cell in the body. After they modify into specific types of cells, like neurons or blood cells, they're call specialized cells. Since the cell that gave rise to Dolly was already specialized for its role as a mammary gland cell, most scientists thought it would be impossible to clone anything from it but other mammary gland cells. Dolly proved them wrong.

Many scientists in the '90s were flabbergasted. Dollys advent showed that specialized cells could be used to create an exact replica of the animal they came from. It means all science fiction is true, biology professor Lee Silver of Princeton University told The New York Times in 1997.

The Washington Post reported that "Dolly, depending on which commentator you read, is the biggest story of the year, the decade, even the century. Wilmut has seen himself compared with Galileo, with Copernicus, with Einstein, and at least once with Dr. Frankenstein."

Scientists, lawmakers, and the public quickly imagined a future shaped by unethical human cloning. President Bill Clinton called for review of the bioethics of cloning and proposed legislation that would ban cloning meant ''for the purposes of creating a child (it didn't pass). The World Health Organization concluded that human cloning was "ethically unacceptable and contrary to human integrity and morality" [PDF]. A Vatican newspaper editorial urged governments to bar human cloning, saying every human has "the right to be born in a human way and not in a laboratory."

Meanwhile, some scientists remained unconvinced about the authenticity of Wilmut and Campbells experiment. Norton Zinder, a molecular genetics professor at Rockefeller University, called the study published in Nature "a bad paper" because Dolly's genetic ancestry was not conclusive without testing her mitochondriaDNA that is passed down through mothers. That would have confirmed whether Dolly was the daughter of the sheep that gave birth to her. In The New York Times, Zinder called the Scottish pair's work ''just lousy science, incomplete science." But NIH director Harold Varmus toldthe Times that he had no doubt that Dolly was a clone of an adult sheep.

Because she was cloned from a mammary gland cell, Dolly was nameddad joke alertafter buxom country music superstar Dolly Parton. (Parton didnt mind the attribution.) Like her namesake, Dolly the sheep was a bona fide celebrity: She posed for magazines, including People; became the subject of books, journal articles, and editorials; had an opera written about her; starred in commercials; and served as a metaphor in an electoral campaign.

And that wasn't all: New York Times reporter Gina Kolata, one of the first journalists to give readers an in-depth look at Dolly, wroteClone: The Road to Dolly, and the Path Ahead and contrasted the animal's creation with the archetypes in Frankenstein and The Island of Dr. Moreau. American composer Steve Reich was so affected by Dolly's story that he featured it in Three Tales, a video-opera exploring the dangers of technology.

The sheep also became an inadvertent political player when the Scottish National Party used her image on posters to suggest that candidates of other parties were all clones of one another. Appliance manufacturer Zanussi used her likeness for a poster with her name and the provocative caption "The Misappliance of Science" (the poster was later withdrawn after scientists complained). In fact, so widespread was the (mis)use of her name that her makers eventually trademarked it to stop the practice.

Following Dolly, many larger mammals were cloned, including horses and bulls. Roslin Biomed, set up by the Roslin Institute to focus on cloning technology, was later sold to the U.S.-based Geron Corporation, which combined cloning technology with stem cell research. But despite her popularityand widespread fearDolly's birth didn't lead to an explosion in cloning: Human cloning was deemed too dangerous and unethical, while animal cloning was only minimally useful for agricultural purposes. The sheep'sreal legacy is considered to be the advancement in stem cell research.

Dollys existence showed it was possible to change one cells gene expression by swapping its nucleus for another. Stem cell biologist Shinya Yamanaka told Scientific American that Dollys cloning motivated him to successfully develop stem cells from adult cells. He later won a Nobel Prize for his results, called induced pluripotent stem cells (iPS) because they're artificially created and can have a variety of uses. They reduced the need for embryonic stem cells in research, and today, iPS cells form the basis for most stem cell research and therapies, including regenerative medicine.

Dolly had sixoffspring, and led a productive, sociable life with many human fans coming to visit her. In 2003, a veterinary examination showed that Dolly had a progressive lung disease, and she was put down. But four clonescreated from the same cell line in 2007 faced no such health issues and aged normally.

Dolly is still a spectacle, though, nearly 25 years after her creation: Her body was taxidermied and puton display at the National Museum of Scotland in Edinburgh.

Link:
Dolly the Sheep: '90s Media Sensation - Mental Floss

Regeneron, Pfizer and BioNTech Accused of Infringing Allele Patent in Connection with COVID-19 Technologies – IPWatchdog.com

By Induced Pluripotent Stem Cells

Only through use of mNeonGreen were [Pfizer and BioNTech] able to develop and test the BNT162 vaccine candidate at lightspeed, making them first to market [and] earning them an immediate $400 million in grants and over $4 billion in sales of the vaccine to- date. Allele Complaint

Allele Biotechnology and Pharmaceuticals, Inc. (Allele) has accused Regeneron Pharmaceuticals, Inc. (Regeneron); Pfizer, Inc. (Pfizer); and BioNTech SE and BioNTech US, Inc. (collectively BioNTech) for allegedly infringing U.S. Patent No. 10,221,221 (the 221 patent), which is directed to an artificial flourescent, i.e. mNeonGreen, used for testing COVID-19 assays against vaccine candidates. Allele argues that Regeneron, Pfizer and BioNTech have been infringing the 221 patent by taking mNeonGreen for their own unauthorized commercial testing and development.

Regeneron has been in the news lately for famously providing the antibody cocktail given to President Donald Trump shortly after he tested positive for COVID-19 last week. The cocktail is name in the complaint as one of the allegedly infringing technologies.

The 221 patent, titled Monomeric Yellow-Green Fluorescent Protein from Cephalochordate, was assigned to Allele and directed to high performance monomeric yellow-green fluorescent proteins. Although mNeonGreen was Alleles breakthrough in fluorescent protein technology, Allele has many other achievements, including advances in RNA interference, Fluorescent Proteins, Induced Pluripotent Stem Cells (iPSCs), Genome Editing, and camelid derived Single Domain Antibodies. Most recently, Allele has also been actively engaged in combating COVID-19, initiating impactful diagnostic and therapeutic platforms premised on speed, accuracy, and sensitivity. Alleles mNeonGreen technology has been licensed to hundreds of organizations and universities. As asserted by Allele, mNeonGreen facilitates quick, targeted, and precise receptor research, including for potential therapeutics to treat COVID-19.

Allele filed a Complaint against Regeneron in the U.S. District Court for the Southern District of New York alleging that Regeneron has been using Alleles patented mNeonGreen technology. Allele cited multiple published articles and papers written by Regeneron representatives. The Complaint noted that Regeneron did not have a license to use Alleles mNeonGreen technology, despite Alleles consistent showing that it is willing to license its mNeonGreen technology on reasonable terms in order to help facilitate the use of that protein by third parties in their efforts to develop new and essential technologies. Also, according to the Complaint, Allele sought to discuss licensing arrangements with Regeneron after learning of the infringement of the 221 patent, but Regeneron ignored Alleles attempts.

The Complaint asserted that Regeneron directly infringed the mNeonGreen technology claimed in the 221 patent and, by way of its publications, press releases, and other papers, caused others to directly infringe the mNeonGreen technology claimed in the 221 patent. Thus, Allele asked the court, in part, for: (1) a finding that the 221 patent is valid and enforceable, (2) a judgment that Regeneron had infringed, actively induced infringement of, and/or contributed to the infringement of one or more claims of the 221 patent, (3) a judgment that Regenerons infringement was willful, and (4) an award of damages or other monetary relief to adequately compensate Allele for Regenerons infringement of the 221 patent, and such damages be trebled under 35 U.S.C. 284 and awarded to Allele, with pre-judgment and post-judgment interest as allowed by law.

The Complaint against Pfizer and BioNTech (collectively, Defendants) was filed in the U.S. District Court for the Southern District of California and alleges that the Defendants infringed Alleles 221 patent using mNeonGreen throughout their COVID-19 vaccine trials. Pfizer was engaged with BioNTech in the development of their BNT162 MRNA-based vaccine candidate. Allele asserted that [o]nly through use of mNeonGreen were Defendants able to develop and test the BNT162 vaccine candidate at lightspeed making them first to market, earning them an immediate $400 million in grants and over $4 billion in sales of the vaccine to- date [which]was simply the downstream benefit that Defendants enjoyed (and presumably the world will enjoy from the vaccine) from their choice to use Alleles mNeonGreen.

According to the Complaint, BioNTech adopted Alleles mNeonGreen technology in its COVID-19 vaccine trial and literally infringed claims 1, 2, 4 and 5 of the 221 patent. Allele asserted that it has not granted the Defendants authorization, license, or permission to practice the inventions claimed in the 221 Patent. Allele also asserted that Defendants infringement was willful because the defendants had actual knowledge of the 221 Patent and the obvious risk of infringement by continued use of mNeonGreen throughout their development of their COVID-19 vaccine candidate in the United States. Thus, Allele requested, in part, that the court (1) find that the 221 Patent has been infringed by the Defendants in violation of 35 U.S.C. 271, (2) find that the Defendants infringement of the 221 Patent was been willful, (3) award adequate damages to compensate Allele for the Defendants infringement, and (4) an award of treble damages for the period of any willful infringement by the Defendants pursuant to 35 U.S.C. 284.

Image Source: Deposit Photos Author: Rewat Image ID: 358544690

Rebecca Tapscott is an intellectual property attorney who has joined IPWatchdog as our Staff Writer. She received her Bachelor of Science degree in chemistry from the University of Central Florida and received her Juris Doctorate in 2002 from the George Mason School of Law in Arlington, VA.

Prior to joining IPWatchdog, Rebecca has worked as a senior associate attorney for the Bilicki Law Firm and Diederiks & Whitelaw, PLC. Her practice has involved intellectual property litigation, the preparation and prosecution of patent applications in the chemical, mechanical arts, and electrical arts, strategic alliance and development agreements, and trademark prosecution and opposition matters. In addition, she is admitted to the Virginia State Bar and is a registered patent attorney with the United States Patent and Trademark Office. She is also a member of the American Bar Association and the American Intellectual Property Law Association.

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Regeneron, Pfizer and BioNTech Accused of Infringing Allele Patent in Connection with COVID-19 Technologies - IPWatchdog.com

Proposition 14: With Handful of Cures, Calif. Stem Cell Agency Has Mixed Record. Will Voters Pony Up Another $5.5 Billion? – KQED

By Stem Cell Doctors

A Yes vote authorizes the state to sell $5.5 billion in general obligation bonds primarily for stem cell research and the development of new medical treatments in California. A No vote would mean the state's stem cell research agency will probably shut down by 2023.

In the ramp-up to the 2004 election, a California TV viewer may have come across the popular actor Michael J. Fox urging her to vote Yes on a state proposition. His voice slurred faintly by Parkinsons disease, he still sounded wry, boyish and familiar.

My most important role lately is as an advocate for patients and for finding new cures for diseases, said Fox, eyes level with the camera. Californias Stem Cell Research Initiative 71 will support research to find cures for diseases that affect millions of people, including cancer, diabetes, Alzheimer's and Parkinson's.

Within that 30-second spot, Fox, diagnosed at age 29 with a neurodegenerative disorder that typically does not strike until after 60, used the word "cures" three times.

Proposition 71, which passed with 59% of the vote, authorized the sale of $3 billion in bonds to create an agency that funded stem cell research. The successful campaign grew out of a time, in the early 2000s, when the promise of stem cell and regenerative medicine excited both scientists and the public.

Whether the project has lived up to that promise is a matter of opinion. How voters view the record of the agency may go a long way in their decision whether or not to replenish the fund, which is fast running out of money, with an additional $5.5 billion, to be raised with new bonds authorized by Proposition 14, now on the ballot.

President Bush A Demon to Attack

Scientists since the1800s have known about stem cells, which are not yet dedicated to any particular anatomical function and have the potential to become nerve cells, blood cells, skin cells or any other type. They are found in blastocysts, which are human embryos four to five days after fertilization, and in a few areas, such as bone marrow and gonads, in adults.

In the late 1990s, researchers developed ways to steer the development of these cells, and the possibilities for improving medicine seemed endless. If malfunctioning cells were at the root of a particular disease, could new healthy cells tailored to the job fix what was wrong? Scientists and many members of the public were eager to find out.

Anti-abortion groups, however, a key constituency of President George W. Bush, opposed the research, and in 2001 he limited federal funding to a few existing lines of embryonic stem cells, severely curtailing research.

Some in the state of California wanted to get around Bushs restrictions, and Proposition 71 was born.

"(T)hey had this demon they could attack in the campaign the Bush administration," said David Jensen, author of "California's Great Stem Cell Experiment," who also writes the blog California Stem Cell Report. "They could say, 'This is a great opportunity, and the only way we're going to get it done is to do it here in California.'"

The measure created the California Institute for Regenerative Medicine. The stem cell research agency is unique in the U.S.

"No other state has done this kind of level of funding and focus on this kind of thing, said Jensen. It's a really cutting-edge area of science."

A Few Successes

The pace of innovation has been slower than many hoped. As it turned out, grand discoveries were not around the corner, and to date there is no widespread stem cell treatment approved for the public. To date, CIRM has funded more than 64 trials directly and aided in 31 more. Not all have or will result in treatments.

But despite the lack of a marquee cure like one for Alzheimers or Parkinsons, the agency has seen some notable triumphs.

"Probably one of the most spectacular successes they have certainly so far," said Jensen, "is clinical trials that have saved the lives of what they say are 40 children."

Those children were born with severe combined immunodeficiency (SCID), commonly known as "bubble baby syndrome," a rare, generally fatal condition in which a child is born without a working immune system. An FDA-approved gene therapy that grew out of CIRM-funded research can now cure the disease by taking a patients own blood stem cells and modifying them to correct the SCID mutation. The altered cells generate new, healthy blood cells and repair the immune system.

The FDA has also approved two drugs for rare blood cancers that were developed with CIRM funds.

Sandra Dillon, a graphic designer in San Diego, credits one of the drugs with saving her life. She was diagnosed when she was just 28, in 2006. Her doctors told her they would try to manage her symptoms, but that she was going to get progressively sicker.

"Even just the idea of a cure or getting better wasn't even on the table back then," said Dillon, who is featured in ads for the Yes on 14 campaign.

"I remember just praying and begging into the universe, please, someone just look at my disease, please someone help, who is going to look at this thing.

By 2010, Dillon was extremely ill. She connected with a doctor at UC San Diego who received early-stage funding from CIRM and told her she could take part in clinical trials.

"For the first time, there was this moment of, 'Oh, my gosh! There are researchers doing something. And it could help me and I can get access to it.' It was amazing."

The drug received FDA approval in 2019, and today Dillons cancer has retreated to the point where she can live a normal life.

"I love that I am not tethered to a hospital anymore. I can go out on long backpacking trips and hiking and surfing," she said. "I am a completely different person with this drug. And I have a whole future ahead of me."

The original funding raised by Proposition 71 is running out. Proposition 14 would authorize the sale of a new bond to refill the agency piggy bank. Gov. Gavin Newsom, the UC Board of Regents, and scores of patient advocacy groups also support the measure.

Many newspaper editorial boards, however, oppose the proposition, including the San Francisco Chronicle, Mercury News and Los Angeles Times.

Right now the state still owes about $1 billion toward the debt created by Proposition 71. If Proposition 14 passes, the yearly price tag to pay off the new bond would be about $260 million per year for about 30 years.

One of the selling points of the original proposition was the potential for the state to earn big money in royalties from the treatments it helped develop, says Jeff Sheehy, an HIV patient advocate and the only CIRM board member to oppose Proposition 14.

"The promises were made that this would pay for itself. We would be able to pay back the bonds with the money we would get from royalties, etc., etc.

That has not worked out as envisioned: CIRM estimates it has received less than $500,000 in royalties. Early this year, Forty Seven, a company whose therapies were heavily funded by CIRM, sold to Gilead for $4.9 billion. While millions went to various researchers, neither CIRM nor the state of California received anything.

One of the flaws in the original measure is that we [the agency] cannot hold stock in the products that we develop," says Sheehy. "And that's because the California Constitution says that the state of California cannot, as a government entity, hold equity.

Proposition 14 makes it impossible for the state to use profits from its investment on, say, schools or other funding priorities. Instead, any royalties earned must be fed back into programs to make CIRM-funded treatments more affordable.

"What it does is it basically takes all of our returns that we get from this and gives it back to the pharmaceutical and biotech companies," said Sheehy. "It becomes just a blatant giveaway to these companies when we should be requiring access and requiring fair pricing."

Sheehy says he supports medical research, but doesn't like the state going into more debt to pay for it. The greater the state's obligations in bond money, which has to be paid back with interest, the less there is in the general fund, and Sheehy says the state has more pressing needs than stem cell research things like housing, education and transportation.

"The biggest and perhaps the most compelling reason why I feel so strongly that this is not a good idea is that we simply cannot afford it, he said. "If we think this is so important," asks Sheehy, "why don't we just don't pay for [this research] out of the general fund? It would be cheaper.

Opponents of Proposition 14 also point to longstanding complaints of conflicts of interest among the agency board. Most of the $3 billion distributed by the agency has gone to institutions with connections to board members. Critics say the structural conflicts of interest between the board and agency are not addressed in the new measure. Proposition 14 would balloon an already huge board of 29 members to 35.

Funding needs for stem cell research also are not as acute as they were back in 2004. The federal National Institutes of Health now funds some basic stem cell research, spending about $2 billion a year, with $321 million of that going toward human embryonic stem cell research. And private ventures, like nonprofits started by tech billionaires, are pouring more money into biotech.

The problem with assuming that, says Melissa King, executive director of Americans for Cures, the stem cell advocacy group behind the Yes on 14 campaign, is that CIRM fills a neglected funding need.

The NIH does not fund clinical trials at nearly the rate that CIRM can and has been, King said.

She says that's important because of what she calls the "Valley of Death," where promising early-stage research frequently fails to translate into promising treatments that can be tested in clinical-stage research. (What works well in a test tube often does not work well in an organism.) This weeding-out process is costly but necessary. And its where CIRM focused a lot of its effort.

The first- and maybe even second-phase clinical trials, its very difficult to get those funded, King said. It is too much of a risk for business to take on on its own. Venture [capital] isnt going there. Angel [funding] isnt going there.

What voters have to ask themselves, says writer Jensen, is whether stem cell funding is "a high priority for the state of California? Different people make different judgments about that."

CIRM supporters say if Prop. 14 doesn't pass, critical research will stall. Others say federal and private funding will step in and fill the gap.

Absent new funding, the institute expects it will wind down operations leading to a complete sundown in 2023.

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Proposition 14: With Handful of Cures, Calif. Stem Cell Agency Has Mixed Record. Will Voters Pony Up Another $5.5 Billion? - KQED

Woman who lost her partner to cancer last year set to run 10K in his memory – Warrington Guardian

By Stem Cell Doctors

A 29-YEAR-old who tragically lost her partner to cancer last year will be running 10K to raise vital funds for a blood cancer charity in his memory.

Hannah Kenyon, a teaching assistant from Culcheth, is taking part in the Tatton Park 10K this weekend, in tribute to her boyfriend, Jonny Williams, who died from Non-Hodgkins Lymphoma in February last year.

She will be raising money for Anthony Nolan, a charity which finds matching donors for people with blood cancer.

Speaking about her relationship with Jonny, Hannah said: "Jonny and I met at school, I always liked him but we didnt get together until we were in college.

"In March 2018, after having been together been for nine years, we bought our own home which we wanted to renovate and really make our own."

In July of that year, Jonny, who was an electrician, noticed lumps on his neck and started suffering from extreme abdominal pain.

After several trips to hospital, he was eventually diagnosed with stage four Non-Hodgkins Lymphoma.

Hannah recalled: "It was such a shock and Jonny had to start chemotherapy literally straight away.

"However, it wasnt working the way doctors had hoped and his cancer continued to progress.

"This was when a stem cell transplant was first mentioned - the goal was for chemotherapy to get Jonny into remission so he could then have a stem cell transplant, which would hopefully cure him."

With only one half brother and two half sisters, there was no chance of finding Jonny a match within his own family.

Anthony Nolan jumped into action and searched their register of potential stem cell donors for a special stranger who could save his life.

"We were told that Jonny had three potential donors," Hannah said.

"The day we found out, no words needed to be spoken to know how extremely lucky we felt, as I know there are people out there who desperately need a donor but dont have one."

After just a few months, Jonny and Hannah received the devastating news that Jonnys cancer had progressed, which meant that he was unable to have a transplant.

He died less than one week later.

Hannah explained: "It was and still is completely devastating, and at times it still feels like a blur.

"Jonny was such a positive person, Ive never known anyone so positive, and he tried to live as normal a life as possible during his illness.

"He wanted no fuss and always had hope and optimism for the future.

"Even though Jonny was unable to have a transplant, it is just unreal that three strangers were willing to help him.

"I know what its like to hear the news that someone out there is a match and is willing to save a life, which is why I just wont stop shouting about Anthony Nolan."

After Jonny's death, Hannah continued to renovate the house they had bought together.

She also started running and will now be putting on her trainers this weekend in aid of Anthony Nolan, alongside her friend, Sam.

"I know that Jonny would be buzzing about me doing this, he always was my number one fan," Hannah said.

"Sunday, I am sure, will be a really emotional day, but Ive got a playlist of Jonnys favourite songs that Im going to listen to whilst Im running that will keep me going."

You can sponsor Hannah at justgiving.com/fundraising/10kforjonny.

To find out more about Anthony Nolan, visit anthonynolan.org/events.

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Woman who lost her partner to cancer last year set to run 10K in his memory - Warrington Guardian

Q Stock; The Rise of BioRestorative Therapies Inc (OTCMKTS: BRTXQ) – MicroCap Daily

By Adult Stem Cells

Post Views: 221

BioRestorative Therapies Inc (OTCMKTS: BRTXQ) is heating up fast in recent trading and heading northbound again after several weeks of choppy waters. BioRestorative is among the most exciting stories in small caps that has attracted legions of new shareholders after the Company partnered on a new bankruptcy reorganization plan with one of its creditors Auctus Capital in which it would emerge from bankruptcy with the commons intact, ready to begin phase 2 trials and get BioRestorative back on a national stock exchange.

Penny stock speculators are accumulating BRTXQ as they wait for Judge Grossman to say the word EFFECTIVE. There is a lot of speculation on exactly when this will hapen considering the Judges schedule with holidays, COVID-19, and a logjam of cases on the docket. Interested shareholders are monitoring the developments on PACER.

BioRestorative Therapies Inc (OTCMKTS: BRTXQ) operating out of Melville, New York is a life sciences company focused on the development of regenerative medicine products and therapies using cell and tissue protocols, primarily involving adult (non-embryonic) stem cells. We develop therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs are: Disc/Spine Program (brtxDISCTM): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous cultured mesenchymal stem cells collected from bone marrow. The Company intends that the product will be used for the non-surgical treatment of protruding and bulging lumbar discs in patients suffering from chronic lumbar disc disease. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. The Company has received clearance from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain due to degenerative disc disease related to protruding/bulging discs. Metabolic Program (ThermoStem): BioRestorative is developing a cell-based therapy to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (BAT). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in the body may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

BioRestorative Therapies is developing a cell-based therapy candidate to target obesity and metabolic disorders using brown adipose (fat) derived stem cells, or BADSC, to generate brown adipose tissue, or BAT. BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning, as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

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BioRestorative owns a valuable intelectual property portfolio including unique international Stem Cell patents as well as 8 patents issued, in the United States and other countries, for the Companys brown fat technology related to BioRestoratives metabolic program (ThermoStem Program).

On March 20 BioRestorative filed a voluntary petition commencing a case under chapter 11 of title 11 of the U.S. Code in the United States Bankruptcy Court for the Eastern District of New York. The Companys chapter 11 case is being administered under the caption, In re: BioRestorative Therapies, Inc., Case No. 8-20-71757.

Initially intellectual property lawyer John Desmarais entered into a stalking horse agreement to buy the company. He would pay $500,000 to acquire the company, along with their assets (including the intellectual property). The deal with Desmarais fell apart in July when Auctus Capital partnered with the Company on a new bankruptcy reorganization plan in which the Company would emerge from bankruptcy with the commons intact, ready to begin their phase 2 trials and get BioRestorative back on a national stock exchange. On September 10th, a hearing was held for confirmation of the bankruptcy reorganization plan submitted jointly by the company and Auctus Capital Partners. Further detail will be added upon review of the judges order, but the plan and disclosure statement are available to Pacer or Pacermonitor subscribers.

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Currently on the move and running northbound again after several weeks of choppy waters BRTXQ is an exciting story developing in small caps; BioRestorative filed for bankruptcy protection in March but has partnered on a new bankruptcy reorganization plan with one of its creditors Auctus Capital in which the Company would emerge from bankruptcy with the commons intact, ready to begin their phase 2 trials and get BioRestorative back on a national stock exchange. Penny stock speculators are accumulating BRTXQ as they wait for Judge Grossman to say the word EFFECTIVE. There is a lot of speculation on exactly when this will happen considering the Judges schedule with holidays, COVID-19, and a logjam of cases on the docket. Interested shareholders are monitoring the developments on PACER.We will be updating on BioRestorative when more details emerge so make sure you are subscribed to Microcapdaily so you know whats going on with BioRestorative.

Disclosure: we hold no position in BRTXQ either long or short and we have not been compensated for this article.

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Q Stock; The Rise of BioRestorative Therapies Inc (OTCMKTS: BRTXQ) - MicroCap Daily

A Uniquely Patient-Focused Take on Treating AML in Older Adults – Medscape

By Adult Stem Cells

A diagnosis of acute myeloid leukemia (AML) is particularly challenging in older adults, whose age makes them highly susceptible to the disease and treatment-related toxicity. To help patients and practitioners navigate the clinical decision-making process, the American Society of Hematology (ASH) convened an panel of experts who conducted a thorough review of the literature. The result of their work can be found in a new set of guidelines for the treatment of newly diagnosed AML in older adults.

Dr Mikkael Sekeres

Medscape spoke with Mikkael Sekeres, MD, chair of the ASH AML guideline panel and director of the Leukemia Program at Cleveland Clinic Taussig Cancer Institute. Sekeres shared the rationale behind the panel's key recommendations and the importance of keeping the patient's goals in mind.

Medscape: What is the average life expectancy of a 75-year-old developing AML compared with someone of the same age without AML?

Dr Sekeres: A 75-year-old developing AML has an average life expectancy measured in fewer than 6 months. Somebody who is 75 without leukemia in the United States has a life expectancy that can be measured in a decade or more. AML is a really serious diagnosis when someone is older and significantly truncates expected survival.

What is the median age at AML diagnosis in the United States?

About 67 years.

What are the biological underpinnings for poor outcomes in older AML patients?

There are a few of them. Older adults with AML tend to have a leukemia that has evolved from a known or unknown previous bone marrow condition such as myelodysplastic syndrome. Older adults also have worse genetics driving their leukemia, which makes the leukemia cells more resistant to chemotherapy. And the leukemia cells may even have drug efflux pumps that extrude chemotherapy that tries to enter the cell. Finally, older adults are more likely to have comorbidities that make their ability to tolerate chemotherapy much lower than for younger adults.

In someone who is newly diagnosed with AML, what initial options are they routinely given?

For someone who is older, we divide those options into three main categories.

The first is to take intensive chemotherapy, which requires a 4-6 week hospitalization and has a chance of getting somebody who is older into a remission of approximately 50% to 60%. But this also carries with it significant treatment-related mortality that may be as high as 10% to 20%. So, I have to look my older patients in the eyes when I talk about intensive chemotherapy and say, "There is a 1 in 10 or 1 in 5 chance that you might not make it out of the hospital alive."

The second prong is lower-dose therapy. While the more-intensive therapy requiring hospitalization does have a low, but real, chance of curing that person, less-intensive therapy is not curative. Our best hope with less-intensive therapy is that our patients enter a remission and live longer. With less-intensive therapy, the chance that someone will go into remission is probably around 20%, but again it is not curative. The flip side to that is that it improves a person's immediate quality of life, because they're not in the hospital for 4 to 6 weeks.

The final prong is to discuss palliative care or hospice upfront. We designed these guidelines to be focused on a patient's goals of therapy and to constantly revisit those goals to make sure that the treatment options we are offering are aligning with them.

The panel's first recommendation is to offer antileukemic therapy over best supportive care in patients who are appropriate candidates. Can you provide some context for this recommendation?

Doesn't that strike you as funny that we even have to make a recommendation about getting chemotherapy? Some database studies conducted over the past two decades show that, as recently as 15 years ago, only one third of patients who were over the age of 65 received any type of chemotherapy for AML. More recently, as we have had a few more drugs available that allow us to use lower-dose approaches, that number has crept up to probably about 50%. We still have half the patients offered no therapy at all. So, we felt that we had to deliberately make a recommendation saying that, if it aligns with a patient's goals, he or she should be offered chemotherapy.

The second recommendation is that patients considered candidates for intensive antileukemic therapy should receive it over less-intensive antileukemic therapy. How did you get to that recommendation?

There is a debate in our field about whether older adults should be offered intensive inpatient chemotherapy at all or whether we should be treating all of them with less-intensive therapy. There are not a huge amount of high-quality studies out there to answer some of these questions, in particular whether intensive chemotherapy should be recommended over less-intensive therapy. But with the available evidence, what we believe is that patients live longer if they are offered intensive antileukemic chemotherapy. So, again, if it aligns with a patient's goals, we support that patient receiving more-intensive therapy in the hospital.

What does the panel recommend for patients who achieve remission after at least a single cycle of intensive antileukemic therapy and who are not candidates for allogeneic hematopoietic stem cell transplantation?

Once again, this may seem at first blush to be an obvious recommendation. The standard treatment of someone who is younger with AML is to offer intensive inpatient chemotherapy to induce remission. This is followed by a few cycles of chemotherapy, mostly in an outpatient setting, to consolidate that remission.

What is the underlying philosophy for this approach?

Every time we give chemotherapy, we probably get about a 3 to 4 log kill of leukemia cells. Imagine when a person first presents with AML, they may have 10 billion leukemia cells in his or her body. We are reducing that 3 to 4 log with the first course of chemotherapy.

When we then look at a bone marrow biopsy, it may appear to be normal. When leukemia is at a lower level in the body, we simply can't see it using standard techniques. But that doesn't mean the leukemia is gone. For younger patients, we give another cycle of chemotherapy, then another, then another, and then even another to reduce the number of leukemia cells left over in the body until that person has a durable remission and hopefully cure.

For someone who is older, the data are less clear. While some studies have shown that if you give too much chemotherapy after the initial course, it doesn't help that much, there is a paucity of studies that show that any chemotherapy at all after the first induction course is helpful. Consequently, we have to use indirect data. Older people who are long-term survivors from their acute leukemia always seem to have gotten more than one course of chemotherapy. In other words, the initial course of chemotherapy that a patient receives in the hospital isn't enough. They should receive more than that.

What about older adults with AML considered appropriate for antileukemic therapy but not for intensive antileukemic therapy?

This again gets to the question of what are a patient's goals. It takes a very involved conversation with a person at the time of their AML diagnosis to determine whether he or she would want to pursue an aggressive approach or a less-aggressive approach. If a person wants a less-aggressive approach, and wants nothing to do with a hospital stay, then he or she is also prioritizing initial quality of life. In this recommendation, based on existing studies, we didn't have a preference for which of the available less-aggressive chemotherapies a person selects.

There's also debate about what to do in those considered appropriate for antileukemic therapy, such as hypomethylating agents (azacitidine and decitabine) or low-dose cytarabine, but not for intensive antileukemic therapy. What did the available evidence seem to indicate about this issue?

There have been a lot of studies trying to add two drugs together to see if those do better than one drug alone in patients who are older and who choose less-intensive therapy. The majority of those studies have shown no advantage to getting two drugs over one drug.

Our recommendation is that in these situations a patient gets one drug, not two, but there are a couple of caveats. One caveat is that there has been a small study showing the effectiveness of one of those low-dose chemotherapies combined with the drug glasdegib. The second caveat is that there have been results presented combining one of these low-dose chemotherapies with the drug venetoclax. One of those was a negative study, and another was a positive study showing a survival advantage to the combination vs the low-dose therapy alone. We had to couch our recommendation a little bit because we knew this other study had been presented at a conference, but it hadn't come out in final form yet. It did recently, however, and we will now revisit this recommendation.

The other complicated aspect to this is that we weren't 100% convinced that the combination of venetoclax with one of these lower-dose therapies is truly less-intensive therapy. We think it is starting to creep up toward more-intensive chemotherapy, even though it is commonly given to patients in the outpatient setting. It gets into the very complicated area of what are we defining as more-intensive therapy and less-intensive therapy.

Is there a recommended strategy for older adults with AML who achieve a response after receiving less-intensive therapy?

This is also challenging because there are no randomized studies in which patients received less-intensive therapy for a finite period of time vs receiving those therapies ad infinitum. Given the lack of data and also given a lot of anecdotal data out there about patients who stopped a certain therapy and relapsed thereafter, we recommended that patients continue the less-intensive therapy ad infinitum. So as long as they are receiving a response to that therapy, they continue on the drug.

Of course, there are also unique considerations faced by older patients who are no longer receiving antileukemic therapy, and have moved on to receiving end-of-life care or hospice care. What advice do the guidelines offer in this situation?

There are a lot of aspects of these recommendations that I think are special. The first is the focus on patient goals of care at every point in these guidelines. The second is that the guidelines follow the real disease course and a real conversation that doctors and patients have at every step of the way to help guide the decisions that have to be made in real time.

A problem we have in the United States is that once patients enter a hospice, most will not allow blood transfusions. One reason is that some say it is antithetical to their philosophy and consider it aggressive care. The second reason is that, to be completely blunt, economically it doesn't make sense for hospices to allow blood transfusions. The amount that they are reimbursed by Medicare is much lower than the cost of receiving blood in an infusion center.

We wanted to make a clear recommendation that we consider transfusions in a patient who is in a palliative care or hospice mode to be supportive and necessary, and that these should be provided to patients even if they are in hospice, and as always if consistent with a patient's goals of care.

How does a patient's age inform the discussion surrounding what intensity treatment to offer?

With younger adults, this is not as complicated a conversation. A younger person has a better chance of being cured with intensive chemotherapy and is much more likely to tolerate that intensive chemotherapy. For someone who is younger, we offer intensive chemotherapy and the chance of going into remission is higher, at 70% to 80%. The chance of dying is lower, usually less than 5%. It is an easy decision to make.

For an older adult, the riskbenefit ratio shifts and it becomes a more complicated option. Less-intensive therapy or best supportive care or hospice become viable.

Are there other factors confounding the treatment decision-making process in older adults with AML that practitioners should consider?

Someone who is older is making a different decision than I would. I have school-aged children and believe that my job as a parent is to successfully get them to adulthood, so I would take any treatment under the sun to make sure that happens. People who have lived a longer life than I have may have children and even grandchildren who are adults, and they might have different goals of care. My goals are not going to be the same as my patient's goals.

It is also harder because someone who is older may feel that he or she has lived a good life and doesn't need to go through heroic measures to try to be around as long as possible, and those goals may not align with the goals of that person's children who want their parent to be around as long as possible. One of the confounding factors in this is navigating the different goals of the different family members.

Dr Sekeres has disclosed no relevant financial relationships.

Kate O'Rourke is a freelance writer in Portland, Maine. She has covered the field of oncology for over 10 years.

For more news, follow Medscape on Facebook, Twitter, Instagram, andYouTube.

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A Uniquely Patient-Focused Take on Treating AML in Older Adults - Medscape

VERIFY: Was the antibody cocktail used to treat President Trump developed using human embryonic stem cells? – CBS News 8

By Stem Cell Treatment

Social media is buzzing with the claim President Trump, who is pro-life, used an antibody cocktail developed using human embryonic stem cells.

The antibody cocktail used to treat President Donald Trump for COVID-19 is getting a lot of attention on social media.

Some users are claiming Regeneron - the company that developed the treatment - used human embryonic stem cells to create it, but is this true?

News 8 reached out to Regeneron for comment.

"This particular discovery program (regn-cov2) did not involve human stem cells or embryonic stem cells," wrote Regeneron spokesperson Alexandra Bowie in a statement.

So, where did that claim about human embryonic stem cells come from?

It appears to have developed from this statement Regeneron issued back in April 2020 regarding stem cell research:

"As is the case with many other science-focused biotechnology companies, Regeneron uses a wide variety of research tools and technologies to help discover and develop new therapeutics. stem cells are one such tool. the stem cells most commonly used at Regeneron are mouse embryonic stem cells and human blood stem cells. currently, there are limited research efforts employing human-induced pluripotent stem cell lines derived from adult human cells and human embryonic stem cells that are approved for research use by the national institutes of health and created solely through in vitro fertilization."

According to the American Association for the Advancement of Science, here's what the antibody cocktail used to treat the president is made of:

"One antibody comes from a human who had recovered from a SARS-COV-2 infection; a B cell that makes the antibody was harvested from the person's blood and the genes for the immune protein isolated and copied. The other antibody is from a mouse, which was engineered to have a human immune system, that had the spike protein injected into it."

Bowie also told News 8 the statement about stem cell research on its website reflects the company's general position on stem cell research, but does not mean human embryonic stem cells were used in creating the antibody cocktail used to treat the president.

Nevertheless, some said the company's position on using stem cells in general contradicts President Trump's pro-life stance and that of Supreme Court Nominee Amy Coney Barrett.

But the bottom line, were human embryonic stem cells used in Regeneron's antibody cocktail to treat the president? News 8 can verify the answer is no.

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VERIFY: Was the antibody cocktail used to treat President Trump developed using human embryonic stem cells? - CBS News 8

Global Stem Cell Therapy Market 2020 Industry Analysis, Size, Share, Growth, Trend and Forecast to 2025 – re:Jerusalem

By Stem Cell Treatment

MarketsandResearch.biz has published the latest market research study on Global Stem Cell Therapy Market 2020 by Company, Type and Application, Forecast to 2025 which investigates a few critical features of the market such as industry condition, division examination, market insights. The report studies the global Stem Cell Therapy market share, competition landscape, market share, growth rate, future trends, market drivers, opportunities and challenges, sales channels. The report has referenced down to earth ideas of the market in a straightforward and unassuming way in this report. The research contains the categorization of the market by top players/brands, region, type, and end-user. The report exhaustive essential investigation of current market trends, opportunities, challenges, and detailed competitive analysis of the industry players in the market.

The research report has comprehensively included numbers and figures with the help of graphical and pictorial representation which embodies more clarity on the global Stem Cell Therapy market. Then the report delivers key information about market players such as company overview, total revenue (financials), market potential, global presence, as well as market share, prices, production sites and facilities, products offered, and strategies adopted by them. Market status and outlook of global and major regions, from angles of players, countries, product types, and end industries have been analyzed.

NOTE: Our report highlights the major issues and hazards that companies might come across due to the unprecedented outbreak of COVID-19.

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Key strategic manufacturers included in this report: Osiris Therapeutics, Molmed, JCR Pharmaceutical, NuVasive, Anterogen, Chiesi Pharmaceuticals, Medi-post, Pharmicell, Takeda (TiGenix)

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The market can be segmented into product types as: Autologous, Allogeneic

The market can be segmented into applications as: Musculoskeletal Disorder, Wounds & Injuries, Cornea, Cardiovascular Diseases, Others

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