Category Archives: Connecticut Stem Cells

Message from the Department Head

Animal Science was one of the first disciplines taught at the University of Connecticut, established as the historical Storrs Agricultural School in 1881. Today the Department of Animal Science is the home of more than 400 undergraduate students (both 2-year and 4-year programs) as well as dozens of graduate students pursuing advanced degrees. The Department offers ample hands-on learning and student employment opportunities with a total of 1,000+ dairy and beef cattle, sheep, chickens, pigs, and horses all within minutes of walking distance on campus.

The Department's faculty are accomplished educators and scientists for winning university, regional and national teaching and research awards, for publishing in international scientific journals and for serving as leaders in professional societies. Together, they cover the diverse areas of animal genetics/genomics, breeding, biotechnology (genetic engineering and stem cells), animal reproduction, embryology, growth biology and endocrinology, food microbiology and safety, dairy technology and safety, equine science, dairy production and management, meat chemistry, laboratory animal science as well as diversified livestock.

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Bob Falkenberg, a 13-year leukemia survivor, is just one example of a transplant recipient that Be the Match (BTM) has been able to treat and save by connecting him with a blood marrow donor. But while Falkenberg is a face of success in matching patients with a donor, the 12,000 patients diagnosed with life-threatening blood cancers or other blood cell diseases each year are not always as easily treated, especially with financial barriers and a disparity in match rates for nonwhite patients.

Just two years after his transplant, and with a push from a 100-mile bike ride challenge from his friend, Falkenberg has been biking to raise money and awareness for the need for transplant donors for the past 11 years. He and his team of nine riders took to the Island July 20 to continue this support for Be the Match, part of their monthlong East Coast ride event, Tour De TC. This annual bike ride raises critical funds for Be the Match, with this years ride aimed at raising enough funds to financially support 25 families in need of treatment.

In his past years of biking for Be tThe Match, Falkenberg has embarked on rides from Boston to Key West, Vancouver to San Francisco, and Vancouver to Florida. His hope is to hit all 50 states with future rides. For the second half of this years July tour, the crew has already gone from Boston to the Cape and Marthas Vineyard, but will continue on via ferry to Rhode Island and Connecticut. From there, the crew will ferry to the east end of Long Island and into New York City to meet people from the transplant center there. Finally, the riders will head to the childrens hospital in Philadelphia.

In past years, the rides have been more family-and-friends-oriented, according to Falkenberg. But this year, he said that the rides have been more open to participation. From this, he added, they have gotten a larger response, and have already raised $100,000 for this year, three times as much as last years raised funds. This is just the start, as he expects they will double all raised funds from this year next year.

Funds raised go toward adding more donors to the Be the Match registry, research to ease the safety of transplant procedures, as well as financial assistance for families and patients in need of transplants and in post-transplant recovery. For adding donors, there is a cost to do the human leukocyte antigen (HLA) tests in order to add donors to the registry, and match them to patients. Funds for researching the transplant procedures include identifying and preventing issues that can impact chance of survival, which has increased from 30 percent to closer to 50 percent in the past 13 years, according to Falkenberg. For many people, the journey of treatment and recovery can even be such a financial toll it can prevent patients from moving forward with potentially lifesaving procedures if careers are put on hold, decreasing household income, says BTM in an information sheet.

Leukemia is the No. 1 childhood cancer, so a lot of this is for kids. When the parents travel, they have to stay there for a long time sometimes, Falkenberg says, which takes time away from work and puts financial strain on family support. There are financial grants through BTM that increase this family and patient support while covering costs that insurance will not.

Money is not the only thing that decreases the success of patient survival, as there has grown to be a disparity in the diversity of donors. According to BTM, out of almost 300,000 potential U.S. donors added to the registry last year, only 31 percent were ethnically diverse. Falkenberg commented on this issue, saying, Theres about 20 million people on the registry, but if youre Black, you only have about a 29 percent chance right now of finding a single donor on the registry, because there just arent enough Black donors, and its tied to your DNA and ethnicity. Falkenberg also said that there is a similar struggle for Asian or Pacific Islander patients, Hispanic or Latino patients, and Native American patients, though not quite as bad as the odds for Black or African American patients.

Elle Crofton, a first-year rider diagnosed with a blood cancer nine years ago, works as an advocate for BTM alongside Falkenberg, and spoke to The Times about this issue of ethnic disparity in donors. Like Falkenberg, Crofton was able to find multiple full matches on the BTM registry that allowed her to get a transplant seven years ago, but said, For people who are not white, they have a lot less likelihood of finding a match. She added that the team is trying to get the word out to get more people of color on the registry, saying, We hope we can make the need for everyone to have that equal ability to find a match smaller.

Beyond volunteering and riding, Falkenberg and Crofton have begun legislative advocacy work, lobbying Congress to provide legal support to donors. The two reached out to Joe Neguse, the U.S. representative for Colorados 2nd Congressional District for support. Falkenberg and Crofton had a virtual meeting surrounding their current work on a Life Saving Leave Act, which Neguse co-sponsored the next day. The act would work to allow 40 hours of nonconsecutive time off of work, and protect workers from being fired while undergoing the donation process. This process includes a physical exam and an injection to increase stem cell production, so the travel and donation can take up to two days to complete. So while not a paid leave, the act would mitigate the fear for potential donors of losing their job.

Alongside the act, Be the Match reimburses for associated costs with the donation process. Its common-sense stuff, just not the law right now, Falkenberg said, and added, Unfortunately, the people that are more likely to say, Im worried about losing my job also line up with the groups underrepresented on the registry. So, every donor who donates matters.

To donate, become a donor and join the registry, or find out other ways to support the organization, visit bethematch.org. Eligibility to become a donor is met if you meet the health guidelines and are between 18 and 40 years old. For registration, completion of a health history form and a swab of cheek cells is needed. The swab kit is mailed to the registrants home.

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Blood, sweat, and many miles for cellular therapy - Martha's Vineyard Times

Blocking the mutant protein with an antibody didnt stop the strange, abnormal bone growths in mice. But the knowledge gained could steer scientists toward more promising approaches, report researchers from UConn and Alexion Pharmaceuticals in the 15 June issue of The Journal of Clinical Investigation.

Fewer than 4,000 people worldwide are afflicted with fibrodysplasia ossificans progressiva (FOP), an inherited disease in which small injuries or bruises to skeletal muscle provoke the growth of massive, abnormal bone and cartilage. Gradually much of the bodys soft tissue turns to bone. Now, researchers at UConn and Alexion Pharmaceuticals who were investigating a potential cure instead found a concerning surpriseblocking the protein responsible for the disease with a monoclonal antibody made the abnormal bone growth worse in mice .

Normally, stem cells help repair muscle damaged by injury or disease. But in people with FOP, certain stem cells get the wrong message from a mutant receptor on their surface. Instead of promoting muscle regeneration, the stem cells develop into bone.

UConn Professor of Molecular and Cell Biology David Goldhamer, Alexion Pharmaceuticals researcher Jeffrey Hunter, and colleagues worked for years to discover a potential antibody therapy for FOP using accurate genetic mouse models of the disease developed by the two groups. The idea was that the antibody would block the mutant receptor and prevent the responsible stem cells from making new bone. But the results were exactly the opposite.

The unexpected result: injecting the antibody into FOP mice caused a dramatic increase in inappropriate bone formation, instead of protecting them as wed hoped, Goldhamer says.

Goldhamer, Hunter and their teams worked with an antibody discovered by Alexion that interferes with the specific cell-surface receptor involved in FOP called Activin A receptor type 1, or ACVR1. The researchers thought that if they blocked ACVR1, the abnormal bone growth would stop. But instead, it was exacerbated.

The antibody appears to lower the injury threshold needed to stimulate bone growth within muscle tissue. Mild injuries that normally dont make bone in FOP mice suddenly make lots of bone. Additionally, the antibody increases and prolongs the immune response to the injury, Goldhamer says.

Another team working on antibody-based therapies for FOP ran into the same effect. Regeneron Pharmaceuticals used different antibodies they derived independently, as well as a different strain of FOP mice, but got the same adverse result. Their paper also appears in the JCI this week.

The teams dont yet know precisely why the antibodies dramatically worsen the disease in mice, but their work raises serious safety and efficacy concerns for the clinical application of this approach, which has not yet been tested in humans. Neither team has plans to pursue this clinically.

This work was funded by a grant from the National Institutes of Health (R01AR072052) and a sponsored research agreement between Alexion Pharmaceuticals and the University of Connecticut.

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An Experimental Treatment Failed in Mice, and Researchers Did the Right Thing: They Published About It - UConn Today - UConn

Netta Blondheim-Shraga, PhD Appointed as VP R&DAntalPearl-Lendner, Adv. Appointed as Chief Legal Counsel

NEW YORK, May 12, 2022 /PRNewswire/ --BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced two senior management appointments. Netta Blondheim Shraga, PhD has been appointed as VP, Research & Development, and AntalPearl-Lendner, Adv. has been appointed to the newly created position of Chief Legal Counsel. Both will report directly to Chaim Lebovits, CEO.

"We are thrilled to welcome Netta and Antal, each of whom brings valuable experience in their respective areas of R&D and Legal Affairs," said Chaim Lebovits, Chief Executive Officer of BrainStorm. "As we prepare the company for growth, it is important that we continue to build out our senior executive team and attract professionals with the appropriate skillsets. We look forward to leveraging their backgrounds as we execute on our mission to bring autologous cell therapies to patients with debilitating neurodegenerative diseases."

Dr. Blondheim-Shraga will be responsible for advancing the company's pipeline and steering the R&D team towards significant breakthroughs in the field of cell therapy and development of novel solutions to positively impact patients' health. Dr. Blondheim-Shraga joins BrainStorm with over 14 years of translational research experience in academic, biotech and pharma settings, having led teams in Israel, USA and China, combining scientific, entrepreneurial and management skills. Prior to joining BrainStorm, she was Project Leader on the Academic Affairs team at Teva Pharmaceuticals, Israel. In this role, she managed a portfolio of diverse and highly impactful strategic scientific collaborations with Teva's academic partners and managed Teva's involvement in several international consortia. Prior to Teva, she was Study Director and Senior Scientist at CrownBio, San Diego, CA. Earlier in her career, she was a Senior Scientist at Lifemap Sciences LTD in Tel-Aviv and served as Scientific Advisor to ImmunoHiTech LTD, Ramat Hasharon, Israel for several years. Dr. Blondheim-Shraga received a PhD from the Faculty of Medicine, Bar-Ilan University, Safed, Israel, an MSc Med from The Faculty of Medicine, Tel Aviv University, Israel and a BSc Med from The Faculty of Medicine, Hebrew University Jerusalem, Israel.

AntalPearl-Lendner, Adv. is an experienced bilingual attorney with a proven track record in legal and business development capacities. Prior to joining Brainstorm, Ms. Pearl-Lendner spent 8 years at Mizrahi-Tefahot Bankin Israel where her responsibilities included spearheading bank-wide complex projects, negotiating large scale international contracts and providing ongoing advice regarding the international activities of the bank. Before her tenure at the bank, she worked at GE Capital in Chicago and Connecticut, USA, where she served in GE's premier commercial leadership program, working in business development, strategy & analytics. Earlier in her career, Ms. Pearl-Lendner was an Associate Attorney in the international department of Caspi & Co. Advocates & Notaries in Tel Aviv, Israel. In this role she represented clients in M&A transactions and led due diligence processes for investments ranging from $5M to $350M. Ms. Pearl-Lendner received an MBA from the MIT Sloan School of Management in Cambridge, Massachusetts and an LLB from Tel Aviv University.

AboutBrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect,""likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of BrainStorm's NurOwn treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our products and services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; the impacts of the COVID-19 pandemic on our clinical trials, supply chain, and operations; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

CONTACTS

Investor Relations:John MullalyLifeSci Advisors, LLCPhone: +1 617-429-3548 [emailprotected]

Media:Uri Yablonka[emailprotected]

SOURCE BrainStorm Cell Therapeutics Inc.

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BrainStorm Strengthens Executive Team with Key Appointments in R&D and Legal USA - English - USA - English - PR Newswire

What Are Stem Cells?

Stem cells are cells that are capable of becoming new stem cells (self-renewal) or specialized cells that perform specific functions (differentiation).

There are 2 types of stem cells:

Another type is induced pluripotent stem cells, which are adult stem cells that are changed in a lab to be closer to embryonic stem cells, though unlike embryonic stem cells they cannot develop into every kind of cell and tissue

What Are Stem Cells Used For?

Currently, the only stem cells now used to treat disease are from blood cell-forming adult stem cells found in bone marrow.

These types of cells are used in procedures such as bone marrow transplants, as adjunct therapy for the treatment of leukemia, or to treat people with conditions such as Fanconi anemia.

Hematopoietic stem cells (stem cells that form blood and immune cells) are used for burn therapy, bone grafting, and corneal transplant tissues.

Scientists believe stem cells can be used for many different medical applications in the future, for example, by creating new heart tissue to transplant into a damaged heart to treat heart disease.

What Is Stem Cell Research?

Stem cells are being investigated in several possible roles in medicine:

Is Stem Cell Research Illegal in The United States?

Stem cell research is legal in the United States, however, there are restrictions on its funding and use.

State laws regarding research on stem cells vary widely, particularly in regard to use of embryonic stem cells. On one end of the spectrum, eight states (California, Connecticut, Illinois, Iowa, Maryland, Massachusetts,New Jersey and New York) encourage embryonic stem cell research,while on the other end of the spectrum, South Dakota strictly forbids research on embryos.

A number of states restrict research on aborted fetuses or embryos, but in some cases, research may be permitted with consent of the patient.

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Is Stem Cell Research Illegal in The United States?

SIOUX FALLS, S.D. (KELO) Since the start of the COVID-19 pandemic, the world has seen remarkable strides made in the swift development of safe and effective vaccines to protect against the illness. At the time of writing one of these vaccines, the Pfizer-BioNTech vaccine, has been granted FDA approval for those age 16 and older.

However, questions and concerns still swirl around the vaccine, including what it contains, who made it and the outcomes that can result from its use. KELOLAND News gathered the facts to lay out the answers to these questions.

Who makes the Pfizer-BioNTech vaccine?

The Pfizer-BioNTech vaccine is manufactured by Pfizer, Inc., and BioNTech.

Pfizer is a multinational pharmaceutical and biotechnology company that produces products such as Xanax, Robitussin, Advil and Viagra.

BioNTech is a German biotech and immunotherapy company that had pioneered tech using messenger RNA (more on this later) joined with Pfizer in 2018 to jointly develop an mRNA-based flu vaccine prior to the onset of the COVID-19 pandemic.

According to their website, BioNTechs collaboration with Pfizer allowed them to utilize Pfizers broad expertise in vaccine research and development, regulatory capabilities, and global manufacturing and distribution network while BioNTech and its partners provided a clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe.

Pfizer-BioNTech/COMIRNATY

Some confusion has been caused by the appearance of the vaccine marketed as COMIRNATY, which has led some to claim that the Pfizer-BioNTech vaccine has not been granted FDA approval. This is false. The vaccine received FDA approval on August 23, 2021, for individuals 16 years of age and older.

The confusion appears to stem from the fact that once FDA approval has been granted, companies are then allowed to market the vaccines under brand names. COMIRNATY is the brand name for the Pfizer-BioNTech COVID-19 Vaccine.

Due to the fact that the vaccine has only received full authorization for those aged 16 and up, the name Pfizer-BioNTech will still be used for those in the 12-15 year age range. While the names are different, the makeup of the vaccines is identical, and no change has been made.

The name Pfizer-BioNTech will be used for the remainder of this article.

What is the Pfizer-BioNTech vaccine?

The Pfizer-BioNTech vaccine is an mRNA vaccine. What this means is that as opposed to many other vaccines which insert a weakened or inactive germ/virus into our bodies, mRNA COVID-19 vaccines contain no actual sample of the COVID-19 virus.

Instead, mRNA in the vaccine functions as an instructional guide for bodies cells to create a harmless piece of the spike protein that the COVID-19 virus uses to enter our cells. According to the CDC, once the cells produce the spike protein, the messenger RNA is no longer needed and is broken down by the cell. It is important to note that while RNA (ribonucleic acid) is similar to DNA (deoxyribonucleic acid), mRNA does not enter the nucleus of our cells where our DNA is stored. This means that the mRNA does not affect and cannot change our genetic material.

Following the creation of this dummy spike protein, the cell displays the spike on its surface, allowing it to be noticed by our immune system, which then begins building an immune response and producing antibodies, just as it would in the event of an exposure to the actual COVID-19 virus, but without the risk of actually catching the virus.

While mRNA vaccines are a new technology, the research on it goes back decades. According to Johns Hopkins University, mRNA was discovered in the 1960s and research into its application to human cells was developed in the 1970s.

One of the biggest barriers to the application of mRNA in the early years of study was the speed with which it is broken down by the human body, leading to its destruction before it ever had the chance to deliver to the cells the info which it was carrying.

The solution to this problem came from advances in nanotechnology: the development of fatty droplets (lipid nanoparticles) that wrapped the mRNA like a bubble, which allowed entry into the cells.

Johns Hopkins states that the first use of mRNA vaccines using this method of delivery was developed to counter the Ebola virus, but due since the virus was only found in a handful of African countries, the vaccine had no commercial development in the U.S., where only four patients were ever diagnosed with the illness.

The CDC notes that mRNA vaccines have also been studied for flu, Zika, rabies, and cytomegalovirus. They also report that cancer research has used mRNA to trigger the immune system to target specific cancer cells.

What ingredients are in the vaccine?

mRNA:

Lipids: Lipids are fatty, waxy or oily compounds that are able to be dissolved in organic solvents such as those found in the body. According to the Connecticut Department of Public Health (CDPH), lipids protect the mRNA and provide a greasy exterior that helps the mRNA slide inside cells.

Salts, sugars and buffers: The CDPH explains that salts, sugars and other buffers are used in the vaccine to help balance acidity in the body and to assist the molecules in keeping their shape while frozen for storage and transportation. Sodium chloride is basic table salt, while Sucrose is just sugar.

You can view a full list of the ingredients in all three vaccines authorized for use in the U.S. here.

The Pfizer-BioNTech vaccine does not contain eggs, preservatives, latex or metals of any kind.

How effective is the vaccine?

According to the CDC, based on evidence from clinical trials in people 16 years and older, the Pfizer-BioNTech vaccine was 95% effective at preventing laboratory-confirmed infection with the virus that causes COVID-19 in people who received two doses and had no evidence of being previously infected.

The vaccine has also been highly effective in the prevention of COVID-19 infection in adolescents 1215 years old, and the immune response in people 1215 years old was at least as strong as the immune response in people 1625 years old.

What are the known side effects?

Possible side effects of the vaccine include pain, redness and swelling at the site of the injection. Tiredness, headaches, muscle pain, chills, fever and nausea have all been reported as well. These side effects are not signs of illness caused by the vaccine, but rather the effect of our bodies immune systems reacting to the spike protein and working to build an immune response.

Side effects generally can be expected within the first two days after vaccination, and generally, go away within a few days.

Adverse effects to the vaccine

Serious adverse effects to the Pfizer-BioNTech vaccine are rare, but possible. The CDC gathers reports of adverse events through its Vaccine Adverse Event Reporting System (VAERS).

Anaphylaxis: Anaphylaxis is a severe allergic reaction leading to skin rash, nausea, vomiting, difficulty breathing, and shock. It can be fatal. Anaphylaxis following COVID-19 vaccination is rare, and according to CDC data has occurred in around 2-5 people per million vaccinated in the U.S. Severe allergic reactions of this sort can occur after any vaccination.

Thrombosis with thrombocytopenia syndrome (TTS): TTS is a rare syndrome in which the formation of blood clots combines with low blood platelet levels which can lead to long-term disability or death if not treated. The CDC and FDA have identified 47 confirmed reports of TTS in those who have received a dose of the J&J/Janssen COVID-19 vaccine, which has been administered to nearly 15 million Americans.

To date, there have been two reported cases of TTS in people who have received the Moderna vaccine, which has been administered to more than 376 million people in the U.S. So far, there do not appear to be any reports of TTS in those who have received the Pfizer-BioNTech vaccine in the U.S.

Myocarditis and pericarditis: Myocarditis isinflammation of the heart muscle, and pericarditis is inflammation of the outer lining of the heart. These conditions are rare following COVID-19 vaccination. As of Sept. 29, VAERS had received 1,590 reports of myocarditis or pericarditis among people ages 30 and younger who received the COVID-19 vaccine.

Most cases have been reported after mRNA COVID-19 vaccination (Pfizer-BioNTech or Moderna), particularly in male adolescents and young adults. Through follow-up, including medical record reviews, CDC and FDA have confirmed 906 reports of myocarditis or pericarditis.

It is not yet known whether there is a relationship between these instances of myocarditis and pericarditis and the COVID-19 vaccines, but the CDC says the matter is being investigated.

Death: More than 396 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through October 4, 2021, according to the CDC.

Through this time, VAERS received 8,390 reports of death (0.0021%) among people who had received a COVID-19 vaccine. It is extremely important to understand that these are reports of people who died and were also vaccinated, and not people who died because they were vaccinated.

Understanding VAERS data

The Vaccine Adverse Event Reporting System is an early warning system used to monitor adverse events that happen after vaccination. The purpose of the system is to allow vaccine safety experts to study any and all potential adverse effects of a vaccine. Due to this, when a health problem is reported to VAERS, it does not necessarily mean that the vaccine caused the problem.

The FDA requires healthcare providers to report any death after COVID-19 vaccination to VAERS, even if its unclear whether the vaccine was the cause. Due to this, a person killed in a car crash who also happened to be vaccinated would be included in this statistic.

Reports of adverse events to VAERS following vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem.

The CDC states that a review of available clinical information, including death certificates, autopsy, and medical records, has not established a causal link to COVID-19 vaccines.

It should also be noted that VAERS is not a closed system. Anyone can submit areport to VAERS, including patients, parents or caregivers, healthcare providers, and vaccine manufacturers.

Vaccine safety experts review all reports of serious adverse events submitted to VAERS, which include permanent disability, hospitalization or an extended hospital stay (if vaccinated while in the hospital), life-threatening illness, birth defects (congenital anomalies) and death.

When VAERS staffmembers follow-up on a report of a serious adverse event, they ask forthe patients medical recordsrelated to the event to learn more about what happened.

The CDC emphasizes that VAERS reports alone generally cannot be used to determine if a vaccine caused or contributed to an adverse event or illness.

Some reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. VAERS reports often lack contextual information, such as total vaccinations given or information on unvaccinated groups for comparison. Most reports to VAERS are voluntary, which means they may be subject to biases. Data from VAERS reports should always be interpreted with these limitations in mind.

Due to these factors, any claim citing VAERS data that attempts to state that the vaccine has resulted in thousands of deaths is inaccurate, misleading and unsubstantiated.

Black box warnings

Black box warnings are the strongest form of warning required by the FDA for prescription drugs, and are meant to alert patients and health care providers to increased risk of serious adverse reactions with a medication or restrictions to using the particular drug.

Courtney Feist, a Clinical Pharmacist for Lewis Drug explained to KELOLAND News via email that the Pfizer-BioNTech vaccine does not carry a black box warning. There are warnings/precautions, but not a specific black box warning, she said. Like I mentioned there are warnings and precautions with the Pfizer vaccine, which can be found in the patient and provider fact sheets thatare available.

Link:
The Pfizer-BioNTech vaccine explained: Whats in it and how does it work - KELOLAND.com

Dec 2 (Reuters) - The following is a roundup of some of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines for COVID-19, the illness caused by the virus.

New coronavirus may have reached the U.S. last December

The new coronavirus may have been circulating in the United States last December, well before the first COVID-19 case was diagnosed on Jan. 19, a new analysis of donated blood reveals. Researchers at the U.S. Centers for Disease Control and Prevention looked for COVID-19 antibodies in archived samples of blood donations collected by the American Red Cross from Dec. 13, 2019 to Jan. 17 from non-identifiable donors in nine states (California, Connecticut, Iowa, Massachusetts, Michigan, Oregon, Rhode Island, Washington, and Wisconsin). Of the 7,389 blood donors, 106 had antibodies specific to the new virus. There were samples found with COVID-19 antibodies from all nine states, according to a report of the study published on Tuesday in Clinical Infectious Diseases. The findings suggest the virus may have been present in western states as early as Dec. 13 and in eastern states as early as Dec. 30, according to a press statement from Dr. Susan Stramer, vice president of Scientific Affairs at the American Red Cross. It is not possible from these findings to determine whether these potential early COVID-19 infections were due to community spread or were travel related, she said. (bit.ly/33C401l)

Some cancer therapies may prolong COVID-19 infectiousness

COVID-19 patients who received cancer treatments that suppress their immune system may remain contagious and able to spread the coronavirus for two months or more, according to a study published on Tuesday in The New England Journal of Medicine. The U.S. Centers for Disease Control and Prevention (CDC) currently recommends that COVID-19 patients with compromised immune systems be isolated for up to 20 days after symptoms appear. In the new study, researchers analyzed sputum and swab samples from 20 immunosuppressed cancer patients infected with the new coronavirus. They found that three were contagious for more than three weeks after their symptoms began, including one who remained contagious for 61 days. The three patients had received either a stem-cell transplant or therapy with genetically engineered immune cells called CAR T-cells within the previous six months. Current public health recommendations for COVID-19 patients with weak immune systems are based on limited data and may need to be revised, the researchers said. While only a small proportion of cancer patients with COVID-19 are likely to remain contagious for prolonged periods, "it's a residual risk that we need to address," said coauthor Mini Kamboj from Memorial Sloan Kettering Cancer Center. "We need to keep an open mind about how (much) longer immunocompromised patients could pose an infection risk to others." (bit.ly/3lsx6Gv)

Lingering pain after COVID-19 may be nerve injuries

Patients with lingering pain after COVID-19 may have nerve injuries, according to a report published on Tuesday in Radiology. The researchers said lingering pain in COVID-19 survivors can be due to nerve dysfunction caused by the virus itself or it may be a side effect of treatment received in the hospital. These could include nerve issues arising from being positioned in a way that helped the lungs recover but put pressure on other body parts, or from pressure on a nerve from blood that pooled after blood clot prevention. High-tech imaging methods like magnetic resonance and ultra high-resolution ultrasound can help identify the location and extent of nerve damage, the researchers found when they reviewed earlier study reports. "Clinicians should (suspect nerve injury) in COVID patients who are left with chronic pain and weakness, particularly since early diagnosis and appropriate treatment is crucial to prevent irreversible damage," coauthor Dr. Swati Deshmukh of Northwestern University in Evanston, Illinois told Reuters. During the pandemic, Deshmukh added, when patients come in with unexplained new nerve and muscle symptoms, doctors should consider testing them for COVID-19. (bit.ly/37tP2LS)

Open tmsnrt.rs/3a5EyDh in an external browser for a Reuters graphic on vaccines and treatments in development.

Reporting by Nancy Lapid, Marilynn Larkin, and Manas Mishra; Editing by Bill Berkrot

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COVID SCIENCE-Coronavirus may have reached U.S. last December; some cancer therapies may prolong infectiousness - Reuters

At a press conference this week, doctors from Yale New Haven Health System gave a snapshot of the Covid-19 uptick in Connecticut.

On Tuesday the System had 90 inpatients, more than 3-1/2 times the number at the end of September.

In the past two weeks the System had seen a 50% increase from 64 on Oct 13th to 92 cases on Monday.

A month ago there were only two Covid patients in the Systems ICUs. On Tuesday there were 22 with eight on ventilators. That was after many days with no ventilated Covid-positive patients.

While the numbers represent an uptick, they are still well below the peak of 800 cases last spring.

But it doesnt feel very good, said CEO Marna Borgstron. People are tired. Tired of the pandemic. Tired of social distancing. Tired of wearing masks.

As of Tuesday, the 90 Covid-19 cases across the System were as follows:

51 at Yale New Haven Hospital 16 at Bridgeport Hospital 11 at Lawrence and Memorial Hospital in New London 5 at Greenwich Hospital 6 at Westerly Hospital.

Dr. Tom Balcezak, Chief Medical Officer for the System, and Yale New Haven Hospital Infectious Disease Specialist Dr. Onyema Ogbuagu, who is working on the Pfizer trial for a vaccination and is deeply involved in care for Covid-19 patients, talked about the recent uptick.

We didnt know that (mask wearing) worked in the first part of this pandemic, Balcezak said. There is now scientific certainty that mask wearing and social distancing does work.

How Bad Will It Get?

Balcezak said it was impossible to forecast numbers or predict when a peak might come.

He said a wastewater sampling model showed the Greenwich area was seeing some slow growth, and the hot spot area to watch was eastern Connecticut.

As for Thanksgiving and Halloween, Balcezak said, We all have families and desire to reconnect with out families and friends, but this is not the time to be doing that.

Implications for Flu Season

Balcezak said with the arrival of fall, there was the potential for a flu pandemic in addition to Covid-19. He urged residents to get flu shots to avoid a twindemic of flu and Covid-19.

Dr. Ogbuagu said there was concern about how the flu would mimic Covid-19.

Balcezak agreed, adding the challenge wold be to sort out flu patients from Covid patients, who need different therapies and cohorting.

Balcezak said the southern hemisphere foreshadows what might be in store for Connecticut.

It appears the southern hemisphere had a very light flu season this year, he said. But we need to do everything we can to lock that in. That means getting your flu shot this year. We dont need our emergency departments and doctors offices clogged with folks that have respiratory illness.

Vaccine Trial at Yale New Haven Hospital with Pfizer

Dr. Ogbuagu said there are 300 people in the trial in New Haven. The target number is 44,000, which they are approaching, as the trial is multinational.

Enrollment is going well. Up to 70% of participants have already received the second of two vaccines. (The second vaccine comes three weeks after the first.)

I think the earliest a vaccine would receive approval would be end of December or January 2021, at best, Dr. Ogbuagu said.

Its been incredible to watch the speed with which our science has moved with this pandemic, Balcezak said. Were already talking about novel therapeutics and hopefully will have a vaccine approved in the next couple of months.

Balcezak added that when the first vaccine becomes available, it might not be the best vaccine, and wont prevent the virus.

He explained when the Covid-19 virus enters the body through the respiratory system, the immunity will stop it replicating, but the vaccine will not prevent infection. It will prevent symptoms but vaccinated people could still be contagious.

We may have to wait for a vaccine that prevents infection, he said. Even if you have got the vaccine, you will still be infectious. Therefore, mask wearing will still be the standard.

Dr. Ogbuagu said the Pfizer trial has already gone through phases 1 and 2, and the phase 3 trials are advanced. The trials are randomized. Half the people receive the vaccine and the others receive a placebo.

Dr. Ogbuagu said the study has a diverse enrollment, and not only enrolls adults and elderly individuals, but also enrolls pediatric age participants from age 12 +, and immune-compromised patients including HIV patients. Over half the people enrolled in the trial identify as racial minorities.

Asked about the use of embryonic stem cells in some vaccine trials, Dr. Ogbuagu said that scenario was not unique to Covid vaccines.

There were vaccines long before Covid, like Rubella, which is German measles, and shingles vaccines, which have utilized human embryonic cells to advance development, he said.

Dr. Balcezak said it was important to note that these are tissues have been grown over many years.

They are involved in early development, he said. But for large scale mass production of these vaccines, theyre going to use traditional manufacturing methodologies that dont involve stem cells.

Why are Covid-19 Illnesses Less Severe than in the Spring?

Dr. Balcezak said much had been learned about treating Covid-19 patients.

Were more liberal with the use of steroids than we were early on, he said. And we have figured out what medications do not work.

Theres been a lot of negative studies whether it be Hydroxychloroquine, or Azithromycin weve stopped the utilization of those drugs, Balcezak said.

We continue to use Rendesivir, which seems to have a small benefit, at least in terms of length of hospitalization.

He said theyd also learned more about non therapeutic therapies.

Its putting patients on their bellies, or proning them. Its how you manage the ventilator and how you use oxygen and high flow oxygen, he said. Weve seen mortality rates fall substantially.

Balcezak cautioned, Doing better was far from perfect, and while the System is seeing a small number of deaths compared to the spring, theyd like to see the number fall to zero.

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Yale New Haven Health Docs: Interpreting the Uptick in Covid-19 Cases - Greenwich Free Press

Physicians and researchers have studied stem cells as alternatives in curing joint injuries and musculoskeletal conditions naturally. Stem cells have regenerative properties that can be used for treating joint pain and injuries.

Today, your own stem cells can be used for treatments with the help of science and technology. This treatment is called stem cell therapy. We are now using this option to treat patients who want a fast and effective recovery.

At The Boston Stem Cell Center, we only treat orthopedic, joint, muscular, soft tissue, ligament and tendon disorders. Despite that, scientific organizations are praising the healing capabilities of stem cells. Many people in the scientific community believe that there is no extent to what stem cells could cure in the future. According to them, it may even cure diseases that may not have any formal treatment yet. Stem cells are important to a persons body due to their ability to regenerate and replace other cells.

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Stem Cell Therapy Connecticut - Boston Stem Cell Center

Healing broken bones could get easier with a device that provides both a scaffold for the bone to grow on and electrical stimulation to urge it forward, University of Connecticut engineers reported on June 27 in the Journal of Nano Energy.

Although minor bone breaks usually heal on their own, large fractures with shattered or missing chunks of bone are more difficult to repair. Applying a tiny electrical field to the site of the fracture to mimic the bodys natural electrical field helps the cells regenerate. But the medical devices that do this are usually bulky, rely on electrical wires or toxic batteries, require invasive removal surgery, and cant do much for serious injuries.

Now, a group of biomedical engineers from UConn have developed a scaffold of non-toxic polymer that also generates a controllable electrical field to encourage bone growth. The scaffold helps the body bridge large fractures. Although many scientists are exploring the use of scaffolding to encourage bone growth, pairing it with electrical stimulation is new.

The team demonstrated the device in mice with skull fractures.

The electrical voltage the scaffold generates is very small, just a few millivolts. And uniquely for this type of device, the voltage is generated via remotely-controlled ultrasound. The ultrasound vibrates the polymer scaffolding, which then creates an electrical field (materials that create electricity from vibration, or vice versa, are called piezoelectric.) To help heal a thigh fracture, for example, the polymer scaffold can be implanted across the broken bone. Later, the person with the broken bone can wave the ultrasound wand over their own thigh themselves. No need for batteries, and no need for invasive removal surgery once the bone is healed.

The electrical field relates to the natural signal generated by your body at the injury location. We can sustain that voltage, on demand and reversible, for however long is needed using ultrasound, says UConn biomedical engineer Thanh Nguyen. The piezoelectric polymer Nguyen and his colleagues use to build the scaffold is called poly(L-lactic acid), or PLLA. In addition to being non-toxic and piezoelectric, PLLA gradually dissolves in the body over time, disappearing as the new bone grows.

The electric field created by the piezoelectric PLLA scaffold seems to attract bone cells to the site of the fracture, and promote stem cells to evolve into bone cells. This technology can possibly be combined with other factors to facilitate regeneration of other tissues, like cartilage, muscles, or nerves, says Ritopa Das, a graduate student in Nguyen group and the first author of the published paper.

Currently, Nguyen and his colleagues are working to make the polymer more favorable to bone growth, so that it heals a large fracture more quickly. They are also trying to understand why electrical fields encourage bone growth at all. Bone itself is somewhat piezoelectric, generating a surface charge when the bone is stressed by everyday life activities. That surface charge encourages more bone to grow. But scientists dont know whether its because it helps cells stick to the surface of the bone, or whether it makes the cells themselves more active.

Once we understand the mechanism, we can devise a better way to improve the material and the whole approach of tissue stimulation, Nguyen says.

This work was supported by the National Institutes of Health.

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Buzzing to Rebuild Broken Bone: Its Electric! - UConn Today