Muscle tissue hydrogel heals tissues from the inside out

 A new biomaterial that can be injected intravenously, reduces inflammation in tissue and promotes cell and tissue repair. The biomaterial was tested and proven effective in treating tissue damage caused by heart attacks in both rodent and large animal models. Researchers also provided proof of concept in a rodent model that the biomaterial could be beneficial to patients with traumatic brain injury and pulmonary arterial hypertension.

"This biomaterial allows for treating damaged tissue from the inside out," said Karen Christman, a professor of bioengineering at the University of California San Diego, and the lead researcher on the team that developed the material. "It's a new approach to regenerative engineering."

A study on the safety and efficacy of the biomaterial in human subjects could start within one to two years, Christman added. The team, which brings together bioengineers and physicians, presented their findings in the Dec. 29 issue of Nature Biomedical Engineering.

There are an estimated 785,000 new heart attack cases in the United States each year, and there is no established treatment for repairing the resulting damage to cardiac tissue. After a heart attack, scar tissue develops, which diminishes muscle function and can lead to congestive heart failure.

"Coronary artery disease, acute myocardial infarction, and congestive heart failure continue to be the most burdensome public health problems affecting our society today," said Dr. Ryan R. Reeves, a physician in the UC San Diego Division of Cardiovascular Medicine. "As an interventional cardiologist, who treats patients with coronary artery disease and congestive heart failure on a daily basis, I would love to have another therapy to improve patient outcomes and reduce debilitating symptoms."

In previous studies, the team led by Christman developed a hydrogel made from the natural scaffolding of cardiac muscle tissue, also known as the extracellular matrix (ECM), that can be injected into damaged heart muscle tissue via a catheter. The gel forms a scaffold in damaged areas of the heart, encouraging new cell growth and repair. Results from a successful phase 1 human clinical trial were reported in fall 2019. But because it needs to be injected directly into heart muscle, it can only be used a week or more after a heart attack -- sooner would risk causing damage because of the needle-based injection procedure.

The team wanted to develop a treatment that could be administered immediately after a heart attack. This meant developing a biomaterial that could be infused into a blood vessel in the heart at the same time as other treatments such as angioplasty or a stent, or injected intravenously.

"We sought to design a biomaterial therapy that could be delivered to difficult-to-access organs and tissues, and we came up with the method to take advantage of the bloodstream -- the vessels that already supply blood to these organs and tissues," said Martin Spang, the paper's first author, who earned his Ph.D. in Christman's group in the Shu Chien-Gene Lay Department of Bioengineering.

One advantage of the new biomaterial is that it gets evenly distributed throughout damaged tissue, because it's infused or injected intravenously. By contrast, hydrogel injected via a catheter remains in specific locations and doesn't spread out.

How the biomaterial is made

Researchers in Christman's lab started with the hydrogel they developed, which was proven to be compatible with blood injections as part of safety trials. But the particle size in the hydrogel was too big to target leaky blood vessels. Spang, then a Ph.D. student in Christman's lab, solved this issue by putting the liquid precursor of the hydrogel through a centrifuge, which allowed for sifting out bigger particles and keeping only nano-sized particles. The resulting material was put through dialysis and sterile filtering before being freeze dried. Adding sterile water to the final powder results in a biomaterial that can be injected intravenously or infused into a coronary artery in the heart.

How it works

Researchers then tested the biomaterial on a rodent model of heart attacks. They expected the material to pass through the blood vessels and into the tissue because gaps develop between endothelial cells in blood vessels after a heart attack.

But something else happened. The biomaterial bound to those cells, closing the gaps and accelerating healing of the blood vessels, reducing inflammation as a result. Researchers tested the biomaterial in a porcine model of heart attack as well, with similar results.

The team also successfully tested the hypothesis that the same biomaterial could help target other types of inflammation in rat models of traumatic brain injury and pulmonary arterial hypertension. Christman's lab will undertake several preclinical studies for these conditions.

Next steps

"While the majority of work in this study involved the heart, the possibilities of treating other difficult-to-access organs and tissues can open up the field of biomaterials/tissue engineering into treating new diseases," Spang said.

Meanwhile, Christman along with Ventrix Bio, Inc., a startup she cofounded, are planning to ask for authorization from the FDA to conduct a study in humans of the new biomaterial's applications for heart conditions. This means that human clinical trials begin in be one or two years.

"One major reason we treat severe coronary artery disease and myocardial infarction is to prevent left ventricular dysfunction and progression to congestive heart failure," said Dr. Reeves. "This easy-to-administer therapy has the potential to play a significant role in our treatment approach."

Journal Reference:

1. Martin T. Spang, Ryan Middleton, Miranda Diaz, Jervaughn Hunter, Joshua Mesfin, Alison Banka, Holly Sullivan, Raymond Wang, Tori S. Lazerson, Saumya Bhatia, James Corbitt, Gavin D’Elia, Gerardo Sandoval-Gomez, Rebecca Kandell, Maria A. Vratsanos, Karthikeyan Gnanasekaran, Takayuki Kato, Sachiyo Igata, Colin Luo, Kent G. Osborn, Nathan C. Gianneschi, Omolola Eniola-Adefeso, Pedro Cabrales, Ester J. Kwon, Francisco Contijoch, Ryan R. Reeves, Anthony N. DeMaria, Karen L. Christman. Intravascularly infused extracellular matrix as a biomaterial for targeting and treating inflamed tissues. Nature Biomedical Engineering, 2022; DOI: 10.1038/s41551-022-00964-5

https://www.sciencedaily.com/releases/2023/01/230130144805.htm

Former President Jimmy Carter to receive hospice care at home after series of hospital stays

 The Carter Center said Saturday that former President Jimmy Carter has entered home hospice care.

The charity created by the 98-year-old former president said on Twitter that after a series of short hospital stays, Carter “decided to spend his remaining time at home with his family and receive hospice care instead of additional medical intervention."

It said he has the full support of his medical team and family, which “asks for privacy at this time and is grateful for the concern shown by his many admirers.”

Carter, a Democrat, became the 39th U.S. president when he defeated former President Gerald R. Ford in 1976. He served a single term and was defeated by Republican Ronald Reagan in 1980.

https://www.wcvb.com/article/jimmy-carter-to-receive-hospice-care-at-home-following-series-of-hospital-stays/42968892#

Ill. Supreme Court issues opinion over ongoing White Castle biometric privacy case

 The Illinois Supreme Court issued an opinion Friday in an ongoing case against White Castle in connection to the state’s Biometric Information Privacy Act (BIPA) that could potentially result in massive fines. 

The opinion came after the U.S. Court of Appeals for the 7th District requested for the state’s highest court to certify whether BIPA claims accumulate with each biometric data scan or transmission that allegedly violates the law or just the first instance. The Illinoise Supreme Court ruling was 4-3.

In the proposed class action case, the plaintiff sued White Castle on accusations the fast-food chain had "unlawfully collected her biometric data and unlawfully disclosed her data to its third-party vendor" without her consent for several years after implementing fingerprint-scanning for employee computer access, according to the Illinois Supreme Court document.

"We conclude that the plain language of section 15(b) and 15(d) shows that a claim accrues under the Act with every scan or transmission of biometric identifiers or biometric information without prior informed consent," the Illinois Supreme Court said Friday the ruling. 

In a statement, White Castle told FOX Business it was "deeply disappointed with the court’s decision and the significant business disruption that will be caused to Illinois businesses, which now face potentially huge damages." 

"We are reviewing our options to seek further judicial review, given the strong dissenting opinion, which included the Court’s Chief Justice," the fast-food chain continued. "This dissent justifiably raises serious concerns about today’s opinion."

Meanwhile, James Zouras, the attorney representing the plaintiff, told Reuters that "hopefully, today’s decision will encourage employers and other biometric data collectors to finally start taking the law seriously."

Private entities are barred from "collect[ing], captur[ing], purchas[ing], receiv[ing] through trade, or otherwise obtain[ing]" someone’s biometric data without getting informed consent beforehand under BIPA. The law also puts restrictions on them "disclos[ing], redisclos[ing], or otherwise disseminat[ing]" such data without consent, among other provisions.

Negligent violations can come with $1,000 fines, according to the state law. For intentional or reckless violations, the penalties are $5,000 each.

White Castle contended alleged claims "can accrue only once – when the biometric data is initially collected or disclosed," the majority opinion said. 

White Castle Empty Boxes (iStock)

"It will lead to consequences that the legislature could not have intended," Illinois Supreme Court Justice David Overstreet argued about the majority opinion in the dissent. "Moreover, the majority’s interpretation renders compliance with the Act especially burdensome for employers."

White Castle said damages could be upwards of an estimated $17 billion "if plaintiff is successful and allowed to bring her claims on behalf of as many as 9500 current and former White Castle employees," the majority opinion stated.

The case will return to the lower court. 

https://www.foxbusiness.com/markets/illinois-supreme-court-issues-opinion-ongoing-white-castle-biometric-privacy-case

Starbucks Frappuccino bottles recalled over foreign object

 PepsiCo, Inc is recalling for more than 25,000 cases of Starbucks coffee drinks that had been contaminated, according to federal officials. 

PepsiCo said in a statement to FOX Business that it initiated the recall for select lots of Starbucks Frappuccino Vanilla bottles, on behalf of the North American Coffee Partnership, that were shipped around the nation. 

The world's second-largest food and beverage business didn't say why the products were being recalled. 

However, the U.S. Food and Drug Administration (FDA) posted a note on its website that the product has been recalled because of a "foreign object (glass)." 

Customer chooses different tastes of Starbucks bottled Frappuccino.  (Zhang Peng/LightRocket via Getty Images / Getty Images)

The FDA has also classified it as a "Class II" recall. 

This means "the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote," according to the FDA. 

"The North American Coffee Partnership is committed to a high level of quality in the products we serve," PepsiCo said in a statement on behalf of the North American Coffee Partnership. 

As part of this partnership, PepsiCo has agreed to sell and distribute Starbucks ready-to-drink coffee and energy beverages, "leveraging its expansive network and experience," according to Starbucks. 

"Delivering a quality experience to our consumers is our top priority, and we always act with an abundance of caution whenever a potential concern is raised," PepsiCo continued in a statement. 

The impacted products have best-by dates of Mar. 8, May 29, June 4 and June 10 of this year. 

PepsiCo said the products are already being removed from the market and that they are not sold at any Starbucks retail locations. 

https://www.foxbusiness.com/lifestyle/starbucks-frappuccino-bottles-recalled-foreign-object

AlloVir's cell therapy tackles infection in midphase kidney transplant trial

 AlloVir has generated early evidence its lead prospect works in solid organ transplant patients, reporting phase 2 data that suggest it has a shot at expanding beyond its initial focus on stem cell transplants. 

The Massachusetts-based biotech has already taken posoleucel, an off-the-shelf, multi-virus specific T-cell therapy, into phase 3 trials in three indications for allogeneic hematopoietic stem cell transplant patients. In parallel, AlloVir has laid the groundwork for an expansion into the solid organ field by assessing the ability of posoleucel to treat a virus called BK viremia (BKV) in adult kidney transplant recipients.

Once a person is infected with BKV, one of six pathogens targeted by posoleucel, the virus stays in the body but doesn’t typically cause problems. However, the drugs taken to prevent organ rejection give the virus a chance to proliferate and, given the lack of effective therapies, cause negative health outcomes.

The phase 2 trial provides early evidence that posoleucel may improve outcomes in BKV patients. After 24 weeks, 39% of recipients of posoleucel had a one log or greater reduction in viral load, compared to 14% of people on placebo. Posoleucel appears to be most effective when given biweekly and in people with a high initial viral load, with 75% of patients in that small subgroup having a one-log reduction. 

With posoleucel outperforming placebo on other viral load measures, and adverse events reports being consistent with the underlying patient population and background immunosuppression, AlloVir and its collaborators think the cell therapy has a shot at targeting the solid transplant space. 

“The safety profile of posoleucel and its antiviral activity, which is amplified in high viral load patients who have the greatest unmet need, suggest it could potentially offer a transformative treatment option for kidney transplant patients with BK viremia,” Brigham and Women's Hospital’s Anil Chandraker, M.D., the principal investigator of the posoleucel BKV treatment study, said in a statement. 

AlloVir plans to work with regulatory authorities and transplant specialists to formulate a plan for further development in kidney transplant patients and potentially in recipients of other solid organs.

https://www.fiercebiotech.com/biotech/allovirs-cell-therapy-tackles-infection-midphase-kidney-transplant-trial

Gamida Cell: New Hodgkin trial data support May target PDUFA action date

 New data add to the body of evidence supporting efficacy of omidubicel, Gamida Cell’s lead product candidate, which has a target PDUFA action date with U.S. Food and Drug Administration (FDA) of May 1, 2023

New data for GDA-201, Gamida Cell’s natural killer (NK) cell therapy candidate in ongoing Phase 1/2 study for non-Hodgkin lymphoma, show robust immune system engagement and high cytotoxicity levels

https://finance.yahoo.com/news/data-presented-gamida-cell-omidubicel-173000062.html

Biden administration has 'quietly' (?!?) helped to ‘score’ conservative speech

 Last year, the Biden administration caved to public outcry and disbanded its infamous Disinformation Governance Board under its “Disinformation Nanny,” Nina Jankowicz. Yet, as explored in a recent hearing (in which I testified), the Biden administration never told the public about a far larger censorship effort involving an estimated 80 FBI agents secretly targeting citizens and groups for disinformation.

Now it appears that the administration also was partially funding an “index” to warn advertisers to avoid what the index deemed to be dangerous disinformation sites. It turns out that all ten of the “riskiest” sites identified by the Global Disinformation Index are popular with conservatives, libertarians and independents. 

The index, run by a British organization, appears to be an effort to score and sanction sites based on their “reliability” to those in the political and media establishments.

That sounds like a knockoff of China’s “social credit” system which scores its citizens, based in part on social media monitoring.

Clearly, the administration never abandoned its intent to fund and field efforts to curtail speech on the internet — with the support of many in the media and academia. In an Atlantic article in 2020, for example, Harvard Law School professor Jack Goldsmith and University of Arizona law professor Andrew Keane Woods declared that “in the great debate of the past two decades about freedom versus control of the network, China was largely right and the United States was largely wrong.” They concluded that “significant monitoring and speech control are inevitable components of a mature and flourishing internet, and governments must play a large role in these practices to ensure that the internet is compatible with society norms and values.”

Despite fierce opposition from Democrats in Congress, Twitter continues to release evidence of a comprehensive effort by FBI agents to coordinate the banning or suspensions of people accused of disinformation, including people who were clearly joking. 

The Global Disinformation Index (GDI) is a particularly insidious part of that effort. Funded in part by $330 million from the U.S. State Department through the National Endowment for Democracy (which contributes to GDI’s budget), the GDI was designed to steer advertisers and subscribers away from “risky” sites which it says pose “reputational and brand risk” and to help companies avoid “financially supporting disinformation online.” 

GDI warned advertisers that these sites could damage their reputations and brands: the New York Post, Reason, Real Clear Politics, the Daily Wire, The Blaze, One America News Network, The Federalist, Newsmax, the American Spectator, and the American Conservative.

The inclusion of Reason was particularly glaring; the site regularly posts legal analysis from conservative and libertarian scholars. With the diminishing number of such academics on university faculties, Reason is a relative rarity in offering a different take on legal cases and issues. GDI incorrectly claimed the site offers “no information regarding authorship attribution.” It also said Reason lacks “pre-publication fact-checking or post-publication corrections processes, or policies to prevent disinformation in its comments section.” 

There is a reason why Reason does not have policies posted on the removal of disinformation: It opposes content moderation policies of groups like GDI on free-speech grounds and disinformation “processes” used to limit free speech. 

However, that is the point in this and other disinformation efforts: “Disinformation” appears based on what GDI and the Biden administration believe to be the truth. That may explain why some of the most biased sites on the political left are given higher rankings by the index.

While claiming that the conservative sites lacked transparency, GDI is fairly opaque on its own conclusions and standards. The explanations for tagging those sites are riddled with subjective, ambiguous terms. For example, GDI includes RealClearPolitics due to what GDI considers “biased and sensational language” while heralding sites like HuffPost as among the most trustworthy. 

GDI further says that RealClearPolitics “lacked clear and diverse sources.” Yet HuffPost and Mother Jones — both of which rate highly on the index — have a range of diversity that runs from the left to the far left.

In discouraging advertisers from supporting the New York Post, the GDI declares that “content sampled from the Post frequently displayed bias, sensationalism and clickbait, which carries the risk of misleading the site’s reader.” Yet the GDI’s self-appointed monitors of disinformation make no effort to explain what constitutes “clickbait” or “sensationalism” by the Post in comparison to favored sites like HuffPost.

Indeed, GDI’s definition of “disinformation” is heavily laden with subjective terms. including any site that GDI views as offering “adversarial narratives.” Disinformation can include anything that is “financially or ideologically motivated” … “foster[s] long-term social, political or economic conflict” or simply creates “a risk of harm by undermining trust in science or targeting at-risk individuals or institutions.” Under that definition, the Gutenberg Bible might be flagged by some skeptics as disinformation.

Last year, GDI’s cofounder and executive director, Daniel Rogers, wrote an op-ed for Time magazine calling for government intervention to change the “rules that govern the manipulation of our information environment in order to prevent another nihilistic narcissist gaining power.” That includes not just Donald Trump but “someone like” him who lies “outright solely to further their own immediate interests.” Rogers does not explain how the federal government will be barring candidates who might otherwise be elected. He also called for liability for social media companies for any postings linked to a reader or viewer becoming radicalized and violent.

The funding of GDI, and the FBI’s censorship efforts, are consistent with President Biden’s pronounced anti-free-speech policies since taking office in 2020. The president previously asked “how do people know the truth” if social media companies did not control what they could read or hear on these platforms. 

The full range of such efforts by the Biden administration is still unclear. What is clear is that the government is working to censor and harass sites with opposing views on subjects ranging from the pandemic to climate change to elections. This includes efforts to deter others from supporting these sites through advertising revenue. The financial viability of these sites could depend on the GDI’s good-citizen score.

Congress should ban the use of federal funds from such anti-free speech grants and programs. The first step, however, is to force the transparency that is being opposed by so many politicians and pundits. That should include any prior such efforts by the Trump or Obama administrations; the public can handle the truth of finding out if our government has been in the business of speech control. Otherwise, we may have succeeded in ridding the government of the “Mary Poppins of Disinformation” but not of her underlying philosophy. 

At least the original Mary Poppins was open and warned her wards: “First of all, I would like to make one thing clear: I never explain anything.”

Jonathan Turley is the Shapiro Professor of Public Interest Law at The George Washington University. 

https://thehill.com/opinion/judiciary/3864526-how-the-biden-administration-has-quietly-helped-to-score-conservative-speech/