PRESS-NEWS.org - Press Release Distribution
PRESS RELEASES DISTRIBUTION

Ninth Circuit reverses lower court, reinforces FDA's authority to regulate unproven stem cell products

2024-09-30
(Press-News.org) In an important step to protect the public from unproven stem cell products, the U.S. Court of Appeals for the Ninth Circuit ruled in favor of the U.S. Food and Drug Administration in U.S. v. California Stem Cell Treatment Center, Inc., reversing the district court. The reversal fortifies FDA’s tiered, risk-based framework for the regulation of cell therapies and is consistent with a similar ruling in the Eleventh Circuit in 2021.

The appellees urged the Ninth Circuit to uphold the lower court’s ruling that their SVF (stromal vascular fraction) product was not a “drug” within the meaning of the Federal Food, Drug, and Cosmetic Act and that, even if it was, their use of SVF falls under an exception from FDA regulation for certain surgical procedures. The three-judge panel unanimously rejected the argument that SVF is not a drug, finding that the SVF procedure produces a “liquid concentrate of cells and cell debris” administered to treat diseases, and is therefore subject to premarket review by the FDA. The panel also found that the SVF procedure does not qualify for the Same Surgical Procedure exception. The case has been remanded to the lower court for further proceedings.

As a long-time advocate dedicated to preventing the proliferation of unproven stem cell products, on 7 June 2024, the ISSCR submitted an amicus brief in support of the government’s appeal. Unproven treatments marketed by stem cell clinics have resulted in hundreds of adverse events, including patients being blinded, paralyzed, and infected with dangerous pathogens. This ruling preserves FDA’s authority to regulate these dangerous and ineffective products to protect public health.

Sean Morrison, chair of the ISSCR Public Policy Committee, said “This ruling is an important step toward protecting Americans from unproven cell therapies that have not been shown to be safe or effective in controlled clinical trials and yet are being marketed as being effective for the treatment of diverse medical conditions, without any compelling scientific rationale.”

About the International Society for Stem Cell Research
With nearly 5,000 members from more than 80 countries, the International Society for Stem Cell Research is the preeminent, global, cross-disciplinary, science-based organization dedicated to stem cell research and its translation to the clinic. The ISSCR mission is to promote excellence in stem cell science and applications to human health. For more information about stem cell science, visit AboutStemCells.org.

###

END



ELSE PRESS RELEASES FROM THIS DATE:

Wnt happens in kidney development?

Wnt happens in kidney development?
2024-09-30
A group of essential signaling molecules known as the Wnt pathway emerged early in the evolution of multicellular life. Scientists have been studying Wnt actions for four decades to comprehend its complex roles in development and disease. In development of the mammalian kidney, USC Stem Cell scientists from Andy McMahon’s lab undertook a pair of complementary studies, published today in the journal Development, that provide new insight into the critical role of Wnt signaling in initiating the development of the mammalian kidney. “Many stem and progenitor cells require Wnt signaling, ...

Where flood policy helps most — and where it could do more

2024-09-30
Flooding, including the devastation caused recently by Hurricane Helene, is responsible for $5 billion in annual damages in the U.S. That’s more than any other type of weather-related extreme event. To address the problem, the federal government instituted a program in 1990 that helps reduce flood insurance costs in communities enacting measures to better handle flooding. If, say, a town preserves open space as a buffer against coastal flooding, or develops better stormwater management, area policy owners get discounts on their ...

Combining AI and thermal video offers a new window into weightlifting

Combining AI and thermal video offers a new window into weightlifting
2024-09-30
WASHINGTON — Researchers have developed a new method that combines video from thermal cameras with AI-based digital processing to enhance weightlifting training. By providing data-driven insights that enable targeted training and recovery strategies, the approach could help to optimize performance and safety in a variety of sport and exercise contexts. Thermal, or infrared, images can provide valuable information for sports and health by tracking muscle activation and detecting areas of strain or fatigue. This information can be used to prevent injuries, monitor thermal responses and quantify physical exercise, ultimately helping athletes boost their skills. However, most ...

Childhood social interactions combat stereotypes

2024-09-30
Prior research has found that exposure to social diversity in early life, such as through day care, influences how people communicate. Those early social experiences can also moderate tendencies toward stereotyping down the road, according to a new study published in the NPJ Science of Learning. "The more time an individual spent in day care as a child, the more likely they are to overcome their own stereotypical beliefs during social interactions later in life," says senior author Arjen Stolk, an assistant professor in the Department ...

Researchers harness liquid crystal structures to design simple, yet versatile bifocal lenses

Researchers harness liquid crystal structures to design simple, yet versatile bifocal lenses
2024-09-30
WASHINGTON — Researchers have developed a new type of bifocal lens that offers a simple way to achieve two foci (or spots) with intensities that can be adjusted by applying external voltage. The lenses, which use two layers of liquid crystal structures, could be useful for various applications such as optical interconnections, biological imaging, augmented/virtual reality devices and optical computing. “Most liquid-crystal-based devices are made from single-layer structures, but this limits light field modulation ...

Suicide attempts decreased after adding suicide care to primary care, study finds

2024-09-30
After suicide care was integrated into routine primary care visits, researchers saw a 25% decrease in the rate of suicide attempts in the following 90 days, a new Kaiser Permanente study finds. The study, published in the Annals of Internal Medicine, is the first to show that suicide risk screening in primary care, followed by safety planning, improved suicide prevention efforts in a health care setting. The trial took place at Kaiser Permanente clinics in Washington state, using data from January 2015 to July 2018. “Our findings are important because we know many people seek primary care prior to fatal and nonfatal suicide attempts,” ...

One in three Americans has a dysfunctional metabolism, but intermittent fasting could help

One in three Americans has a dysfunctional metabolism, but intermittent fasting could help
2024-09-30
LA JOLLA (Sept 30, 2024)—More than one-third of adults in the United States have metabolic syndrome, a cluster of conditions that significantly raise a person’s risk of heart disease, stroke, and type 2 diabetes. These conditions include high blood pressure, elevated blood sugar, excess abdominal fat, and abnormal cholesterol levels. In a new clinical trial, researchers at the Salk Institute and University of California San Diego School of Medicine found that time-restricted eating—also known as intermittent fasting—could offer significant health benefits to adults with metabolic syndrome. Patients ...

Time-restricted eating associated with greater blood sugar control and fat loss than standard nutrition counseling

2024-09-30
Embargoed for release until 5:00 p.m. ET on Monday 30 September 2024   @Annalsofim        Below please find summaries of new articles that will be published in the next issue of Annals of Internal Medicine. The summaries are not intended to substitute for the full articles as a source of information. This information is under strict embargo and by taking it into possession, media representatives are committing to the terms of the embargo not only on their own behalf, but also on behalf of ...

New imaging technique brings us closer to simplified, low-cost agricultural quality assessment

New imaging technique brings us closer to simplified, low-cost agricultural quality assessment
2024-09-30
URBANA, Ill. – Hyperspectral imaging is a useful technique for analyzing the chemical composition of food and agricultural products. However, it is a costly and complicated procedure, which limits its practical application. A team of University of Illinois Urbana-Champaign researchers has developed a method to reconstruct hyperspectral images from standard RGB images using deep machine learning. This technique can greatly simplify the analytical process and potentially revolutionize product assessment in the agricultural industry. “Hyperspectral ...

Purdue-led TOMI project receives $3.5M grant to turn a decade of data into new tools and strategies for tomato farmers

Purdue-led TOMI project receives $3.5M grant to turn a decade of data into new tools and strategies for tomato farmers
2024-09-30
Purdue-led TOMI project receives $3.5M grant to turn a decade of data into new tools and strategies for tomato farmers WEST LAFAYETTE, Ind. — Indiana ranks third in the nation for tomato production. Lori Hoagland, a professor in Purdue University’s Department of Horticulture and Landscape Architecture, recently received ​​a third grant from the U.S. Department of Agriculture’s National Institute of Food and Agriculture (USDA-NIFA) for the Tomato Organic Management and ...

LAST 30 PRESS RELEASES:

University of Tennessee, Lockheed Martin expand Master Research Agreement

Testing thousands of RNA enzymes helps find first ‘twister ribozyme’ in mammals

Groundbreaking study provides new evidence of when Earth was slushy

International survey of more than 1600 biomedical researchers on the perceived causes of irreproducibility of research results

Integrating data from different experimental approaches into one model is challenging – this study presents a community-based, full-scale in silico model of the rat hippocampal CA1 region that integra

SwRI awarded grant to characterize Las Moras Springs watershed

Water overuse in MATOPIBA could mean failure to meet up to 40% of local demand for crop irrigation

An extra year of education does not protect against brain aging

Researchers from Uppsala and Magdeburg obtain an ERC Synergy Grant to advance cancer immunotherapy

Deaf male mosquitoes don’t mate

Recognizing traumatic brain injury as a chronic condition fosters better care over the survivor’s lifetime

SwRI’s Dr. James Walker receives Distinguished Scientist Award from Hypervelocity Impact Society

A mother’s health problems pose a risk to her children

Ensuring a bright future for diamond electronics and sensors

The American Pediatric Society selects Dr. Maria Trent as the Recipient of the 2025 David G. Nichols Health Equity Award

The first 3D view of the formation and evolution of globular clusters

Towards a hydrogen-powered future: highly sensitive hydrogen detection system

Scanning synaptic receptors: A game-changer for understanding psychiatric disorders

High-quality nanomechanical resonators with built-in piezoelectricity

ERC Synergy Grants for 57 teams tackling major scientific challenges

Nordic research team receives €13 million to explore medieval book culture 

The origin of writing in Mesopotamia is tied to designs engraved on ancient cylinder seals

Explaining science through dance

Pioneering neuroendocrinologist's century of discovery launches major scientific tribute series

Gendered bilingualism in post-colonial Korea

Structural safety monitoring of buildings with color variations

Bio-based fibers could pose greater threat to the environment than conventional plastics

Bacteria breakthrough could accelerate mosquito control schemes

Argonne to help drive AI revolution in astronomy with new institute led by Northwestern University

Medicaid funding for addiction treatment hasn’t curbed overdose deaths

[Press-News.org] Ninth Circuit reverses lower court, reinforces FDA's authority to regulate unproven stem cell products