Clinical Research

No one likes getting a needle but most want a vaccine. A new paper shows progress for messenger RNA (mRNA), that can be sprayed and inhaled thanks to improved lipid-polymer nanoparticle technology for holding mRNA that is stable when nebulized and successfully delivers aerosols, liquid droplets, in mouse lungs.  A mouse study means this is only EXPLORATORY but the authors of the paper, including scientists from oRNA Therapeutics (RNA medicine) and Moderna (mRNA medicine), have filed for a patent while they get ready to see about human trials.  The benefit to mRNA medicines is…

Attorney Robert F. Kennedy Jr. and his US followers over the last 25 years have staunchly opposed vaccines, latching on to any claim that they cause autism or should be available for lawsuits even if they harm no one. They really won't like a new experimental vaccine for Smallpox and Monkeypox that avoids the side effects of a current live virus version while not needing two doses, as the replication-deficient virus version does. It uses the horsepox virus as a protective agent to confer the safety of a multi-dose vaccine in a single shot.  Smallpox, caused by the variola virus…

The world is aging. After centuries of relentless growth, many advanced economies are getting older, and even in poorer nations, the share of elderly people is rising. Larger and older populations are creating historic pressures on health care systems across the world. There are not enough doctors, nurses, and other health care workers, even as the number of patients increases. Health care workers are under constant pressure, with many suffering from burnout and others planning to leave the industry. According to the New England Journal of Medicine, in 2022, exhausted from the pressures they…

Bipolar disorder, a mental illness with both manic and depressed moods, is often resulting in earlier death than others, by up to 15 years. In two groups, people with bipolar disorder were four to six times more likely as people without the condition to die prematurely, while people who had ever smoked were about twice as likely to die prematurely than those who had never smoked – whether or not they had bipolar disorder. When it comes to bipolar disorder, the differences in health and lifestyle change mortality a lot. “Bipolar disorder has long been seen as a risk factor for mortality, but…

Sepsis - blood poisoning - is a severe immunological overreaction to an infection, and hospitals can often be a cause rather than a solution. A guess by the World Health Organisation is that up to 20 percent of deaths worldwide have sepsis as a factor. A new analysis finds that up to 40 percent of people who don't die still can't return to work after two weeks. A new analyis retrieved figures from the Norwegian Patient Registry and from the Norwegian Labour and Welfare Administration’s information on absence due to illness. The figures included 36,000 sepsis patients aged 18 to 60. The…

In the future, people in need of an organ transplant will have one grown using their own stem cells. That means no immunosuppressive drugs, no risk of failure, no hoping someone compatible dies. Until then, the best solution to get rid of waiting lists is donor animals. A new study completed the longest-documented case of a genetically engineered pig kidney functioning in a human body; 61 days. It used a GalSafe pig, an animal engineered by Revivicor Inc., and approved in 2020 by the U.S. Food and Drug Administration as a potential source for human therapeutics, as well as a food source for…

Atherosclerosis, a condition that causes arteries to thicken, is a risk factor for a number of diseases that as a group are the leading cause of death in the U.S. What it really means, why it happens, and why it matters is unclear, since nearly half of Americans are told they have it. Understanding its progression and possible impact of fatty buildup in the arteries is important, as is calcification. A new pilot is geared toward learning where that calcification comes from, and if perhaps its origin is inside the arteries. Texas Tech biologist Peter Keyel says, “The arteries are made up of…

Screening is underway to find a patient for the world's first bladder transplant in humans.  Like hearts or eyes, the patient’s diseased bladder will be removed and replaced with a healthy bladder from a deceased donor. The roadmap is to grow new organs from a patient's own stem cells, meaning no need for immunosuppressive drugs or other complications, but transplants can help tens of millions of people with bladder disease and dysfunction, some which require bladder reconstruction, a surgical procedure wherein the bladder is removed, and a new bladder is made from the patient’s own…

Phase 2 data showing a reduction in amyloid-beta plaques in early Alzheimer's patients is good enough for FDA to give it temporary approval under their Accelerated Approval pathway. The positive results occurred in mild cognitive impairment or mild dementia patients. Lecanemab-irmb is a 100 mg/mL injection for intravenous use, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (“protofibril”) and insoluble forms of amyloid beta (Aβ) for the treatment of Alzheimer’s disease (AD). The approval is based on Phase 2 data that demonstrated that…

From insulin to lowering environmental strain to grow food, genetic engineering is one of the marvels of the 20th century. In the 21st, CRISPR-Cas9 or something else may achieve the same lofty status but genetic engineering isn't done yet. Glioblastoma is an aggressive cancer in the brain or spinal cord, with a very short life expectancy. The usual treatment is temozolomide chemotherapy (TMZ) to slow or stop the growth of the cancer cells and the United States Food and Drug Administration clearance of an Investigational New Drug, application to launch a Phase 2 clinical trial. The trial…