Categories : COVID Ethics and LawTags :

The Rise of Phony Stem Cell COVID Treatments

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SARS-CoV-2 virus. Source: Fusion Medical Animation on Unsplash

The global race to develop new stem cell-based COVID treatments during the pandemic was filled with violations of government regulations, inflated medical claims and distorted public communication, according to an article appearing in Stem Cell Reports.

While stem cell therapy has treatment applications for a limited range of diseases and conditions, at present no clinically tested or government-approved cell therapies are available for the treatment or prevention of COVID or long COVID.

Despite this, some clinics have started offering unproven and unsafe “stem cell” therapies that promise to prevent COVID by strengthening the immune system or improving overall health, according to lead author Laertis Ikonomou, PhD, associate professor of oral biology in the University at Buffalo School of Dental Medicine.

The article explores the negative effects that misinformation about cell therapies has on public health, as well as the roles that researchers, science communicators and regulatory agencies should play in curbing the spread of inaccurate information and in promoting responsible, accurate communication of research findings.

“Efforts to rapidly develop therapeutic interventions should never occur at the expense of the ethical and scientific standards that are at the heart of responsible clinical research and innovation,” said Prof Ikonomou.

Other investigators include Megan Munsie, PhD, professor of ethics, education and policy in stem cell science at the University of Melbourne; and 

Many of the studies on possible stem cell-based COVID treatments are at an early stage of investigation and further evaluation on larger sample sizes is required, says Munsie. However, the findings from preliminary studies are frequently exaggerated through press releases, social media and uncritical news media reports.

“Given the urgency of the ongoing pandemic, even the smallest morsel of COVID science is often deemed newsworthy and rapidly enters a social media landscape where—regardless of its accuracy – it can be widely shared with a global audience,” said Aaron Levine, PhD, associate professor of public policy at Georgia Institute of Technology..

Clinics selling such treatments sometimes use these findings and news reports to exploit the fears of vulnerable patients by unethically advertising unproven stem cell treatments benefits of boosting the immune system, regenerating lung tissue and preventing transmission of COVID, said co-author Leigh Turner, PhD, professor of health, society and behaviour at the University of California, Irvine.

Reportedly some harm to patients resulted from unproven stem cell therapies, including blindness and death. Patients suffer financially as well, said Prof Ikonomou, as the products range in price from a few thousand to tens of thousands of dollars, and people are often encouraged to receive the expensive treatments every few months.

Patients who COVID may decline vaccines, stop wearing masks and stop other COVID safety measures, Prof Turner warned. They may also be less likely to participate in ethically conducted clinical trials.

“The premature commercialisation of cell-based therapeutics will inevitably harm the field of regenerative medicine, increase risks to patients and erode the public’s trust,” said Prof Ikonomou.

Despite warnings, many offending companies continue to make false claims. The authors recommend that regulatory agencies consider implementing stronger measures.

They also suggest that scientific and professional societies lobby regulatory agencies to increase enforcement of laws and regulations. The authors recommended that science communicators and journalists can combat misinformation by not engaging in hyperbolic coverage of research results and conveying study limitations.

Source: University at Buffalo

Categories : Cardiovascular Disease GenderTags :

Not Enough Women in Stroke Clinical Trials

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Photo by Loren Joseph on Unsplash

A new study published in Neurology shows that women are underrepresented in stroke clinical trials compared to the proportion who have strokes in the general population. 

“Making sure there are enough women in clinical studies to accurately reflect the proportion of women who have strokes may have implications for future treatment recommendations for women affected by this serious condition,” said study author Cheryl Carcel, MD, of The George Institute for Global Health in Sydney, Australia. “When one sex is underrepresented in clinical trials, it limits the way you can apply the results to the general public and can possibly limit access to new therapies.”

The study analysed 281 stroke trials conducted between 1990 and 2020, with a total of 588 887 participants. Of these, only 37.4 % were women. The average prevalence of stroke in women across the countries included was 48%.

Results were calculated in participation-to-prevalence ratio, a relative measure that weights the percentage of women in a trial compared to their proportion in the total population with that disease. A ratio of one indicates that the percentage of women in the study is the same as the percentage of women with the disease in the general population. An acceptable range for an ideal ratio of female participation is between 0.8 and 1.2.

Overall, women were found to be underrepresented relative to their prevalence in the underlying population, with a consistent ratio of 0.84 over time. They found the greatest differences in trials of intracerebral haemorrhage, with a ratio of 0.73; trials with average participant age under 70, with a ratio of 0.81; non-acute interventions, with a ratio of 0.80; and rehabilitation trials, with a ratio 0.77.

“Our findings have implications for how women with stroke may be treated in the future, as women typically have worse functional outcomes after stroke and require more supportive care,” Dr Carcel said. “We will only achieve more equitable representation of women in clinical trials when researchers look at the barriers that are keeping women from enrolling in studies and actively recruit more women. People who fund the research also need to demand more reliable, sex-balanced evidence.”

Source: American Academy of Neurology

Categories : COVIDTags :

Long COVID in More Than Half of Survivors

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Photo by Joice Kelly on Unsplash

More than half of the 236 million people diagnosed with COVID around the world will experience ‘long COVID’ up to six months after recovering, according to Penn State College of Medicine researchers.

During their illnesses, many patients with COVID experience symptoms, such as tiredness, difficulty breathing, chest pain, sore joints and loss of taste or smell.

There have been few studies focussing on patients’ health after recovering from COVID. The researchers examined worldwide studies involving unvaccinated patients who recovered from COVID in order to understand the short and long term impacts of infection. The study found that both adults and children can experience several adverse health issues for six months or longer after recovering from COVID.

The researchers conducted a systematic review of 57 reports that included data from 250 351 unvaccinated adults and children who were diagnosed with COVID from December 2019 through March 2021. Among those studied, 79% were hospitalised, and most patients (79%) lived in high-income countries. Patients’ median age was 54, and 56% were male.

Patients’ health post-COVID was analysed during three intervals at one month (short-term), two to five months (intermediate-term) and six or more months (long-term).

Survivors were found to experience an array of residual health issues associated with COVID,.which generally affected a patient’s general well-being, their mobility or organ systems. Overall, half of survivors experienced long-term COVID manifestations, and these rates remained largely constant from one month through six or more months after their initial illness.

Several trends were observed among survivors, such as:

  • General well-being: More than half of all patients reported weight loss, fatigue, fever or pain.
  • Mobility: Roughly a fifth of survivors had a decrease in mobility.
  • Neurologic concerns: Nearly one quarter of survivors had difficulty concentrating.
  • Mental health disorders: Nearly a third of patients were diagnosed with generalised anxiety disorders.
  • Lung abnormalities: Six in ten survivors had chest imaging abnormality and more than a quarter of patients had difficulty breathing.
  • Cardiovascular issues: Chest pain and palpitations were among the commonly reported conditions.
  • Skin conditions: Nearly a fifth of patients experienced hair loss or rashes.
  • Digestive issues: Stomach pain, lack of appetite, diarrhoea and vomiting were among the commonly reported conditions.

“The burden of poor health in COVID survivors is overwhelming,” said co-lead investigator Dr Paddy Ssentongo, assistant professor at the Penn State Center for Neural Engineering. “Among these are the mental health disorders. One’s battle with COVID doesn’t end with recovery from the acute infection. Vaccination is our best ally to prevent getting sick from COVID and to reduce the chance of long-COVID even in the presence of a breakthrough infection.”

The mechanisms behind long COVID remain little understood. These symptoms could result from immune-system hyperactivation, lingering infection, reinfection or an increased production of tissue-attacking autoantibodies. SARS-CoV-2 can access, enter and live in the nervous system, resulting in commonly occurring nervous system symptoms such as taste or smell disorders, memory impairment and decreased attention and concentration commonly.

Dr Ssentongo noted that the study did not rule out other causes from the symptom besides COVID.

Early intervention will be crucial for improving the quality of life for many COVID survivors, and in the years ahead, health care providers will likely see an influx of patients with psychiatric and cognitive problems, such as depression, anxiety or post-traumatic stress disorder who were otherwise healthy before contracting COVID. Healthcare systems in low- and middle-income countries risked being overwhelmed with 

“Since survivors may not have the energy or resources to go back and forth to their health care providers, one-stop clinics will be critical to effectively and efficiently manage patients with long COVID,” Dr Ssentongo said. “Such clinics could reduce medical costs and optimise access to care, especially in populations with historically larger health care disparities.”

Source: Penn State

Categories : Pain ManagementTags :

Ultra-thin Microelectrodes to Combat Severe Pain

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First author Matilda Forni with the ultra-thin microelectrodes during production (Photo: Agata Garpenlind)

In an entirely new stimulation method to combat severe pain, researchers at Lund University in Sweden have developed ultra-thin microelectrodes which are inserted into the pain centres of the brain.

This approach, which was tested in rats, provides effective and personalised analgesia, without the side effects of drugs. The findings were reported in Science Advances.

The quality of life of patients experiencing pain is greatly impacted by the lack of side-effect free treatment, and pain also impacts society in terms of reduced productivity. Side effects of pain medication can include reduced mental capacity and, in some cases, addiction. According to a recent American report, about 8% of the American population suffer from high-impact chronic pain.

To address this, professor of neurophysiology Jens Schouenborg led a research team which developed a method to combat pain via personalised stimulation using ultra-thin, tissue-friendly microelectrodes.

“The electrodes are very soft and extremely gentle on the brain. They are used to specifically activate the brain’s pain control centres without simultaneously activating the nerve cell circuits that produce side effects. The method involves implanting a cluster of the ultra-thin electrodes and then selecting a sub-group of the electrodes that provide pure pain relief, but no side effects. This procedure enables extremely precise and personalised stimulation treatment that was shown to work for every individual,” explained Prof Schouenborg.

Pain control is achieved by activating the brain’s pain control centres, these in turn block only the signal transfer in the pain pathways to the cerebral cortex.

“We have achieved an almost total blockade of pain without affecting any other sensory system or motor skill, which is a major breakthrough in pain research. Our results show that it is actually possible to develop powerful and side effect-free pain relief, something that has been a major challenge up to now,” explained first author and doctoral student Matilde Forni.

Over several years, the researchers developed a tissue-friendly, gelatine-based technology and surgical techniques that allowed them to precisely implant the flexible microelectrodes. According to the researchers, the new technique should work on all sorts of pain that are conveyed by the spinal cord, which is most types of pain.

“In our study we also compared our method with morphine, which was shown to deliver considerably less pain relief. In addition, of course, morphine has a powerful sedative effect as well as other cognitive effects. In the study we could also show that pain after sensitisation (hyperalgesia), which is common in chronic pain, was blocked”, said Prof Schouenborg.

The researchers plan to test the technology in humans and that within five to eight years yield an effective pain treatment, for pain from cancer or chronic pain in connection with spinal cord injuries, for which there is no currently satisfactory pain treatment..

The researchers also consider that the method could be used in a broader way to treat conditions besides pain.

“In principle, the method can be tailored to all parts of the brain, so we believe that it could also be used in the treatment of degenerative brain diseases such as Parkinson’s disease as well as in depression, epilepsy and probably stroke as well. The electrode technique also has applications in diagnostics and not least in research on how the mysterious brain works,” said Prof Schouenborg.

Source: Lund University

Categories : PaediatricsTags :

Daily Oxytocin Does not Improve Social Functioning in Children with ASD

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Phot by Ben Wicks on Unsplash

Giving children with autism spectrum disorder (ASD) regular doses of the hormone oxytocin does not appear to overcome deficits in social functioning, according to a study funded by the National Institutes of Health. 

The findings contradict earlier reports that indicated oxytocin, a hormone associated with empathy and social bonding, could alleviate the difficulties in social functioning characteristic of ASD. 

The study, believed to be the largest of its kind to date, appears in the New England Journal of Medicine, and was conducted by Linmarie Sikich, MD, of Duke University, and colleagues.

ASD is a complex neurological and developmental disorder that begins early in life and affects how a person interacts with others, communicates and learns. Many individuals with ASD have been prescribed oxytocin by their physicians. Several small studies have tested the potential of oxytocin to improve social functioning in ASD but have produced inconsistent results.

For the current study, oxytocin was administered by nasal spray every day for 24 weeks to children with ASD who are minimally or fluently verbal. Participants ranged from 3 to 17 years old. Of those completing the study, 139 received oxytocin and 138 received a placebo. During the study, participants’ caregivers rated them on a questionnaire measuring irritability, social withdrawal and other behaviors associated with ASD. When the participants completed the trial, the differences between the two groups’ initial score and last score did not differ significantly. The researchers concluded that the 24-week course of oxytocin did not improve social interaction or other measures of social function related to ASD.

Source: National Institutes of Health

Categories : VaccinesTags :

Typhoid Vaccine Safe for Children in Sub-Saharan Africa

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Source: Pixabay CC0

A typhoid vaccine has proven to be safe and effective for children, which raises hope of fighting the disease in Sub-Saharan Africa, according to a new study conducted in Malawi.

There are more than 1.2 million typhoid cases and 18 703 deaths per year in the region, the researchers wrote. The World Health Organization (WHO) recommended the typhoid conjugate vaccine in 2018 for use in countries where the disease is endemic.

Clinical trials in Malawi showed that a single dose of typhoid conjugate vaccine (the only one licensed for children as young as six months) prevented typhoid in roughly 84% of 14 069 children aged 9 months to 12 years.

“It is a great result for Malawi and for Africa,” says study co-author Melita Gordon, professor of clinical infection, microbiology and immunology at the University of Liverpool and the Malawi-Liverpool-Wellcome Trust Clinical Research Programme.

“We were the only site chosen for the trial on the continent. The other sites were in Nepal and Bangladesh and the results were completely consistent across the three sites.”

Typhoid is endemic in Malawi, which records 400 to 500 cases per 100 000 every year, according to Queen Dube, chief of health services at Malawi’s Ministry of Health.

While typhoid is treatable, it can impair physical and cognitive development in children, affect school attendance and performance, limit productivity and reduce earning potential.

“The existing vaccine could not be used in very young children. In addition, the first line antibiotics have been found to be ineffective against multi-drug resistant strains,” Prof Gordon said. “With this vaccine, we can now expect a reduced typhoid burden.”

After 18 to 24 months of surveillance, the vaccine was found to be safe, with no serious adverse effects on children. It also worked equally well on pre-school aged children.

Prof Gordon explains that the study encountered challenges such as a few children moving out of the research sites within the study period, and COVID-19 forced them to suspend the study for two months.

“However, we eventually managed a good retention rate due to regular text messaging to parents and the hard work of health surveillance assistants in mobilisation activities,” she added.

The efficacy data of the typhoid conjugate vaccine is the first in Africa, according to Gordon, who hopes that other African countries will follow Malawi’s example in planning to roll out the vaccine.

Source: SciDev.Net

Categories : Substance UseTags :

Paediatricians Can Help Adolescents Quit Vaping

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Even though e-cigarette- or vaping-associated lung injury (EVALI) were “a drop in the bucket” compared with COVID, vaping remains a significant health risk for teens, reported Anne Griffiths, MD, of the Children’s Hospital of Minnesota, during her presentation entitled “Updates on Youth Vaping” at the American Academy of Pediatrics virtual meeting. 

According to the 2021 National Youth Tobacco Survey, 11.3% (1.72 million) of high school students (ages 16 to 18) and 2.8% (320 000) of middle school students (ages 12 to 15)  reported using e-cigarettes in the past 30 days.
As more than half of youths who tried to stop vaping, there is an opportunity fo paediatricians to intervene, Dr Griffiths said.

Middle school students often start with zero-nicotine, flavour-only products before “they move on to a nicotine-based product and ultimately a THC-based product,” Griffiths noted. Of the middle and high school students who vape, 85% use flavoured products, with sweet and fruity flavours favoured.
Notably, disposable e-cigarettes are now more popular than refillable pods and cartridges this year, with 53.7% of all vaping students reporting use of these products. This comes down to messaging not to reuse vaping products during COVID, Dr Griffiths said.

However, vaping could be a risk factor for COVID, being diagnosed five times more often in vaping adolescents, according to a study in the Journal of Adolescent Health.

E-cigarette flavouring can suppress innate immune function, as demonstrated by studies. Others have shown that e-cigarette vapour may increase ACE2 expression in the lungs, which the receptor that enables entry of SARS-CoV-2 into host cells.

Adolescents presenting with EVALI or COVID (or both) can be differentiated Dr Griffiths said. The patient’s reaction to steroid treatment can be diagnostic: “Unlike SARS-CoV-2 where the [patient’s] improvement might be subtle [with a] gradual response to steroids, in EVALI, one day on high-dose steroids and they feel like a million bucks in comparison.”

In addition, EVALI may present with leukocytosis and high erythrocyte sedimentation rates and C-reactive protein levels, while COVID patients are more likely to have lymphopenia.

Dr Griffiths that in spite of the risks of vaping, “there’s an entire culture surrounding [kids] that can glamorise vaping life.”

Vaping companies reach out to children using methods such as YouTube vape championships, in which competitors perform various smoke tricks. In addition, vaping companies provide scholarships to students, often requiring them to write an essay on the benefits of vaping.

Source: MedPage Today

Categories : COVID Obstetrics & GynaecologyTags :

Delta Variant Causes Pregnancy Complications

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Source: Anna Hecker on Unsplash

Pregnant women have been a population of concern for physicians since the beginning of the COVID pandemic, and early on the frequency of caesarean delivery, preterm birth and pregnancy-related hypertension was reported to be increased in pregnant women who developed severe or critical illness from the novel coronavirus.

In May and June this year, there was a lull in COVID cases and hospitalisations, to the relief of physicians at the University of Alabama at Birmingham Hospital and their pregnant patients. However, the Delta variant soon caused a rise in cases, hospitalisations and deaths across the US state of Alabama. Along with this there was a seemingly higher number of pregnant patients with COVID in hospitals and intensive care units than in previous surges.

“We saw an alarming increase in pregnant patients hospitalised with the Delta variant in July and August,” said Akila Subramaniam, MD, associate professor in UAB’s Division of Maternal-Fetal Medicine. “Even more, many of our patients were delivering pre-term because of the effects of the virus on these women.”

Researchers tracked admission rates and maternal and neonatal outcomes of pregnant COVID patients at UAB Hospital from March 22, 2020, to Aug. 18, 2021. Outcomes were compared between pre-Delta and Delta groups, with preliminary findings seriousindicating  morbidity and adverse outcomes associated with the Delta variant and pregnancy.

Prior to the Delta variant, UAB Hospital saw the highest admission of pregnant women with active COVID in July 2020. A total of 28 pregnant patients were admitted that month, three of whom were admitted to the intensive care unit. In comparison, 39 pregnant patients, with 11 in ICU, were hospitalised in just the first 18 days of August.

“Pregnant women are a high-risk population with low-vaccination rates overall,” said Jodie Dionne, MD, associate director of UAB Global Health in the Center for Women’s Reproductive Health and associate professor in the Division of Infectious Diseases. “There is misinformation circulating that causes doubt in the vaccines or downplays the effect of the virus. This study highlights how dangerous contracting the virus, especially the Delta variant, can be for the mom and baby.”

From the study’s early findings, the UAB researchers emphasize recommendations from the Society of Maternal-Fetal Medicine, the American College of Obstetricians and Gynecologists, and the Centers for Disease Control and Prevention to vaccinate pregnant patients to mitigate severe perinatal morbidity and mortality.

The findings were published in the journal of Obstetrics and Gynecology.

Source: University of Alabama at Birmingham

Categories : NeurologyTags :

Long Stays in Space can Cause Brain Injury

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Source: Wikimedia Commons

A study of five Russian cosmonauts who had stayed on the International Space Station (ISS) reveals that extended time in space causes signs of brain injury. The study is published in the scientific journal JAMA Neurology. 

Scientists followed five male Russian cosmonauts working on the permanently manned International Space Station (ISS), in an orbit 400km above the surface of the Earth.

Early on in spaceflight history, extended time in zero gravity was found to result in muscle atrophy and bone loss. More recently, changes in vision were discovered during long flights, a potentially serious hazard. The vision changes were ascribed to increased cerebral pressure caused by the lack of gravity no longer pulling fluid into the lower extremities. On Earth this is similar to lying with a head-down tilt, causing fluids to pool in the upper body and head.

Blood samples were taken from the cosmonauts, whose mean age was 49, 20 days before their departure to the ISS, where they had an average stay of 169 days.

After landing on Earth, follow-up blood samples were taken one day, one week, and about three weeks after landing. Concentrations of three of the biomarkers analysed – NFL, GFAP and the amyloid beta protein Aβ40 – were increased after their stay in space. The peak readings did not occur simultaneously after the men’s return to Earth, but their biomarker trends nonetheless broadly tallied over time.

“This is the first time that concrete proof of brain-cell damage has been documented in blood tests following space flights. This must be explored further and prevented if space travel is to become more common in the future,” said Henrik Zetterberg, professor of neuroscience and one of the study’s two senior coauthors.

”To get there, we must help one another to find out why the damage arises. Is it being weightless, changes in brain fluid, or stressors associated with launch and landing, or is it caused by something else? Here, loads of exciting experimental studies on humans can be done on Earth,” he continued.

Changes also seen in magnetic resonance imaging (MRI) of the brain after space travel add evidence to the notion of spaceflight causing brain injurt. Clinical tests of the men’s brain function that show deviations linked to their assignments in space further support this, but the present study was too small to investigate these associations in detail.

Prof Zetterberg and his coauthors are currently discussing follow-up studies.

“If we can sort out what causes the damage, the biomarkers we’ve developed may help us find out how best to remedy the problem,” Prof Zetterberg said.

Source: University of Gothenburg

Categories : Mental HealthTags :

Simple Talking Therapy Relieves Loneliness in Elderly

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A simple form of talking therapy, delivered telephonically by trained support workers, successfully reduced loneliness in older people left isolated during the pandemic, according to initial results from a new study.

The intervention lasted for eight weeks and was designed in partnership with older people. People were contacted weekly and were encouraged to maintain their social contacts and to stick to a daily schedule, which included both routine and enjoyable activities.

The intervention developed in the BASIL-C19 (Behavioural Activation in Social Isolation) study lasted for eight weeks and was designed in partnership with older people who had direct experience of social isolation, loneliness and depression during the pandemic.  

The importance of social connection was highlighted by the COVID pandemic and its restrictions. Pre-pandemic research identified 1.4 million older adults in England as experiencing significant loneliness with impacts on their mental health.  Research since the pandemic shows that rates of loneliness and depression have increased, particularly for those who were self-isolating.

A team of leading researchers and clinicians anticipated the impacts of the pandemic on mental health and re-focussed their research expertise to examine the psychological impact of enforced isolation, disruption to daily routines, loss of social contact and loneliness.

They designed a very brief telephone delivered intervention to combat depression and loneliness.  Older people appreciated the offer of telephone contact and they found the intervention to be helpful in maintaining daily routines and social contact.

In the preliminary results, published in PLOS Medicine, the research team found evidence of improved mental health, and a strong indication that loneliness rates were substantially reduced in the first three months. A much larger trial follow-on trial is now currently recruiting over 600 older people and is the largest study ever undertaken to tackle loneliness and depression in this way.  

Source: University of York