Antisecretory Factor Reduces Mortality in Severe TBI Trial

Key Summary:

• A phase II trial tested an antisecretory factor in 100 adults with severe TBI in South Africa.
• 30-day mortality was 20% with antisecretory factor versus 39% with placebo (RR 0.52, P=0.040).
• Findings support larger multicentre trials of antisecretory factor for TBI in resource-limited settings.

A PHASE II TRIAL has revealed that antisecretory factor therapy reduced 30-day mortality in patients with severe traumatic brain injury (TBI), offering a promising, low-cost intervention for low- and middle-income countries where treatment options remain scarce.

Isolated severe TBI has remained a leading cause of death and disability worldwide, particularly in low- and middle-income countries (LMICs) with limited neurocritical care access. While pharmacological and non-pharmacological therapies have shown promise experimentally, no trial has demonstrated robust clinical efficacy in humans. Antisecretory factor (AF), a 41 kDa endogenous protein with antisecretory and anti-inflammatory properties, has emerged as a candidate therapy delivered via Salovum®, an AF-rich egg yolk powder classified as a food supplement for specific medical purposes in the EU and US.

Trial Design and Patient Population

This prospective, double-blind, placebo-controlled phase II trial ran from September 2017 to February 2022 at a tertiary trauma centre in Cape Town, South Africa (NCT03339505). Investigators enrolled adults aged 18 to 61 years with isolated severe TBI (Glasgow Coma Score 6 to 8) requiring intracranial pressure (ICP) monitoring. Participants received Salovum® or placebo via nasogastric tube, dosed by bodyweight (10 to 17 g every 4 hours) from a mean of 32.9 hours post-injury, for up to 5 days.

The primary outcome was 30-day mortality; secondary outcomes were therapy intensity level (TIL) and ICP. In total, 100 participants were randomised (49 treatment, 51 control); 96% were male, with a mean age of 33 years.

Mortality Outcomes and Safety Findings

The 30-day mortality rate was 20% in the Salovum® group versus 39% in the placebo group, a relative risk of 0.52 (95% CI: 0.271 to 0.997, P=0.040, chi-square test). TIL and ICP scores were similar between groups, and no significant adverse events occurred in either arm.

Future Multicentre Trials

Antisecretory factor therapy has demonstrated a significant reduction in 30-day mortality among adults with severe TBI in a resource-limited LMIC setting, researchers report. Although its precise mechanism of action remains unclear, AF’s favourable safety profile and ease of administration support further evaluation in larger, multicentre randomised controlled trials. Given the single-centre design and modest sample size, antisecretory factor warrants validation in wider populations before informing routine TBI management.

 

 

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Lesser Known Causes of Dementia

Dementia refers to the overall decline in brain functioning. It affects memory, language, problem-solving and other thinking skills. There are various types of dementia depending on the cause. It can take on multiple form. Scientists are currently working on finding the cause of dementia but cannot pin-point a single reason. There are ways in which dementia symptoms, such as reduced concentration, withdrawal or depression, memory problems and increasing confusion, can be managed. Progressive dementia refers to types of dementia that cannot be reversed with any medication or nutrient. Dementia caused by protein deposits or certain vitamin deficiencies can be reversed with treatment. Other than bleeding and sweating on the football ground, there are other various other complex reasons that can cause progressive dementia in an individual.

Alzheimer's disease: One of the causes of dementia is Alzheimer’s disease. Patients of Alzheimer’s have plaques and tangles in their brains. These plagues and tangles are made up of proteins called tau and beta-amyloid, respectively. They can damage healthy neurons and fibres in the brain. Apart from protein, Alzheimer’s also contains a genetic factor, which could also lead to dementia in Alzheimer’s patients.

Damage to blood vessels: Other than stroke and heart attack, damaged blood vessels that supply oxygen to the brain can also damage fibres in the white matter of the brain. This condition is called vascular dementia. Stroke can also damage your brain causing difficulties in problem-solving, slowed thinking and trouble focusing. 

Huntington's disease: This inherited condition can cause the breakdown (degeneration) of certain nerve cells in the brain and spinal cord. Huntington’s usually affects people in the mid-30s. Signs and symptoms, include an intense decline in thinking and cognitive skills.

Traumatic brain injuries: Traumatic brain injuries like falling down and hitting your head at home or hitting your head in a car accident can cause major impact on the skull. This impact can lead to abnormal functioning of brain proteins. This could potentially harm your brain and cause dementia.

Heavy metal poisoning: According to a study, constant exposure to heavy metals, such as lead, can damage the brain causing dementia. According to the study, heavy metals can tinker with the person’s genes and stunt children's growth and damage their brain. 

 

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Breakthrough cell therapy to improve memory following traumatic brain injury

Researchers have developed a breakthrough cell therapy to improve memory and prevent seizures in mice following traumatic brain injury.

The study — ‘Transplanted interneurons improve memory precision after traumatic brain injury’ — was published in the journal of ‘Nature Communications.’

Traumatic brain injuries (TBI) affect two million Americans each year and cause cell death and inflammation in the brain. People, who experience a head injury often, suffer from lifelong memory loss and can develop epilepsy.

In the study, the team transplanted embryonic progenitor cells capable of generating inhibitory interneurons, a specific type of nerve cell that controls the activity of brain circuits, into the brains of mice with traumatic brain injury. They targeted the hippocampus, a brain region responsible for learning and memory.

The researchers have discovered that the transplanted neurons migrated into the injury where they formed new connections with the injured brain cells and thrived long term.

Within a month after treatment, the mice showed signs of memory improvement such as being able to tell the difference between a box where they had an unpleasant experience from one where they did not.

They were able to do this just as well as mice that never had a brain injury. The cell transplants also prevented the mice from developing epilepsy, which affected more than half of the mice who were not treated with new interneurons.

“Inhibitory neurons are critically involved in many aspects of memory, and they are extremely vulnerable to dying after a brain injury,” said Robert Hunt, PhD, assistant professor of anatomy and neurobiology at UCI School of Medicine, who led the study.

“While we cannot stop interneurons from dying, it was exciting to find that we can replace them and rebuild their circuits,” added Hunt.

To further test their observations, Hunt and his team silenced the transplanted neurons with a drug, which caused the memory problems to return.

“It was exciting to see the animals’ memory problems come back after we silenced the transplanted cells because it showed that the new neurons really were the reason for the memory improvement,” said Bingyao Zhu, a junior specialist and first author of the study.

Currently, there are no treatments for people who experience a head injury. If the results in mice can be replicated in humans, it could have a tremendous impact on patients. The next step is to create interneurons from human stem cells.

“So far, nobody has been able to convincingly create the same types of interneurons from human pluripotent stem cells,” Hunt said. “But I think we’re close to being able to do this.

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Researchers find new drug to prevent neural deaths

A team of scientists has found a new drug that may prevent neural death through glucose metabolism modification in stressed neurons.

The trials conducted on mice are rather promising for future use in humans. The new drug can be advantageous in neurological conditions ranging from Amyotrophic lateral sclerosis, Alzheimer's and Huntington's diseases to traumatic brain injury and ischemic stroke.

According to WHO, stroke is the 2nd most common cause of mortality and more than a third of people who have survived a stroke will have a severe disability.

As the population ages, many more millions are poised to develop Alzheimer's or Parkinson's disease in the near future.

Glycolysis is generally considered as the metabolic pathway essential for cell survival since it meets cell energy needs in case of intensive energy consumption.

However, it is already known that in the brain tissue, the situation is quite different-different cell types show distinct glucose metabolism patterns.

In Neurons, only a small portion of glucose is consumed vie the glycolysis pathway. At the same time, astrocytes provide nutrients to neurons and utilise glycolysis to metabolise glucose.

These differences are mostly due to the special protein called PFKFB3, which is normally absent in neurons and is active is astrocytes.

In the case of certain neurological diseases, stroke being one of them, the amount of active PFKFB3 increases in neurons, which is highly stressful for these cells and leads to cell death.
Researchers in the in vivo experiments confirmed that a small molecule, the inhibitor or PFKFB3, may prevent cell death in the case of ischemia injury.

Inhibition of PFKFB3 improves co-ordination of mice after stroke and reduced brain infarct volume. Moreover, PFKFB3 inhibitor protects neurons from the amyloid-beta peptide, the main component of the amyloid plaques found in the brains of Alzheimer's disease patients. 

A Prof. said, " Excitotoxicity is a hallmark of various neurological diseases, stroke being one of them. Our group has previously established a link between this pathological condition and high activity of PFKFB3 enzyme in neurons, which leads to severe oxidative stress and neuronal death".

These promising results bring hope to dozens of millions of patients suffering from life-threatening neurological disease, mentioned a researcher.

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