Tag: 18/3/21

Categories : CancerTags :

Electromagnetic Fields Could Inhibit Breast Cancer Cell Spread

On By ModernMedia

A new study has shown that electrical fields can slow, and in some cases halt, the spread of breast cancer cells through the body.

The research also found how electromagnetic fields (EMFs) have the ability to hinder the number of cancer cells that can spread. Pulsed EMFs have also been shown to have some effectiveness in pain management, and low level EMFs were shown also to reduce blood glucose in animal models, a possible first step to treating diabetes.

“We think we can hinder metastasis by applying these fields, but we also think it may be possible to even destroy tumours using this approach,” said senior author Vish Subramaniam, former professor of mechanical and aerospace engineering at The Ohio State University. Subramaniam retired from Ohio State in December.

“That is unclear at this stage, but we are working on understanding that – how big should the electromagnetic field be, how close should it be to the tumour? Those are the next questions we hope to answer,” he said.
Subramaniam said that this had the effect of the EMF is to slow down some of the cancer cells. “It makes some of them stop for a little while before they start to move, slowly, again. As a group, they appear to have split up. So how quickly the whole group is moving and for how long they are moving becomes affected.”

The effect was applied to human cancer cells in vitro and has not been applied in humans.

The EMFs seem to selectively slow down the cancer cells’ metabolism by affecting the electrical fields inside the individual cells—completely noninvasively and without side effects like ionising radiation, which would mean a revolutionary form of cancer treatment if it could be made to work in practice. This ability to access a cell’s internal workings is new to the study of how cancer metastasises, said Prof  Subramaniam.

“Now that we know this, we can start to answer other questions, too,” Subramaniam said. “How do we affect the metabolism to the point that we not only make it not move but we choke it, we completely starve it. Or can we slow it down to the point where it will always remain weak?”

Source: News-Medical.Net

Journal information: Jones, T.H., et al. (2021) Directional Migration of Breast Cancer Cells Hindered by Induced Electric Fields May Be Due to Accompanying Alteration of Metabolic Activity. Bioelectricity. doi.org/10.1089/bioe.2020.0048.

Categories : TransplantsTags :

$16 Million Payout to BioJoint Knee Surgery Plaintiffs

On By ModernMedia

The University of Missouri has settled claims over ‘BioJoint’  knee surgeries for $16.2 million, in what appears to be one of its largest public payouts in recent years.

The surgeries in question used the BioJoint system, a “biological joint restoration” which involves replacing parts of the knee with bones or cartilage from cadavers to treat arthritis or joint damage. This technology was pioneered by James Stannard, MD, and veterinarian James Cook, DVM.
The 22 plaintiffs, some of whom were minors, allege that they were not informed about the highly experimental nature of the BioJoint knee surgeries, with a failure rate of as high as 86%. This often required patients to have additional corrective surgeries or knee replacements. Some plaintiffs said that the surgery was pitched to them as a way to avoid a total knee joint replacement. They also allege that Dr Stannard negligently allowed Dr Cook—a veterinarian surgeon—to perform parts of the surgery without supervision.

The University denied wrongdoing, and settled without admission of liability or wrongdoing after claims against the defendants, Dr Stannard, Cook and another employee were dismissed. 

“It’s not uncommon to have vets as part of your research team, but it would be uncommon to have them as part of your clinical patient care team,” said Patrick McCulloch, MD, vice chairman of Houston Methodist’s orthopaedic surgery department.

“You have to be licensed as a physician to perform surgery on a human being,” added Jeff Howell, executive vice president of the Missouri State Medical Association.

A key part of the plaintiff’s case involved false advertising, including local airing at the Super Bowl and at Chicago’s O’Hare International Airport, and which they claim led them to the procedure. It was speculated that the false advertising claim made the settlement amount larger than the medical malpractice suit alone.

Source: St. Louis Post-Dispatch

Categories : Mental Health New Compounds and TreatmentsTags :

Zuranolone, a New Drug for MDD Shown to Be Safe and Effective in Trials

On By ModernMedia

A recent trial showed that nightly 30mg doses of zuranolone, a new drug to treat major depressive disorder (MDD), are safe and only requires about two courses to achieve clinical improvement.

Zuranolone is one of a new class of neuroactive steroid drugs that positively modulates GABAA receptors. It has high bioavailability, can be taken orally and has a half-life suitable for daily administration. 

The SHORELINE Study is a Phase III, open-label, one year longitudinal study to evaluate the safety, tolerability, and need for repeat dosing with zuranolone in adults with MDD. Two cohorts with either zuranolone 30mg or 50mg as a starting dose taken once nightly for 14 days. Need for repeated dosing is assessed every 14 days based on a patient-reported assessment, with a maximum of five courses over a year.

Analysis of the data showed that the study’s primary endpoint of safety and tolerability show that zuranolone was generally well-tolerated in both dosage cohorts, with adverse events being generally consistent with those seen in previous zuranolone trials.

Secondary endpoints included response and remission as evaluated by the 17-item Hamilton Rating Scale for Depression (HAMD-17) and the number of times a patient received retreatment. A mean of 2.2 treatments resulted in patients with a clinical response (baseline HAMD-17 reduction of ≥50%) to the initial course of zuranolone 30mg. Additional data from patients in the 50 mg dose cohort is expected to be reported in late 2021.

“Sage embarked on the LANDSCAPE clinical program to evaluate the safety and efficacy of zuranolone with the ambition of reimagining the treatment for depression with the goal of a rapid-acting, durable, treat-as-needed option in a disease where innovation is lacking and the incidence rate has unfortunately increased exponentially in the last 20 years,” said Barry Greene, Chief Executive Officer at Sage Therapeutics. “Today we are announcing additional positive data from the SHORELINE Study that demonstrate continued strong results from the 30 mg dose and strengthens our confidence in the potential of the 50 mg dose. Designed as a naturalistic study, these data approximate real-world evidence of use of zuranolone at 30 mg and 50 mg doses. We look forward to the results of the WATERFALL and CORAL Phase 3 pivotal data readouts in MDD this year.”

Source: Sage Therapeutics

Categories : Implants and Prostheses PaediatricsTags :

Lab-made Heart Valves That Can Grow With The Recipient

On By ModernMedia

In a new study, lab-made heart valves were shown to grow along with their recipient when implanted into lambs for a year, making a new alternative possible for thousands of paediatric patients who need replacement heart valves. 

Researchers from the University of Minnesota Twin Cities’ College of Science and Engineering and the Medical School published the results in Science Translational Medicine. The production procedure for the valves has also been patented and licensed to the University of Minnesota startup company Vascudyne, Inc.

Compared to currently used animal-derived valves, these new valves also showed reduced calcification and improved blood flow when tested in the same growing lamb model. Current solutions for children involve prosthetic valves, but these calcify over time and cannot grow with the patient. This requires up to five open-heart surgeries to replace them as the children grow towards adulthood, involving considerable risk and expense, as well as demanding lifelong anticoagulation therapy.

“This is a huge step forward in paediatric heart research,” commented senior researcher Robert Tranquillo, a University of Minnesota professor in the Departments of Biomedical Engineering and the Department of Chemical Engineering and Materials Science. “This is the first demonstration that a valve implanted into a large animal model, in our case a lamb, can grow with the animal into adulthood. We have a way to go yet, but this puts us much farther down the path to future clinical trials in children. We are excited and optimistic about the possibility of this actually becoming a reality in years to come.”

Using a combination of tissue engineering and regenerative medicine, they were able to grow the heart valves. Implementing a tissue engineering technique they had previously developed, they grew tube-like structures out of skin cells. This involved combining the skin cells in fibrin, and providing nutrients in a bioreactor. After washing the skin cells out with detergent, the researchers were left with a collageneous matrix which would not provoke an immune response when implanted. They then sewed and trimmed three of these tubes together to make a 19mm diameter heart valve-like structure.

“After these initial steps, it looked like a heart valve, but the question then became if it could work like a heart valve and if it could grow,” Tranquillo said. “Our findings confirmed both.”

The valves grew from 19mm to 25mm over a year, and showed little of the calcification or clotting associated with prosthetic valves, while performing better than animal-derived valves.”We knew from previous studies that the engineered tubes have the capacity to regenerate and grow in a growing lamb model, but the biggest challenge was how to maintain leaflet function in a growing valved conduit that goes through 40 million cycles in a year,” said lead researcher Zeeshan Syedain, a University of Minnesota senior research associate in Tranquillo’s lab. “When we saw how well the valves functioned for an entire year from young lamb to adult sheep, it was very exciting.”

The next steps are to implant the valve into the right ventricle of the heart to see how it performs, and apply for FDA approval to proceed to human trials. 

Source: Medical Xpress

Journal information: Zeeshan H. Syedain et al, Pediatric tri-tube valved conduits made from fibroblast-produced extracellular matrix evaluated over 52 weeks in growing lambs, Science Translational Medicine (2021). DOI: 10.1126/scitranslmed.abb7225

Categories : COVID Lab Tests and ImagingTags :

New French COVID Variant Invisible to PCR Tests

On By ModernMedia

French authorities have announced the detection of a variant of SARS-CoV-2 in the northwestern region of Brittany that has escaped detection by standard polymerase chain reaction (PCR) tests.

Real-time PCR tests are considered to be the current gold standard for detection of SARS-CoV-2, and currently take 4-6h to yield a result. PCR tests make millions to billions of copies of a small sample of DNA to create a larger sample for analysis.

Eight carriers of the variant were identified using genomic sequencing among a cluster of 79 cases in the town of Lannion in the Côtes d’Armor on March 13th.

In a statement on Monday, the French health ministry said that according to initial analyses, the new variant did not appear more transmissible or cause more severe disease. However, on Tuesday, authorities said that this variant was able to escape detection in PCR tests is raising concern.

Belgian virologist and interfederal COVID spokesperson Steven Van Gucht clarified the situation, in that about eight individuals presented with standard coronavirus symptoms, “but the tests remained negative.”

The World Health Organization has labelled this new French COVID variant a ‘variant under investigation’ (VUI), of which there are many thousands currently being monitored, as opposed to more serious variants like the South African B.1.351 variant which is more transmissible and is a ‘variant of concern’ (VOC).

However, just because this variant escaped the PCR tests being used in that area does not mean that it necessarily can escape all of them, as laboratories vary in the tests that they perform.

According to Gucht, tests differ in the different parts of the virus they look for, and also test for at least two to three. “Usually, a good test does not depend on detecting one specific part. So, if there is a mutation in one part of the virus, that signal may be lost, but there is usually a second or third signal that will be found,” explained Gucht.

French authorities are setting up systems to monitor the spread of this variant, and are also putting measures in place to contain it.

Source: News-Medical.Net

Categories : COVIDTags :

AstraZenaca Ineffective Against SA Variant in Early Trial

On By ModernMedia

In a phase Ib/II trial, the AstraZeneca vaccine was ineffective against both the South African SARS-CoV-2 variant or the wild-type virus.

In this South African trial, the vaccine’s overall efficacy versus mild-to-moderate COVID was 21.9% and efficacy against the B.1.351 variant was 10.4%.

Participants’ median age was 30, about 56% were men, and 71% were black. Almost 20% of participants were obese, 42% were smokers, and about 3% of those had underlying hypertension or chronic respiratory conditions. All were HIV negative. The median time between doses was 28 days.

Overall, 19 of 750 in the vaccine group (2.5%) and 23 of 717 in the placebo group (3.2%) developed mild-to-moderate COVID. 

In regard to the secondary outcome of testing effectiveness against the B.1.351 variant, the authors note that “the trial was powered for the primary objective of a vaccine efficacy of at least 60% in preventing COVID-19 of any severity, regardless of variants.”

Exploratory analyses found about 33.5% efficacy against COVID of any severity more than 14 days after the first dose. No cases of severe COVID were reported among the participants, but with the groups’ demographics, especially their relatively young age, it was unlikely that severe COVID would be observed in such a small trial.

Professor Shabir Madhi, Executive Director of the Vaccines and Infectious Diseases Analytics Research Unit at Wits, said in a press release that the AstraZeneca results “threw a curveball” after the initial “euphoria” over the effectiveness of the first COVID vaccines. He nevertheless stressed that the AstraZeneca vaccine was still important in preventing hospitals being overrun with COVID patients.

Despite the disappointing results, Prof Madhi said these findings “need to be made in the context of ongoing global spread and community transmission of the B.1.351 variant”.

Source: MedPage Today

Journal information: Madhi SA, et al “Efficacy of the ChAdOx1 nCOV-19 Covid-19 vaccine against the B.1.351 variant” N Engl J Med 2021; DOI: 10.1056/NEJM2102214.