Discoveries and Innovations: 3D Printing Tumors for Treatment
Researchers have used brain cancer patients’ cells to replicate their tumors via 3D printing to test therapies before using them in the patients’ bodies. Scientists at Tel Aviv University began the project by extracting bits of a tumor from patients with an aggressive and usually fatal form of brain cancer known as glioblastoma. They used the cells to grow a 3D-printed model of each tumor to match their MRI scans. Then, to start testing treatments on the tumor models, they pumped the patients’ blood through their respective models followed by a drug. The tumor is made with a compound that mimics brain material along with the patient’s cells, creating the first viable tumor to be used to test treatments for specific patients.
“We have about two weeks [to] test all the different therapies that we would like to evaluate [on] that specific tumor, and get back with an answer—which treatment is predicted to be the best fit,” Professor Ronit Satchi-Fainaro, PhD, who led the research at Tel Aviv University, reported. The researchers watch the printed tumors to see which therapies they react best to, hoping to see the modeled tumors shrink or lower metabolic activity.
The research is a huge step in finding efficient treatment quickly for glioblastoma, the most common form of adult brain cancer that is difficult to treat due to the fact it spreads to other areas of the brain so quickly. While bioprinting has mimicked cancer environments for treatment testing before, using actual patient cells and blood in the modeling process is a huge step in personalizing medicine and therefore getting more accurate predictions for what will work.
Med Device Department: Novel Nerve Implant Approved for Stroke Rehab
MicroTransponder received FDA approval for a first-of-its-kind nerve stimulation implant. The Vivistim system is a device designed to help those with long-term effects of stroke recover control in their arms and hands. The device targets the body’s vagus nerves, which run down the sides of the neck and connect the brain to the heart, lungs, and diaphragm. The device is used during rehabilitation exercises, during which it sends electrical pulses to the brain that should retrain it to respond to motor signals. This can help the brain relearn the mechanics needed to move the upper limbs at will.
The Vivistim system has a pulse generator implanted beneath the skin with electrodes attached to the vagus nerve on the left of the neck. This requires no drugs. HCPs can prompt stimulation wirelessly during exercises and patients can use the device for a 30-minute exercise themselves at home.
“People who have lost mobility in their hands and arms due to ischemic stroke are often limited in their treatment options for regaining motor function,” Christopher Loftus, MD, Director of the FDA’s Office of Neurological and Physical Medicine Devices, said in an agency statement. “Today’s approval of the Vivistim Paired VNS System offers the first stroke rehabilitation option using vagus nerve stimulation.” So far, the device helped about half of the 108-person study group increase their movement progression significantly over a control group.
Trend Setting: Drones Deliver Defibrillators
Sweden is testing the feasibility of airborne drones dropping defibrillators at homes in need at a faster pace than ambulances can respond. Stockholm’s Karolinska University Hospital describes the experiment as the world’s first real-world feasibility study of drone-based defibrillator deliveries, during which first-responders found drones delivered the devices about two minutes quicker than an ambulance did. This is a crucial sliver of time for patients in cardiac arrest; every minute that passes without CPR or an electric shock from a defibrillator lowers the chances of survival. In fact, mortality rates for heart attacks that happen far from a hospital can reach 90%.
“Emergency medical service response times are getting longer and people rarely have an AED at home,” study author Sofia Schierbeck said in a statement. “We believe that novel ways to provide AEDs are needed to increase the chance of survival in these patients.” The experiment took place in Gothenburg, which has a population of about 580,000. When a 911 call was received for cardiac arrest, they sent a drone as well as an ambulance. The drones were capable of flying 5 kilometers, with automated flight programs overseen by trained drone pilots. When they arrived at the scene, they hovered at 100 feet and lowered an AED to the ground by a winch.
About two-thirds of the time, the drones arrived before the ambulance. However, as many as 39 heart attack cases were not included in the study because drones could not be launched due to factors such as rain and high winds as well as locations being in high-rise buildings or restricted airspace. Schierbeck is hopeful that by 2022 we will have drones able to fly in the dark and in moderate rains. She states, “drone delivery of AEDs could be common practice in the coming years. It could also be expanded to other medical scenarios in the very near future, such as delivery of epinephrine to patients with anaphylactic shock or delivery of glucose to diabetic patients with low blood sugar.”
Patient Pages: Teens Are Having a Hard Time Quitting Their Vapes
Half of teenagers who vape would like to quit but many aren’t successful, a new survey published in Pediatrics suggests. According to the study, 53.4% of current e-cigarette users reported intention to quit vaping and 67.4% reported having tried to quit vaping, of the 14,500 teens surveyed between 11 and 18 years old. Many teens are aware of the negative effects of vaping now and want to quit because of this, but withdrawal symptoms can make this difficult. In fact, the study finds that those who wanted to quit tried an average of five times over the past year.
Those students who used JUUL or other pod products reported fewer quit attempts than users of disposable e-cigarettes, the authors point out, which could be in part because of its discreet usage, many flavors, and extensive marketing. Addiction to vaping is stronger than that to cigarettes because the delivery of nicotine to the body is quicker via vaping products. In the case of JUUL products, they contain nicotine salt with a high nicotine concentration, which may increase both its appeal and potential for nicotine dependence. There are numerous programs to help teens quit, including Talk Vaping with Your Teen, an online resource developed by Hopelab, the American Heart Association, and All Mental Health.
Ascendis Pharma receives FDA approval for Skytrofa (lonapegsomatropin-tcgd), a human growth hormone treatment for children with growth hormone deficiency. The hGH therapy is designed for children over 1 year old with short stature due to inadequate secretion of endogenous growth hormone to take via under the skin injection on a weekly basis as opposed to the usual daily hGH therapies.
The FDA approved a new indication for Xywav to treat idiopathic hypersomnia (IH) in adults, an uncommon chronic sleep disorder that causes people to be excessively sleepy during the day even after a quality night’s sleep. The Jazz Pharmaceuticals’ drug was already approved for cataplexy, or excessive daytime sleepiness in patients with narcolepsy. Xywav is made with a controlled substance and comes with boxed warnings for central nervous system depression and abuse and misuse. Because of its serious side effects, it will only be deliverable by specialty pharmacies.
The FDA approved the first interchangeable biosimilar insulin product indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes and in adults with type 2 diabetes. Semglee (insulin glargine-yfgn), developed by Mylan Pharmaceuticals, is a biosimilar to Sanofi’s Lantus (insulin glargine), in terms of safety and effectiveness. Studies show no potential risks in switching from Lantus to Semglee (risks are the same as continuing to use Lantus).