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Study documents safety, improvements from stem cell therapy after spinal cord injury – Mayo Clinic

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Neurosciences

April 1, 2024

ROCHESTER, Minn. A Mayo Clinic study shows stem cells derived from patients' own fat are safe and may improve sensation and movement after traumatic spinal cord injuries. The findings from the phase 1 clinical trial appear in Nature Communications. The results of this early research offer insights on the potential of cell therapy for people living with spinal cord injuries and paralysis for whom options to improve function are extremely limited.

In the study of 10 adults, the research team noted seven participants demonstrated improvements based on the American Spinal Injury Association (ASIA) Impairment Scale. Improvements included increased sensation when tested with pinprick and light touch, increased strength in muscle motor groups, and recovery of voluntary anal contraction, which aids in bowel function. The scale has five levels, ranging from complete loss of function to normal function. The seven participants who improved each moved up at least one level on the ASIA scale. Three patients in the study had no response, meaning they did not improve but did not get worse.

"This study documents the safety and potential benefit of stem cells and regenerative medicine," says Mohamad Bydon, M.D., a Mayo Clinic neurosurgeon and first author of the study. "Spinal cord injury is a complex condition. Future research may show whether stem cells in combination with other therapies could be part of a new paradigm of treatment to improve outcomes for patients."

No serious adverse events were reported after stem cell treatment. The most commonly reported side effects were headache and musculoskeletal pain that resolved with over-the-counter treatment.

In addition to evaluating safety, this phase 1 clinical trial had a secondary outcome of assessing changes in motor and sensory function. The authors note that motor and sensory results are to be interpreted with caution given limits of phase 1 trials. Additional research is underway among a larger group of participants to further assess risks and benefits.

The full data on the 10 patients follows a 2019 case report that highlighted the experience of the first study participant who demonstrated significant improvement in motor and sensory function.

Watch: Dr. Mohamad Bydon discusses improvements in research study

Journalists: Broadcast-quality sound bites are available in the downloads at the end of the post. Please courtesy: "Mayo Clinic News Network." Name super/CG: Mohamad Bydon, M.D./Neurosurgery/Mayo Clinic.

In the multidisciplinary clinical trial, participants had spinal cord injuries from motor vehicle accidents, falls and other causes. Six had neck injuries; four had back injuries. Participants ranged in age from 18 to 65.

Participants' stem cells were collected by taking a small amount of fat from a 1- to 2-inch incision in the abdomen or thigh. Over four weeks, the cells were expanded in the laboratory to 100 million cells and then injected into the patients' lumbar spine in the lower back. Over two years, each study participant was evaluated at Mayo Clinic 10 times.

Although it is understood that stem cells move toward areas of inflammation in this case the location of the spinal cord injury the cells' mechanism of interacting with the spinal cord is not fully understood, Dr. Bydon says. As part of the study, researchers analyzed changes in participants' MRIs and cerebrospinal fluid as well as in responses to pain, pressure and other sensation. The investigators are looking for clues to identify injury processes at a cellular level and avenues for potential regeneration and healing.

The spinal cord has limited ability to repair its cells or make new ones. Patients typically experience most of their recovery in the first six to 12 months after injuries occur. Improvement generally stops 12 to 24 months after injury. In the study, one patient with a cervical spine injury of the neck received stem cells 22 months after injury and improved one level on the ASIA scale after treatment.

Two of three patients with complete injuries of the thoracic spine meaning they had no feeling or movement below their injury between the base of the neck and mid-back moved up two ASIA levels after treatment. Each regained some sensation and some control of movement below the level of injury. Based on researchers' understanding of traumatic thoracic spinal cord injury, only 5% of people with a complete injury would be expected to regain any feeling or movement.

"In spinal cord injury, even a mild improvement can make a significant difference in that patient's quality of life," Dr. Bydon says.

Stem cells are used mainly in research in the U.S., and fat-derived stem cell treatment for spinal cord injury is considered experimental by the Food and Drug Administration.

Between 250,000 and 500,000 people worldwide suffer a spinal cord injury each year, according to theWorld Health Organization.

An important next step is assessing the effectiveness of stem cell therapies and subsets of patients who would most benefit, Dr. Bydon says. Research is continuing with a larger, controlled trial that randomly assigns patients to receive either the stem cell treatment or a placebo without stem cells.

"For years, treatment of spinal cord injury has been limited to supportive care, more specifically stabilization surgery and physical therapy," Dr. Bydon says. "Many historical textbooks state that this condition does not improve. In recent years, we have seen findings from the medical and scientific community that challenge prior assumptions. This research is a step forward toward the ultimate goal of improving treatments for patients."

Dr. Bydon is the Charles B. and Ann L. Johnson Professor of Neurosurgery. This research was made possible with support from Leonard A. Lauder, C and A Johnson Family Foundation, The Park Foundation, Sanger Family Foundation, Eileen R.B. and Steve D. Scheel, Schultz Family Foundation, and other generous Mayo Clinic benefactors. The research is funded in part by a Mayo Clinic Transform the Practice grant.

Review thestudyfor a complete list of authors and funding.

###

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Study documents safety, improvements from stem cell therapy after spinal cord injury - Mayo Clinic

Stem Cells Spark Hope in Spinal Cord Recovery – Neuroscience News

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Summary: A phase 1 clinical trial has revealed that stem cells derived from patients own fat may safely enhance sensation and movement in individuals with traumatic spinal cord injuries. In the study, seven out of ten adults showed measurable improvements on the ASIA Impairment Scale, experiencing increased sensation, muscle strength, and improved bowel function without serious side effects.

The findings challenge the longstanding belief that spinal cord injuries are irreparable, offering new hope for treatments. With the spinal cords limited repair capability, this research signifies a crucial step towards innovative therapies, emphasizing the need for further studies to unlock the full potential of stem cell treatments.

Key Facts:

Source: Mayo Clinic

AMayo Clinicstudy shows stem cells derived from patients own fat are safe and may improve sensation and movement after traumaticspinal cord injuries.

The findings from the phase 1 clinical trial appear inNature Communications.

The results of this early research offer insights on the potential of cell therapy for people living with spinal cord injuries and paralysis for whom options to improve function are extremely limited.

In the study of 10 adults, the research team noted seven participants demonstrated improvements based on the American Spinal Injury Association (ASIA) Impairment Scale. Improvements included increased sensation when tested with pinprick and light touch, increased strength in muscle motor groups, and recovery of voluntary anal contraction, which aids in bowel function.

The scale has five levels, ranging from complete loss of function to normal function. The seven participants who improved each moved up at least one level on the ASIA scale. Three patients in the study had no response, meaning they did not improve but did not get worse.

This study documents the safety and potential benefit of stem cells and regenerative medicine, saysMohamad Bydon, M.D., a Mayo Clinic neurosurgeon and first author of the study.

Spinal cord injury is a complex condition. Future research may show whether stem cells in combination with other therapies could be part of a new paradigm of treatment to improve outcomes for patients.

No serious adverse events were reported after stem cell treatment. The most commonly reported side effects were headache and musculoskeletal pain that resolved with over-the-counter treatment.

In addition to evaluating safety, this phase 1 clinical trial had a secondary outcome of assessing changes in motor and sensory function. The authors note that motor and sensory results are to be interpreted with caution given limits of phase 1 trials. Additional research is underway among a larger group of participants to further assess risks and benefits.

The full data on the 10 patients follows a 2019case reportthat highlighted the experience of the first study participant who demonstrated significant improvement in motor and sensory function.

Stem cells mechanism of action not fully understood

In the multidisciplinary clinical trial, participants had spinal cord injuries from motor vehicle accidents, falls and other causes. Six had neck injuries; four had back injuries. Participants ranged in age from 18 to 65.

Participants stem cells were collected by taking a small amount of fat from a 1- to 2-inch incision in the abdomen or thigh. Over four weeks, the cells were expanded in the laboratory to 100 million cells and then injected into the patients lumbar spine in the lower back. Over two years, each study participant was evaluated at Mayo Clinic 10 times.

Although it is understood that stem cells move toward areas of inflammation in this case the location of the spinal cord injury the cells mechanism of interacting with the spinal cord is not fully understood, Dr. Bydon says.

As part of the study, researchers analyzed changes in participants MRIs and cerebrospinal fluid as well as in responses to pain, pressure and other sensation. The investigators are looking for clues to identify injury processes at a cellular level and avenues for potential regeneration and healing.

The spinal cord has limited ability to repair its cells or make new ones. Patients typically experience most of their recovery in the first six to 12 months after injuries occur. Improvement generally stops 12 to 24 months after injury.

One unexpected outcome of the trial was that two patients with cervical spine injuries of the neck received stem cells 22 months after their injuries and improved one level on the ASIA scale after treatment.

Two of three patients with complete injuries of the thoracic spine meaning they had no feeling or movement below their injury between the base of the neck and mid-back moved up two ASIA levels after treatment.

Each regained some sensation and some control of movement below the level of injury. Based on researchers understanding of traumatic thoracic spinal cord injury, only 5% of people with a complete injury would be expected to regain any feeling or movement.

In spinal cord injury, even a mild improvement can make a significant difference in that patients quality of life, Dr. Bydon says.

Stem cells are used mainly in research in the U.S., and fat-derived stem cell treatment for spinal cord injury is considered experimental by the Food and Drug Administration.

Between 250,000 and 500,000 people worldwide suffer a spinal cord injury each year, according to theWorld Health Organization.

An important next step is assessing the effectiveness of stem cell therapies and subsets of patients who would most benefit, Dr. Bydon says. Research is continuing with a larger, controlled trial that randomly assigns patients to receive either the stem cell treatment or a placebo without stem cells.

For years, treatment of spinal cord injury has been limited to supportive care, more specifically stabilization surgery and physical therapy, Dr. Bydon says.

Many historical textbooks state that this condition does not improve. In recent years, we have seen findings from the medical and scientific community that challenge prior assumptions. This research is a step forward toward the ultimate goal of improving treatments for patients.

Dr. Bydon is the Charles B. and Ann L. Johnson Professor of Neurosurgery. This research was made possible with support from Leonard A. Lauder, C and A Johnson Family Foundation, The Park Foundation, Sanger Family Foundation, Eileen R.B. and Steve D. Scheel, Schultz Family Foundation, and other generous Mayo Clinic benefactors. The research is funded in part by a Mayo Clinic Transform the Practice grant.

Review thestudyfor a complete list of authors and funding.

Author: Megan Luihn Source: Mayo Clinic Contact: Megan Luihn Mayo Clinic Image: The image is credited to Neuroscience News

Original Research: Open access. Intrathecal delivery of adipose-derived mesenchymal stem cells in traumatic spinal cord injury: Phase I trial byMohamad Bydon et al. Nature Communications

Abstract

Intrathecal delivery of adipose-derived mesenchymal stem cells in traumatic spinal cord injury: Phase I trial

Intrathecal delivery of autologous culture-expanded adipose tissue-derived mesenchymal stem cells (AD-MSC) could be utilized to treat traumatic spinal cord injury (SCI).

This Phase I trial (ClinicalTrials.gov: NCT03308565) included 10 patients with American Spinal Injury Association Impairment Scale (AIS) grade A or B at the time of injury.

The studys primary outcome was the safety profile, as captured by the nature and frequency of adverse events.

Secondary outcomes included changes in sensory and motor scores, imaging, cerebrospinal fluid markers, and somatosensory evoked potentials. The manufacturing and delivery of the regimen were successful for all patients.

The most commonly reported adverse events were headache and musculoskeletal pain, observed in 8 patients. No serious AEs were observed. At final follow-up, seven patients demonstrated improvement in AIS grade from the time of injection.

In conclusion, the study met the primary endpoint, demonstrating that AD-MSC harvesting and administration were well-tolerated in patients with traumatic SCI.

Excerpt from:

Stem Cells Spark Hope in Spinal Cord Recovery - Neuroscience News

The evolution of robotics: research and application progress of dental implant robotic systems | International Journal of … – Nature.com

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Implantology is widely considered the preferred treatment for patients with partial or complete edentulous arches.34,35 The success of the surgery in achieving good esthetic and functional outcomes is directly related to correct and prosthetically-driven implant placement.36 Accurate implant placement is crucial to avoid potential complications such as excessive lateral forces, prosthetic misalignment, food impaction, secondary bone resorption, and peri-implantitis.37 Any deviation during the implant placement can result in damage to the surrounding blood vessels, nerves, and adjacent tooth roots and even cause sinus perforation.38 Therefore, preoperative planning must be implemented intraoperatively with utmost precision to ensure quality and minimize intraoperative and postoperative side effects.39

Currently, implant treatment approaches are as follows: Free-handed implant placement, Static computer-aided implant placement, and dynamic computer-aided implant placement. The widely used free-handed implant placement provides less predictable accuracy and depends on the surgeons experience and expertise.40 Deviation in implant placement is relatively large among surgeons with different levels of experience. When novice surgeons face complex cases, achieving satisfactory results can be challenging. A systematic review41 based on six clinical studies indicated that the ranges of deviation of the platform, apex, and angle from the planned position with free-handed implant placement were (1.250.62)mm(2.771.54)mm, (2.101.00)mm(2.911.52)mm, and 6.904.409.926.01, respectively. Static guides could only provide accurate guidance for the initial implantation position. However, it is difficult to precisely control the depth and angle of osteotomies.42 The lack of real-time feedback on drill positioning during surgery can limit the clinicians ability to obtain necessary information.42,43,44 Besides, surgical guides may also inhibit the cooling of the drills used for implant bed preparation, which may result in necrosis of the overheated bone. Moreover, the use of static guides is limited in patients with limited accessibility, especially for those with implants placed in the posterior area. Additionally, the use of guides cannot flexibly adjust the implant plan intraoperatively. With dynamic computer-aided implant placement, the positions of the patient and drills could be tracked in real-time and displayed on a computer screen along with the surgical plan, thus allowing the surgeon to adjust the drilling path if necessary. However, the surgeons may deviate from the plan or prepare beyond it without physical constraints. During surgery, the surgeon may focus more on the screen for visual information rather than the surgical site, which can lead to reduced tactile feedback.45 The results of a meta-analysis showed that the platform deviation, apex deviation, and angular deviation were 0.91mm (95% CI 0.791.03mm), 1.26mm (95% CI 1.141.38mm), and 3.25 (95% CI 2.843.66) respectively with the static computer-aided implant placement, and 1.28mm (95% CI 0.871.69mm), 1.68mm (95% CI 1.451.90mm), and 3.79 (95% CI 1.875.70), respectively, with dynamic computer-aided implant placement. The analysis results showed that both methods improved the accuracy compared to free-handed implant placement, but they still did not achieve ideal accuracy.46 Gwangho et al.47 believe that the key point of a surgical operation is still manually completed by surgeons, regardless of static guide or dynamic navigation, and the human factors (such as hand tremble, fatigue, and unskilled operation techniques) also affect the accuracy of implant placement.

Robotic-assisted implant surgery could provide accurate implant placement and help the surgeon control handpieces to avoid dangerous tool excursions during surgery.48 Furthermore, compared to manual calibration, registration, and surgery execution, automatic calibration, registration, and drilling using the dental implant robotic system reduces human error factors. This, in turn, helps avoid deviations caused by surgeons factors, thereby enhancing surgical accuracy, safety, success rates, and efficiency while also reducing patient trauma.7 With the continuous improvement of technology and reduction of costs, implant robotics are gradually becoming available for commercial use. Yomi (Neocis Inc., USA) has been approved by the Food and Drug Administration, while Yakebot (Yakebot Technology Co., Ltd., Beijing, China), Remebot (Baihui Weikang Technology Co., Ltd, Beijing, China), Cobot (Langyue dental surgery robot, Shecheng Co. Ltd., Shanghai, China), Theta (Hangzhou Jianjia robot Co., Ltd., Hangzhou, China), and Dcarer (Dcarer Medical Technology Co., Ltd, Suzhou, China) have been approved by the NMPA. Dencore (Lancet Robotics Co., Ltd., Hangzhou, China) is in the clinical trial stage in China.

Compared to other surgeries performed with general anesthesia, dental implant surgery can be completed under local anesthesia, with patients awake but unable to remain completely still throughout the entire procedure. Therefore, research related to dental implant robotic system, as one of the cutting-edge technologies, mainly focuses on acquiring intraoperative feedback information (including tactile and visual information), different surgical methods (automatic drilling and manual drilling), patient position following, and the simulation of surgeons tactile sensation.

The architecture of dental implant robotics primarily comprises the hardware utilized for surgical data acquisition and surgical execution (Fig. 4). Data acquisition involves perceiving, identifying, and understanding the surroundings and the information required for task execution through the encoders, tactile sensors, force sensors, and vision systems. Real-time information obtained also includes the robots surrounding environment, object positions, shapes, sizes, surface features, and other relevant information. The perception system assists the robot in comprehending its working environment and facilitates corresponding decision-making as well as actions.

The architecture of dental implant robotics

During the initial stage of research on implant robotics, owing to the lack of sensory systems, fiducial markers and corresponding algorithms were used to calculate the transformation relationship between the robots and the models coordinate system. The robot was able to determine the actual position through coordinate conversions. Dutreuil et al.49 proposed a new method for creating static guides on casts using robots based on the determined implant position. Subsequently, Boesecke et al.50 developed a surgical planning method using linear interpolation between start and end points, as well as intermediate points. The surgeon performed the osteotomies by holding the handpieces, with the robot guidance based on preoperatively determined implant position. Sun et al.51 and McKenzie et al.52 registered cone-beam computed tomography (CBCT) images, the robots coordinate system, and the patients position using a coordinate measuring machine, which facilitated the transformation of preoperative implant planning into intraoperative actions.

Neocis has developed a dental implant robot system called Yomi (Neocis Inc.)53 based on haptic perception and connects a mechanical joint measurement arm to the patients teeth to track their position. The joint encoder provides information on the drill position, while the haptic feedback of handpieces maneuvered by the surgeon constrains the direction and depth of implant placement.

Optical positioning is a commonly used localization method that offers high precision, a wide -field -of -view, and resistance to interference.54 This makes it capable of providing accurate surgical guidance for robotics. Yu et al.55 combined image-guided technology with robotic systems. They used a binocular camera to capture two images of the same target, extract pixel positions, and employ triangulation to obtain three-dimensional coordinates. This enabled perception of the relative positional relationship between the end-effector and the surrounding environment. Yeotikar et al.56 suggested mounting a camera on the end-effector of the robotic arm, positioned as close to the drill as possible. By aligning the cameras center with the drills line of sight at a specific height on the lower jaw surface, the cameras center accurately aligns with the drills position in a two-dimensional space at a fixed height from the lower jaw. This alignment guides the robotic arm in drilling through specific anatomical landmarks in the oral cavity. Yan et al.57 proposed that the use of eye-in-hand optical navigation systems during surgery may introduce errors when changing the handpiece at the end of the robotic arm. Additionally, owing to the narrow oral environment, customized markers may fall outside the cameras field of view when the robotic arm moves to certain positions.42 To tackle this problem, a dental implant robot system based on optical marker spatial registration and probe positioning strategies is designed. Zhao et al constructed a modular implant robotic system based on binocular visual navigation devices operating on the principles of visible light with eye-to-hand mode, allowing complete observation of markers and handpieces within the cameras field of view, thereby ensuring greater flexibility and stability.38,58

The dental implant robotics execution system comprises hardware such as motors, force sensors, actuators, controllers, and software components to perform tasks and actions during implant surgery. The system receives commands, controls the robots movements and behaviors, and executes the necessary tasks and actions. Presently, research on dental implant robotic systems primarily focuses on the mechanical arm structure and drilling methods.

The majority of dental implant robotic systems directly adopt serial-linked industrial robotic arms based on the successful application of industrial robots with the same robotic arm connection.59,60,61,62 These studies not only establish implant robot platforms to validate implant accuracy and assess the influence of implant angles, depths, and diameters on initial stability but also simulate chewing processes and prepare natural root-shaped osteotomies based on volume decomposition. Presently, most dental implant robots in research employ a single robotic arm for surgery. Lai et al.62 indicated that the stability of the handpieces during surgery and real-time feedback of patient movement are crucial factors affecting the accuracy of robot-assisted implant surgery. The former requires physical feedback, while the latter necessitates visual feedback. Hence, they employed a dual-arm robotic system where the main robotic arm was equipped with multi-axis force and torque sensors for performing osteotomies and implant placement. The auxiliary arm consisted of an infrared monocular probe used for visual system positioning to address visual occlusion issues arising from changes in arm angles during surgery.

The robots mentioned above use handpieces to execute osteotomies and implant placement. However, owing to limitations in patient mouth opening, performing osteotomies and placing implants in the posterior region can be challenging. To overcome the spatial constraints during osteotomies in implant surgery, Yuan et al.63 proposed a robot system based on earlier research which is laser-assisted tooth preparation. This system involves a non-contact ultra-short pulse laser for preparing osteotomies. The preliminary findings confirmed the feasibility of robotically controlling ultra-short pulse lasers for osteotomies, introducing a novel method for a non-contact dental implant robotic system.

It can be challenging for patients under local anesthesia to remain completely still during robot-assisted dental implant surgery.52,64,65,66,67 Any significant micromovement in the patients position can severely affect clinical surgical outcomes, such as surgical efficiency, implant placement accuracy compared to the planned position, and patient safety. Intraoperative movement may necessitate re-registration for certain dental implant robotic systems. In order to guarantee safety and accuracy during surgery, the robot must detect any movement in the patients position and promptly adjust the position of the robotic arm in real time. Yakebot uses binocular vision to monitor visual markers placed outside the patients mouth and at the end of the robotic arm. This captures motion information and calculates relative position errors. The robot control system utilizes preoperatively planned positions, visual and force feedback, and robot kinematic models to calculate optimal control commands for guiding the robotic arms micromovements and tracking the patients micromovements during drilling. As the osteotomies are performed to the planned depth, the robotic arm compensates for the patients displacement through the position following the function. The Yakebots visual system continuously monitors the patients head movement in real time and issues control commands every 0.008s. The robotic arm is capable of following the patients movements with a motion servo in just 0.2s, ensuring precise and timely positioning.

Robot-assisted dental implant surgery requires the expertise and tactile sense of a surgeon to ensure accurate implantation. Experienced surgeons can perceive bone density through the resistance they feel in their hands and adjust the force magnitude or direction accordingly. This ensures proper drilling along the planned path. However, robotic systems lack perception and control, which may result in a preference for the bone side with lower density. This can lead to inaccurate positioning compared to the planned implant position.61,62 Addressing this challenge, Li et al.68 established force-deformation compensation curves in the X, Y, and Z directions for the robots end-effector based on the visual and force servo systems of the autonomous dental robotic system, Yakebot. Subsequently, a corresponding force-deformation compensation strategy was formulated for this robot, thus proving the effectiveness and accuracy of force and visual servo control through in vitro experiments. The implementation of this mixed control mode, which integrates visual and force servo systems, has improved the robots accuracy in implantation and ability to handle complex bone structures. Based on force and visual servo control systems, Chen et al.69 have also explored the relationship between force sensing and the primary stability of implants placed using the Yakebot autonomous dental robotic system through an in vitro study. A significant correlation was found between Yakebots force sensing and the insertion torque of the implants. This correlation conforms to an interpretable mathematical model, which facilitates the predictable initial stability of the implants after placement.

During osteotomies with heat production (which is considered one of the leading causes of bone tissue injury), experienced surgeons could sense possible thermal exposure via their hand feeling. However, with free-handed implant placement surgery, it is challenging to perceive temperature changes during the surgical process and establish an effective temperature prediction model that relies solely on a surgeons tactile sense. Zhao et al.70, using the Yakebot robotic system, investigated the correlation between drilling-related mechanical data and heat production and established a clinically relevant surrogate for intraosseous temperature measurement using force/torque sensor-captured signals. They also established a real-time temperature prediction model based on real-time force sensor monitoring values. This model aims to effectively prevent the adverse effects of high temperatures on osseointegration, laying the foundation for the dental implant robotic system to autonomously control heat production and prevent bone damage during autonomous robotic implant surgery.

The innovative technologies mentioned above allow dental implant robotic systems to simulate the tactile sensation of a surgeon and even surpass the limitations of human experience. This advancement promises to address issues that free-handed implant placement techniques struggle to resolve. Moreover, this development indicates substantial progress and great potential for implantation.

The robotic assistant dental implant surgery consists of three steps: preoperative planning, intraoperative phase, and postoperative phase (Fig. 5). For preoperative planning, it is necessary to obtain digital intraoral casts and CBCT data from the patient, which are then imported into preoperative planning software for 3D reconstruction and planning implant placement. For single or multiple tooth gaps using implant robotic systems (except Yakebot),61,62,71,72 a universal registration device (such as the U-shaped tube) must be worn on the patients missing tooth site using a silicone impression material preoperatively to acquire CBCT data for registration. The software performs virtual placement of implant positions based on prosthetic and biological principles of implant surgery, taking into account the bone quality of the edentulous implant site to determine the drilling sequence, insertion depth of each drill, speed, and feed rate. For single or multiple tooth implants performed using Yakebot, there is no need for preoperative CBCT imaging with markers. However, it is necessary to design surgical accessories with registration holes, brackets for attaching visual markers, and devices for assisting mouth opening and suction within the software (Yakebot Technology Co., Ltd., Beijing, China). These accessories are manufactured using 3D printing technology.

Clinical workflow of robotic-assisted dental implant placement

For the intraoperative phase, the first step is preoperative registration and calibration. For Yakebot, the end-effector marker is mounted to the robotic arm, and the spatial positions are recorded under the optical tracker. The calibration plate with the positioning points is then assembled into the implant handpiece for drill tip calibration. Then, the registration probe is inserted in the registration holes of the jaw positioning plate in turn for spatial registration of the jaw marker and the jaw. Robot-assisted dental implant surgery usually does not require flapped surgery,73,74, yet bone grafting due to insufficient bone volume in a single edentulous space or cases of complete edentulism requiring alveolar ridge preparation may require elevation of flaps. For full-arch robot-assisted implant surgery, a personalized template with a positioning marker is required and should be fixed with metallic pins for undergoing an intraoperative CBCT examination, thus facilitating the robot and the jaws registration in the visual space and allowing the surgical robot to track the patients motion. The safe deployment of a robot from the surgical site is an essential principle for robot-assisted implant surgery. In the case of most robots, such as Yomi, the surgeon needs to hold the handpieces to control and supervise the robots movement in real time and stop the robotic arms movement in case of any accidents. With Yakebot, the entire surgery is performed under the surgeons supervision, and immediate instructions are sent in response to possible emergencies via a foot pedal. Additionally, the recording of the entrance and exit of the patients mouth ensures that the instruments would not damage the patients surrounding tissues. The postoperative phase aims at postoperative CBCT acquisition and accuracy measurement.

In clinical surgical practice, robots with varying levels of autonomy perform implant surgeries differently. According to the autonomy levels classified by Yang et al.6,8,33 for medical robots, commercial dental implant robotic systems (Table 2) currently operate at the level of robot assistance or task autonomy.

The robot-assistance dental implant robotic systems provide haptic,75 visual or combined visual and tactile guidance during dental implant surgery.46,76,77 Throughout the procedure, surgeons must maneuver handpieces attached to the robotic guidance arm and apply light force to prepare osteotomies.62 The robotic arm constrains the 3D space of the drill as defined by the virtual plan, enabling surgeons to move the end of the mechanical arm horizontally or adjust its movement speed. However, during immediate implant placement or full-arch implant surgery, both surgeons and robots may struggle to accurately perceive poor bone quality, which should prompt adjustments at the time of implant placement. This can lead to incorrect final implant positions compared to the planned locations.

The task-autonomous dental implant robotic systems can autonomously perform partial surgical procedures, such as adjusting the position of the handpiece to the planned position and preparing the implant bed at a predetermined speed according to the pre-operative implant plan, and surgeons should send instructions, monitor the robots operation, and perform partial interventions as needed. For example, the Remebot77,78 requires surgeons to drag the robotic arm into and out of the mouth during surgery, and the robot automatically performs osteotomies or places implants according to planned positions under the surgeons surveillance. The autonomous dental implant robot system, Yakebot,73,79,80 can accurately reach the implant site and complete operations such as implant bed preparation and placement during surgery. It can be controlled by the surgeon using foot pedals and automatically stops drilling after reaching the termination position before returning to the initial position. Throughout the entire process, surgeons only need to send commands to the robot using foot pedals.

Figure 6 shows the results of accuracy in vitro, in vivo, and clinical studies on robot-assisted implant surgery.20,46,48,55,62,64,67,68,69,70,71,72,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89 The results suggest that platform and apex deviation values are consistent across different studies. However, there are significant variations in angular deviations among different studies, which may be attributed to differences in the perception and responsiveness to bone quality variances among different robotic systems. Therefore, future development should focus on enhancing the autonomy of implant robots and improving their ability to recognize and respond to complex bone structures.

Accuracy reported in studies on robotic-assisted implant placement

Xu et al.77 conducted a phantom experimental study comparing the implant placement accuracy in three levels of dental implant robotics, namely passive robot (Dcarer, level 1), semi-active robot (Remebot, level 2), and active robot (Yakebot, level 2) (Fig. 7). The study found that active robot had the lowest deviations at the platform and apex of the planned and actual implant positions, While the semi-active robot also had the lowest angular deviations. Chen et al.46 and Jia et al.79 conducted clinical trials of robotic implant surgery in partially edentulous patients using a semi-active dental implant robotic system (level 1) and an autonomous dental implant robot (level 2). The deviations of the implant platform, apex, and angle were (0.530.23)mm/(0.430.18)mm, (0.530.24)mm/(0.560.18)mm and 2.811.13/1.480.59, respectively. These results consistently confirmed that robotic systems can achieve higher implant accuracy than static guidance and that there is no significant correlation between accuracy and implant site (such as anterior or posterior site). The platform and angle deviation of autonomous dental implant robots were smaller than those of semi-active dental implant robotic systems. Li et al.73 reported the use of the autonomous dental implant robot (level 2) to complete the placement of two adjacent implants with immediate postoperative restoration. The interim prosthesis fabricated prior to implant placement was seated without any adjustment, and no adverse reactions occurred during the operation.

Comparison of accuracy of dental implant robotics with different levels of autonomy (phantom experiments) (*P<0.05, **P<0.01, ***P<0.001)

Bolding et al.,53 Li et al.,20 Jia et al.,79 and Xie et al.90 used dental implant robots to conduct clinical trials in full-arch implant surgery with five or six implants placed in each jaw. The deviations of implant platform, apex, and angle are shown in Fig. 8. The haptic dental implant robot (level 1) used by Bolding et al.,53 achieved more deviations compared to other studies that used semi-active (level 1) or active robots (level 2). As its handpiece must be maneuvered by the surgeon, human errors such as surgeon fatigue may not be avoided. Owing to the parallel common implant placement paths between various implant abutments, prefabricated temporary dentures could be seated smoothly, and some patients wore temporary complete dentures immediately after surgery. These results indicate that robotic systems can accurately locate and perform implant placement during surgery.

Comparison of accuracy in robotic-assisted full-arch implant placement

As there are relatively few studies of implant robots in clinical applications, Tak acs et al.91 conducted a meta-analysis under in vitro conditions with free-handed, static-guided, dynamic navigated, and robotic-assisted implant placements, as shown in Fig. 9. It was found that, compared to free-handed, static guided and dynamic navigated implant placements, robotic-assisted implant placements have more advantages in terms of accuracy. However, in vitro studies cannot fully simulate the patients oral condition and bone quality. Recent clinical studies89,92,93 have shown a lower deviation in robotic-assisted implant placements compared to static-guided and dynamic-navigated implant placements. Common reasons for deviations in static-guided and dynamic-navigated implant placements include the following: deflection caused by hand tremors due to dense bone during surgery, surgeons experience, and other human factors. Larger clinical studies will be needed in the future to evaluate the differences between robotic and conventional surgical approaches and to provide guidance for the further development and refinement of robotic techniques.

Comparison of accuracy of free-handed, static, dynamic, and robotic-assisted implant placement. (FHIP free-hand implant placement, SCAIP static computer-aided implant placement, DCAIP dynamic computer-aided implant placement, RAIP robot-assisted implant placement)

For the long-term follow-up performance of robotic systems used in dental implant procedures, none of the comparative studies was longer than a year. One 1-year prospective clinical study by Xie et al.90 showed that the peri-implant tissues after robot-assisted full arch surgery at 1-year visit remained stable. There is little evidence indicating clinical outcomes especially for patient-reported outcomes. A more detailed clinical assessment should be included for further research.

Although robotic-assisted dental implant surgery can improve accuracy and treatment quality,94 it involves complex registration, calibration, and verification procedures that prolong the duration of surgery. These tedious processes may introduce new errors,61 and lower work efficiency, especially in single tooth implant placement62 that could extend visit times and affect patient satisfaction.62 Besides, surgeons are required to undergo additional training to familiarize themselves with the robotic system.87

During implantation, the drill tips at the end of the robotic arms cannot be tilted, and this can increase the difficulty of using robots in posterior sections with limited occlusal space.61,62 In addition, currently available marker systems require patients to wear additional devices to hold the marker in place. If these markers are contaminated or obstructed by blood, the visual system may not be able to detect them, limiting surgical maneuverability to some extent. During immediate implant placement or in cases of poor bone quality in the implant site, the drill tips may deviate towards the tooth sockets or areas of lower bone density, seriously affecting surgical precision.

Currently, only one study has developed a corresponding force-deformation compensation strategy for robots,68 but clinical validation is still lacking. Additionally, the dental implant robotic system, along with other dental implant robots developed for prosthetics, endodontics, and orthodontics, is currently single-functional. Multi-functional robots are required for performing various dental treatments.

Despite the enormous potential of robotic systems in the medical field, similar to the development of computer-aided design/computer-aided manufacturing technology, introducing and applying this technology faces multiple challenges in the initial stages. The high cost of robotic equipment may limit its promotion and application in certain regions or medical institutions. Surgeons require specialized technical training before operating robotic systems, which translates to additional training costs and time investment.95

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Wegovy Approved to Cut Heart Disease and Stroke Risk – Futurism

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The maker of Ozempic and Wegovy has been granted government approval to sell its wares to help cut the risk of heart attack, heart disease, and stroke a move that could help expand insurance coverage to the highly sought-after drugs.

In a press release, the Food and Drug Administration announced that Novo Nordisk, the Danish company behind the outrageously popular weight loss injectables, has been granted the first-ever stamp of approval for heart health specifically geared towards people who are overweight or obese.

"Wegovy is now the first weight loss medication to also be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight," John Sharretts, the FDA's diabetes and obesity czar, said in the press release. "This patient population has a higher risk of cardiovascular death, heart attack and stroke. Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health."

Last August, Novo announced that semaglutide, the active ingredient in both Wegovy and Ozempic, had showed significant heart health benefits in a large-scale human trial. Specifically, the 2.4 milligram dosage, which is what's used in Wegovy as compared to the 1 mg version used for Ozempic, showed a link with lowered heart disease risk.

This beneficial usage of the drug, which belongs to a class of medicine known as GLP-1 agonists that mimics the feeling of fullness in the stomach, is just the latest in a growing list of positive semaglutide side effects a list that is, unfortunately, tempered with a rap sheet of mild-to-severe issuesit's been linked with.

Due to semaglutide's incredible boom in popularity in the nearly three years since the FDA approved the higher-dose Wegovy injectable as a weight loss treatment, it's been flying off the shelves even as insurers demonstrate a reticence to shell out for it, leading some folks to either go without or seek unregulated and often dangerous grey-market alternatives.

In an interview withNPR, cardiologist Martha Gulati of Los Angeles' Cedars-Sinai Medical Center estimated that up to 70 percent of her patients could be eligible for the medication which as of nowis still not covered by many insurance companies.

"The hope," Gulati said, "is that insurers will start understanding that this is not a vanity drug."

More on semaglutide benefits: Semaglutide Can Cut Diabetic Kidney Disease Progression

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Diet Sodas Linked to Heart Issues – Futurism

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Image by Justin Sullivan via Getty / Futurism

Bad news for diet soda lovers: artificially-sweetened soft drinks may come with a heart-shaped price tag.

Published in the American Heart Association's journal Circulation:Arrhythmia and Electrophysiology, the new research out of a Shanghai teaching hospital suggests that there may be a link between regularly drinking significant amounts of diet soda and dangerously irregular heartbeats.

As the Mayo Clinic explains, atrial fibrillation, the medical term for irregular heartbeats, is associated with a group of symptoms that also include heart palpitations, fatigue, dizziness, and shortness of breath.

Looking at a database cohort of more than 200,000 patients, the team comprised primarily of endocrinology researchers at the Shanghai Ninth People's Hospital found that over a period of nearly 10 years, those who drank more than 2 liters of sodas with nonsugar sweeteners were significantly more likely to develop a-fib compared to those who drank fruit juice or regular soda.

Specifically, the study indicates that people who drank more than two liters of diet beverages per week were 20 percent more likely to develop a-fib than those who don't drink any though the researchers struggled to explain exactly why it might cause the scary heart-related symptoms.

If you're thinking of switching back to regular soda, that's not a perfect solution either.The Shanghai researchers also found that drinking more than two liters per week of conventionally sweetened cola saw a 10 percent increase in a-fib symptoms.

When looking at the portion of the cohort that drank only pure, unsweetened fruit or vegetable juice, the researchers found something even more fascinating: they appeared to have an eight percent lower risk of developing irregular heartbeats than their soda-drinking counterparts.

While there's been lots of research looking into other negative health effects associated with diet sodas, Penn State nutritionist Penny Kris-Etherton pointed out in an interview withCNNthat this appears to be the first looking at its association with a-fib.

"We still need more research on these beverages to confirm these findings and to fully understand all the health consequences on heart disease and other health conditions," Kris-Etherton, an American Heart Association contributor who didn't work on the study, told CNN. "In the meantime, water is the best choice, and, based on this study, no- and low-calorie sweetened beverages should be limited or avoided."

At the end of the day, drinking a bunch of diet soda is still probably not as bad for your heart as, say, excessive alcohol intake, but the risk is serious enough to take seriously and to make those pure fruit juices look all the tastier.

More on heart health:Cannabis Use Linked to Higher Risk of Heart Attack and Stroke

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JPM2024: Big Tech Poised to Disrupt Biopharma with AI-Based Drug Discovery – BioSpace

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Pictured: Medical professionals use technology in healthcare/iStock,elenabs

2024 will continue to see Big Tech companies enter the artificial intelligence-based drug discovery space, potentially disrupting the biopharma industry. That was the consensus of panelists at a Tuesday session on AI and machine learning held by the Biotech Showcase, co-located with the 42nd J.P. Morgan Healthcare Conference.

The JPM conference got a reminder of Big Techs inroads into AI-based drug discovery with Sundays announcement that Google parent Alphabets digital biotech company Isomorphic Labs signed two large deals worth nearly $3 billion with Eli Lilly and Novartis.

Big Tech is coming for AI and its coming in a big way, said panel moderator Beth Rogozinski, CEO of Oncoustics, who noted that the AI boom has seen the rise of the Magnificent 7, a new grouping of mega-cap tech stocks comprised of the seven largest U.S.-listed companiestech giants Amazon, Apple, Alphabet, Microsoft, Meta Platforms, Nvidia and Tesla.

Last year, the Magnificent 7s combined market value surged almost 75% to a whopping $12 trillion, demonstrating their collective financial power.

Six of the seven have AI and healthcare initiatives, Rogozinski told the panel. Theyre all coming for this industry.

However, Atomwise CEO Abraham Heifets made the case that with Big Tech getting into biopharma there is a mismatch of business models, with the Isomorphic Labs deals looking, in his words, like traditional tech mentality. Heifets contends that its unclear whether the physics of the business will support the risk models in the industry, adding that the influence of small- to mid-size companies focused on AI-based drug discovery should not be underestimated.

Google DeepMinds AlphaFold is the foundation of Isomorphic Labs platform. The problem, according to ArrePath CTO Kurt Thorn, is that its easy for these technologies to have fast followings only to see their market shares wane over time. If you look at AlphaFold, which was a breakthrough when it came out, within two or three years afterwards there were two or three alternatives.

Thorn concluded that its not clear that the market sizes are large enough to amortize a large AI platform for drug discovery across an entire industry.

Rogozinski emphasized that these switching costs are a potential barrier to entry in moving to such drug discovery platforms as Big Tech tries to get companies to transition.

Vivodyne CEO Andrei Georgescu commented that drug discovery and development is a difficult and complex process that is not a function of how big your team is or how many people you have behind the bench. The key to the success of AI in biopharma is in the generation and curation of datasets, according to Georgescu, who said the industry is facing a bottleneck on the complexity of the data and the applicability of the data to the outcomes that we want to confirm.

Providing some levity and perspective to Tuesdays AI session, Moonwalk Biosciences CEO Alex Aravanis told the audience he was late to arrive as a panelist due to an accident on the freeway involving a Tesla self-driving vehicle. So, clearly, they need more data, Aravanis said.

Marc Cikes, managing director of the Debiopharm Innovation Fund, told BioSpace that while he has been heartened to see the rise of AI and machine learning usage in biopharma, the forecast remains murky in 2024.

The impact of AI for drug discovery is still largely unknown, Cikes said. The public market valuation of the few AI-drug discovery companies is significantly down versus their peak price, and a large chunk of the high-value deals announced between native AI companies and large pharmas are essentially based on future milestone payments which may never materialize.

Greg Slabodkin is the News Editor at BioSpace. You can reach him atgreg.slabodkin@biospace.com. Follow him onLinkedIn.

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Elon Musk expresses concern over FAA’s focus on DEI – Washington Examiner

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Billionaire Elon Musk has directed his attention to the Federal Aviation Administrations focus on diversity, equity, and inclusion, stating Monday morning that he could not believe this is happening.

Musk, who has spoken out against the DEI movement recently, shared a story on social media that revealed the FAA is seeking to hire people withsevere intellectual disabilities. Among these disabilities defined by the FAA include those involving hearing, sight, partial or complete paralysis, and epilepsy.

Just had a conversation with some smart people could not believe this is happening, Musk wrote on X, his social media platform once known as Twitter.

Musks concerns about the FAAs use of DEI in its hiring comes about a week after a Boeing 737 Max 9, operated byAlaska Airlines, had a piece of it blown off during its takeoff. The government is currently investigating what caused the piece to blow off from the plane.

A social media user responding to Musk suggested how catastrophic DEI could be when hiring people in the medical industry, with the user suggesting people could DIE due to DEI. Musk agreed, responding yes to the hypothetical scenario.

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Musk has made himself a vocal critic of DEI over the past few weeks, stating Monday that discrimination based on anything other than merit is wrong. He also argued last week thatDEI discriminatesagainstpeople based on their race and that DEI itself is both immoral and illegal.

Other billionaires who have recently voiced their opinions against DEI include hedge fund billionaire Bill Ackman, Lululemon founder Chip Wilson, and 2024 Republican presidential candidate Vivek Ramaswamy.

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A new COVID variant is dominant in the US: Know these symptoms – Yahoo News

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A heavily mutated, fast-spreading new COVID-19 variant called JN.1 is on the rise in the United States. Last month, JN.1 swept the country and quickly overtook other variants of the coronavirus to become the dominant strain nationwide.

The highly contagious omicron subvariant now accounts for over 60% of all infections in the U.S., and it's expected to continue driving an increasing number of cases as the country approaches peak respiratory virus season. In fact, data show and some experts say the country is currently in its second-largest COVID wave, smaller than only the omicron surge in late 2021 and early 2022.

JN.1 is also gaining speed in other parts of the world. On Dec. 18, the World Health Organization classified JN.1 as a variant of interest due to its rapidly increasing spread globally.

In the U.S., the share of cases caused by the JN.1 variant has nearly doubled in recent weeks. JN.1 is currently considered the fastest-growing variant in the country, according to the U.S. Centers for Disease Control and Prevention.

During a two-week period ending on Dec. 23, JN.1 accounted for about 44% of cases in the U.S., per the CDCs latest data. This was a steep increase from the previous two-week period ending on Dec. 9, when JN.1 made up 21% of cases.

After JN.1, the next most common strain in the U.S. right now is the HV.1 subvariant, which comprised about 22% of cases as of Dec. 23.

Scientists around the world have been closely monitoring JN.1, which has sparked some concern due to its rapid growth and large number of mutations. However, the new variant is closely related to a strain we've seen before: BA.2.86, aka "Pirola," which has been spreading in the U.S. since the summer.

JN.1 has one additional mutation compared to BA.2.86, which has more than 30 mutations that set it apart from the omicron XBB.1.5 variant. XBB.1.5 was the dominant strain for most of 2023 and it's the variant targeted in the updated COVID-19 vaccines, TODAY.com previously reported.

All of the COVID-19 variants that have gained dominance in the U.S. in the last year are descendants of omicron, which began circulating in late 2021. Since emerging, JN.1 has overtaken its parental strain BA.2.86, as well as HV.1, EG.5 or Eris and XBB.1.16, aka Arcturus.

JN.1's growth comes as COVID hospitalizations rise, influenza continues to spread and RSV activity remains high in many places, according to a Dec. 14 update from the CDC. The agency warned that at the end of the month, emergency rooms and hospitals could become strained, similarly to last year, especially in the South.

Will JN.1 cause a COVID-19 surge? Does JN.1 have different symptoms and is it still detected by COVID tests? Does it respond to vaccines and treatments? Here's what experts know about JN.1 so far.

JN.1 was first reported in August 2023 and it has spread to at least 41 countries so far, according to the WHO. It was first detected in the U.S. in September, the CDC said.

Just like the other newer variants, JN.1 is part of the omicron family.

"Think of (the variants) as children and grandchildren of omicron. They're part of the same extended family, but they each have their own distinctive personalities," Dr. William Schaffner, professor of infectious diseases at Vanderbilt University Medical Center, tells TODAY.com.

JN.1 descended from BA.2.86, which is a sublineage of the omicron BA.2 variant, TODAY.com previously reported that's what sets JN.1 and BA.2.86 apart from the other prevailing variants like HV.1 and EG.5, which descended from omicron XBB.

When its parent BA.2.86 emerged, everybody was worried because it had a lot of mutations and looked like it was going to evade a lot of the immunity from vaccines and infection in the population, Andrew Pekosz, Ph.D., professor and vice chair in the Department of Molecular Microbiology and Immunology at the Johns Hopkins Bloomberg School of Public Health, tells TODAY.com. But (BA.2.86) sort of fizzled out, he adds.

Laboratory data suggest that Pirola is less contagious and immune-evasive than scientists once feared, NBC News reported.

JN.1, however, picked up an additional mutation in its spike protein called L455S, says Pekosz. Spike proteins help the virus latch onto human cells and play a crucial role in helping SARS-CoV-2 infect people, per the CDC. This mutation may affect JN.1's immune escape properties, says Pekosz.

"Now it's circulating and growing at a really fast rate compared to other variants, as well as the parent its derived from (BA.2.86), says Pekosz.

In early November, JN.1 accounted for fewer than 1% of COVID-19 cases in the U.S. Several weeks later, it was driving over 20% of cases, Dr. Michael Phillips, chief epidemiologist at NYU Langone Health, tells TODAY.com. Now, it's the dominant strain in the U.S.

Its not known whether JN.1 causes different symptoms from other variants, according the CDC.

Right now, theres nothing that says that JN.1 infection is any different from previous COVID variants in terms of disease severity or symptoms, but were paying close attention, says Pekosz.

The symptoms of JN.1 appear to be similar to those caused by other strains, which include:

According to the CDC, the type and severity of symptoms a person experiences usually depends more on a persons underlying health and immunity rather than the variant which caused infection.

While severe infections do still occur, overall (COVID-19) is causing a lot of milder illness, says Schaffner.

Some doctors have reported that upper respiratory symptoms seem to follow a pattern of starting with a sore throat, followed by congestion and a cough, NBC News previously reported.

The virus is adapting. ... I think its getting better at infecting humans and evading pre-existing immunity in the population ... but its not changing symptomology too much, says Pekosz.

At this time, theres no evidence that JN.1 causes more severe infection, the experts note.

One of the things these (omicron variants) have in common is that they are highly contagious, and as new variants crop up, they seem to be as contagious or even more contagious than the previous variants, says Schaffner.

According to the CDC, the continued growth of JN.1 suggests that the variant is either more transmissible or better at evading our immune systems.

Its probably a little bit more transmissible than its parental virus because weve seen an increase in case numbers that we didnt with (BA.2.86), says Pekosz. However, it is too early to tell how exactly JN.1's transmissibility or immune escape properties compare to other variants, such as HV.1, the experts note.

Many of the newer strains, including JN.1, have another mutation that affects how strongly the spike protein binds to cells in the respiratory tract, says Pekosz. We know that its probably helping the virus become better at replicating and helping the virus evade more of that pre-existing immune response, he adds.

JN.1 does not pose an increased public health risk compared to other variants currently in circulation, the CDC and WHO said.

The genetic changes in JN.1 could give it an advantage over other variants, but its unclear how that will affect cases in the coming months. So far, there doesnt seem to be a massive increase in transmission. ... We would be concerned if there was a huge surge in cases, says Pekosz.

Right now, JN.1 is increasing in terms of the percentage of COVID-19 cases its causing, and theres also been a slight increase in total cases," says Pekosz.

Test positivity, an early indicator of case levels, is also on the rise, says Phillips the rate was 12.7% during the week ending on Dec. 23, up from about 12% the week prior, per the CDC. (The CDC no longer tracks the total number of cases in the U.S.).

Hospitalizations have also risen by 17% and ICU admissions by 16.4% in the last two weeks, according to an NBC News analysis.

"The good news is that as of yet we're not seeing severe disease or hospitalizations going up significantly, and ICU admissions are still very low, but we're going to watch these carefully," says Phillips.

COVID-19 activity was expected to rise around this time as the U.S. enters winter and respiratory virus season, the experts note. In recent years, the virus has followed a pattern of increasing and peaking around new year, according to the CDC.

"Right now, we do not know to what extent JN.1 may be contributing to these increases or possible increases through the rest of December," the CDC said. Only time will tell whether JN.1 or another variant will cause a surge in infections this winter.

All COVID-19 diagnostic tests including rapid antigen tests and PCR tests are expected to be effective at detecting JN.1, as well as other variants, according to the CDC.

Testing is an important tool to protect yourself and others from COVID-19, especially ahead of indoor gatherings, says Schaffner.

The symptoms of COVID-19 are often indistinguishable from those caused by other viruses spreading right now, the experts note. These include respiratory syncytial virus (RSV), influenza and rhinovirus, which causes the common cold.

The experts urge anyone who becomes ill or is exposed to COVID-19 to take a test, especially people at higher risk of severe disease, such as people over the age of 65, who are immunocompromised and who have underlying health conditions.

Every American can order four free at-home COVID-19 tests from the government, which will be delivered by mail via the U.S. Postal Service. To order your free tests, go to COVIDTests.gov.

"Get tested because, whether it's COVID or flu, we have treatment available," says Schaffner. Current treatments are also expected to be effective against JN.1, the CDC said.

"JN.1 should be just as sensitive to the antivirals available as any other variants," says Pekosz, adding that antivirals like Paxlovid are most effective when taken within the first few days after infection.

The new, updated COVID-19 vaccines, recommended for everyone 6 months and older, are expected to increase protection against JN.1, as well as other variants, the CDC said.

Although the shots target omicron XBB.1.5, which has since been overtaken by HV.1, JN.1, EG.5 and others, there is still evidence that it will protect against new strains circulating this winter, TODAY.com previously reported.

Data from laboratory studies show that the vaccine appears to generate a strong immune response against JN.1's parent strain, BA.2.86, Schaffner notes.

The new vaccines also protect against severe disease, hospitalization and death, the experts emphasize. So even if you get COVID-19 after vaccination, the infection will likely be milder and it can keep you out of the hospital, Phillips adds.

However, uptake of the updated booster among the U.S. population has been low so far, the experts say. As of Dec. 22, only about 18% of adults and 7% of children have gotten the updated vaccine, according to the latest CDC data on vaccination trends.

On Dec. 14, CDC officials issued an alert to warn about low vaccination rates against COVID-19, flu and RSV in the U.S.

Now is the best time to get vaccinated if you haven't already, the experts say. "The sooner you get vaccinated, the sooner you'll be protected and it does take seven to 10 days for protection to build up to the maximum," says Schaffner.

Phillips recommends everyone, especially high-risk individuals, to get the seasonal influenza shot, as well. Hospitalizations for flu increased 200% over the past month, according to the CDC's Dec. 14 warning.

"Getting vaccinated is the best present you can give yourself and your family this holiday season," Schaffner adds.

Every day, but especially during respiratory virus season, people can take steps to protect themselves and others from COVID-19.

The experts encourage everyone to:

Stay up to date with COVID-19 vaccines.

Test if you have symptoms.

Isolate if you have COVID-19.

Avoid contact with sick people.

Improve ventilation.

Wear a mask in crowded, indoor spaces.

Wash your hands with soap and water.

This article was originally published on TODAY.com

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A new COVID variant is dominant in the US: Know these symptoms - Yahoo News

The Smithsonian’s collection of brains is linked to eugenics, taken from vulnerable populations – Live Action

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The Washington Post has published a follow-up to its investigation into the Smithsonian Institution, which has a staggering collection of human body parts, including brains and few of the remains were obtained through ethical means. Now, in the follow-up report, the Post has reported that most of the victims were Washington, D.C.s most vulnerable residents.

Ales Hrdlicka (1869-1943) was the anthropologist responsible for much of the collection of body parts, and he had a specific goal in mind: to prove that minorities, but especially Black people, were inferior to whites. Creating a racial brain collection was part of how he would prove this long-debunked theory. Of the 74 brains he got from residents of Washington, D.C., 48 were Black. Others were from disabled persons or were taken from children including 19 obtained from preborn children.

At least one of these brains was taken after the preborn child was killed in an abortion.

One of the children, Moses, died as an infant, and Hrdlicka performed the autopsy on him, with the familys consent; however, they had no idea that he was also taking the childs brain. It has remained in the Smithsonians collection for decades, though Michelle Farris, a distant relative, is now fighting to get it back so it can buried properly.

It feels like my family was robbed of something, Farris said. A child especially of that age cant speak up for themselves. Since the Washington Posts initial investigation, just five of the brains have been returned to either the persons family, or their cultural heirs such as an indigenous tribe.

While the Smithsonian has expressed willingness to return the remains, those remains must be requested through a formal petition, and as in Moses case, most of the families dont even know the collection exists, much less that a relative has body parts in it. Though the Smithsonian has names for at least 100 of the brains, the institution has not attempted to contact anyone or publish the names so their families can reclaim them.

READ: The media is outraged over stolen body parts but only if it doesnt involve abortion

An undercover investigation from the Center of Medical Progress found through documentation and video investigations that Planned Parenthood and the abortion industry still harvest body parts from the most vulnerable among us preborn children and sell them for medical research.

Notably, Hrdlicka was an ardent eugenicist something he had in common with Margaret Sanger, the founder of Planned Parenthood. Sanger accepted an invitation to speak at a Ku Klux Klan meeting and surrounded herself with racists and eugenicists. Lothrop Stoddard was the Exalted Cyclops of the Massachusetts chapter of the Ku Klux Klan and also served on the board of Sangers American Birth Control League (ABCL) the organization that would later become Planned Parenthood. He believed that non-white races must be excluded from America. Clarence Gamble, heir of the Procter and Gamble company fortune, served as a director of both Sangers ABCL and Planned Parenthood boards and was also a eugenicist, supporting laws mandating the sterilization of the disabled. In a letter discussing the notorious Negro Project with Sanger, he said:

The mass of Negroes, particularly in the South, still breed carelessly and disastrously, with the result that the increase among Negroes, even more than among whites, is from that portion of the population least intelligent and fit, and least able to rear children properly.

In his 1904 guide to eugenics, Hrdlicka echoes these beliefs. He wrote of wanting to obtain brains from white people, of which he had abundant opportunity, but also from American negroes, which will be of increasing interest on account of the intellectual progress and mixture of this element in the American population.

In addition to brains, there are still numerous other remains in the collection, including bones and even complete skeletons.

To me, its very upsetting, Native American anthropologist Brad Hatch told the Washington Post. They essentially pulled our ancestors out of the ground, discarded who knows how many of them, and then the large pieces that they could identify, they took back and theyre holding them, essentially in storage where they cant really be given the respect they deserve.

The DOJ put a pro-life grandmother in jail this Christmas for protesting the killing of preborn children. Please take 30-seconds to TELL CONGRESS: STOP THE DOJ FROM TARGETING PRO-LIFE AMERICANS.

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The Smithsonian's collection of brains is linked to eugenics, taken from vulnerable populations - Live Action

Transhumanism: Integrating Cochlear Implants With Artificial Intelligence and the Brain-Machine Interface – Cureus

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Shaping Radiology’s Future in Latin America and the Caribbean – International Atomic Energy Agency

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The IAEA conducted its first-ever regional training course on Dual Energy Computed Tomography (DECT) a type of Computed Tomography (CT) that offers enhanced imaging capabilities for medical professionals from 13 countries across Latin America and the Caribbean.

Held in Bogot, Colombia, in September 2023, the course provided participants from Argentina, Barbados, Bolivia, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Paraguay, Peru, Uruguay, and Venezuela with the knowledge they need to safely and effectively apply this technology within their respective countries.

Radiology is a field of medicine which is constantly evolving and has the potential to revolutionize patient care, explained Virginia Tsapaki, Technical Officer in the Dosimetry and Medical Radiation Physics Section of the IAEA. By sharing insights and knowledge about this cutting-edge technology with course participants, the IAEA is demonstrating its commitment to providing the highest standards of education to medical physicists from around the world, she said. Throughout the five-day training, participants benefitted from expert lectures, hands-on practicals, interactive question-and-answer sessions, and case study discussions. The courses content provided participants with a comprehensive understanding of DECT, equipping them with both practical and theoretical knowledge. In enabling attendees to utilise what they learned within a real-life hospital setting, the training helped bridge the gap between classroom learning and real-world application.

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Shaping Radiology's Future in Latin America and the Caribbean - International Atomic Energy Agency