A Phase 1 clinical trial at Cleveland Clinic has shown that a single infusion of gene-editing therapy can significantly and permanently reduce cholesterol and triglyceride levels in patients whose conditions don't respond to standard medications.

The trial results, presented Saturday November 8, 2025 at the American Heart Association's Scientific Sessions 2025 and published simultaneously in the New England Journal of Medicine, showed the experimental CRISPR-Cas9 treatment reduced LDL cholesterol by approximately 50% and triglycerides by about 55% in study participants.

"This treatment is still very early in development but if future trials continue to demonstrate safety and efficacy, the therapy has the potential to change the way we treat lipid disorders," said Cleveland Clinic cardiologist Dr. Luke Laffin, first author of the study. "Rather than a once-daily pill or monthly injection, this therapy would potentially offer a one-time infusion that is safe and durable for patients with high cholesterol."

The 15-patient trial, conducted between June 2024 and August 2025 at six sites in Australia, New Zealand and the United Kingdom, included adults ages 31 to 68 with uncontrolled high triglycerides and elevated LDL cholesterol levels.

Dr. Steven Nissen, Chief Academic Officer of the Heart, Vascular & Thoracic Institute at Cleveland Clinic and senior author of the study, emphasized the revolutionary nature of the therapy. "Once the gene is edited, this is a one and done treatment," Nissen said. "This is really quite revolutionary because the alternative is to take medication every day or inject it every week or two for the rest of your life."

The treatment, called CTX310, uses CRISPR-Cas9 gene-editing technology that Dr. Laffin described as "molecular scissors" that permanently switches off a gene called ANGPTL3 in the liver. People born with a naturally occurring mutation in this gene have lifelong low cholesterol and triglycerides with lower lifetime risk of heart disease and no apparent harmful effects.

The trial reported no serious adverse events related to the treatment. Three participants experienced minor reactions including back pain and nausea that resolved with medication.

The therapy addresses a critical adherence problem. "We know that up to 50% of people by a year after their statin prescription stop taking it," Dr. Laffin noted. Dr. Nissen explained that because high cholesterol doesn't cause symptoms, people tire of taking daily medications.

For many patients, genetics determine 70-75% of their cholesterol levels. "People can eat like rabbits and exercise daily, and it's going to improve their cholesterol," Dr. Laffin explained. "But these are individuals who still can't get to the targets we need them to be to reduce their cardiovascular risk."

Dr. Nissen reflected on the breakthrough: "I used to tell people, we can change everything about you, we can give you drugs, we can change your cholesterol, the only thing we can't change is your parents, cause we can't change your genes. Well, that was wrong, because now for the first time in history, we can change people's genes."

Based on the positive results, Phase 2 studies are planned to begin in 2026. The researchers hope to have the therapy in Phase 3 studies within 2 to 3 years and are working to bring trials to the United States.

Monica Robins is not a medical doctor. All content presented in this program is for informational purposes only. It is not intended to be a substitute for professional medical advice and should not be relied on as health or personal advice. Always seek the guidance of your personal doctor or qualified healthcare professional with any questions regarding your health or medical condition.

Lung cancer remains one of the most prevalent cancers in the United States, affecting more people than breast, ovarian, and colon cancers combined. Yet misconceptions about who can develop the disease persist, according to Dr. Laurie Matt-Amaral, a medical oncologist at Cleveland Clinic Akron General.

"We see a lot of patients who get diagnosed with lung cancer and have never been a smoker," Dr. Matt-Amaral said during a recent interview for Lung Cancer Awareness Month. "They have no exposure, potentially, and the cause is really unknown."

While smoking remains a significant risk factor, Dr. Matt-Amaral explained that secondhand smoke exposure, asbestos, radon, pollution, and other environmental factors may contribute to lung cancer development. The medical community continues researching these potential triggers.

A particularly concerning trend is the increase in younger patients being diagnosed with lung cancer and other cancers. Dr. Matt-Amaral noted that in recent weeks, she has treated patients younger than herself with metastatic cancers of various types.

"There's really been a focus from a researcher's perspective," she said. "We're just seeing so much of it in younger people."

The rise in younger diagnoses may stem from both increased awareness and an actual increase in cases. Dr. Matt-Amaral observed that younger generations are more proactive about seeking medical care when symptoms appear, while researchers work to identify potential causes and preventive measures.

While vaping and marijuana use show evidence of causing lung damage, Dr. Matt-Amaral emphasized that researchers have not yet established a direct causal link to cancer. However, she noted that any changes to lung tissue DNA can increase cancer risk.

One challenge facing younger patients is being taken seriously by healthcare providers. Dr. Matt-Amaral acknowledged this concern but said the oncology community has worked to educate physicians that cancer can affect anyone, regardless of age or exposure history.

"Some people have had to see two, three, four doctors to sort of get their complaints addressed and come to find out it's a real cancer," she said.

Current screening guidelines from organizations like the American College of Physicians and the U.S. Preventive Services Task Force have not changed, partly because researchers still do not fully understand all risk factors. However, Dr. Matt-Amaral suggested that unexplained symptoms warrant investigation.

Warning signs include a persistent cough, unexplained weight loss, coughing up blood, chest discomfort, and new shortness of breath during normal activities. Dr. Matt-Amaral stressed that coughing up blood requires emergency attention.

For those who smoke, Cleveland Clinic Akron General offers a smoking cessation program with specialized nurses who help patients access resources and develop quit plans. Dr. Matt-Amaral recommends a gradual approach rather than quitting cold turkey, such as reducing cigarette use by one or two per day or per week.

Treatment advances, particularly immunotherapy, have improved outcomes for lung cancer patients. Dr. Matt-Amaral said researchers continue developing new drugs and personalized treatment approaches based on each patient's specific cancer characteristics.

"I always look forward to being able to tell someone, hey, your cancer has this molecular abnormality, but good news, I have a drug to go with it," she said.

Clinical trials are available locally through Cleveland Clinic Akron General and Cleveland Clinic's main campus, as well as through other major medical centers in the region and nationwide. Dr. Matt-Amaral encouraged patients to discuss clinical trial options with their oncologists.

Her message for Lung Cancer Awareness Month is clear: lung cancer can happen to anyone. The best defense is open communication with healthcare providers, attention to symptoms, and smoking cessation for those who smoke.

Monica Robins is not a medical doctor. All content presented in this program is for informational purposes only. It is not intended to be a substitute for professional medical advice and should not be relied on as health or personal advice. Always seek the guidance of your personal doctor or qualified healthcare professional with any questions regarding your health or medical condition.

Medical research funding in Northeast Ohio continues to face significant challenges, with federal grant approval rates dropping to historic lows while private donations increasingly fill critical gaps in clinical trial support.

Dr. Theodoros Teknos, President and Scientific Director of University Hospitals Seidman Cancer Center, reports that while NIH and NCI funding levels have remained stable, the competition for grants has intensified dramatically. Currently, only about 8% of submitted grants receive funding, down from approximately 20-22% when he began his career in medicine.

"There's no question it's been very stressful because there's been a lot of uncertainty," Teknos said during a recent interview. The low funding rate means approximately 1 in 12 grants gets approved, leaving many important studies without government support.

Private philanthropy has become essential to maintaining research momentum. Kathy Coleman's recent $3.5 million gift to the "Because of You: The Campaign for University Hospitals" will fuel expansion of the Kathy and Les Coleman Clinical Trials Center. This donation brings her lifetime giving to more than $14 million, all given in memory of her late husband, former Lubrizol Corp. chairman and CEO Lester Coleman Jr. These funds help offset clinical trial costs, which can range from $50,000 to $100,000 per patient.

The funding challenges are particularly concerning for young scientists entering the field. Dr. Teknos notes that many brilliant PhDs are choosing industry careers over academic research due to concerns about securing funding and job security.

Despite these challenges, University Hospitals Seidman Cancer Center continues expanding its clinical trial portfolio. The center currently offers more than 400 clinical trials annually and plans to triple its capacity by 2030. As a member of the Case Comprehensive Cancer Center, UH Seidman is one of only seven cancer centers in the country with access to novel drugs from the National Cancer Institute.

The institution is developing innovative CAR-T cell therapies through the Wesley Center for Immunotherapy, which can create these specialized cells in just 24 hours compared to the industry standard of 12-30 days. UH is one of only 11 academic medical centers successfully manufacturing CAR-T cells for patient use. Additionally, researchers are advancing theranostic treatments that combine imaging and targeted radiation delivery.

Coleman's donation will relocate the clinical trials center into a dedicated 16,000-square-foot space on the main campus, centralizing care and making room for new machinery to expand theranostic investigations. The expansion will also enable University Hospitals to bring phase one clinical trials directly to community locations, making cutting-edge treatments more accessible to patients who cannot travel to the main campus.

"Clinical trials are critical for so many reasons," Coleman said. "On a global level, they help advance research and move us closer to cures; but for individuals and families, I know personally the hope they bring."

The institution maintains its commitment to serving Northeast Ohio patients while navigating an increasingly competitive research funding environment. More information about the "Because of You" campaign is available at UHGiving.org.

Monica Robins is not a medical doctor. All content presented in this program is for informational purposes only. It is not intended to be a substitute for professional medical advice and should not be relied on as health or personal advice. Always seek the guidance of your personal doctor or qualified healthcare professional with any questions regarding your health or medical condition.

Dr. James Voos, president of the NFL Physicians Society and head team physician for the Cleveland Browns, says the planning for international games begins more than six months in advance. Medical staff must obtain temporary licenses to practice medicine in other countries, establish relationships with local hospitals and healthcare providers, and coordinate supplies and equipment that may be needed during practice or game day.

"It's the exact same consideration of the players knowing that when they walk out on the field, they have the same level of care no matter where they're at," Dr. Voos explained in an interview for the Health Yeah! With Monica Robins podcast. "It just adds another layer to it when we go to another country with different laws and temporary medical licensure."

The NFL has expanded its international presence in recent years, with games now played in London, Dublin, and Brazil. As the league continues to add new locations, the process of replicating the comprehensive medical protocols used in home stadiums has become increasingly refined.

All of the same sideline personnel travel with the teams, including unaffiliated neurotrauma consultants who monitor for potential concussions, airway management physicians, and athletic trainers who serve as additional eyes watching the game from above. The medical equipment and blue sideline medical tent that fans see at every NFL stadium are set up identically at international venues.

Dr. Voos, who also serves as the Jack and Mary Herrick Distinguished Chair of Orthopedics and Sports Medicine at the UH Drusinsky Sports Medicine Institute, says the collaboration with international medical professionals has created valuable exchanges of best practices. Many European and Brazilian healthcare providers have attended NFL games and the NFL Combine to observe protocols firsthand.

"We've been able to translate and match those protocols from each of the different sports together," he said, noting that many international partners work with high-level soccer and rugby programs. "It's one of those exchanges of ideas where you see they're doing this in soccer, or they're doing this in rugby, and how can we integrate all of these together."

One notable difference Dr. Voos observed is that many European stadiums have more comprehensive emergency facilities built directly into the venue—essentially small emergency departments where more thorough evaluations can be performed before a player needs to be transported to a hospital.

The emergency action plans used internationally are designed to mirror those used in the United States. If a player requires hospitalization, protocols are in place to ensure a member of the team's medical staff remains with the athlete to provide continuity of care and help ease anxiety about being in an unfamiliar medical system far from home.

Beyond the immediate medical considerations, teams also address player health in the weeks leading up to international travel. Dr. Voos says education about managing jet lag begins several weeks before departure, with recommendations about sleep schedules, diet, and rest during the flight. Teams typically travel several days before game day to allow time for adjustment.

"That process started several weeks ago of educating the players and really providing those tips and recommendations," he explained. "That way, we're not trying to figure it out when we get there."

The goal, Dr. Voos emphasizes, is for the medical operations to be as invisible as possible so that players and fans can focus on the game itself. While fans at international venues may notice a few additional healthcare providers on the sidelines—the local medical partners working alongside the NFL teams—the evaluation and care processes remain unchanged.

The NFL Physicians Society has made standardizing safety protocols across all venues a priority, working to ensure that the level of care is consistent regardless of location. As the league continues to expand its global footprint, these established relationships and processes will continue to evolve.

"It really shows what a great job the NFL has done working with healthcare systems across the country," Dr. Voos said. "As the head team physician for the Browns and the president of the NFL Physicians Society, it's something we've taken great pride in—really being the leaders in medicine and the leaders in safety."

Monica Robins is not a medical doctor. All content presented in this program is for informational purposes only. It is not intended to be a substitute for professional medical advice and should not be relied on as health or personal advice. Always seek the guidance of your personal doctor or qualified healthcare professional with any questions regarding your health or medical condition.

Men of color in Cleveland face a dangerous myth that could be costing lives: the belief that they must "tough it out" until health problems become unbearable before seeking medical care.

Dr. Randy Vince, director of minority men's health at University Hospitals in Cleveland, says this mentality prevents early detection of serious conditions like hypertension, diabetes, and cancer—diseases that often show no symptoms until they reach advanced stages.

"Usually it does not matter the medical condition when we're talking about hypertension or high blood pressure, diabetes, or even cancer like prostate cancer. You don't have symptoms until things are really advanced," Vince explained during a recent interview.

The consequences extend beyond physical health. Suicide rates are increasing among Black men specifically, a trend Vince calls "very preventable" if men can be connected with mental health resources earlier.

"The rates of suicide are actually increasing in black men specifically, and so I think if we can start to again dispel this myth that you can tough it out, I don't need to see a mental health professional, we can actually end up saving a lot of men," he said.

Vince emphasizes that men need to understand their relationship with healthcare providers differently. "As physicians we work for you," he said, encouraging patients to seek second opinions and find new doctors if they don't feel heard.

For men hesitant about traditional doctor visits, Vince points to alternative options. Nurse practitioners and physician assistants can provide primary care services, and most preventative care is covered 100% by insurance with minimal copays.

Men facing Medicaid cuts still have options, according to Vince. County boards of health, city resources, and federally qualified health centers (FQHCs) can connect patients with care and insurance information.

Starting at age 40, men should prioritize specific health screenings, Vince advises. Blood pressure checks, diabetes screenings, and cholesterol tests form the foundation of preventative care. Colon cancer and prostate cancer screenings become essential as these are "major cancer killers" with high survival rates when caught early.

Mental health deserves equal attention. Vince recommends men start with resources they trust, including faith-based organizations that can connect them with professional help.

"Depression, for instance, or anxiety, that is not abnormal," Vince said. "Many men face that, so I think if they can realize that this is not abnormal and you don't have to try to tough it out, you're not in this battle alone."

Social determinants of health—factors like poverty, housing conditions, and access to nutritious food—significantly impact both physical and mental wellbeing. Vince points to environmental pollution causing respiratory conditions and limited access to healthy foods as examples of how external factors affect health regardless of medical care.

"These social determinants of health all impact our health and it's despite whether or not you just go to the doctor or not," he explained.

The stigma around mental health treatment is slowly lifting in communities, but "not fast enough," according to Vince. He encourages men to understand that seeking help demonstrates strength, not weakness.

"Leaning into your struggles actually takes a lot of strength, not weakness," he said.

For mental health connections: The Cutler Center for Men connects men with mental health resources and can be reached by calling University Hospitals.

For insurance and care resources: Contact your local county board of health or city health department for information about available insurance options and federally qualified health centers.

For general health questions: Many health systems maintain websites with provider directories and appointment scheduling, and most offer telehealth consultations.

Vince's final message to men is simple: "Be empowered. Do not feel like you're in a struggle alone. There's actually strength in numbers, and we are here to help. Knowledge is power, so don't be afraid to seek that knowledge."

Monica Robins is not a medical doctor. All content presented in this program is for informational purposes only. It is not intended to be a substitute for professional medical advice and should not be relied on as health or personal advice. Always seek the guidance of your personal doctor or qualified healthcare professional with any questions regarding your health or medical condition.