With this funding, UofL will launch the Louisville Clinical and Translational Research Center (LCTRC) — a statewide effort that will transform the university’s clinical research infrastructure and find meaningful solutions to combat chronic conditions like cardiac disease, stroke and cancer that disproportionately affect Kentuckians in urban and rural areas alike. The goal is to foster the seamless transition of research findings from the laboratory to patient care.

“UofL has a long-standing commitment to improving the lives of Kentuckians,” said UofL President Kim Schatzel. “This grant represents significant progress toward that commitment, engaging researchers and community members in developing new treatments and training the next generation of experts who will improve lives for years to come.”

LTCRC is funded through the , meant to help institutions build research expertise and infrastructure to support research on diseases and health challenges faced by the populations they serve. CTR-D grants are considered highly competitive.

“CTR grants are a unique resource that are awarded to only a small number of institutions,” said Jon Klein, UofL’s interim executive vice president for research and innovation, a Bucks for Brains endowed researcher and LCTRC’s principal investigator. “UofL’s success in securing this award shows our strength as a research institution and academic medical center, and will drive significant, positive impact throughout the Commonwealth.”

That impact will be far-reaching. LCTRC will enable UofL to launch a series of $75,000 to $125,000 research grants aimed at kickstarting new research projects that help early career and established researchers gather the data needed to secure more NIH or other agency investment.

To train highly competitive, next generation clinical and translational researchers, LCTRC will develop two key programs: Dean’s Scholars, which will pay medical students to spend a full year doing research, and Presidential Scholars, which buys six months of faculty members’ time to do research. These programs will also provide them with additional professional development opportunities, including partnering those researchers with experienced mentors who can help them take their work to the next level.

“The work that this funding will allow us to do is truly transformative,” said Jiapeng Huang, a professor of anesthesiology and perioperative medicine and deputy director for the LCTRC. “LCTRC will develop top notch clinical and translational researchers who cannot only secure more NIH funding, but also develop new therapies and technologies which will benefit our patients and communities in Kentucky. They will shape the future of Kentucky in a very meaningful way. “

LCTRC will also work to expand clinical and translational research infrastructures and develop essential research tools. This includes enhanced research relationships with major health systems, including UofL Health in Louisville and Owensboro Health in western Kentucky. UofL has a long-standing academic partnership with the latter, including a ACGME accelerated family medicine residency program based at Owensboro Health, and an Accelerated Second-Degree Bachelor of Science in Nursing program, where UofL resident physicians and students engage in hands-on clinical experiences in Owensboro.

The new LCTRC funding will double UofL’s clinical trials staff, enabling the university to support more clinical trials at UofL Health, its Owensboro Health rural affiliate, the Louisville Robley Rex VA Medical Center and Norton Healthcare. It also will support ‘citizen science’ projects, giving regular people an opportunity to engage in research backed by grant funding and with mentorship from academic experts.

“Just because you’re not in a lab doesn’t mean you’re not a scientist,” Klein said. “By working collaboratively with our neighbors — with the people who actually live and experience the health problems we’re trying to solve — we can build a bright new future for everyone.”

While the LCTRC builds a bright future for Kentucky, Klein said it wouldn’t be possible without a strong foundation. UofL has been working to secure clinical translational research center funding since 2008, with efforts first being led by Craig McClain, associate vice president for health affairs and research, who worked with Klein to submit this successful proposal. Both are endowed through the Bucks for Brains program, which brings world-class researchers to UofL. 

“The conditions for this grant had to be just right — we had to have an outstanding academic medical center, experience translating research into medical treatments and the talented people who could bring this to life,” McClain said. “With LCTRC, we want to pass the torch. We will use this funding to build the infrastructure and next generation of talent that will help bring even more success to Kentucky researchers and drive new technologies that will save and improve lives.” 

“I just thought there has to be a better way,” said Eiferman.

In his seventies, Eiferman made the decision to embark on an online MBA program at the UofL College of Business to link his 40-year career in ophthalmology with his longtime research interest in developing a new medication delivery system.

“I’ve always been very interested in the business aspects of things, and we always had these research ideas that we’d never had the chance to bring to fruition, so I thought maybe we could put two birds together in one,” he said.

From his decades of experience with eye ailments, Eiferman recognized that a sustained delivery system was needed. “It’s particularly important in ophthalmology, because for example, if you have glaucoma, you have to take drops once or twice a day for the rest of your life, and compliance can be the biggest problem.”

Eiferman connected with a PhD chemist and the two investigated a long-acting sustained release way to deliver medication.

“We discovered a way to put drugs in a wafer that slowly dissolves over two-to-three months, so no drops,” said Eiferman. “It’s a totally new concept. We conducted tests on rabbits and sure enough, it worked beautifully.”

With the help of College of Business faculty, he submitted a proposal and won the top prize of $25,000 in a “Shark Tank” style contest sponsored by the American Academy of Ophthalmology in November 2022. That success led him to present at another contest in April 2023 at Yale University, and again he won the top prize, this time $265,000.  

Eiferman said that the UofL MBA faculty were incredibly receptive and supportive, teaching him a novel approach for his presentation to the Yale panel.

“This was different than any paper or lecture I’ve ever given,” he said. “Five slides and five minutes. I was fixated on the science and the chemistry, but they told me the panelists would want to know about  the market and how to make money from this idea,” he said. “They were 100 percent correct.”

With the patent and his newly formed company, Sustained Drug Delivery, Eiferman plans to use the prize money to fund a study at Michigan State involving beagles that have congenital glaucoma since the FDA requires two species studies, rabbits and dogs in this case. The experiments need to demonstrate the wafers are equivalent in efficacy to the traditional drops.

“We believe it will work and we can then ask for permission to test in humans and evaluate a certain number of people for a certain length of time,” he said. Once Eiferman completes that hurdle, the drug delivery system could be marketed as a device and not a drug, which can reduce the time between testing and approval.

Eiferman said he believes it could be a multi-million-dollar idea because of the technology’s broad applicability.

“In dentistry, for example, they could pack a socket following a tooth extraction or put it in sutures,” explained Eiferman. The other huge market is veterinary medicine to address a severe eye ailment that can make horses go blind.

In May 2023, Eiferman got to wear his green hood and walk at the university’s online MBA graduation ceremony.

“I never expected to be getting an MBA or starting a company in my 70s, but I wanted to prove I could still go to school and learn.”

Science has shown that bacteria, viruses and other microbes that live in and on the human body – the microbiota – are essential in maintaining and restoring health. Researchers across UofL are investigating the roles of specific bacteria and their metabolites – the substances they produce – and how to employ them in improving health.

Two recent studies from researchers in UofL’s have shown that a specific type of bacteria shows significant benefits in the treatment of alcohol-associated liver disease and alcohol use disorder. The research reveals that both probiotics and the metabolites made by the bacteria have beneficial effects.

One study, a clinical trial in which patients took oral doses of the bacterium Lactobacillus rhamnosus GG (LGG), resulted in reduced alcohol use and liver injury in these patients. A related laboratory study in animal models showed that metabolites from LGG are a source of the benefits.

In the multi-center clinical trial, led by Craig McClain, professor of medicine and director of the Alcohol Research Center, LGG reduced liver injury and, just as importantly, reduced drinking in patients with early alcohol-associated liver disease. Study participants who were treated with LGG showed a significant reduction in liver injury after one month. Six months of LGG therapy was associated with a reduction of heavy drinking to social or abstinence levels.

“There are multiple lines of evidence from several groups showing that altering gut flora plays a role in alcohol consumption and alcohol use disorder treatment. We are pursuing this line of inquiry, but the study is early work,” McClain said. The study was  in April.

In preclinical research, lab studies led by Wenke Feng, professor in the UofL Department of Pharmacology and Toxicology, showed that the substances produced by LGG, its metabolites, are responsible for the beneficial effects to the gut and liver of alcohol-treated mice. That study, , was published in Hepatology in April.

“Our ongoing research aims to uncover mechanistic insights that could pave the way for new treatments for alcohol-associated disorders,” Feng said.

“Dr. Feng’s studies show that it is not the live bacteria that is required to obtain benefits, but instead substances that the bacteria make are the active, beneficial ingredients. Working with our metabolomics group, Dr. Xiang Zhang and colleagues, we have identified some of these active substances,” McClain said. Zhang is professor of chemistry and director of the UofL Center for Regulatory and Environmental Analytical Metabolomics.

“These exciting results suggest that probiotics may be a source of new therapies for alcohol-use disorder as well as alcohol-associated liver disease,” McClain said.

Alcohol use disorder (AUD) is a medical condition in which people have limited ability to stop or control their alcohol use. According to the 2021 National Survey on Drug Use and Health, AUD affected 29.5 million Americans over the age of 12 in the past year. Prolonged excessive alcohol use can result in high blood pressure, heart disease, stroke, liver disease and digestive problems, as well as cancer, mental health problems, weakened immune system and social problems.

For more information on alcohol use disorder, visit the .

During the pandemic, health care providers worked tirelessly to treat patients who became seriously ill with COVID-19. Some of those patients developed severe lung disease known as acute respiratory distress syndrome (ARDS) due to an excessive response of the immune system often called cytokine storm.

As they treated these critically ill patients, physicians and other providers at UofL Health shared their clinical insights and patient samples with researchers at UofL to discover the cause of the immune system overresponse.

“At one time we had over 100 patients with COVID in the hospital. Once they were on a ventilator, mortality was about 50%. We were looking at this issue to see why some people would do well while some developed bad lung disease and did not do well or died,” said Jiapeng Huang, anesthesiologist with UofL Health and professor and vice chair of the Department of Anesthesiology and Perioperative Medicine in the UofL School of Medicine.

The UofL researchers, led by immunologist Jun Yan, discovered that a specific type of immune cells, low-density inflammatory neutrophils, became highly elevated in some COVID-19 patients whose condition became very severe. This elevation signaled a clinical crisis point and increased likelihood of death within a few days due to lung inflammation, blood clotting and stroke. Their findings were published in 2021 in .

With the new NIH funding, Yan is leading research to build on this discovery with deeper understanding of what causes a patient’s immune system to respond to an infection in this way and develop methods to predict, prevent or control the response.

“Through this fruitful collaboration, we now have acquired NIH funding for basic and translational studies and even progress toward commercialization of a potential therapy,” Yan said. “That’s why we do this research – eventually we want to benefit the patients.”

Yan, chief of the UofL Division of Immunotherapy in the Department of Surgery, a professor of microbiology and immunology and a senior member of the Brown Cancer Center, will lead the new research, along with Huang and Silvia M. Uriarte, university scholar and professor in the Department of Oral Immunology and Infectious Diseases in the UofL School of Dentistry.

“COVID-19 continues to spotlight the impactful synergy between the clinical and research teams at the University of Louisville,” said Jason Smith, UofL Health chief medical officer. “Innovation is in the DNA of academic medicine. We collaborate to provide each patient the best options for prevention and treatment today, while developing the even better options for tomorrow.”

In addition to two research grants of $2.9 million each awarded directly to UofL, a $306,000 grant to a startup company will support early testing of a compound developed in the lab of UofL Professor of Medicine Kenneth McLeish that shows promise in preventing the dangerous cytokine storm while allowing the neutrophils to retain their ability to kill harmful bacteria and viruses. The compound, DGN-23, will be tested by UofL and Degranin Therapeutics, a startup operated by McLeish, Yan, Huang, Uriarte and Madhavi Rane, associate professor in the Department of Medicine.

“This is one more example of how UofL has led the charge in finding new and innovative ways to detect, contain and fight COVID-19 and other potential public health threats,” said Kevin Gardner, UofL’s executive vice president for research and innovation. “This team’s new research and technology could help keep people healthy and safe here and beyond.”

The knowledge gained through these studies may benefit not only COVID-19 patients, but those with other conditions in which immune dysregulation can occur, such as other types of viral and bacterial pneumonia and autoimmune diseases, and patients undergoing cancer immunotherapy and organ transplantation.

The grants

Grant 1 – $2.9 million, four-year grant to UofL. Investigators will study the new subset of neutrophils Yan identified to better understand how they contribute to acute respiratory distress and clotting. They also will determine whether a novel compound will prevent these complications. They will use lab techniques and studies with animal models that allow for manipulation of certain conditions that cannot be done in human subjects.

Grant 2 – $2.9 million, five-year grant to UofL. This work examines a more comprehensive landscape to characterize different subsets of neutrophils and measure their changes over the course of COVID-19 disease progression and how neutrophils contribute to immune dysfunction.

Grant 3 – $306,000, one-year grant to Degranin Therapeutics and UofL for early testing of DGN-23, a compound developed at UofL, to determine its effectiveness in preventing or reducing immune dysregulation.

This research is supported by the National Heart, Lung, And Blood Institute under award numbers R01HL158779 and R43HL169129 and the National Institute of Allergy and Infectious Diseases under award number R01AI172873. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

“As of now, we do not have a vaccine that is authorized for use in children under age 12,” said Gary S. Marshall, chief of pediatric infectious diseases at Norton Children’s and the UofL School of Medicine, and principal investigator for the Louisville trial. “Having a safe and effective vaccine for children will not only keep them healthy but also would facilitate a return to normal in terms of school and other activities.”

In the randomized clinical trial, two children will be assigned to receive the vaccine for every one child who receives a placebo. The study is blinded, meaning that no one initially will know which injection they receive. Parents and caregivers will be asked to track changes to the child’s health in an electronic diary, and children will have at least six in-person visits over a two-year period, some to include blood draws.

Children who are randomly assigned to receive the placebo will be given the chance to receive the active vaccine after six months; therefore, all children in the study ultimately will have the opportunity to receive the active vaccine.  

The vaccine being studied is the same one that has been authorized for people ages 12 and older. In adults, this vaccine demonstrated 95% efficacy against COVID-19, and as of May 2021, nearly 140 million people in the U.S. had received at least one dose. Preliminary data show the vaccine to be safe in children as well as able to generate a strong immune response.

The research team plans to enroll about 100 local volunteers for the trial; the overall enrollment will be about 4,500. Children ages 6 months to 11 years who are generally healthy are eligible to be included.

“The Pfizer-BioNTech vaccine has been shown to be very safe and effective in adults and adolescents,” said Kimberly A. Boland, chief of staff, Norton Children’s Hospital, and department chair, UofL School of Medicine Department of Pediatrics. “We have every reason to believe this study will show the vaccine to be safe and effective in children and an important step forward for children’s health and for protecting our communities.”

Marshall is known for his work in vaccine development, advocacy and education. In fact, he has worked on many of the vaccines that children routinely receive today.

The clinical trial team has responded to the pandemic, treating children with COVID-19 and its consequences.

“This is the most exciting vaccine trial I have ever been involved with, and I’ve been doing this for over 30 years,” Marshall said.

Parents and caregivers can sign children up to be considered for the trial by going to .

UofL has been designated the first Center of Excellence by Pfizer Vaccines.

“UofL’s Division of Infectious Diseases has a rich history of collaboration with Pfizer through the successful implementation of numerous clinical epidemiological research studies. We are excited to formalize a long-term collaboration that builds on these past successes,” said Julio Ramirez, MD, chief of the Division of Infectious Diseases at the .

The Center of Excellence, directed by Ramirez, is a collaboration between the university and the pharmaceutical corporation aimed at determining the human health burden of important infectious diseases and potential vaccine effectiveness. The data will provide robust evidence to national health officials and independent policy makers who develop recommendations for the use of vaccines in immunization programs worldwide. Studies will take place in hospitals, long-term care facilities and the community.

UofL is the first Center of Excellence selected by Pfizer Vaccines Medical Development and Scientific/Clinical Affairs to be part of an international network of epidemiological research organizations. This designation is for a period of three years with an option for renewal. Pfizer selected UofL because of the university’s exceptional capabilities for conducting population-based surveillance and clinical research that engages multiple health care facilities, health care personnel, industry and communities-at-large.

“Pfizer has had an outstanding working relationship with the University of Louisville for more than 10 years,” said Luis Jodar, PhD, chief medical and scientific affairs officer, Pfizer Vaccines. “The quality of disease burden evidence varies widely worldwide. Deriving accurate and credible population-based incidence estimates require comprehensive surveillance to identify cases of diseases within a well-defined and well-characterized geographic area. Thanks to UofL’s excellent network of research partners, the population available for research studies in Louisville can provide the data to derive estimates of disease burden that can be generalized nationally.”

The demographics of Jefferson County, Kentucky, are similar to the United States in general, including racial and ethnic make-up, socioeconomic status, and the proportion of rural and urban populations.

The research studies conducted as part of the center may lead to economic growth and development for the city of Louisville and the Kentuckiana region, including jobs and educational opportunities in the health care industry.

“This collaboration will provide increased visibility for the university on a global scale, making UofL attractive for high-caliber researchers and research grants,” said Neeli Bendapudi, PhD, president of UofL. ”It also presents an exceptional opportunity for our researchers to improve the human condition by helping to reduce the burden of infectious diseases worldwide by generating data that will inform governments and health care policymakers.”

Pfizer studies anticipated for UofL include population-based surveillance of infectious diseases including Streptococcus pneumoniae, a bacteria which causes pneumonia and other infections, Clostridioides difficile, a bacteria that causes severe diarrhea and colitis, and respiratory syncytial virus (RSV), a common virus associated with mild cold-like symptoms but can cause severe infection in some people, including older adults. Visit for additional information on these diseases and two Center of Excellence studies already underway at UofL:

• The City of Louisville Diarrhea (CLOUD) study launched in September 2019. Pfizer will be providing up to $6.5 million in funding for a one-year study of the incidence of diarrhea among Louisville-area residents.
• The Louisville Pneumonia study is up to $4.5 million in funding provided by Pfizer for a one-year study of the incidence of pneumonia among adults in Louisville that launched in November 2019.

Check out the video for more information: 

Roberto Bolli, MD, director of the University of Louisville Institute of Molecular Cardiology, announced today that a new research trial funded by NIH National Heart, Lung and Blood Institute, the CONCERT-HF Study, is now open to enroll patients. The study is a Phase II, randomized, placebo-controlled trial of the safety, feasibility and efficacy of two types of adult stem cells used alone and in combination in patients with heart failure.

In addition to UofL, the study centers are Stanford University, the University of Miami, Indiana University, the Texas Heart Institute, the University of Florida and the Minneapolis Heart Institute Foundation. The School of Public Health at the University of Texas Health Science Center at Houston will serve as the data coordinating center.

In the study, two types of stem cells will be studied. Both are known as “autologous” stem cells because they come from the same patient in whom they are returned. The two types of adult stem cells used are autologous mesenchymal stem cells (MSCs) and c-kit+ cardiac stem cells (CSCs). MSCs will be manufactured from the patients’ own bone marrow while CSCs will be manufactured from the patients’ own heart tissue.

Bolli, who also serves as scientific director of the Cardiovascular Innovation Institute at UofL, is a pioneer in research using adult stem cells for cardiac disease. In the landmark 2011 SCIPIO trial, he and his research team were the first to successfully show the safety and potential efficacy of autologous c-kit+ stem cells taken via cardiac biopsy from patients who had suffered a previous heart attack.

SCIPIO enrolled 20 stem cell-treated patients with heart failure at UofL; four of the 20 patients discontinued the trial. Although definitive conclusions cannot be made because of the small number of patients, the results suggest a remarkable efficacy of autologous cardiac stem cells. After one year, the 16 patients in the study showed a 40 percent increase in the amount of blood their hearts were pumping. Moreover, MRIs in some patients showed significantly less dead heart tissue after the trial therapy, suggesting that the adult stem cell therapy was regenerative in nature.

Bolli practices with UofL Physicians. His success with the SCIPIO trial and his overall body of work, comprising more than 30 years of cardiac research, led to his successful grant application to establish a (CCTRN) center at UofL. This consortium of leading cardiovascular research organizations is sponsored by the National Heart, Lung, and Blood Institute and conducts early clinical trials of adult stem cell therapies in patients with cardiovascular disease.

“I continue to believe that adult stem cells could be the greatest advancement in cardiovascular medicine in my lifetime,” Bolli said. “CONCERT-HF is very important because it will help determine whether c-kit cardiac stem cells are effective and whether combining two stem cell types is more effective than giving one cell type alone.”