Longeveron and Miller School Stem Cell Research Advances to Finals of XPRIZE Healthspan for Aging Frailty

Key Points

• Longeveron has advanced to the finals of XPRIZE Healthspan and received a $1 million milestone award tied to its aging frailty program.
• The company plans to study laromestrocel, an investigational cell therapy, for effects on frailty, muscle function, cognition, and immune function in older adults.
• The program builds on mesenchymal stem cell (MSC) research licensed from the University of Miami Miller School of Medicine and earlier studies that showed improvement in six-minute walk distance.

Longeveron has advanced to the finals of XPRIZE Healthspan for its work on laromestrocel, an investigational cell therapy being studied for aging frailty. The company also received a $1 million milestone award to support a new clinical study in older adults.

The therapy traces back to research led by Joshua Hare, M.D., at the University of Miami Miller School of Medicine. Longeveron, which he co-founded in 2014, licensed the underlying stem cell technology from the university. The company is now preparing a randomized trial to test whether laromestrocel can improve six-minute walk performance, immune function, and cognitive function. Dr. Hare said Longeveron expects to begin enrolling participants in summer 2027.

Why Frailty Is the Focus

Aging frailty is associated with weakness, exhaustion, slower walking speed, and lower physical function. In older adults, it is also linked to a higher risk of falls, hospitalization, and death. Longeveron is positioning laromestrocel as a potential approach to address those declines, with a focus on muscle, cognitive, and immune function.

Earlier clinical work helped move the program forward. In a 2014 trial at the University of Miami, intravenous stem cell infusions were studied in people with mild to moderate aging frailty. According to the Longeveron, that trial showed improvement in six-minute walk distance, a common measure of mobility and functional capacity. Longeveron later launched another trial in 2017 and reported improved six-minute walk distance there as well. Nine months after treatment, fewer participants were classified as frail.

How the Cell Therapy Is Being Studied

The research centers on mesenchymal stem cell (MSC) therapy derived from adult bone marrow. Dr. Hare’s group and other researchers found that these cells do not appear to remain in the body long term. Instead, they release factors that may help modulate the immune system, affect small blood vessels, and support tissue repair.

The company also states that Dr. Hare and colleagues found allogeneic (donor derived) stem cells appeared to be at least as safe and effective as therapies made from a patient’s own cells, while also being more affordable. That work helped support the development path for laromestrocel.

For the final phase of XPRIZE Healthspan, Longeveron and 19 other finalists will submit trial data for review by independent judges in 2029. XPRIZE plans to announce the winner in 2030. “The XPRIZE catalyzed humans landing on the moon again, and now it’s trying to catalyze treatments for aging,” said Dr. Hare, also the director of the Donald Soffer Endowed Program in Regenerative Medicine, senior associate dean for experimental and cellular therapeutics, the Louis Lemberg Professor of Medicine (Cardiology), a professor of molecular and cellular pharmacology at the Miller School and a University of Miami professor of biomedical engineering. “If you can reduce aging frailty, for which our preliminary data has shown potential efficacy, that may translate to extending healthspan.”

“In 2014, there were very few people acknowledging that aging frailty was even a treatable disease,” he said. “For example, if you’re a geriatrician taking care of an 80-year-old, they can either walk to the grocery store or they can’t,” Dr. Hare explained. “It’s a good measure of quality of life and what we call functional capacity, but it’s also a measure of health. If you can walk a normal distance, you’re probably healthy.”

“The majority of what we develop in academia doesn’t have a commercial application, but it advances humankind by developing knowledge, which is in and of itself an important goal,” he said. “But when the knowledge appears to have a clinical/therapeutic opportunity, I think it’s logical that you hand it off to a group that focuses entirely on development and approval of the therapy and is willing to take a risk financially to make it happen. If it succeeds, everybody benefits.”

“It would be so exciting to see a concept developed in the laboratory reach patients and improve their health,“ Dr. Hare said. “At the end of the day, you want to see your ideas put into practice. That would be such a gratifying fulfillment.”

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