Dr. Hare is also the Founder of Longeveron LLC, a Miami-based life sciences company that licensed the stem cell technology developed at the University of Miami Miller School of Medicine.
Funding from the National Institutes of Health supports Longeveron’s mission to explore the potential medical applications for mesenchymal stem cell therapy. A single injection of the allogeneic mesenchymal stem cells, in fact, was associated with significant gains in functional capacity in both Phase I and Phase II studies Longeveron published in The Journals of Gerontology in 2017.
“Frailty is not an inevitable effect of aging, but can be thought of — in general terms — as unsuccessful aging and an increased vulnerability to stressors,” Dr. Hare said during the interactive panel at the workshop, which featured six experts and was jointly sponsored by the National Institutes of Health and the U.S. Food and Drug Administration.
Addressing a large unmet need is one impetus for developing the stem cell therapy. There are no available medical treatments for Aging Frailty, a condition which affects over 3.6 million individuals over the age 65 in the U.S.. Importantly, the number of people affected with Aging Frailty is expected to grow along with the aging of the population.
People with Aging Frailty tend to lose weight, walk more slowly, and experience weakness and fatigue. In each case, the mechanism of action of the stem cells is linked to these prominent phenotypes of Aging Frailty. The mechanism of action is complex and involves multiple aspects, including growth factors, exosomes and cell organelles.
Depletion of endogenous stem cells is believed to be one contributing factor to Aging Frailty. Dr. Hare and colleagues propose that mesenchymal stem cells will be effective to reverse or prevent effects of Aging Frailty because they are anti-inflammatory, anti-fibrotic (prevent scarring), promote growth of new blood vessels and are pro-regenerative. “These cells could have a benefit in offsetting or reversing Aging Frailty,” he said at the workshop.
In addition to dose-dependent gains in a six-minute walk test after the injection of stem cells, the researchers also reported improvements in lung function tests and decreases in TNF-alpha, a biomarker believed to contribute to the Aging Frailty syndrome.
Encouraged by the results to date, Dr. Hare and colleagues are now enrolling patients in a Phase 2b multi-center national clinical trial sponsored by Longeveron. The study will evaluate Aging Frailty using Longeveron’s proprietary mesenchymal stem cells. The aim is to better define the dose-response observations, validate biomarkers, and overall to further advance the use of mesenchymal stem cells in this population.
“If this bears out in a larger trial, we’ll have a situation where we can apply regenerative medicine to a syndrome with a worldwide unmet need,” Dr. Hare said.
Longeveron is a regenerative medicine therapy company founded in 2014. Longeveron’s goal is to provide the first of its kind biological solution for aging-related diseases, and is dedicated to developing safe cell-based therapeutics to revolutionize the aging process and improve quality of life. The company’s research focus areas include Alzheimer’s disease, Aging Frailty, and the Metabolic Syndrome, and gratefully acknowledges the generous support of the National Institutes of Health and the Alzheimer’s Association. Longeveron is also conducting a Phase 1 trial with the University of Maryland and Johns Hopkins University to study Hypoplastic Left Heart Syndrome, a rare indication that affects infants, and gratefully acknowledges the support and collaboration from the Maryland Stem Cell Foundation.
To learn more, visit Longeveron.com.