Longeveron, founded by Dr. Joshua Hare of the Miller School of Medicine, has been granted a U.S. patent (corrected link) for methods of administering its proprietary mesenchymal stem cell (MSC) therapy to treat aging-related frailty in patients with “inflammaging.”
I’ll be honest, the term “inflammaging” is new to me, but not to the world of geriatric medicine. Seems like it was first proposed around 2000 to describe the chronic, low-grade inflammatory state that typically develops with age and is associated with immunosenescence and age-related diseases. More recent work, including a 2018 “immune–metabolic viewpoint” paper, has helped pull the concept into mainstream aging research.
The proposed link is that aging can cause changes in the immune system that drive chronic inflammation and accelerate age-related frailty, resulting in symptoms such as weakness, reduced physical capability, slowed motor performance, exhaustion, and unintentional weight loss. There are no approved drugs that specifically treat frailty as a disease entity, so it is usually treated as an inevitable part of getting older, managed piecemeal with physical therapy, nutrition, and general medical care rather than a targeted intervention.
It’s important to note that the patent does not cover a novel cell therapy product; rather, it’s a “method-of-use” patent, legally protecting their way of using allogeneic human MSCs in this context.
The claims cover the administration of donor-derived bone marrow MSCs to older adults with signs of inflammaging, then demonstrating treatment benefit through predefined changes in immune biomarkers. These include reductions in “exhausted” B cells, activated T cells, Temra cells, and TNF-α levels, along with increases in switched memory B cells and the CD4:CD8 T-cell ratio. The patent also outlines dose ranges and routes of administration, such as intravenous or intramuscular infusion of approximately 20 million to 200 million MSCs in one or more doses, without HLA matching and without genetic modification of the cells.
Longeveron’s lead investigational product for this indication is laromestrocel (also known as Lomecel-B®), an allogeneic MSC therapy derived from bone marrow of young, healthy adult donors. Laromestrocel has reportedly shown positive initial results in Phase 1 and Phase 2 trials, with improvements in measures such as the six-minute walk test and other physical function endpoints observed among older adults with frailty. As always, these are relatively early-stage, small studies, and the therapy is not yet approved (yet).
The proposed mechanism of action appears to be primarily immunomodulatory, with a potential regenerative angle added. MSCs have well-described anti-inflammatory, pro-angiogenic, and pro-trophic effects, and have been studied in a range of cardiovascular, autoimmune, and orthopedic indications. The patent examples describe an “immunosenescence score” that improves after one or two infusions, which looks to be the core science they are protecting.
Beyond aging-related frailty, Longeveron is developing laromestrocel for additional indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, and pediatric dilated cardiomyopathy (DCM). The company has received several FDA designations across these programs, including Orphan Drug designation and Fast Track designation for HLHS, Rare Pediatric Disease designation, Regenerative Medicine Advanced Therapy (RMAT) designation, and Fast Track designation for its Alzheimer’s program.
For more information about Longeveron’s research pipeline or clinical programs, visit their website.
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