Stem cell therapy shows promise for reversing aging-related frailty in new clinical trial

A clinical trial report evaluates the efficacy and safety of laromestrocel for the treatment of aging-related frailty. Credit: Anastasia Shuraeva: https://www.pexels.com/photo/affectionate-elderly-couples-walking-in-a-park-8795091/

Stem cells are gaining attention for their potential to treat leukemia, certain solid tumor cancers, and inherited metabolic disorders. Now, a clinical trial reports that a single dose can significantly improve physical strength and key signs of aging in older adults with frailty.

Laromestrocel, also known as Lomecel-B, is a stem cell therapy made from the bone marrow of healthy young donors and developed by Longeveron Inc., a clinical-stage biotechnology company focused on regenerative cell therapies. In a recent report published in Cell Stem Cell, researchers shared results from a Phase 2b clinical trial testing of the therapy.

In this trial, researchers evaluated how much of the treatment was needed for it to be effective, following earlier Phase 2a studies that established its safety and potential benefits. The goal was to identify the safest and most effective dose before moving on to a much larger Phase 3 study.

A group of 148 older adults, aged 70 to 85 and with age-related fragility, were given a single dose of laromestrocel. Nine months later, nearly one-third of the patients treated with laromestrocel improved enough to be considered non-frail and showed a major increase in the distance patients could walk in six minutes, compared to those who got the placebo.

Patients who received the 200 million-cell dose of laromestrocel walked 63.4 meters farther than those who didn’t receive the treatment.

Restoring the repair cells

Frailty is a complex, age-related clinical condition that makes older people highly vulnerable to serious health problems, where even everyday activities can become physically stressful. Having frailty often exposes older adults to a series of risks including falls, disability, hospitalization, cognitive decline, and even death.

Estimates suggest that about 12% to 24% of people aged 65 and older live with frailty, and the number is expected to rise as the global population ages. This growing incidence is placing an increasing burden on health care and social care systems in both high- and lower-income countries. Despite how many people it affects, there are currently no effective medical therapies available to treat frailty.

The researchers of this study focused on three biological mechanisms that can give rise to frailty. The first being a low-grade, long-term inflammation often called inflammaging, where inflammation-causing molecules start to accumulate in the body. The second is vascular dysfunction, where problems in blood vessels prevent muscles from getting the nutrients they need. The final one being a decline in the body’s own supply of stem cells.

Laromestrocel therapy uses stem cells, which have the unique ability to develop into various specialized cell types that can help repair or replace damaged tissues and organs. This therapy aims to replenish some of the body’s lost stem cells and encourage the body to repair damage, ultimately helping restore physical strength and improve a person’s mobility.

The previous phase of laromestrocel’s clinical trial found that the treatment had a consistent pro-vascular and anti-inflammatory effect across different conditions. So, in Phase 2b they wanted to explore its impact of frailty and the most effective dose of it. For it, the participants were divided into four treatment groups where every group received a different dose of the medication and a placebo group.

Researchers observed a dose-dependent improvement in the 6-minute walk test (6MWT), meaning higher doses led to greater benefits. About 30.8% of treated patients improved to a non-frail status, suggesting the therapy may help reverse aspects of frailty, not just manage symptoms.

The improvements in physical function, mobility, and upper-body strength were also noticeable to the participants themselves, with patients reporting feeling stronger and more capable in daily activities and the results correlating with what was observed in the walking test.

The findings highlight stem cell therapy as a promising approach to help manage reduced mobility and other symptoms associated with aging-related frailty.

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