A stem cell therapy improved mobility in older adults with age-related frailty after nine months in a phase 2b trial, compared with placebo.
Frailty is a condition in which older people become less able to cope with everyday or sudden stress, leaving them more vulnerable to illness, injury and poor outcomes after surgery.
The study tested laromestrocel, an intravenous therapy derived from donor bone-marrow mesenchymal stem cells.
A total of 148 ambulatory adults with frailty took part, with researchers assessing physical performance and patient-reported outcomes.
Participants receiving the therapy walked further in the six-minute walk test, a standard measure of physical capacity.
After nine months, the treatment group walked an average of 63.4 metres more than those given placebo, a result described as clinically meaningful. At six months, the improvement was 41.3 metres but did not reach statistical significance.
The trial was conducted by Longeveron, a Miami-based clinical stage biotechnology company developing regenerative cell therapies for rare paediatric and chronic age-related conditions.
Joshua M. Hare, chief science officer at Longeveron, said: “We are highly encouraged by these Phase 2b results that demonstrate the potential of stem cell therapy to improve the condition of patients with ageing-related frailty.
“Those with Ageing Frailty are disproportionately compromised in their ability to cope with every day and acute stressors, are at high vulnerability to disease and injury, and are at increased risk for poor outcomes and death after surgery.
“This development area is at the core of Longeveron’s mission advancing stem cell therapies addressing life threatening conditions in the most vulnerable populations children and the elderly.”
Researchers also identified a potential biomarker, meaning a measurable biological indicator, linked to treatment response.
Higher doses of laromestrocel were associated with reductions in soluble TIE-2, a protein involved in blood vessel signalling.
Laromestrocel is being evaluated across several conditions.
The company said the findings point to a possible stem cell therapy approach for managing reduced mobility and other features of age-related frailty.