Longeveron has signed a sponsored clinical research agreement with Japan’s National Center for Geriatrics and Gerontology (NCGG) and Juntendo University Hospital for the Phase II clinical trial of Lomecel-B in the country’s ageing frailty patients.
The double-blind, randomised, placebo-controlled trial will assess the efficacy and safety of Lomecel-B in these patients.
A cell-based therapy product, Lomecel-B is derived from medicinal signalling cells (MSCs) sourced from the bone marrow of young and healthy adult donors.
It has been assessed in Phase I and II clinical studies in the US for ageing frailty.
The product recently received a rare paediatric disease designation from the US Food and Drug Administration for the treatment of hypoplastic left heart syndrome in infants.
Longeveron CEO Geoff Green said: “We are excited to embark on this collaboration with the NCGG, one of the top advanced and specialised medical research centres in Japan, and Juntendo University Hospital.
“We believe our work could be especially impactful in Japan, which has one of the oldest and fastest ageing populations in the world, and where early identification and intervention of frailty is a priority.”
Japan’s Pharmaceuticals and Medical Devices Agency has approved the Phase II clinical trial, which is expected to recruit 45 subjects.
The subjects will be enrolled at NCGG, Juntendo University Hospital in Tokyo and Koto city.
In the trial, three cohorts each comprising 15 subjects will be randomised and given one intravenous infusion of Lomecel-B 50 million cells, Lomecel-B 100 million cells, or a placebo.
The study’s primary goal is to assess Lomecel-B’s safety and efficacy on physical function, daily living activities, biomarkers related to inflammation in the blood, as well as other endpoints.
Last February, Longeveron completed patient enrolment in its Phase IIb Ageing Frailty trial to assess the safety and efficacy of Longeveron Allogeneic Mesenchymal Stem Cells (LMSCs) to treat mild to moderate frailty.