Safety evaluation being the primary objective, the three-arm, parallel design, randomised (1:1:1), placebo-controlled, double-blind single infusion study expects to enrol 45 subjects.
Two different dosages of Lomecel-B will be administered to the subjects with ageing-related frailty, characterised by low activity, slowness, weight loss, mobility impairment, fatigue and weakness.
Longeveron CEO Wa’el Hashad said: “In 2022, Longeveron aligned with the Japan Pharmaceuticals and Medical Devices Agency (PMDA), on the Phase II trial design and we hope the data from this trial will provide support for a limited approval under Japan’s Act on the Safety of Regenerative Medicine (ASRM), which allows regenerative medicine products to be administered to patients by approved hospitals or clinics under the practice of medicine.
“This is the first use of our US-manufactured product in Japan, and we look forward to advancing Lomecel-B as a treatment for ageing-related frailty in Japan.”
National Center for Geriatrics & Gerontology (NCGG/Nagoya) and Juntendo University Hospital (Tokyo) are the partners in the company’s Phase II study.
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NCGG president and Phase II trial principal investigator Hidenori Arai said: “I am pleased to see this clinical trial programme advancing, especially given the large unmet need in Japan, where nearly 30% of the population is over the age of 65.
“I was encouraged by Longeveron’s previously announced Phase IIb ageing-related frailty study in the United States, where subjects receiving a single infusion of Lomecel-B showed a statistically significant and clinically meaningful improvement in walking distance at nine months post-infusion compared to placebo.”
Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva.
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