Ageing-related frailty is characterised by weight loss, mobility impairment, fatigue and weakness. Credit: fizkes via

Longeveron has treated the first patient with Aging-Related Frailty in its first-in-human Phase II clinical trial of Lomecel-B, an allogeneic medicinal signalling cell (MSC) therapy product in Japan.

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.”

Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.