Longeveron announces first patient dosed in Phase 2 trial of lomecel-B

Longeveron announced that the first patient has been treated with Lomecel-B in its Phase 2 clinical trial in patients with Aging-Related Frailty in Japan. The trial aims to enroll 45 patients and its primary objective is to evaluate safety. "We are excited to announce the dosing of the first patient in our Japanese Aging-Related Frailty trial," said Wa’el Hashad, Longeveron’s Chief Executive Officer. "In 2022, Longeveron aligned with the Japan Pharmaceuticals and Medical Devices Agency, on the Phase 2 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, 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 U.S.-manufactured product in Japan, and we look forward to advancing Lomecel-B(TM) as a treatment for Aging-Related Frailty in Japan."