Rohto starts Phase II trial of RE-01 cell therapy for refractory ischemic leg ulcers

• Rohto began CDMO manufacturing for RE-01 cell therapy used in a Phase II investigator-led trial for refractory ischemic lower-limb ulcers.
• Trial targets non-arteriosclerotic ulcers linked to Buerger’s disease or collagen diseases; designed as a multicenter randomized controlled study versus standard care.
• Investigational product will be produced at subsidiary Rohto Cell Factory Tokyo under a manufacturing outsourcing agreement with Riail.
• Program follows completion of a Phase I investigator-led study of RE-01 assessing safety, efficacy, multiple dosing (jRCT2033220413).
• Development aims to address lack of effective treatments, with progression often leading to amputation.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Rohto Pharmaceutical Co. Ltd. published the original content used to generate this news brief on September 16, 2026, and is solely responsible for the information contained therein.