ADRセラピューティクス' board of directors has decided to initiate a clinical trial of a treatment using adipose tissue-derived regenerative cells for critical limb ischemia. Following joint research with Nagoya University and completion of the PMDA consultation, the trial protocol has largely been finalized.
ADRセラピューティクス' board of directors has decided to initiate a clinical trial of a treatment using ADRCs for critical limb ischemia. The trial will be conducted as a confirmatory study at a phase equivalent to a Phase III clinical trial, with the aim of commercializing the treatment and securing insurance coverage.
The trial has been conducted under a joint research agreement with Nagoya University. The joint research agreement with Nagoya University was announced in May 2025, and validation of the treatment's efficacy has been underway.
The PMDA consultation has been completed, and the trial protocol has reportedly been largely finalized. Preparations for conducting the clinical trial are progressing.
In previous clinical trials, 29 patients and 34 limbs were studied, primarily at Nagoya University. Amputation was avoided in more than 90% of the patients, and reductions in wound size and increases in walking distance were also confirmed, according to reports.
Representative Director and President 鈴木 隆二 (鈴木隆二) has expressed an intention to pursue the early commercialization of the treatment.