2024-08-29

CTBE announces start of clinical trial for regenerative ligament for ACL reconstruction using decellularization technology

CTBE is pleased to announce that the 30-day investigation into the clinical trial application submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) for a pivotal study for regenerative ligament for Anterior Cruciate Ligament (ACL) reconstruction (hereinafter CT-ACL001) has been completed, and that the company will begin clinical trial in Japan. This clinical trial is a randomized, multicenter study evaluating the safety and efficacy of CT-ACL001 compared to standard of care in patients with ACL injuries requiring reconstruction surgery, with the goal of completing patient enrollment in the second half of 2025. This research and development, including this clinical trial, is supported by the Japan Agency for Medical Research and Development (AMED)'s CiCLE Practical Application Development Program. 　CT-ACL001 is developed as a ligament (medical device) that uses a unique decellularization process, freeze-drying and sterilization process using biological tissue as a material, into which the patient's own cells will infiltrate and ultimately regenerate after ACL reconstruction surgery. The core technologies of this product are "decellularization technology that can efficiently remove cellular components even from thick biological tissue" and "freeze-drying and sterilization technology that maintains the mechanical strength of tissue," developed by Professor Kiyotaka Iwasaki of Waseda University, founder of CTBE. These technologies simultaneously address the issues of "durability" and "biocompatibility," making it possible to put ligaments into practical use, which was previously impossible with chemically synthesized products.