The Nagoya University has received the Japanese Ministry of Health, Labor and Welfare (MHLW approval to carry out an independent clinical study to assess the efficacy of adipose-derived stem and regenerative cells (ADRCs) in the treatment of stress urinary incontinence, using Cytori Therapeutics’ Celution Systems.
MHLW approval to proceed with the study reflects Cytori’s open operating system model in which hospital-based Celution Systems are used by different specialties for their own clinical research.
The study is a open label, non-randomized and enrolls up to 20 patients with mild incontinence, both females and males, at the Nagoya University Graduate School of Medicine and a potential second site.
Each patient will receive an injection of Celution derived ADRCs directly into the urethral sphincter and a periurethral injection of ADRC-enhanced fat graft to act as a bulking agent.
The study is used as the basis for a pivotal trial or to apply for regulatory approvals both in Japan and around the world.
The study is led by Nagoya University Graduate School of Medicine Department of Urology professor and chairman Momokazu Gotoh and associate professor Tokunori Yamamoto.
Cytori’s other products include StemSource for cell banking and research applications and PureGraft for fat grafting procedures.