First Patient Treated in Adipose Stem & Regenerative Cell Study for Stress Urinary Incontinence
Friday January 30, 9:29 am ET
NAGOYA, Japan--(BUSINESS WIRE)--Cytori (NASDAQ: CYTX - News) announced that the first patient was enrolled in an investigator-initiated safety and feasibility study using adipose-derived stem and regenerative cells to treat stress urinary incontinence. The 10-patient study is being conducted independently by Nagoya University Hospital in Japan. Cytori's Celution® 800 System is being used to process and extract the patients' own adipose tissue-derived stem and regenerative cells at the time of surgery.
“The Celution System is uniquely able to provide real-time access to clinical grade stem and regenerative cells to meet the growing demand Cytori is seeing from physicians seeking regenerative medicine-based treatments,” said Seijiro Shirahama, President, Cytori Asia Pacific. “As a result, hospitals are increasingly interested in a Celution purchase to fill this need in the marketplace. This demand is partially reflected in the seven investigator-initiated clinical studies taking place in Japan which use the Celution System.”
As part of the study, stem cells were injected intra-muscularly into the sphincter as well as in combination with a measured volume of the patient’s own fat tissue to create a bulking agent to support the urethra. The study will evaluate safety, functional endpoints including intraurethral pressure and leak point pressure, as well as subjective assessments of patient and physician satisfaction. Current treatments include use of collagen as a bulking agent to provide pressure against and support the urethra.
"There are a growing number of scientific publications that show adipose derived stem and regenerative cells can ameliorate urinary incontinence,” said Momokazu Gotoh, M.D., Ph.D., Professor and Chairman, Department of Urology, Nagoya University Graduate School of Medicine. “Celution is the only feasible way to derive the cells in a clinically practical manner. This first case could not have gone better and the Celution System performed flawlessly."
Stress urinary incontinence can have a significant impact on a patient’s quality of life, resulting in involuntary release of urine due a weakened urethral sphincter. The condition is more common in women and often comes about following child birth or menopause. It is estimated that approximately 9 million people in Japan, and more than 13 million women in the U.S., are affected by stress urinary incontinence. |
