San Diego, USA-headquartered Cytori Therapeutics says that the first subject has been 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," he added.
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, the firm said.
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