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Phase I Trial of Cytori Cell Therapy for Inflammatory Bowel Disease Published

SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today the publication of the results of a pilot clinical trial of Cytori Cell Therapy" for the treatment of recalcitrant enterocutaneous fistula in patients with inflammatory bowel disease. This single center, single arm exploratory study enrolled six patients with fistulas that had failed to heal following conventional therapy including antibiotics, drainage, irrigation and ileostomy. Four patients had fistula associated with Ulcerative Colitis (one following surgery for rectal cancer) and two patients had fistula secondary to Crohns Disease. All patients received a single treatment with the adipose derived cellular therapeutic injected into the peri-fistular region and into the fistula tract. Patients received a total dose of between approximately 1x107 and 1.4x108 adipose cells. Patients were followed for fistula closure and epithelialization at 4, 12, and 24 weeks after treatment.

Two serious adverse advents were observed in the trial. One patient had extended hospitalization resulting from relapse of their underlying Crohns disease and a second patient experienced a parastomal hernia. Neither complication was considered to be associated with adipose tissue harvest or delivery of the cell therapy.

A fistula closure rate of 83% (5 of 6 patients) was observed within four weeks after treatment. A fistula closure rate of 100% (all six patients treated) was observed at 24 weeks after treatment. A single patient had a recurrent fistula 10 months after the initial procedure related to a relapse in the primary disease.

This trial, published in the journal Surgery Today, was executed at the Osaka University Graduate School of Medicine in Osaka, Japan, by Professor Masaki Mori and colleagues. The study builds on prior reports using Cytori Cell Therapy" in a different kind of enterocutaneous fistula (fistula-in-ano) published by Dr. David Borowski and collaborators at North Tees Hospital...