Cytori Therapeutics, Inc. announced enrollment of the first two patients in an investigator-initiated clinical trial of Cytori Cell Therapy™ for the treatment of the orphan indication, fistula-in-ano associated with Crohn's Disease. This 10 patient open label trial is being performed by Professor Jean-Charles Grimaud and colleagues at the Hôpital Nord, Marseille, France under the authority of the Agence Nationale de Sécurité du Médicament (ANSM), the French equivalent of the US Food and Drug Administration (FDA). As with the SCLERADEC I trial of Cytori Cell Therapy performed by a different group in Marseille, this trial is being executed in an indication that has been recognized as orphan by both the European Medicines Agency and the US FDA.

Fistula-in-ano is an abnormal tunnel linking the interior of the lower intestine to the skin adjacent to the anus such that the contents of the intestines can leak through by-passing the anal sphincter. They are associated with substantial pain, risk of infection, and reduced quality of life. Fistulas occur in 20-40% of patients with Crohn's Disease with approximately 90% of these requiring surgical intervention.

More than 20% of patients do not achieve complete healing and recurrence is common, occurring in 20-35% of cases.