- Enrollment is underway in a Phase 2 clinical trial assessing Cytori Therapeutics' (CYTX +2.9%) Cytori Cell Therapy for the treatment of fistula-in-ano associated with Crohn's disease. The 10-patient open-label study will be conducted at a single site in France. If successful, it could provide the basis for a formal clinical development program. It is designated an Orphan indication in both the EU and U.S.
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Fistula-in-ano is an abnormal linking of the interior of the lower intestine to the skin adjacent to the anus which results in the leakage of contents via by-passing the anal sphincter. It occurs in up to 40% of Crohn's patients. Nine out of 10 require surgical intervention. Recurrence is common, affecting up to 35% of cases.
- The study will combine the placement of a mixed cell/tissue product into the tissue surrounding the fistula while placing additional therapeutic cells within the fistula itself.