Cx601: Phase I/II final data

Final data from an open-label, Spanish Phase I/II trial in 24 patients showed that Cx601 was safe with no treatment-related adverse events reported that indicated any clinical safety concerns at 6-month follow up. At week 24, Cx601 produced a reduction in the number of draining fistulas from baseline in 69.2% of patients. Furthermore, 56.3% of patients achieved a complete closure of the treated fistula and 30% of the cases presented complete closure of all existing fistula tracts. Cx601 produced significant reductions in severity as measured by MRI from baseline to week 12. Closure was defined as the absence of suppuration through the external orifice and complete re-epithelization, plus the absence of collections as measured by MRI scan. Patients received 20 million allogenic expanded adipose derived stem cells (eASCs) implanted into the wall of a single fistula tract, with a second dose of 40 million eASCs implanted if closure of the tract was not observed at week 12. Data were published in the International Journal of Colorectal Disease. ...