(NASDAQ: CYTX) announced this morning that a peer-reviewed case series using Cytori’s cell therapy to treat patients suffering from complex cryptoglandular fistula has been published in the current issue of the
British Medical Journal: Case Reports
. The patients were treated by Dr. David Borowski and Dr. Pud Bhaskar, Consultant Surgeons at the University Hospital of North Tees, a National Health Service (NHS) hospital in the United Kingdom.
In this case series, three patients suffering from long-standing complex cryptoglandular fistula-in-ano were treated using fat grafts enriched with their own adipose-derived stem and regenerative cells (ADRCs), processed using Cytori’s Celution® system. The ADRC-enriched graft was injected directly into the tissue surrounding the fistula to close the fistula track. The interior opening of the fistula was closed with a mucosal advancement flap. All three patients remain fully healed at two to three year follow-up, with one patient undergoing colostomy reversal to restore bowel continuity.
“These three patients are the initial cases treated within a phase I feasibility study; all three had been suffering from the symptoms of their fistulae with considerable reduction in their ability to lead a normal life,” said Dr. Borowski. “Other treatments had failed, and the successful treatment with ADRC-enriched lipofilling has helped them to resume a normal lifestyle. With these encouraging results, we are currently collaborating with several other centers in the UK and Europe to explore the efficacy of this treatment in a greater number of patients, and for other indications, in the setting of clinical trials.”
This successful case series at a respected NHS hospital in the UK illustrates the breadth of Cytori’s soft tissue business and the potential of Cytori’s cell therapy to help patients who have few, if any, alternative treatment options. The data, showing that ADRC-enriched fat grafting appears to be safe and feasible for cryptoglandular fistula patients, validates the expansion of Cytori’s CE Mark claims to include cryptoglandular fistula and other soft tissue and wound indications in August of this year.