January 19, 2016 8:28am

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 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.

 

 

The Bottom Line: The approach taken by Prof. Grimaud combines placement of a mixed cell/tissue product into the tissue surrounding the fistula while placing additional therapeutic cells within the fistula itself.

CYTX closed last Friday at $0.15 which was UP +$0.01; for any appreciation. It is a positive but, any appreciation stays and plays out in the hands of day traders. CYTX needs a reverse to take “care” of share pricing <shares outstanding = 158.93 M with a 133.97 M float, NASDAQ listing and 9.21% holding by Sabby <hedge fund>

 

 

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.

The Crohn’s and Colitis Foundation of America estimates that as many as 1.6 million Americans are affected by inflammatory bowel disease. It has been estimated that the incidence of rectoanal fistula in the USA is 68,000-96,000 cases per year.