Cytori Therapeutics has expanded its Celution system's CE mark approval to include several new indications including cryptoglandular fistula.
The Celution system, which pulls stem cells and other regenerative cells out of fat , provides clinical researchers with easy access to adipose-derived stem and regenerative cells at the point-of-care.
In addition, Cytori has expanded its European CE Mark indications to three other indications including tissue ischemia and soft tissue wounds or fistulae associated with trauma, diabetes, ischemia or radiation injury.
Cytori Therapeutics president Marc H. Hedrick said the initial impact to the company from the new indications is expected to come from additional translational system and consumable sales to meet demand by international hospitals to perform cell therapy clinical studies.
"Japan has been a working example of the impact from translational sales, which has historically represented a significant percentage of our product revenues," Hedrick added.
The new Ministry of Health, Labor and Welfare (MHLW) has approved an investigator-sponsored clinical study in Japan, using the Celution System for treatment of cryptoglandular fistulae, under its new Guidelines on Clinical Research Using Human Stem Cells.
Patients enrollment, which is currently underway in Japan sponsored trial, will be evaluated at six months for adverse event profile of frequency, type, severity and duration with a secondary endpoint of fistula closure ratio.
Osaka University Graduate School of Medicine chairman and gastroenterological surgery department professor Masaki Mori said, "We would like to treat our patients and collect clinical data to validate this new methodology."