Cytori Therapeutics has expanded the Celution system’s CE mark approval to include new indications including cryptoglandular fistula, caused by perianal infection, abnormal fecal contamination and incontinence.
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.
The new indication of cryptoglandular fistula repair will facilitate the use of the Celution system for clinical cases potentially, as part of independently sponsored and funded studies, according to the company.
In addition, Cytori has expanded its CE mark indications to three other applications including tissue ischemia and soft tissue wounds or fistulae associated with trauma, diabetes, ischemia or radiation injury.
Marc H. Hedrick, Cytori Therapeutics president, 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.
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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 in the ongoing 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.
Masaki Mori, Osaka University Graduate School of Medicine chairman and gastroenterological surgery department professor, said: "We would like to treat our patients and collect clinical data to validate this new methodology."
University Hospital of North Tees general and colorectal surgeon consultant Dr. David Borowski said: "Based on the feasibility study and the new indications for Celution, we are planning a larger, controlled, multicentre study in the UK to investigate the benefit of the addition of adipose derived regenerative cells."