Cryptoglandular Fistula Repair Case Series Using Cytori Cell Therapy
Published in the British Medical Journal: Case Reports
SAN DIEGO -- November 12, 2012
Cytori Therapeutics (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
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.
Based on a report of the American College of Surgeons, there are between
43,000 and 140,000 fistula cases per year in Europe, of which cryptoglandular
fistula are a subset. Cryptoglandular fistula is the most common cause of
persistent perianal infection, causing abnormal fecal contamination and
Cytori Therapeutics, Inc. is developing cell therapies based on autologous
adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and
repair soft tissue defects. Our scientific data suggest ADRCs improve blood
flow, moderate the immune response and keep tissue at risk of dying alive. As
a result, we believe these cells can be applied across multiple “ischemic”
conditions. These therapies are made available to the physician and patient at
the point-of-care by Cytori’s proprietary technologies and products, including
the Celution® system product family. www.cytori.com
Cautionary Statement Regarding Forward-Looking Statements
This communication includes forward-looking statements regarding events,
trends and business prospects, which may affect our future operating results
and financial position. Such statements, including, but not limited to, those
regarding the potential of Cytori’s cell therapy to help no-option patients,
and statements regarding the safety and feasibility of this procedure for
cryptoglandular fistula patients, are subject to risks and uncertainties that
could cause our actual results and financial position to differ materially.
Some of these risks and uncertainties include the uncertainties regarding the
collection and results of clinical data, as well as our history of operating
losses, regulatory uncertainties, dependence on third party performance, and
other risks and uncertainties described under the "Risk Factors" section in
Cytori's Securities and Exchange Commission Filings on Form 10-K and Form
10-Q. Cytori assumes no responsibility to update or revise any forward-looking
statements contained in this press release to reflect events, trends or
circumstances after the date of this press release.
The Celution® System is available in the United States for investigational use
Cytori Therapeutics, Inc.
Tom Baker, +1.858.875.5258
Megan McCormick, +1.858.875.5279
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