Cryptoglandular Fistula Repair Case Series Using Cytori Cell Therapy Published in the British Medical Journal: Case Reports
SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics (NAS: 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.
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 potentially incontinence.
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 only.
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