Phase I Trial of Cytori Cell Therapy for Inflammatory Bowel Disease Published
Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today the publication of the results of a pilot clinical trial of Cytori Cell Therapy™ for the treatment of recalcitrant enterocutaneous fistula in patients with inflammatory bowel disease. This single center, single arm exploratory study enrolled six patients with fistulas that had failed to heal following conventional therapy including antibiotics, drainage, irrigation and ileostomy. Four patients had fistula associated with Ulcerative Colitis (one following surgery for rectal cancer) and two patients had fistula secondary to Crohn's Disease. All patients received a single treatment with the adipose derived cellular therapeutic injected into the peri-fistular region and into the fistula tract. Patients received a total dose of between approximately 1x107 and 1.4x108 adipose cells. Patients were followed for fistula closure and epithelialization at 4, 12, and 24 weeks after treatment.
Two serious adverse advents were observed in the trial. One patient had extended hospitalization resulting from relapse of their underlying Crohn's disease and a second patient experienced a parastomal hernia. Neither complication was considered to be associated with adipose tissue harvest or delivery of the cell therapy.
A fistula closure rate of 83% (5 of 6 patients) was observed within four weeks after treatment. A fistula closure rate of 100% (all six patients treated) was observed at 24 weeks after treatment. A single patient had a recurrent fistula 10 months after the initial procedure related to a relapse in the primary disease.
This trial, published in the journal "Surgery Today", was executed at the Osaka University Graduate School of Medicine in Osaka, Japan, by Professor Masaki Mori and colleagues. The study builds on prior reports using Cytori Cell Therapy™ in a different kind of enterocutaneous fistula (fistula-in-ano) published by Dr. David Borowski and collaborators at North Tees Hospital in the United Kingdom in the journal "Surgical Innovation". A follow on European physician initiated trial for patients with fistula-in-ano is planned to begin enrollment later in 2015. More details can be found on clinicaltrials.gov (NCT02558543) and the company will provide updates as appropriate.
"This small but carefully performed trial led by the Chief of Surgery at Osaka University in Japan is encouraging for a number of reasons," said Dr. Marc H. Hedrick, President & CEO of Cytori. "This trial supports other published clinical data reporting benefit of our cellular therapeutics on impaired wound biology through mechanisms of actions that are likely similar to that proposed in many conditions and clinical situations such as scleroderma and further supported in our BARDA funded preclinical work. Poor wound healing, broadly construed, represents a very large market opportunity therefore we are carefully evaluating the business case to expand similar clinical trials."
A fistula is an abnormal tunnel linking the interior of the stomach or intestines to the skin such that the contents of the intestines leak through. They are associated with substantial pain, risk of infection, and reduced quality of life. Fistulas of this kind are both more common and more difficult to treat in patients with inflammatory bowel diseases such as Crohn's Disease and Ulcerative Colitis. 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.
Mizushima et al, Surg. Today doi: 10.1007/s00595-015-1246-8 "A clinical trial of autologous adipose-derived regenerative cell transplantation for a postoperative enterocutaneous fistula." http://www.ncbi.nlm.nih.gov/pubmed/26342817
Borowski et al, Surg Innov. pii: 1553350615572656 "Adipose Tissue-Derived Regenerative Cell-Enhanced Lipofilling for Treatment of Cryptoglandular Fistulae-in-Ano: The ALFA Technique." http://www.ncbi.nlm.nih.gov/pubmed/25710946
Statistical information on fistula in Crohn's Disease cited from Geltzeiler et al (2014) Ann Gastroenterol 27 (4) 320-30 and from Nelson and Abcarian in "Anal Fistula: Principles and Management" edited by M Abcarian (2014) Springer NY
Other info from the Crohn's and Colitis Foundation of America http://www.ccfa.org/assets/pdfs/updatedibdfactbook.pdf
About Cytori Therapeutics, Inc.
Cytori Therapeutics is a late stage cell therapy company developing autologous cell therapies from adipose tissue to treat a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori's proprietary technologies and products. For more information: visit www.cytori.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, without limitation, conduct of future clinical trials, are all subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include, but are not limited to, inherent risk and uncertainty in the protection intellectual property rights, regulatory uncertainties, risks in the conduct of clinical trials, risks in the collection and results of clinical data, final clinical outcomes, dependence on third party performance, performance and acceptance of our products in the marketplace, as well as other risks and uncertainties described under the heading "Risk Factors" in Cytori's Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
Cytori Therapeutics, Inc.
Tiago Girao, +1 (858) 458.0900