SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today enrollment of the first two patients in an investigator-initiated clinical trial of Cytori Cell Therapy™ for the treatment of the orphan indication, fistula-in-ano associated with Crohn’s Disease.
This 10 patient open label trial is being performed by Professor Jean-Charles Grimaud and colleagues at the Hôpital Nord, Marseille, France under the authority of the Agence Nationale de Sécurité du Médicament (ANSM), the French equivalent of the US Food and Drug Administration (FDA). As with the SCLERADEC I trial of Cytori Cell Therapy performed by a different group in Marseille, this trial is being executed in an indication that has been recognized as orphan by both the European Medicines Agency and the US FDA.
“This trial continues and expands the use of Cytori Cell Therapy in strategic niche indications such as orphan diseases. When coupled with the previously published trial data in fistula repair from Japan and the United Kingdom this trial could provide the basis for a follow-on sponsored clinical trial as part of a formal clinical development program,” said Dr. Steven Kesten, Chief Medical Officer at Cytori.
Fistula-in-ano is an abnormal tunnel linking the interior of the lower intestine to the skin adjacent to the anus such that the contents of the intestines can leak through by-passing the anal sphincter. They are associated with substantial pain, risk of infection, and reduced quality of life. 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.
The approach taken by Prof. Grimaud combines placement of a mixed cell/tissue product into the tissue surrounding the fistula while placing additional therapeutic cells within the fistula itself. Prof. Grimaud has considerable experience in this field with several published studies in the surgical management of fistula in patients with Crohn’s disease.
This trial builds on prior reports using Cytori Cell Therapy in fistula repair published by Mr. David Borowski and collaborators at North Tees Hospital in the United Kingdom and, most recently, by Professor Masaki Mori at Osaka University Graduate School of Medicine in Osaka, Japan. Links to further information about these studies are copied below.
Further details on Prof. Grimaud’s trial can be found at: https://clinicaltrials.gov/ct2/show/NCT02520843
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, clinical performance of our technology, including its safety and feasibility, the use of existing clinical data and data from ongoing investigator-initiated trials to support our development program, and publication of our study data, 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.