First Patients Enrolled in Trial for Crohn’s Disease-associated Fistulas

First Patients Enrolled in Trial for Crohn’s Disease-associated Fistulas

Cytori Therapeutics, a company specializing in the development of cell therapies for the treatment of various medical conditions, recently announced the start of a clinical trial for Cytori Cell Therapy, a potential treatment for a serious infection associated with Crohn’s disease.

Inflammatory bowel disease (IBD) involves a chronic inflammation of the colon and small intestine; the two principal types are Crohn’s disease and ulcerative colitis.

Cytori reports the first two patients have been recruited in the Cytori Cell Therapy trial. Ten will eventually be enrolled. The trial is for a disorder called fistula-in-ano, or anal fistula, where an abnormal tunnel forms linking the interior of the lower intestine to the skin near the anus, resulting in pain, infection, and leakage from the intestines.

According to the Crohn’s and Colitis Foundation of America, between 68,000 and 96,000 incidents of anal fistulas are reported every year in the U.S., and up to 1.6 million Americans are affected by IBD.

Between 20 and 40 percent of Crohn’s patients suffer from fistulas, and surgery is required in 90 percent of the cases. However, even with surgery, 20 to 35 percent of patients may experience recurrence, and 20 percent of those who undergo surgery do not reach full healing.

Due to the limitations of current therapeutic strategies, cell therapy has emerged as a promising option for treating various incurable conditions, including fistula in-ano, which has been granted an orphan designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency.

The Cytori open-label trial will be conducted at the Hôpital Nord in Marseille, France, by Prof. Jean-Charles Grimaud and colleagues under the authority of the Agence Nationale de Sécurité du Médicament (ANSM), the French equivalent of the FDA.

The approach taken by Grimaud is built on previous publications by David Borowski and colleagues at North Tees Hospital in the United Kingdom, and recent work by Prof. Masaki Mori at Osaka University Graduate School of Medicine in Japan.

Grimaud, an experienced and published author in the surgical management of fistula in patients with Crohn’s disease, will utilize Cytori Cell Therapy in fistula repair by injecting a combination of cell tissue material into the tissue around the fistula in addition to injecting therapeutic cells inside the fistula itself.

“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,” Dr. Steven Kesten, chief medical officer at Cytori, said in a press release.

For more information about this ongoing clinical trial in France, please visit the website link.

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