A phase III randomized double blind parallel group placebo controlled international multicentre study to assess efficacy and safety of Cx601 adult allogeneic expanded adipose-derived stem cells (eASC) for the treatment of complex perianal fistula(

Brief description of study

The purpose of this study is to confirm (1) how well the investigational drug, Cx601, works at a single dose of 120 million cells compared to a placebo (looks just like Cx601, but contains no active ingredient); (2) how safe and tolerable the study drug is in patients with fistulizing Crohn’s disease (CD). Crohn's disease causes inflammation of the digestive tract, which can lead to abdominal pain, severe diarrhea, fatigue, weight loss and malnutrition. The inflammation caused by Crohn's disease often spreads deep into the layers of affected bowel tissue, which can lead to further complications including ulceration, resulting in the formation of abscesses and fistulas or tunnel-like formations in the skin and deeper tissues that surround the anal area. Cx601 is being investigated by the Sponsor for the treatment of complex perianal fistulas in CD patients. Cx601 is a solution containing fat-derived stem cells obtained from healthy donors. The study drug has shown the potential to prevent inflammation in some non-clinical studies. It is considered an investigational drug because it is still being tested in research studies like this one and does not have Food and Drug Administration (FDA) approval to be prescribed as a clinical treatment for complex perianal fistulas in people with CD.

Clinical Study Identifier: s18-00176
ClinicalTrials.gov Identifier: NCT03279081

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