Aurora St. Luke’s Medical Center in Milwaukee is one of the first two sites in Wisconsin to join a clinical trial evaluating a stem cell treatment for people with Crohn’s disease.
“As a quaternary care center, Aurora St. Luke’s can offer highly specialized and experimental treatments, in this case, utilizing our Regenerative Medicine Center to participate in a study of an investigational drug that uses stem cells donated by healthy patients to treat perianal fistulas in study participants with Crohn’s disease,” said gastroenterologist Nilay Kumar, MD, MPH, Advocate Aurora Research Institute’s site principal investigator for the study.
Crohn’s disease is a chronic, disabling condition that causes inflammation of the gastrointestinal tract. It affects more than 3 million Americans, according to the Crohn’s and Colitis Foundation. Left untreated, it can result in weight loss, fatigue, delayed growth in children, and bowel obstruction or the formation of abscesses and fistulas in the digestive tract.
“A perianal fistula is an abnormal channel that forms between the perianal tissue and the rectum/anus and frequently gets infected and painful,” Dr. Kumar said. “Studies have shown that up to 40% of patients with Crohn’s disease suffer from these painful and debilitating lesions.”
Participants in the study must have had an inadequate response to previous treatment for their fistulas. Some fistulas can be treated with antibiotics or other medications while others are severe enough to require surgery in order to be drained and closed.
For this clinical trial, participants will receive either a placebo or the study drug Cx601, a local injection of a solution containing stem cells derived from a healthy donor’s adipose tissue, or fatty connective tissue, which is an abundant source of adult stem cells.
In previous studies, Cx601 has shown the potential to aid the body’s immune system in healing complex fistulas in people with Crohn’s disease. The drug has been approved for use in Europe but not yet in the U.S.
“People with perianal fistulizing Crohn’s disease report a lower quality of life due to the nature of the disease,” said Laura Wrona, MSN, director of specialty clinical trials research at the Research Institute. “Stem cell therapy, or regenerative therapy, in conjunction with minimal colorectal surgical intervention promotes healing of fistulas from within and has been shown to be a very effective and minimally invasive technique that is currently in clinical use in Europe.”
Researchers across the country plan to enroll more than 500 participants in the clinical trial, “Study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC) for the treatment of complex perianal fistula(s) in participants with Crohn's disease (CD) (ADMIRE-CD-II),” which is sponsored by Tigenix S.A.U., manufacturer of the study drug.
To learn more about Advocate Aurora Health’s research, visit aurora.org/research.
