ROCHESTER, Minn. — Dissolvable plug enables stem cell therapy with few side effects for single-tube patients perianal fistula, mayo clinic discovered by researchers. Perianal fistulas are painful tunnels between the intestines and skin that often do not go away with standard medical or surgical treatments.person who has crohn’s disease or other inflammatory bowel disease Who is at highest risk for this condition?
In a prospective Phase 1 clinical trial, researchers loaded stem cells from a patient’s own adipose tissue into a bioabsorbable plug that was surgically implanted to close the anal fistula tract. They followed patients for a year and reported their initial study results. Diseases of the colon and rectum.
“In this initial study, our team documented healing of single-canal fistulas.” Dr. Eric Dozois, a colorectal surgeon and lead author of the study. “In my 20 years of clinical experience, our fistula research suggests we are moving closer to a model of care.”
26% of patients with Crohn’s disease develop perianal fistulas. Most cases start as an infection within the anal glands, which often progresses to an abscess and sometimes requires surgery. If left untreated, a perianal fistula can leak fecal material, causing a permanent colostomy and, in some cases, cancer. A colostomy is a surgical opening in the abdomen that bypasses the damaged colon and removes solid waste from the body. Perianal fistulas can cause quality of life issues, such as having to wear pads to protect clothing and prevent odor.
“Perianal fistulas are a complex medical condition that can recur even after surgical repair, causing great suffering to patients,” he says. William Fabion Jr., MD, a gastroenterologist and senior author of the study. “Our hope with this research is to advance cell-based therapies that can be easily implanted in the operating room into routine clinical care, providing new options for patients with unmet needs.”
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The research team extracted mesenchymal stem cells from the adipose tissue of 20 patients with perianal fistulas who had not responded to standard medical or surgical treatments. Mesenchymal stem cells are adult stem cells with healing potential and are well-studied. After growing the stem cells in the lab, the researchers combined them with a plug made of a dissolvable material. They surgically implanted a plug to close the anal fistula tract, and he then monitored the patient seven times within 12 months, with an emphasis on safety studies. They also studied whether the therapeutic intervention led to a clinical cure and whether this could be confirmed through deep tissue imaging.
Dr. Dozois’ team recorded complete recovery in 14 patients at six months and 13 patients at one year. Three patients withdrew for various reasons during the clinical trial.
Four participants reported side effects, including infections requiring hospitalization or surgical drainage of abscesses. Twelve participants experienced reactions considered minor, including redness, fever, and nausea.
Based on their findings, Dr. Dozois’ team recommends further study of stem cell-coated fistula plugs using larger sample sizes and more types of fistulas. If all goes well, it could take him two to three years before the procedure is approved as routine clinical treatment.
Dr. Dozois, Dr. Fabion, and Mayo Clinic have a financial interest in regenerative fistula plug technology. All profits earned by Mayo Clinic from business ventures are reinvested into research and education efforts at Mayo.
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