In a clinical trial, researchers loaded stem cells from a patient’s own fat tissue onto a bioabsorbable plug that was then surgically implanted to close an anal fistula tract. They followed the patients for one year and reported results.
Perianal fistulas are painful tunnels between the intestine and the skin that often do not go away with standard medical or surgical care. People with Crohn’s disease or other inflammatory bowel conditions are most at risk for this condition.
“Perianal fistulas are a complex medical condition that, even when repaired surgically, can reoccur, causing a lot of suffering for patients,” says William Faubion Jr., M.D
The research team extracted mesenchymal stem cells from adipose (fat) tissue of 20 patients with perianal fistulas who had not responded to standard medical or surgical treatment. The team combined the cells with a plug created from a dissolvable material. They surgically implanted the plug to close the anal fistula tract then monitored the patients seven times within 12 months.
Of the 20 patients enrolled, 3 were not included in the 12-month analysis because of study withdrawal. Through 12 months, no patient experienced a serious adverse event related to the stem cell–loaded plug. Dr. Dozois’ team documented complete healing of 14 patients at six months and 13 patients at one year.
Based on their findings, Dr. Dozois’ team is recommending further study of the stem cell-coated fistula plug with larger sample sizes and more types of fistulas. If all goes well, it could take two or three years before this procedure is approved for routine clinical care.
Sources:
Eric J. Dozois, Amy L. Lightner, Allan B. Dietz, Joel G. Fletcher, Yong S. Lee, Jessica J. Friton, William A. Faubion. Durable Response in Patients With Refractory Fistulizing Perianal Crohn’s Disease Using Autologous Mesenchymal Stem Cells on a Dissolvable Matrix: Results from the Phase I Stem Cell on Matrix Plug Trial. Diseases of the Colon & Rectum, 2022; 66 (2): 243 DOI: 10.1097/DCR.0000000000002579
Mayo Clinic. “Research finds hope in stem cell therapy for perianal fistulas in patients with Crohn’s disease.” ScienceDaily. ScienceDaily, 3 March 2023. <www.sciencedaily.com/releases/2023/03/230303105317.htm>.
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