Hope in stem cell therapy for perianal fistulas in patients with Crohn's disease
A dissolvable plug delivered stem cell therapy with few side effects in patients with single tract perianal fistulas, Mayo Clinic researchers discovered. 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. In a prospective, phase 1 clinical trial, researchers loaded stem cells from a patient's own fat tissue onto a bioabsorbable plug that was then surgically implanted to close the anal fistula tract.
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. After multiplying the stem cells in the lab, 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, with a focus on investigating safety. They also studied whether the treatment intervention led to clinical healing that could be confirmed through deep tissue imaging.
Dr. Dozois' team documented complete healing of 14 patients at six months and 13 patients at one year. Three patients withdrew for various reasons during the course of the clinical trial.4 Four participants reported side effects such as infections that required admission to the hospital or surgical draining of an abscess. Twelve participants experienced reactions considered to be minor, such as redness, fever or nausea.
Reference:
Eric Dozois, et al,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.
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