Photo Credit: Anusorn Nakdee
Researchers found that iltamiocel, an experimental cellular therapy made of autologous muscle-derived cells, was safe and potentially effective in treating adult fecal incontinence, with a significant decrease in the number of incontinence episodes, and improved QOL.
The following is a summary of “Safety and Efficacy of Iltamiocel Cellular Therapy for the Treatment of Fecal Incontinence. Results of a Phase 1/2 Study,” published in the December 2023 issue of Surgery by Knowles, et al.
For a study, researchers sought to determine if iltamiocel, an experimental cellular therapy made of autologous muscle-derived cells, is safe and effective for treating adult fecal incontinence (FI). Patients with FI who don’t respond to safe treatments don’t have many treatment choices. Autologous muscle-derived cells used in cell therapy are a hopeful and minimally invasive way to restore the function of the anal sphincter. In this prospective, multicenter, non-randomized study, 48 people were given a single dose of 250×106 iltamiocel cells.
The main result was the number of serious adverse events (AEs) linked to the product or treatment. Changes in the number of FI events, the Cleveland Clinic Incontinence Score, the Faecal Incontinence Quality of Life, and anorectal manometry at 3, 6, and 12 months compared to the start of the study were the secondary outcomes. There were no major adverse events (AEs), and one AE linked to the product was redness at the injection site. After a year, the median number of FI episodes (-6.0; 95% CI: -10.0 to -1.0) and days with episodes (-4.0; 95% CI: -8.0 to -1.0) went down. 53.7% of the people who took part had a 50% or greater drop in FI events, and 24.4% regained their continence.
The mean Cleveland Clinic Incontinence Score went down (-2.9; 95% CI: −3.7, −2.1), meaning symptoms improved and quality of life improved. Also, the quality of life for fecal incontinence increased (2.2; 95% CI:1.4, 2.9). Anorectal manometry readings showed that there were no major changes. A history of episiotomy was strongly linked to treatment success in a multivariate study. Iltamiocel cellular treatment can be given without any problems. Iltamiocel can potentially improve fecal incontinence symptoms and quality of life.