May 26, 2024

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Treatment of fecal incontinence by transplanting autologous cells from skeletal muscles

Treatment of fecal incontinence by transplanting autologous cells from skeletal muscles

Injection of a high dose of autologous skeletal muscle cells followed by electrical stimulation of the pelvic floor significantly improved symptoms of fecal incontinence (FI). This was particularly true in patients who had short-term faecal incontinence with recurring episodes of incontinence (IEF).

It has previously been suggested that injection of autologous cells derived from skeletal muscle can improve faecal incontinence. In this multicenter, placebo-controlled study, an international research group tested the efficacy and safety of this cell therapy, with the goal of determining the appropriate dose and identifying which patients would benefit most from the treatment.

Researchers randomly assigned 251 patients with weakness or damage to the external anal sphincter who had had fecal incontinence for at least 6 months to a placebo, which is a low or high dose of the cells. In addition, all patients received pelvic floor electrical stimulation before and after treatment. IEF, FI, quality of life (QoL), and disease burden FI were determined on a visual analogue scale, Wexner score, and anorectal physiological function measures over a 12-month follow-up period.

Cell therapy improved IEF disease burden, FI QoL, and FI. The improvement in IEF compared to placebo reached a prespecified statistical significance threshold. Furthermore, post-hoc exploratory analyzes showed that patients with limited duration of IF and high IEF at baseline responded better to treatment. Effects persisted or intensified in the high cell group between 6 and 12 months, but stabilized or diminished in the low cell group and placebo group. Most physiological parameters remained unchanged and no unexpected adverse events occurred.

Cell therapy may become a valuable treatment option in the future after results are confirmed in phase III trials.

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Frudinger A, Gauruder-Burmester A, Graf W et al. Skeletal muscle cell transplantation for the treatment of fecal incontinence: a randomized, placebo-controlled study. Clen Gastronerol Hepatol 2023; 21:476-486.e8.