2023-04-26 10:06:56
Injection of a high dose of autologous skeletal muscle cells followed by electrical stimulation of the pelvic floor significantly improved fecal incontinence (FI) symptoms. This was especially true in patients who had had FI for a short time and a high incontinence episode frequency (IEF).
It has been previously suggested that injection of autologous cells derived from skeletal muscle could improve FI. In this multicenter, placebo-controlled study, an international research group tested the effectiveness and safety of this cell therapy, with the aim of determining an appropriate dose and identifying which patients would benefit most from the therapy.
The researchers randomized 251 patients with weakness or damage to the external anal sphincter who had suffered from FI for at least 6 months to placebo, a low or high dose of cells. In addition, all patients received electrical pelvic floor stimulation before and after treatment. The IEF, FI quality of life (QoL), FI burden of disease on a visual analog scale, the Wexner score and parameters for anorectal physiological function were determined over a 12-month follow-up period.
The cell therapy improved IEF, FI QoL and FI disease burden. The improvement in IEF compared to placebo reached the predefined threshold of statistical significance. Furthermore, exploratory post-hoc analyzes showed that patients with limited duration of IF and high IEF at baseline responded best to therapy. The effects persisted or even intensified in the high cell group between 6 and 12 months, but stabilized or diminished in the low cell group and the placebo group. Most physiological parameters remained unchanged and no unexpected adverse events occurred.
The cell therapy may become a valuable treatment option in the future after confirmation of results in phase III trials.
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#Treatment #faecal #incontinence #implantation #autologous #cells #skeletal #muscle