Treatment of fecal incontinence with autologous expanded mesenchymal stem cells: results of a pilot Study.

AIM Management of faecal incontinence (FI) remains challenging because no definitive optimal treatment for this condition has yet been determined. Regenerative medicine could be an attractive therapeutic alternative for treating FI. Here, we aimed to determine the safety and feasibility of autologous expanded AdMSCs in the treatment of patients diagnosed with structural FI. METHOD This was a randomized, multicenter, triple-blinded, placebo-controlled pilot study conducted at four sites in Spain in 16 adults with FI and a sphincter defect. Autologous AdMSCs were obtained from patients from surgically excised adipose tissue. These patients were intralesionally infused with a single dose of 4 × 107 AdMSCs or a placebo while under anesthesia. We assessed the safety and feasibility of the treatment as the cumulative incidence of adverse events (AEs) and the treatment efficacy using the Cleveland Clinic Faecal Incontinence Score (CCFIS), Faecal Incontinence Quality of Life (FIQL) score, Starck criteria to classify sphincter defects, and anorectal physiology outcomes. RESULTS Adipose tissue extraction, cell isolation, and intralesional infusion procedures were successful in all the patients. There was only one adverse event connected to adipose tissue extraction (a hematoma) and none were associated with the injection procedure. There were no significant differences in any of the assessed clinical, manometric, or ultrasonographic parameters. CONCLUSION This study indicates that this infusion procedure in the anal sphincter is feasible and safe. However, it failed to demonstrate efficacy to treat patients with structural FI.