Treatment of faecal incontinence with autologous expanded mesenchymal stem cells: results of a pilot study

Abstract

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 mesenchymal stem cells derived from adipose tissue (AdMSCs) in the treatment of patients diagnosed with structural FI. Method This was a randomized, multicentre, triple‐blinded, placebo‐controlled pilot study conducted at four sites in Spain with 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 anaesthesia. We assessed the safety and feasibility of the treatment as the cumulative incidence of adverse events and the treatment efficacy using the Cleveland Clinic Faecal Incontinence Score, Faecal Incontinence Quality of Life score and 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 haematoma), and none was 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.

Reply to Balaphas et al.

“…We would like to thank Balaphas et al for the interest shown in our article [1]. Many of the observations they make in their kind letter have already been discussed in our paper and therefore we are in agreement with them.…”

A technique to reconstruct the anal sphincters following iatrogenic stretching related to a pull-through for Hirschsprung disease

“…Recent modifications of this technique by using elastic bands in adults with fecal incontinence has shown promising results [18] . Other new techniques like autologous expanded mesenchymal stem cells infusions still lack demonstrated efficacy [19] .…”

Stem Cells in Clinical Trials for Pelvic Floor Disorders: a Systematic Literature Review

“…Overall, 11 studies met the inclusion criteria and were incorporated into the final assessment [16][17][18][19][20][21][22][23][24][25][26]. Specifically, we found 7 papers dealing with stem cell therapy for stress urinary incontinence [16][17][18][19][20][21][22] and 4 with anal incontinence [23][24][25][26]. No papers concerning the use of SC for prolapse repair were retrieved.…”

“…In evaluating the impact of stem cell therapy on anal incontinence, 4 studies were analyzed (Table 2) [23][24][25][26]. Studies' design included two prospective single-arm studies [24,25] and two randomized controlled trials [23,26]. In total, 66 patients underwent stem cell therapy in the considered studies, including 10 men.…”