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

• Published in: Colorectal disease Vol. 23; no. 3; pp. 698 - 709
• Main Authors: Portilla, Fernando, Guerrero, José Luis, Maestre, Maria Victoria, Leyva, Laura, Mera, Santiago, García‐Olmo, Damián, Rodríguez, Antonio, Mata, Rosario, Lora, Fabiola
• Format: Journal Article
• Language: English
• Published: England Wiley Subscription Services, Inc 01-03-2021
• Subjects: Adipose tissue; adipose‐derived stem cells; Adverse events; Anesthesia; Anorectal; anorectal disease; Autografts; clinical trials; faecal incontinence; Fecal incontinence; Hematoma; Mesenchymal stem cells; Patients; Placebos; Quality of life; Regenerative medicine; Sphincter; Stem cells; adipose-derived stem cells; stem cells; anorectal disease; clinical trials; faecal incontinence
• ISSN: 1462-8910; 1463-1318
• DOI: 10.1111/codi.15382

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.