Objective: To treat anal incontinence due to obstetric external anal sphincter disruption via injection of autologous myoblast cells.
Design: Observational pilot study.
Setting: University hospital and district hospital
Patients: 10 women suffering from anal incontinence due to obstetric anal sphincter injury, refractory to conventional non-surgical therapy.
Interventions: Autologous myoblasts were cultured from a pectoralis muscle biopsy, harvested, and injected into the external anal sphincter defect using direct ultrasound guidance.
Main outcome measures: Wexner incontinence score, anal squeeze pressures, and quality of life 12 months after injection. Safety and technical feasibility.
Results: The procedure was well tolerated and no adverse events were observed. At 12 months the Wexner incontince score had decreased by a mean of 13.7 units (95% CI, −16.3 to −11.2), anal squeeze pressures were unchanged, and overall quality of life scores improved by a median of 30 points (95% CI, 25 to 42). Anal squeeze pressures did rise significantly at 1 month and 6 months post-injection (p = 0.03).
Conclusions: Injection of autologous myoblasts is safe, well tolerated, and significantly improves symptoms of anal incontinence due to obstetric anal sphincter trauma.
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The views expressed in this publication are those of the authors and not necessarily those of the UK Department of Health.
Funding This study was funded by the Medical University of Graz (Investgator time and clinical facilities for implantation) and University College London (Investigator time). Innovacell Biotechnology cultured the myoblast cells free of charge but had no role in the study design, patient recruitment, data collection, data analysis, data interpretation, or writing of the manuscript. Statistical analysis was performed by an independent biostatistician who is not employed by the corporate entity. The guarantors (AF and SH) had full access to all study data and had final responsibility for the decision to submit for publication. Additionally, a proportion of this work was undertaken at UCLH/UCL, which receives funding from the UK Department of Health’s NIHR Comprehensive Biomedical Research Centre funding scheme.
Competing interests WS is an employee of Innovacell Biotechnology, Innsbruck, Austria, who provided the autologous myoblasts described in the manuscript. Innovacell had no role in the study design, patient recruitment, data collection, data analysis, data interpretation, or manuscript writing. The other authors have no conflicts of interest to declare.
Ethics approval The study protocol was approved by the Ethics Committee of the Medical Universities of Innsbruck and Graz, and registered with the European Union Drug Regulatory Authorities: EudraCT-Nr.2005-003759-11.
Provenance and Peer review Not commissioned; externally peer reviewed.
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