Autologous Muscle-Derived Cells for Urinary Sphincter Regeneration: Where are we now?

Abstract

Stress urinary incontinence (SUI) remains a strikingly common condition faced by women with substantial economic and quality of life impact. Embarking upon treatment for incontinence often culminates with invasive surgical procedures with recognized complication profiles. Innovative directions for SUI therapeutics are on the horizon, including the utilization of adult autologous muscle-derived cells for urinary sphincter regeneration (AMDC-USR). Current published literature presents safety and efficacy data regarding AMDC-USR injection in 80 patients at 12-month follow-up. No adverse events attributed to the cellular product were reported. Compared to lower dose groups, the higher dose groups demonstrated enhanced percentages of patients with at least 50% reduction in stress leaks and pad weight at 12-month follow-up. All dose groups had statistically significant improvement in patient-reported incontinence-specific quality of life scores at 12-month follow-up. Conclusions from the pooled analyses indicate that injection of AMDC-USR across a range of dosages appears safe. Efficacy data suggests a dose response with more patients responsive to the higher doses of AMDC-USR. Promising technologies for utilization of autologous cellular therapies for treatment of SUI, and conceivably multiple additional indications, are approaching fruition. Multiple phase III randomized, placebo-controlled studies for AMDC-USR are ongoing to bring this regenerative option forth for the millions of patients who may ultimately benefit.