Treatment of Stress Urinary Incontinence
Stress urinary incontinence (SUI), defined as “the complaint of any involuntary loss of urine on effort or physical exertion (e.g sporting activities) or on sneezing or coughing”, is a highly prevalent and under-diagnosed disorder, which affects over 200 million people worldwide. It has a severe impact on physical and psychological health, and imposes a high financial burden on affected individuals, employers, healthcare systems and society.
Women are affected twice as often as men, with an estimated 30-60% of women above the age of 40 suffering from SUI. All existing treatment options have drawbacks that range from low and short-term efficacy (for conservative treatments) to potentially serious adverse events associated either with invasiveness or the introduction of foreign material (for more potent surgical approaches).
Our novel regenerative approach aims to provide a safe and effective treatment to patients suffering from SUI, allowing them to live to their full personal and professional potential.
In a first step, a small muscle biopsy is obtained from the patient. From this tissue, muscle precursor cells are isolated and expanded under strictly controlled GMP conditions. Following rigorous quality testing by an external, certified laboratory, the product is released and brought to the hospital for injection, where it is injected into the sphincter muscle of the patient. Once injected the cells begin to regenerate the sphincter muscle tissue, restoring strength and allowing it to perform its original function again.
If safety and efficacy can be proven through clinical trials, our therapy will present a low-risk, minimally invasive treatment for SUI which does not involve any synthetic material and addresses an underlying cause of the disease (i.e. intrinsic sphincter deficiency). Additionally, it is not prohibitive for follow-up treatments and does not complicate later childbirth.
Status of Clinical Development
Following over 12 years of preclinical research at the University of Zurich, our team received the approval for a first in-man trial in 2015 and completed GMP validation of our patented production process, leading to the start of the phase I clinical study at the University Hospital of Zurich in January 2020. The first patient was treated in March 2020 and the trial was completed in late 2021. Phase II was initiated in September 2022 and is currently ongoing.