Stress Urinary Incontinence Study to Assess Safety and Efficacy of Muvon's Muscle Precursor Cell Therapy — SUISSE MPC2  

Female Stress Urinary Incontinence Clinical Trial

Official title: Stress Urinary Incontinence Study to Assess Safety and Efficacy of Muvon's Muscle Precursor Cell Therapy

Status Recruiting

Clinical Trial Summary

The aim of the SUISSE MPC 2 study is to treat stress urinary incontinence in adult women.

Clinical Trial Description

Stress urinary incontinence is the loss of small amounts of urine associated with coughing, laughing, sneezing, exercising or other movements that increase pressure on the abdomen and therefore increasing the pressure on the bladder.

The goal of the SUISSE MPC2 study is to treat SUI in women using their own autologous muscle precursor cells. To guarantee enough outcome data, a sufficient number of patients will be enrolled to complete the study with 70 patients.

The study will last approximately 8-9 months per patient. Each patient's baseline measurements serve as comparison for the treated measurements.

Patients will participate in the study for up to approximately 8 to 9 months, including a baseline visit for screening, a visit to obtain a muscle biopsy up to 12 weeks later, an injection of MPCs up to 5 weeks later, and follow-up visits after 1, 3 and 6 months post injection. The injection is performed with ultrasound guidance using an endocavity ultrasound probe mounted on an Injection Device specifically designed for the clinical trial.

All patients will be treated with one of the two doses of MPCs, assigned according to the study's randomization method.

Half of the participating patients will receive the cell therapy that was previously studied in the completed phase I study. The other half of the participants will receive a higher dose of the cell therapy to investigate the effects of dose increase. Both groups of patients will be additionally monitored by medical examinations performed by clinicians to ensure the safety of the treatment.

Furthermore, separate to the Principal Investigator, safety events will be reported to and investigated by the independent Data Safety Monitoring Board consisting of independent physicians and experts in the field. Data regarding the functionality and safety of the Injection Device will also be collected. ;

Related Conditions & MeSH terms

• Enuresis
• Female Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

• NCT number: NCT05534269
• Study type: Interventional
• Source: University of Zurich
• Contact: Markus Veit
• Phone: +41442551223
• Email: markus.veit@usz.ch
• Status: Recruiting
• Phase: Phase 2
• Start date: October 17, 2022
• Completion date: November 2025