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

SUISSE MPC2

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

2022-10-17

2024-11-01

2025-11-01

Recruiting

Early phase I

70

Inclusion Criteria: * Predominant clinical diagnosis of SUI * Stress incontinence ≥ grade I for at least 6 months * Patient has at least once been treated with, and failed prior conservative treatments * Patient had no improvement of SUI symptoms for at least 6 months before enrollment * Patients with a certain amount of leaks or /and a predefined pad weight at screening * Candidate for a surgical treatment * Negative blood test: Human immunodeficiency virus (HIV 1/2), Hepatitis B HBsAg, Anti HBc, Hepatitis C, Anti-HCV-Ab and Syphilis * Negative laboratory or blood test, and medical examination to eliminate risk of sexually transmitted diseases (STD) per investigators' discretion * Competent to comprehend, sign, and date informed consent form before any study-specific procedure is performed * Able to communicate well with the Investigator, and to understand and comply with the requirements of the study including answering the required questionnaires Exclusion Criteria: * History of anti-incontinence surgery or prolapse surgery. * Prolapse * Diagnosed Hypermobile Urethra * Previous diagnosis of any of the following conditions, disorders, or diseases of the urinary tract: * Clinically significant cystocele or rectocele * Ureteric bladder, urethral or rectal fistula * Uncorrected congenital abnormality leading to urinary incontinence * Interstitial cystitis * Urinary urgency that results in leakage (as a predominant symptom) * Adult enuresis * Urodynamically proven detrusor instability or detrusor sphincter dyssynergia (DSD) * Sensory urgency defined as first sensation of bladder fill (urge to void) of \<100 ml * No sensation at any time during the simple filling cystometry procedure * Known urethral Stenosis (ureterocystoscopy) or urethral diverticulum * History of cancer (\< 5 year of remission) or history of pelvic radiotherapy * Immunosuppressed patients * Women who are pregnant or become pregnant during the course of the study, breast feeding or \<12 months postpartum * Untreated symptomatic urinary tract infection * Fever (as defined by ≥ 38,5°C, axillar measurement), any infectious disease, cold or flu within the last 7 days * Unstable severe systemic disease including uncontrolled hypertension, unstable angina, or myocardial infarction, severe coagulation disorders, bleeding diathesis, emboli, thrombophlebitis, infectious diseases, poor wound healing, and poorly controlled diabetes mellitus within 6 months before enrolment * Known allergy/intolerance to at least one of the active ingredients or excipients of the investigational products * Known allergy/intolerance to Penicillin or Streptomycin. * Known genetically determined or acquired muscular disease, known neurological disorder (Parkinson's disease, multiple sclerosis, spina bifida, medullary traumatism, Creutzfeldt-Jakob disease). * Medication regimen including estrogens, anti-estrogens or diuretics where dose and/or frequency has not been stable for at least the past 12 weeks or is anticipated to change during the course of the study. * Chronic use of defined drugs and not stopped prior to inclusion into or including the study. Selective serotonin and norepinephrine reuptake inhibitor antidepressant (SSNRI), alpha-receptor antagonists/agonists, beta-3-receptor agonists or anticholinergic/-muscarinic drugs. * Have any clinically significant coexisting condition or symptoms that, in the opinion of the investigator, would put the safety of the participant at risk. * Any organic or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results. * Medication known to affect lower urinary tract function. * Patients having any electrical device inside their body (such as a cochlear implant, TENS stimulator (for pain), vagal nerve stimulator, brain stimulator, gastric pacemaker, bladder stimulator, or an implanted mechanical pump (such an insulin pump or pain pump). * Patients having a cardiac pacemaker or defibrillator implant. * Patients with Starr-Edwards artificial heart valve. * Patients that suffer from claustrophobia.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Low dose and High dose evaluation', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Neither patient nor sponsor will know which patient gets which dose', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 70, 'type': 'ESTIMATED'}}

2023-10-24