Treatment of stress urinary incontinence using autologous muscle precursor cells

ID di studio ICTRP
NCT05534269 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
Stress Urinary Incontinence Study to assess Safety and Efficacy of Muvon's Muscle Precursor Cell Therapy (BASEC)

Titolo accademico
Stress Urinary Incontinence Study to Assess Safety and Efficacy of Muvon's Muscle Precursor Cell Therapy (ICTRP)

Titolo pubblico
Stress Urinary Incontinence Study to Assess Safety and Efficacy of Muvon's Muscle Precursor Cell Therapy (ICTRP)

Malattie studiate
Female Stress Urinary Incontinence (ICTRP)

Intervento studiato
Biological: autologous muscle precursor cells (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant). (ICTRP)

Criteri di inclusione/esclusione
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 = 38,5C, 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. (ICTRP)

non disponibile

Endpoint primari e secondari
Change of SUI episode frequency (ICTRP)

Incidence of (S)AEs;Number of patients with any clinical significant findings;Change in 24 hour pad weight (ICTRP)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
GCP-Service International Ltd. & Co. KG (ICTRP)

Contatti aggiuntivi
Markus Veit, markus.veit@usz.ch, +41 44 255 12 23 (ICTRP)

ID secondari
SUISSE MPC2 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT05534269 (ICTRP)