Evaluation of treatment effectiveness and safety of somatic cell based therapy for urinary incontinence in patients after radical prostatectomy.
- Conditions
- urinary incontinenceMedDRA version: 20.0Level: LLTClassification code: 10021643Term: Incontinence urinary Class: 10038359Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]
- Registration Number
- CTIS2023-509812-27-00
- Lead Sponsor
- icolaus Copernicus University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 45
Patient expresses willingness to participate in the study, and after receiving information about the study, patients/legal guardians will sign an informed consent form to participate., Males over 18 years old at the time of signing the Informed Consent for Participation in the Clinical Trial, following robot assisted radical prostatectomy., Grade 2 stress urinary incontinence in a 24-hour pad test - total daily pad weight 100-400 g/24 hours., Confirmed stress urinary incontinence in a urodynamic study (UDS)., Postoperative prostate cancer stage pT2c N0 M0 Gleason 3+3, Gleason 3+4, Gleason 4+3., BMI >20 kg/m2, adipose tissue in the abdominal cavity and buttocks eligible for liposuction., Negative results in tests for: HIV 1 and 2, Anti-HIV, HBsAg and Anti-HBc, Anti-HCV, specific syphilis tests (criteria related to the production of the ATIMP product).
Postoperative positive surgical margins and PSA > 0.1 ng/ml in the 7th week after prostatectomy., Local recurrence of prostate cancer. PSA increase during observation despite initially negative margins., Past or ongoing radiotherapy or other pelvic floor surgeries before radical prostatectomy., Presence of bladder-urethral stricture, overactive bladder syndrome., Positive PET-PSMA scan results., Positive results in tests for: HIV 1 and 2, Anti-HIV, HBsAg and Anti-HBc, Anti-HCV, specific syphilis tests (criteria related to the production of the ATIMP product)., Diagnosed urinary tract infection., Use of another investigational drug within 6 months before enrollment or participation in other trials at the time of qualification., 9. Exclusion criteria based on laboratory results: a) Severe anemia with hemoglobin concentration < 8g/l; b) chronic kidney disease with eGFR <30ml/min; c) leukopenia with WBC concentration <1500/microliter; d) coagulation disorders with INR >2 and/or APTT >60 sec.; e) twice tested blood glucose >200mg/dl in interval 2 h; f) CRP test result >50 mg/l; g) hypoalbuminemia < 2g/dl; g) abnormal liver function test results ALT and/or AST 3 times above normal, total bilirubin concentration > 2 mg/dl, excluding individuals with Gilbert's syndrome; i)decreased total protein concentration < 4g/l
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1. Evaluation of urinary incontinence in the pad test and product safety after injecting ATIMP within the urethral sphincter complex compared to a placebo.<br>2. Assessment of ATIMP safety after injection within the urethral sphincter compared to a placebo.;Secondary Objective: Evaluation of product therapeutic effectiveness after injection within the urethral sphincter compared to a placebo.;Primary end point(s): Percentage of patients with 24-hour pad test showing a 50% reduction in pad weight after injecting ATIMP within he urethral sphincter compared to a placebo., Early frequency of SAEs (Serious Adverse Events) after injecting ATIMP within the urethral sphincter compared to a placebo., Long-term frequency of SAEs after injecting ATIMP within the urethral sphincter compared to a placebo.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Percentage of patients achieving visible sphincter contractility in flexible uretroscopy.;Secondary end point(s):Percantage of patients achieving improvement of bladder parameters and urinary continency measured in urodynamic test (cystometry and uroflowmetry).;Secondary end point(s):Percentage of patients achieving improvement in lower urinary tract symptoms (LUTS), IPSS scale (minimum 20% reduction of LUTS symptoms measured in IPSS scale).