AUTOLOGOUS ADIPOSE-DERIVED MESENCHYMAL STEM CELLS IN VITRO EXPANDED for Stress urinary incontinence | Post-prostatectomy urinary incontinence

Inclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- Males over 18 years old at the time of signing the Informed Consent for Participation in the Clinical Trial, following robot assisted radical prostatectomy."}
• {"criterion_text":"- Grade 2 stress urinary incontinence in a 24-hour pad test - total daily pad weight 100-400 g/24 hours."}
• {"criterion_text":"- Confirmed stress urinary incontinence in a urodynamic study (UDS)."}
• {"criterion_text":"- Postoperative prostate cancer stage pT2c N0 M0 Gleason 3+3, Gleason 3+4, Gleason 4+3."}
• {"criterion_text":"- BMI >20 kg/m2, adipose tissue in the abdominal cavity and buttocks eligible for liposuction."}
• {"criterion_text":"- 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)."}

Exclusion criteria

• {"criterion_text":"- Postoperative positive surgical margins and PSA > 0.1 ng/ml in the 7th week after prostatectomy."}
• {"criterion_text":"- Local recurrence of prostate cancer. PSA increase during observation despite initially negative margins."}
• {"criterion_text":"- Past or ongoing radiotherapy or other pelvic floor surgeries before radical prostatectomy."}
• {"criterion_text":"- Presence of bladder-urethral stricture, overactive bladder syndrome."}
• {"criterion_text":"- Positive PET-PSMA scan results."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- Diagnosed urinary tract infection."}
• {"criterion_text":"- Use of another investigational drug within 6 months before enrollment or participation in other trials at the time of qualification."}
• {"criterion_text":"- 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)\tdecreased total protein concentration < 4g/l"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measured by 24-hour pad test; endpoint is proportion of patients achieving a ≥50% reduction in 24-hour pad weight after injection of ATIMP versus placebo."}
• {"endpoint_text":"- Early frequency of SAEs (Serious Adverse Events) after injecting ATIMP within the urethral sphincter compared to a placebo.","definition_or_measurement_approach":"Frequency (incidence) of serious adverse events occurring in the early post-injection period after ATIMP versus placebo."}
• {"endpoint_text":"- Long-term frequency of SAEs after injecting ATIMP within the urethral sphincter compared to a placebo.","definition_or_measurement_approach":"Frequency (incidence) of serious adverse events occurring in the long-term follow-up after ATIMP versus placebo."}

Secondary endpoints

• {"endpoint_text":"- Percentage of patients achieving visible sphincter contractility in flexible uretroscopy.","definition_or_measurement_approach":"Assessed by flexible urethroscopy: proportion of patients with visually observed sphincter contractility."}
• {"endpoint_text":"- Percantage of patients achieving improvement of bladder parameters and urinary continency measured in urodynamic test (cystometry and uroflowmetry).","definition_or_measurement_approach":"Improvement assessed by urodynamic testing (cystometry and uroflowmetry); proportion of patients with improved bladder parameters and continence."}
• {"endpoint_text":"- Percentage of patients achieving improvement in lower urinary tract symptoms (LUTS), IPSS scale (minimum 20% reduction of LUTS symptoms measured in IPSS scale).","definition_or_measurement_approach":"Measured by IPSS scale; proportion of patients with at least 20% reduction in LUTS symptoms."}

Poland

Earliest CTIS Part Ii Submission Date

04-03-2024

Latest Decision Or Authorization Date

08-04-2024

Processing Time Days

35

Number Of Sites

2

Number Of Participants

45

Primary sponsor

Full Name

Nicolaus Copernicus University

Organisation Type

Educational Institution

Country Of Registered Address

Poland

Third parties

• {"country":"Poland","full_name":"50bio.Com Sp. z o.o.","duties_or_roles":"sponsorDuties codes: 1, 12, 5","organisation_type":"Pharmaceutical company"}