Evaluation of treatment effectiveness and safety of somatic cell based therapy for urinary incontinence in patients after radical prostatectomy, multicenter randomized, double-blind, placebo controlled, clinical trial. - SUICell-T1

icolaus Copernicus University0 sites45 target enrollmentNovember 30, 2023

Overview

No summary available.

Registry

who.int

Start Date

November 30, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

icolaus Copernicus University

•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