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Evaluation of treatment effectiveness and safety of somatic cell based therapy for urinary incontinence in patients after radical prostatectomy.
EU CTIS ID: 2023-509812-27-00
What this study is testing
1. Evaluation of urinary incontinence in the pad test and product safety after injecting ATIMP within the urethral sphincter complex compared to a placebo. 2. Assessment of ATIMP safety after injection within the urethral sphincter compared to a placebo.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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).
See the full eligibility criteria
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.