Evaluation of treatment effectiveness and safety of somatic cell based therapy for urinary incontinence in patients after radical prostatectomy.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Nicolaus Copernicus University

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Male Urogenital Diseases [C12]

Decision date (initial)

2024-04-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Agencja Badań Medycznych

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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.

Secondary objectives 1

1. Evaluation of product therapeutic effectiveness after injection within the urethral sphincter compared to a placebo.

Conditions and MedDRA coding

urinary incontinence

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 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.
2. Males over 18 years old at the time of signing the Informed Consent for Participation in the Clinical Trial, following robot assisted radical prostatectomy.
3. Grade 2 stress urinary incontinence in a 24-hour pad test - total daily pad weight 100-400 g/24 hours.
4. Confirmed stress urinary incontinence in a urodynamic study (UDS).
5. Postoperative prostate cancer stage pT2c N0 M0 Gleason 3+3, Gleason 3+4, Gleason 4+3.
6. BMI >20 kg/m2, adipose tissue in the abdominal cavity and buttocks eligible for liposuction.
7. 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 9

1. Postoperative positive surgical margins and PSA > 0.1 ng/ml in the 7th week after prostatectomy.
2. Local recurrence of prostate cancer. PSA increase during observation despite initially negative margins.
3. Past or ongoing radiotherapy or other pelvic floor surgeries before radical prostatectomy.
4. Presence of bladder-urethral stricture, overactive bladder syndrome.
5. Positive PET-PSMA scan results.
6. 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).
7. Diagnosed urinary tract infection.
8. Use of another investigational drug within 6 months before enrollment or participation in other trials at the time of qualification.
9. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. 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.
2. Early frequency of SAEs (Serious Adverse Events) after injecting ATIMP within the urethral sphincter compared to a placebo.
3. Long-term frequency of SAEs after injecting ATIMP within the urethral sphincter compared to a placebo.

Secondary endpoints 3

1. Percentage of patients achieving visible sphincter contractility in flexible uretroscopy.
2. Percantage of patients achieving improvement of bladder parameters and urinary continency measured in urodynamic test (cystometry and uroflowmetry).
3. Percentage of patients achieving improvement in lower urinary tract symptoms (LUTS), IPSS scale (minimum 20% reduction of LUTS symptoms measured in IPSS scale).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Nicolaus Copernicus University

Sponsor organisation

Nicolaus Copernicus University

Address

Ul. Jurija Gagarina 11

City

Torun

Postcode

87-100

Country

Poland

Scientific contact point

Organisation

Nicolaus Copernicus University

Contact name

Science and Projects Department

Public contact point

Organisation

Nicolaus Copernicus University

Contact name

Press office

Third parties 1

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Application history

1 submissions — initial application plus substantial / non-substantial modifications