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Study on the Effectiveness and Safety of Stem Cell Therapy for Urinary Incontinence in Patients After Prostate Surgery

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on evaluating a new treatment for urinary incontinence, a condition where individuals experience involuntary leakage of urine. This study is specifically for patients who have undergone a surgical procedure called radical prostatectomy, which is the removal of the prostate gland. The treatment being tested involves the use of autologous adipose-derived mesenchymal stem cells, which are special cells taken from a patient's own fat tissue, expanded in a laboratory, and then injected back into the body. This treatment is referred to by the code name SUICell. The study will compare the effects of this treatment to a placebo to determine its effectiveness and safety.

Participants in the study will receive injections of the stem cell treatment or a placebo into the urethral sphincter, which is a muscle that helps control the release of urine. The main goal is to see if the treatment can reduce the amount of urine leakage, as measured by a pad test, and to monitor any side effects. The study will also assess the safety of the treatment over time. The trial is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo, to ensure unbiased results.

The study will take place over several years, with participants being monitored for changes in their urinary symptoms and any potential side effects. The researchers aim to determine if the stem cell treatment can improve bladder function and reduce symptoms of urinary incontinence. This trial represents an important step in finding new ways to help patients manage urinary incontinence after prostate surgery.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will have already expressed willingness to participate and signed an informed consent form.
The patient must be a male over 18 years old who has undergone a robot-assisted radical prostatectomy and meets specific medical criteria, including stress urinary incontinence and certain cancer stages.
Step 2
Initial assessment
The patient will undergo a 24-hour pad test to confirm stress urinary incontinence, with a total daily pad weight between 100-400 grams.
A urodynamic study will be conducted to further confirm the condition.
Step 3
Treatment administration
The treatment involves injecting a product called ATIMP, which contains autologous adipose-derived mesenchymal stem cells, into the urethral sphincter complex.
The injection is performed intramuscularly, and the product is prepared using a solvent called Natrium chloratum 0.9% Kabi.
Step 4
Monitoring and follow-up
The patient will be monitored for any serious adverse events (SAEs) following the injection.
The effectiveness of the treatment will be evaluated by measuring the reduction in pad weight and improvement in urinary symptoms.
Step 5
Final assessment
The study aims to assess the percentage of patients achieving a 50% reduction in pad weight and improvement in bladder parameters.
Additional assessments include evaluating sphincter contractility and improvement in lower urinary tract symptoms.

Who can join the trial?

7 criteria

The patient must be willing to participate in the study and sign a form agreeing to join after receiving information about the study.
The patient must be a male over 18 years old who has had a **robot-assisted radical prostatectomy**, which is a type of surgery to remove the prostate gland.
The patient must have **Grade 2 stress urinary incontinence**, which means they experience involuntary leakage of urine during activities like coughing or exercising. This is measured by a **24-hour pad test** showing a total daily pad weight of 100-400 grams.
The patient must have confirmed stress urinary incontinence through a **urodynamic study (UDS)**, which is a test that checks how well the bladder and urethra are storing and releasing urine.
The patient must have had prostate cancer at a specific stage after surgery, described as **pT2c N0 M0 Gleason 3+3, Gleason 3+4, Gleason 4+3**. This refers to the extent and grade of the cancer.
The patient must have a **BMI** (Body Mass Index) greater than 20 kg/m², with enough fat in the abdominal area and buttocks for **liposuction**, which is a procedure to remove fat.
The patient must have negative test results for **HIV 1 and 2**, **Anti-HIV**, **HBsAg and Anti-HBc**, **Anti-HCV**, and specific tests for **syphilis**. These are tests to check for certain infections.

Who cannot join the trial?

2 criteria

Individuals who are not male cannot participate in the study.
Individuals who are considered part of a vulnerable population are not eligible. A vulnerable population includes groups who may have limited ability to protect their own interests, such as children or people with certain disabilities.

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Investigated drugs

ATIMP is a somatic cell-based therapy being tested for its effectiveness and safety in treating urinary incontinence in patients who have undergone radical prostatectomy. This therapy involves injecting cells into the urethral sphincter complex to help improve urinary control. The trial aims to evaluate how well this treatment works in reducing urinary incontinence and to ensure it is safe for patients.

What is already known about the treatment

ATIMP – This medication is administered through an injection directly into the urethral sphincter complex. It is currently being evaluated in clinical trials for its effectiveness and safety in treating urinary incontinence, particularly in patients who have undergone radical prostatectomy. The main therapeutic indication is to improve urinary control by enhancing the function of the urethral sphincter. At the molecular level, ATIMP works by utilizing somatic cell-based therapy to potentially regenerate or repair the sphincter tissue. It falls under the pharmacological classification of advanced therapy medicinal products (ATMPs), specifically focusing on cell-based treatments.

Investigated diseases

Urinary Incontinence – Urinary incontinence is a condition characterized by the involuntary leakage of urine. It occurs when the muscles that control the bladder are weakened or damaged, leading to a loss of control over urination. This condition can vary in severity, from occasional leaks when coughing or sneezing to a complete inability to control urination. It can be caused by a variety of factors, including age, childbirth, or certain medical conditions. Over time, urinary incontinence can affect daily activities and quality of life. The progression of symptoms can vary, with some individuals experiencing gradual worsening while others may have stable symptoms.