Recruiting

A Study of Autologous Urothelial Cell Treatment with Bioprinter During Bladder Reconstruction Surgery in Patients with Muscle-Invasive Bladder Cancer

Verified siteInvestigationalNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This study involves people with muscle-invasive bladder cancer who need to have their bladder removed and replaced with a new bladder made from a piece of intestine, a procedure called orthotopic neobladder surgery. The treatment being tested is called aUroCell-Tx, which is made from the patient's own bladder cells that are grown in a laboratory. These cells are delivered to the inside of the newly created bladder using a special device called a bioprinter during the surgery. The purpose of this study is to check if this treatment is safe and to see if it might help improve how well the new bladder works.

During the study, patients will undergo the standard surgery to remove their diseased bladder and create a new one from intestinal tissue. At the same time, the expanded autologous urothelial cells, which are the patient's own bladder lining cells, will be placed onto the inside of the new bladder using the bioprinter. The study will monitor patients for any serious problems such as death, rejection of the new bladder, or the need for additional surgery to fix complications. Doctors will also watch for any side effects or complications that happen during or after the surgery.

The study will also look at how well the bioprinter works and whether it is easy to use during surgery. Patients will be checked to see if the new bladder functions properly, including whether they can control urination, if there is mucus production, and if there are any chemical imbalances in the blood. Tissue samples will be examined to see how well the bladder lining cells have grown on the new bladder. The study will also measure changes in quality of life to understand how patients feel after the treatment.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Tissue collection procedure
Before the main bladder removal surgery, a small sample of tissue will be collected from your bladder. This tissue contains urothelial cells, which are the cells that normally line the inside of the bladder.
These cells will be sent to a laboratory where they will be grown and expanded to create a larger number of cells. This process is called cell expansion.
The expanded cells will form the treatment product called aUroCell-Tx, which is a suspension of your own urothelial cells.
Step 2
Radical cystectomy and neobladder surgery
You will undergo radical cystectomy, which is a surgical procedure to remove your bladder completely.
During the same operation, the surgeon will create a neobladder, which is a new bladder made from a section of your intestine. This new bladder will serve as a replacement for your original bladder.
The neobladder is constructed using a portion of the ileum, which is part of the small intestine.
Step 3
Application of expanded urothelial cells
During the neobladder surgery, the expanded urothelial cells that were previously prepared from your tissue will be applied to the inside surface of the newly created neobladder.
The cells will be delivered using a special device called an in vivo bioprinter. This device is designed to place the cells precisely onto the intestinal tissue that forms the neobladder.
The method of delivery is called implantation. The goal is to cover the inner surface of the neobladder with your own urothelial cells, which may help the neobladder function more like a natural bladder.
Step 4
Recovery and monitoring after surgery
After the surgery, you will be monitored for any complications related to the procedure, including issues with the neobladder and the application of the cells.
The medical team will check for signs of neobladder rejection, which would indicate that your body is not accepting the new bladder.
You will also be monitored for any need for additional surgery, known as revision surgery, to address any complications.
Step 5
Follow-up assessments
You will have regular follow-up visits to assess how well the neobladder is functioning.
The assessments will include checking your urinary continence, which means the ability to control when you urinate without leaking.
The presence of mucus in your urine will be evaluated. Mucus is a thick fluid that intestinal tissue naturally produces, and its presence will be monitored.
Blood tests will be performed to check for metabolic imbalances and blood acidosis. These conditions can occur when the intestinal tissue used for the neobladder affects the balance of chemicals in your blood.
The extent to which the urothelial cells have covered the inner surface of the neobladder will be assessed.
If needed, tissue samples may be taken to examine the histological profile of the regenerated tissue. This means looking at the tissue under a microscope to see how well the urothelial cells have grown and formed a new lining.
You will be asked to complete quality of life questionnaires to assess how the treatment affects your daily life and well-being. The questionnaire used is called EORTC QLQ-C30, which measures various aspects of health-related quality of life.
Step 6
Long-term safety monitoring
Throughout the study, any adverse events or complications will be recorded and evaluated.
The medical team will monitor for any serious adverse events, including death, rejection of the neobladder, or the need for additional surgical procedures.
The study will continue to track your health and the function of the neobladder over an extended period to assess the long-term safety and effectiveness of the treatment.

Who can join the trial?

7 criteria

You must be between 18 and 75 years old, male or female
You must have a good overall physical condition, meaning you are fully active or able to do light work (this is measured using a scale called ECOG score of 0 or 1, where 0 means fully active and 1 means some restrictions in physical activity)
Your doctors expect that you will live for at least one year
You must have a confirmed diagnosis of bladder urothelial carcinoma, which is a type of cancer that starts in the cells lining the inside of the bladder. This diagnosis must be confirmed by examining tissue under a microscope (called histologically confirmed)
Your cancer must be muscle-invasive, meaning it has grown into the muscle layer of the bladder wall, and must be at a specific stage (classified as pT2cN0M0 to pT4acN0M0). This means the cancer is in the bladder muscle but has not spread to nearby lymph nodes or other parts of the body
You must be suitable for a surgery called radical cystectomy, which means complete removal of the bladder, followed by orthotopic ileal neobladder surgery, which is a procedure to create a new bladder using a part of your intestine
You must sign an Informed Consent form, which means you agree to participate in the study after understanding all the information about it

Who cannot join the trial?

3 criteria

The source data does not provide specific exclusion criteria (reasons why patients cannot participate) for this clinical trial
Without detailed exclusion criteria listed in the trial information, it is not possible to specify which patients would be excluded from participation
Generally, clinical trials have exclusion criteria to ensure patient safety and study accuracy, but these specific details are not available in the provided data

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Laiko General Hospital Of Athens
Verified
Athens, Greece

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

InvivoLPrint-U-Therapy is an experimental treatment that combines two parts: specially grown cells from the patient's own bladder lining and a special device called a bioprinter. The cells are taken from the patient, grown in a laboratory to increase their number, and then delivered back into the patient's body using the bioprinter during surgery to create a new bladder. This therapy is being tested to see if it is safe and can help patients who need bladder reconstruction surgery.

AUROCELL-TX

What is already known about the treatment

InvivoLPrint-U-Therapy – This is an experimental treatment currently being tested in its first human clinical trial for patients with muscle-invasive bladder cancer who are undergoing surgery to create a new bladder after removal of their cancerous bladder. The therapy combines a special bioprinter device called InvivoLPrint-U with the patient's own urothelial cells (the cells that normally line the inside of the bladder) that have been grown and multiplied in a laboratory. During the surgery to construct the new bladder, the bioprinter applies these expanded cells directly onto the surgical site, with the goal of helping to rebuild the bladder's inner lining using the patient's own tissue. This approach is classified as an advanced therapy medicinal product and is being studied primarily to determine if it is safe to use in patients undergoing this type of reconstructive bladder surgery.

Investigated diseases

Muscle-Invasive Bladder Cancer – Muscle-invasive bladder cancer is a type of bladder cancer where abnormal cells have grown beyond the inner lining of the bladder and invaded the muscular wall of the bladder. This is a more advanced form of bladder cancer compared to non-invasive types. The cancer cells penetrate deeper layers of the bladder tissue, affecting the muscle layer that controls bladder function. As the disease progresses, the cancerous growth can spread further into surrounding tissues and potentially to other parts of the body. Patients with this condition often require major surgical intervention to remove the affected bladder. The invasion of muscle tissue distinguishes this form from earlier stages where cancer remains only in the superficial layers of the bladder.