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Long-Term Safety and Efficacy of aUroCell-Tx in Muscle-Invasive Bladder Cancer Patients Undergoing Neobladder Reconstruction – Extension Study

Verified siteInvestigationalNo placebo

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What is this trial about?

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

Muscle-invasive bladder cancer is a form of bladder cancer that has grown into the muscle layer of the bladder wall. Treatment often involves a major operation called radical cystectomy, in which the bladder is removed, followed by neobladder reconstruction that creates a new bladder using a piece of intestine. In this study, the new bladder is helped by a therapy named InvivoLPrint-U, which uses a patient’s own (autologous) bladder‑lining cells that are grown in a laboratory and placed into the new bladder with a special printer.

The purpose of the study is to collect additional data on the long‑term safety of this therapy after the initial surgery. Participants who completed the earlier trial will be monitored for several years with regular visits that include urine checks, imaging scans, and questionnaires about daily life and bladder control. During follow‑up, doctors will look for serious problems such as death, rejection of the new bladder, or the need for another operation, as well as issues like infections, urinary leakage, stone formation, and changes in blood chemistry that could cause metabolic acidosis. Quality of life will also be assessed using a standard questionnaire.

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
Enrollment in extension study
After completing the u-laserprint-1 trial you are asked to join the extension study to gather long‑term safety information.
You provide written consent confirming that you understand the purpose of the study and agree to the planned procedures.
Step 2
Surgical implantation of aUroCell‑Tx
During the scheduled neobladder reconstruction surgery the surgeon implants aUroCell‑Tx, an autologous urothelial cell suspension created from your own bladder cells.
The product is placed directly into the newly formed bladder using a specialized bioprinter; it is a single administration performed at the time of surgery and does not require additional dosing.
Step 3
Post‑operative hospital monitoring
After surgery you remain in the hospital for the standard recovery period.
Clinical staff monitor vital signs, urinary output, and any immediate signs of infection or rejection of the neobladder.
Step 4
Scheduled follow‑up visits
You attend regular follow‑up appointments after discharge. each visit includes physical examination, laboratory tests, and imaging as needed to assess the safety of the implanted cells.
The study specifically looks for serious adverse events such as death, neobladder rejection, need for revision surgery, late post‑surgical complications, and recurrent urinary tract infections.
Step 5
Assessment of urinary function and quality of life
During follow‑up you complete questionnaires that evaluate urinary continence, presence of mucus in the urine, formation of urinary stones, electrolyte balance, and overall quality of life using the eortc qlq‑c30 instrument.
These assessments help determine the long‑term effectiveness of the treatment.
Step 6
Study completion
The extension study continues until the final scheduled visit, after which all data are collected and analyzed for long‑term safety and efficacy outcomes.

Who can join the trial?

5 criteria

Have muscle‑invasive bladder cancer and be planned for a neobladder reconstruction after the bladder is surgically removed (a procedure called radical cystectomy).
Have already taken part in and finished the earlier U‑LaserPrint‑1 clinical trial.
Agree to sign a written informed consent form, which explains the study and confirms you understand and agree to join.
Be an adult (generally 18 years of age or older).
Be male or female; both sexes are allowed to participate.

Who cannot join the trial?

2 criteria

Refusing to take part in the extension study (the extra part of the research after the main trial).
Not following the protocol procedures (the specific steps and rules of the study) during the original trial, or being unable to meet the required follow‑up requirements (the scheduled check‑ups after surgery).

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Verified sites

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Laiko General Hospital Of Athens
Verified
Athens, Greece

Trial locations

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Investigated drugs

aUroCell-Tx is a treatment that uses cells taken from the patient’s own bladder lining. These cells are grown in the laboratory and then placed into a special implant that can be printed and positioned during neobladder reconstruction surgery. By using the patient’s own cells, the therapy aims to help the new bladder tissue heal, function more naturally, and reduce the risk of rejection or complications over the long term.

AUROCELL-TX

What is already known about the treatment

aUroCell-Tx - This therapy is an autologous urothelial cell suspension that is implanted directly into the newly created bladder during surgery. It is currently an experimental cell‑based product being studied in clinical trials and is not yet approved for general medical use. The treatment is intended for patients with muscle‑invasive bladder cancer who are having a neobladder rebuilt after bladder removal. It works by delivering the patient’s own bladder cells, which attach to the surgical site, grow, and help rebuild a healthy bladder lining, classifying it as a regenerative cell therapy.

Investigated diseases

Muscle-invasive bladder cancer - A type of bladder cancer that has grown through the inner lining into the muscular wall of the bladder. Once the cancer reaches the muscle layer, it can spread to nearby tissues, lymph nodes, or distant organs if not controlled. The disease often presents with blood in the urine, urgency, or pelvic discomfort. As it advances, the tumor may become larger and involve deeper layers of the bladder wall. Growth into muscle increases the risk of further spread, leading to a more extensive disease process.