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AUROCELL-TX

Clinical trials are investigating AUROCELL-TX in people with muscle-invasive bladder cancer who may have neobladder reconstruction after bladder removal surgery. The study is looking at safety and early signs of benefit during and after surgery. It is a first-in-human Phase 1 trial.

Table of contents

Trial overview

The available trial is a first-in-human study, which means it is the first time this approach is being tested in people.[1] It is designed to study the safety and preliminary efficacy of expanded autologous urothelial cells bioprinted during orthotopic neobladder surgery.[1]

The study is interventional, so the research team gives the study procedure as part of the trial instead of only observing patients.[1] The planned enrollment is 6 patients.[1]

Who can participate

The trial is for patients with muscle-invasive bladder cancer (MIBC) who are eligible for neobladder reconstruction after radical cystectomy.[1] Radical cystectomy means surgery to remove the bladder.[1]

This means the study is focused on a very specific group of people who are already planned for major bladder surgery and may receive a new bladder, called an orthotopic neobladder.[1]

What is being studied

The trial is studying AUROCELL-TX, listed in the source as aUroCell-Tx, used with the InvivoLPrint-U bioprinter during neobladder surgery.[1] A bioprinter is a device that places living cells in a planned shape or structure for medical use.[1]

The study summary says the goal is to evaluate the safety of the expanded autologous urothelial cells and the bioprinter combination in the surgical setting.[1] In simple terms, researchers want to see whether this approach can be used safely during surgery and whether there are early signs that it may help.[1]

What outcomes are measured

The main outcomes focus on safety after surgery.[1] These include the proportion of patients with a fatal event (death), neobladder rejection, and the need for revision surgery.[1]

The trial also measures the proportion of patients who are free from the combined endpoint of death, neobladder rejection, and need for revision surgery.[1] A composite endpoint is one result that combines several important events into a single measure.[1]

Researchers will also record peri- and post-surgical complications and serious adverse events (SAEs).[1] These are important because they show what problems happen during surgery and in the recovery period.[1]

Trial phase and status

This is a Phase 1 trial.[1] Phase 1 studies are early trials that mainly look at safety and how the study approach performs in a small number of people.[1]

The study status is Authorised.[1] That means the trial has been approved to move forward.[1]

Key patient terms

Autologous means the cells come from the same person who will receive them.[1] This is important because the trial is using the patient’s own urothelial cells.[1]

Urothelial cells are cells that line the inside of the urinary tract, including the bladder.[1] Orthotopic neobladder means a new bladder made during surgery and placed in the usual bladder position.[1]

Revision surgery means another operation is needed to fix or adjust the first surgery result.[1] Peri-surgical means around the time of surgery, and post-surgical means after surgery.[1]

Trial IDPhaseCondition studiedStatusEnrollment
2025-522963-14-00Phase 1Muscle-invasive bladder cancer in patients eligible for neobladder reconstruction after radical cystectomyAuthorised6

FAQ

  • What is AUROCELL-TX being studied for? AUROCELL-TX is being studied in neobladder surgery after radical cystectomy, which is removal of the bladder. The trial is checking safety and early efficacy in this surgery setting.
  • Who can take part in the trial? The study is for patients with muscle-invasive bladder cancer who are eligible for neobladder reconstruction after radical cystectomy. Only a small number of participants are planned.
  • What phase is this trial? This is a Phase 1 trial. Phase 1 studies are early trials that mainly look at safety and whether the treatment can be given as planned.
  • What does the trial measure? The trial measures death, neobladder rejection, need for revision surgery, and surgical complications. It also looks at how many patients remain free from this combined set of problems.
  • Is this a treatment study or a device study? The trial studies AUROCELL-TX together with the InvivoLPrint-U bioprinter in the surgical setting. It is an interventional study, which means the research team gives the study treatment as part of the trial.

Ongoing Clinical Trials on AUROCELL-TX

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

    Recruiting

    1 1
    Investigated drugs:
    Greece

Glossary

  • Autologous cells: Cells taken from the same person who will receive them. This can help lower the chance of rejection.
  • Urothelial cells: Cells that line the inside of the urinary tract, including the bladder.
  • Bioprinter: A device that places living cells in a planned shape or structure for medical use.
  • Orthotopic neobladder: A new bladder made during surgery and placed in the usual bladder position.
  • Radical cystectomy: Surgery to remove the bladder, often used to treat bladder cancer.
  • Muscle-invasive bladder cancer: Bladder cancer that has grown into the muscle layer of the bladder wall.
  • Phase 1: An early clinical trial phase that mainly checks safety and how the study treatment can be used.
  • Interventional study: A study where researchers assign a treatment or procedure to participants.
  • Primary outcome: The main result the trial is designed to measure.
  • Serious adverse event (SAE): A serious medical problem during a study, such as one that needs hospital care or causes major harm.

References

  1. https://clinicaltrials.gov/study/2025-522963-14-00