In short
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.
Key points
- AUROCELL-TX is being studied in a first-in-human Phase 1 trial for people with muscle-invasive bladder cancer who may receive neobladder reconstruction after bladder removal surgery. The study is authorised and plans to enroll 6 patients. Researchers are mainly checking safety, including death, neobladder rejection, need for revision surgery, and surgical complications. The trial also looks at preliminary efficacy, which means early signs that the approach may help. This is an interventional study using AUROCELL-TX in the surgical setting with the InvivoLPrint-U bioprinter.
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. It is designed to study the safety and preliminary efficacy of expanded autologous urothelial cells bioprinted during orthotopic neobladder surgery.
The study is interventional, so the research team gives the study procedure as part of the trial instead of only observing patients. The planned enrollment is 6 patients.
Who can participate
The trial is for patients with muscle-invasive bladder cancer (MIBC) who are eligible for neobladder reconstruction after radical cystectomy. Radical cystectomy means surgery to remove the bladder.
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.
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. A bioprinter is a device that places living cells in a planned shape or structure for medical use.
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. 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.
What outcomes are measured
The main outcomes focus on safety after surgery. These include the proportion of patients with a fatal event (death), neobladder rejection, and the need for revision surgery.
The trial also measures the proportion of patients who are free from the combined endpoint of death, neobladder rejection, and need for revision surgery. A composite endpoint is one result that combines several important events into a single measure.
Researchers will also record peri- and post-surgical complications and serious adverse events (SAEs). These are important because they show what problems happen during surgery and in the recovery period.
Trial phase and status
This is a Phase 1 trial. Phase 1 studies are early trials that mainly look at safety and how the study approach performs in a small number of people.
The study status is Authorised. That means the trial has been approved to move forward.
Key patient terms
Autologous means the cells come from the same person who will receive them. This is important because the trial is using the patient’s own urothelial cells.
Urothelial cells are cells that line the inside of the urinary tract, including the bladder. Orthotopic neobladder means a new bladder made during surgery and placed in the usual bladder position.
Revision surgery means another operation is needed to fix or adjust the first surgery result. Peri-surgical means around the time of surgery, and post-surgical means after surgery.