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A FIH study to investigate the safety and preliminary efficacy of expanded autologous urothelial cells bioprinted during orthotopic neobladder surgery
EU CTIS ID: 2025-522963-14-00
What this study is testing
Evaluate the safety of the expanded autologous urothelial cells and InvivoLPrint-U bioprinter (combination) for administration in the context of neobladder surgery.
- Human Pharmacology (Phase I)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and female patients aged 18 to 75 years.
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
- A minimum life expectancy of at least one year.
- Histologically confirmed diagnosis of bladder urothelial carcinoma prior to any treatment
- Disease confirmed as muscle invasive bladder cancer (MIBC) and staged from pT2cN0M0 to pT4acN0M0 according to Tumor, Node, Metastasis (TNM) Classification (2017, 8th edition).
- Eligible radical cystectomy followed by orthotopic ileal neobladder surgery
You likely can't join if
- Diagnosis of upper tract urothelial carcinoma (UTUC) or presence of the following aggressive histological variants of urothelial carcinoma: 1. plasmacytoid, signet ring; 2. lymphoepithelioma-like; 3. giant cell, diffuse, undifferentiated; 4. sarcomatoid urothelial carcinoma; 5. pure neuroendocrine carcinoma (including small and large cell NE carcinomas; 6. pure adenocarcinoma; 7. pure squamous carcinoma
- Any medical condition or laboratory abnormality during the Screening Period that, in the opinion of the Investigator, is clinically significant and could interfere with the participant's ability to be included in the study.
- Poor cognitive function that might impair the patient’s ability to manage continence or self-catheterize if needed.
- History of preoperative radiation therapy.
- Breastfeeding or pregnant women and women seeking to become pregnant.
- Presence of urethral stricture and urethral sphincter incontinence.
See the full eligibility criteria
- Male and female patients aged 18 to 75 years.
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
- A minimum life expectancy of at least one year.
- Histologically confirmed diagnosis of bladder urothelial carcinoma prior to any treatment
- Disease confirmed as muscle invasive bladder cancer (MIBC) and staged from pT2cN0M0 to pT4acN0M0 according to Tumor, Node, Metastasis (TNM) Classification (2017, 8th edition).
- Eligible radical cystectomy followed by orthotopic ileal neobladder surgery
- Provision of signed Informed Consent.
- Diagnosis of upper tract urothelial carcinoma (UTUC) or presence of the following aggressive histological variants of urothelial carcinoma: 1. plasmacytoid, signet ring; 2. lymphoepithelioma-like; 3. giant cell, diffuse, undifferentiated; 4. sarcomatoid urothelial carcinoma; 5. pure neuroendocrine carcinoma (including small and large cell NE carcinomas; 6. pure adenocarcinoma; 7. pure squamous carcinoma
- Any medical condition or laboratory abnormality during the Screening Period that, in the opinion of the Investigator, is clinically significant and could interfere with the participant's ability to be included in the study.
- Poor cognitive function that might impair the patient’s ability to manage continence or self-catheterize if needed.
- History of preoperative radiation therapy.
- Breastfeeding or pregnant women and women seeking to become pregnant.
- Presence of urethral stricture and urethral sphincter incontinence.
- History of HIV-1, HIV-2, hepatitis B, or hepatitis C
- Another active malignant disease.
- History of chronic inflammatory bowel disease.
- Severely impaired liver or renal function 1. Severe renal impairment is defined as eGFR <50 mL/min/1.73 m². 2. Severe hepatic impairment is defined as the presence of any of the following: total bilirubin >2.5 mg/dL, albumin <3.5 g/dL, INR or prothrombin time >1.7, presence of ascites, or presence of hepatic encephalopathy.
- Detection of a mutation or combination of mutations in any of the 25 genes included in the bladder cancer assay kit
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.