Taking people in GreecePhase 1
Bioprinting a patient's own bladder lining cells during neobladder surgery for bladder cancer
Tests printing a patient's own bladder cells during neobladder surgery for bladder cancer.
Key facts
- Who runs it
- Phosprint S.A.
- Where
- Athens, GreeceSee the 2 sites
- Trial code
- Registry title
- A FIH study to investigate the safety and preliminary efficacy of expanded autologous urothelial cells bioprinted during orthotopic neobladder surgery
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 6 people, planned
- Started
- 9 May 2026
- Expected to end
- 1 Apr 2027
- Type of study
- Interventional
- Record updated
- 23 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with muscle-invasive bladder cancer who will have the bladder removed and a new bladder (neobladder) made from bowel.
- Age
- 18 to 75 years
- Sex
- Men and women can join.
- Disease stage
- Bladder urothelial carcinoma that invades the muscle, staged pT2cN0M0 to pT4acN0M0, confirmed before any treatment; radical cystectomy followed by ileal neobladder surgery is planned.
- Earlier treatment
- People who had radiation therapy before the operation cannot join.
- Biomarker or test result
- A mutation in any of the 25 genes of the bladder cancer assay kit rules a person out.
Main reasons for not taking part
- Upper tract urothelial carcinoma or certain aggressive tumour types
- History of HIV-1, HIV-2, hepatitis B or hepatitis C
- Another active cancer or chronic inflammatory bowel disease
- Severely impaired liver or kidney function
- Pregnant or breastfeeding women, or women seeking to become pregnant
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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 (2026, 9th edition)
- Eligible radical cystectomy followed by orthotopic ileal neobladder surgery
- Provision of signed Informed Consent
Who cannot take part
- History of preoperative radiation therapy
- History of HIV-1, HIV-2, hepatitis B, or hepatitis C
- Another active malignant disease
- History of chronic inflammatory bowel disease
- Detection of a mutation or combination of mutations in any of the 25 genes included in the bladder cancer assay kit
- 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
- 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
- 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
- Poor cognitive function that might impair the patient’s ability to manage continence or self-catheterize if needed
- Breastfeeding or pregnant women and women seeking to become pregnant
- Presence of urethral stricture and urethral sphincter incontinence
Where in Greece
- General Hospital of Athens "G. Gennimatas"Athens, GreeceTaking people
- Laiko General Hospital of AthensAthens, GreeceTaking people
About the trial
What the trial wants to find out
Evaluate the safety of the expanded autologous urothelial cells and InvivoLPrint-U bioprinter (combination) for administration in the context of neobladder surgery.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- An Exploratory, First-in-Human, study to investigate the safety and preliminary efficacy of InvivoLPrint-U-Therapy, a combination of an advanced therapy medicinal product (ATMP) of expanded autologous urothelial cells with an in vivo bioprinter for administration during orthotopic neobladder surgery
- Plain-language title
- Bioprinting a patient's own bladder lining cells during neobladder surgery for bladder cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 23 October 2026