A FIH study to investigate the safety and preliminary efficacy of expanded autologous urothelial cells bioprinted during orthotopic neobladder surgery

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Phosprint S.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]

Trial duration

9 May 2026 → ongoing

Decision date (initial)

2025-12-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

PhosPrint PC

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

Evaluate the safety of the expanded autologous urothelial cells and InvivoLPrint-U bioprinter (combination) for administration in the context of neobladder surgery.

Secondary objectives 2

1. Evaluate the medical device performance and the feasibility of the procedure in humans
2. Assessment of neobladder reconstruction and functionality up to 6 months

Conditions and MedDRA coding

Μuscle-invasive bladder cancer (MIBC) patients, eligible for neobladder reconstruction following radical cystectomy

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Male and female patients aged 18 to 75 years.
2. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
3. A minimum life expectancy of at least one year.
4. Histologically confirmed diagnosis of bladder urothelial carcinoma prior to any treatment
5. Disease confirmed as muscle invasive bladder cancer (MIBC) and staged from pT2cN0M0 to pT4acN0M0 according to Tumor, Node, Metastasis (TNM) Classification (2017, 8th edition).
6. Eligible radical cystectomy followed by orthotopic ileal neobladder surgery
7. Provision of signed Informed Consent.

Exclusion criteria 11

1. 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
2. History of preoperative radiation therapy.
3. Breastfeeding or pregnant women and women seeking to become pregnant.
4. Presence of urethral stricture and urethral sphincter incontinence.
5. History of HIV-1, HIV-2, hepatitis B, or hepatitis C
6. Another active malignant disease.
7. History of chronic inflammatory bowel disease.
8. 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.
9. Detection of a mutation or combination of mutations in any of the 25 genes included in the bladder cancer assay kit
10. 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.
11. Poor cognitive function that might impair the patient’s ability to manage continence or self-catheterize if needed.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

1. Proportion of patients with fatal event (death)
2. Proportion of patients with neobladder rejection
3. Proportion of patients for whom revision surgery was required
4. Proportion of patients who were free from the composite endpoint of death, neobladder rejection and need for revision surgery
5. Peri-and post-surgical complications/SAEs

Secondary endpoints 9

1. 1.1 Device success, defined as successful delivery of the ATMP onto the neobladder according to the study protocol
2. 1.2 Device adverse effects and deficiencies
3. 1.3 Ease of use of the bioprinter
4. 2.1 Urinary continence
5. 2.2 Absence of mucus
6. 2.3 Metabolic imbalances and blood acidosis (blood)
7. 2.4 Extent of coverage of the denuded intestinal tissue
8. 2.5 Histological profile of regenerated urothelium
9. 2.6 Change from baseline in total score and in each specific domain of the Health-related quality of life (HRQoL) questionnaire EORTC QLQ-C30

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Phosprint S.A.

Sponsor organisation

Phosprint S.A.

Address

Attika Technology Park Lefkippos Patriarchou Grigoriou, Neapoleos 27 Neapoleos 27

City

Agia Paraskevi

Postcode

153 41

Country

Greece

Scientific contact point

Organisation

Phosprint S.A.

Contact name

Ioanna Zergioti

Public contact point

Organisation

Phosprint S.A.

Contact name

Ioanna Zergioti

Third parties 2

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications