Clinical trial · Observational

Urothelium Tissue Engineering Using Biopsies From Transurethral Resection of Prostate

Urothelium Tissue Engineering Using Bladder Mucosa From Transurethral Resection of Prostate

NCT03698721CI-TRIAL-00035183IMOPUnot yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Different clinical conditions can require urinary bladder augmentation or replacement. Tissue engineered bladder has been clinically evaluated but is not recommended due to diverse side effects. Thus, there is a real interest for the development of regenerative approach with innovative scaffolds and cell transplantation. The investigators propose the use of urothelial cells obtained by Trans-Urethral Resection of Prostate or bladder (TURP) to obtain a tissue engineered urothelium in association with different scaffolds.

Conditions

Conditions (5)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Bladder Exstrophy	—	UNRESOLVED	—
Bladder, Neurogenic	—	UNRESOLVED	—
Hypospadias	—	UNRESOLVED	—
Spina Bifida	—	UNRESOLVED	—
Urothelial Neoplasm	Urothelial Neoplasm	ONTOLOGY_EXACT	0.98

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Transurethral Resection of Prostate	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Histological analysis of biopsy.
timeFrame
6 month
description
Histological analysis with standard coloration will assess the viability of urothelium. Signs of necrosis (ulcerations, destructions of urothelium structure) will be noted.

Secondary outcomes (16)

measure
Immunohistological analysis of biopsy.
timeFrame
6 month
description
Immunohistological analysis using specific antibodies will locate the urothelium (Keratin, Uroplakin), the smooth muscle (Smooth muscle actin), the prostatic gland (Prostatic specific antigen).
measure
RT-qPCR analysis of biopsy.
timeFrame
6 month
description
RT-qPCR analysis will measure the level of expression (compared to housekeeping gene RPLP0) of RNA specific to urothelium (Keratin, Uroplakin), the smooth muscle (Smooth muscle actin), the prostatic gland (Prostatic specific antigen). This level will be compared to cultured urothelial cells.

Eligibility

Eligibility (as posted)

Sex: Male
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Patient needing a Transurethral Resection of Prostate (TURP)
* Weight of prostate (evaluated by ultrasonography)greater than or equal to 30 grams
* Affiliation to a social security system
* Patient over the age of majority
* Patient receiving complete information on research organization without opposition to the use of biological specimen

Exclusion Criteria:

* Patient for whom no TURP is realized during endoscopic procedure
* Patient for whom no resection is realized on the bladder neck
* Patient with prostate weight estimated under 30 grams
* Patient who opposed to the realization of the study

References

Publications (4)

BACKGROUNDAdamowicz J, Kowalczyk T, Drewa T. Tissue engineering of urinary bladder - current state of art and future perspectives. Cent European J Urol. 2013;66(2):202-6. doi: 10.5173/ceju.2013.02.art23. Epub 2013 Aug 13. PMID 24579029
BACKGROUNDLam Van Ba O, Aharony S, Loutochin O, Corcos J. Bladder tissue engineering: a literature review. Adv Drug Deliv Rev. 2015 Mar;82-83:31-7. doi: 10.1016/j.addr.2014.11.013. Epub 2014 Nov 14. PMID 25446136
BACKGROUNDGarthwaite M, Hinley J, Cross W, Warwick RM, Ambrose A, Hardaker H, Eardley I, Southgate J. Use of donor bladder tissues for in vitro research. BJU Int. 2014 Jan;113(1):160-6. doi: 10.1111/bju.12285. PMID 24053725
BACKGROUNDBaker SC, Shabir S, Southgate J. Biomimetic urothelial tissue models for the in vitro evaluation of barrier physiology and bladder drug efficacy. Mol Pharm. 2014 Jul 7;11(7):1964-70. doi: 10.1021/mp500065m. Epub 2014 Apr 17. PMID 24697150