Urothelium Tissue Engineering Using Biopsies From Transurethral Resection of Prostate

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

365 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-31

Study Completion Date

2026-10-31

Brief Summary

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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.

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Detailed Description

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Bladder biopsies will be obtained during cystoscopy, conserved in culture medium (DMEM®), digested by dispase and sowed on collagen-coated culture support. Keratinocyte Serum Free Medium (KSFM) will be used for proliferation. Microscopy, immunohistochemistry, RNA extraction, Reverse Transcription and quantitative Polymerase Chain Reaction (RT-qPCR) will be performed during passages. Cell culture conditions will be optimized to improve proliferation and avoid loss of differentiation. The investigators will develop scaffolds based on sodium alginate hydrogels, followed by freeze-drying to generate porous sponges (at -20°C and -80°C). Cultured cells will be associated to these original scaffolds and to other scaffolds, for example alginate hydrogels or Collagen Cell Carrier (CCC), cultivated for 28 days and analyzed. Histological and immunohistological appearance of cellularized scaffolds will be compared to assess the effectiveness of each scaffold for tissue engineering in urothelium.

Cellularized scaffolds will be studied in vitro (Transepithelial Electrical Resistance, impermeability, ability to be stitched, resistance to urine) and in vivo in ectopic location (subcutaneous location in Nude mice) or in orthotopic location (bladder augmentation in small animal).

Conditions

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Spina Bifida Urothelial Neoplasm Bladder, Neurogenic Bladder Exstrophy Hypospadias

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Transurethral Resection of Prostate

Transurethral resection of the prostate is a urological operation used to treat benign prostatic hyperplasia (BPH). It is performed by visualising the prostate through the urethra and removing tissue by electrocautery or sharp dissection with a resectoscope. This is considered the most effective treatment for BPH. This procedure is done with spinal or general anaesthetic. A triple lumen catheter is inserted through the urethra to irrigate and drain the bladder after the surgical procedure is complete. Outcome is considered excellent for 80-90% of BPH patients.

Intervention Type PROCEDURE

Other Intervention Names

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TURP TURPs TUPR

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No