Urothelium Tissue Engineering Using Biopsies From Transurethral Resection of Prostate
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorCentral Hospital, Nancy, France
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Male patient requiring TURP for Benign Prostatic Hyperplasia with prostate weight evaluated preoperatively greater than or equal to 30 grams
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Transurethral Resection of Prostate
Procedure/SurgeryTransurethral 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Histological analysis of biopsy.
Histological analysis with standard coloration will assess the viability of urothelium. Signs of necrosis (ulcerations, destructions of urothelium structure) will be noted.
Time frame
6 monthSecondary outcomes
1
Immunohistological analysis of biopsy.
Immunohistological analysis using specific antibodies will locate the urothelium (Keratin, Uroplakin), the smooth muscle (Smooth muscle actin), the prostatic gland (Prostatic specific antigen).
Time frame
6 month2
RT-qPCR analysis of biopsy.
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.
Time frame
6 month3
Digestion of the biopsy and culture with adapted medium. Optimization of culture conditions.
The biopsy will be digested using dispase. Cells will be sowed on collagen coated supports and cultured using Keratinocyte Serum Free Medium (KSFM). Trypsination will be done at confluence. RT-qPCR (level of expression of each specific marker) will be realized at each passage to assess evolution during culture.
Time frame
12 months4
Histological analysis of the cultured cells.
Cultured cells (Outcome 4) will be analyzed in contrast phase microscopy and with standard microscopy coloration to assess their morphology, the number of cellular types and their evolution throughout passages.
Time frame
12 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: