Urothelium Tissue Engineering Using Biopsies From Transurethral Resection of Prostate
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transurethral Resection of Prostate.
- Who it may be relevant to
- Registry conditions: Spina Bifida, Urothelial Neoplasm, Bladder, Neurogenic, Bladder Exstrophy. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Urothelium Tissue Engineering Using Bladder Mucosa From Transurethral Resection of Prostate
Overview
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.
Detailed description
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).
Interventions
- Procedure 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 com
Primary outcome measures
- Histological analysis of biopsy. [Time frame: 6 month]
Secondary outcome measures (12)
- Immunohistological analysis of biopsy. [Time frame: 6 month]
- RT-qPCR analysis of biopsy. [Time frame: 6 month]
- Digestion of the biopsy and culture with adapted medium. Optimization of culture conditions. [Time frame: 12 months]
- Histological analysis of the cultured cells. [Time frame: 12 months]
- Immunocytological analysis of the cultured cells. [Time frame: 12 months]
- RT-qPCR analysis of the cultured cells. [Time frame: 12 months]
- Development of original alginate freezed-dried scaffold [Time frame: 12 months]
- Association of the cultured cells with different scaffolds. Culture of cellularized scaffolds. [Time frame: 36 months]
- Histological analysis of cellularized scaffolds [Time frame: 36 months]
- Immunohistological analysis of cellularized scaffolds [Time frame: 36 months]
- RT-qPCR analysis of cellularized scaffolds [Time frame: 36 months]
- Biophysical analysis of cellularized scaffolds [Time frame: 36 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Adamowicz 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
- Lam 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
- Garthwaite 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
- Baker 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
Identifiers
NCT: NCT03698721 · PSS2017/IMOPU-BERTE/MS