Spina Bifida Clinical Trial
— IMOPUOfficial title:
Urothelium Tissue Engineering Using Bladder Mucosa From Transurethral Resection of Prostate
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.
Status | Not yet recruiting |
Enrollment | 365 |
Est. completion date | October 2026 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Central Hospital, Nancy, France |
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. Review. — View Citation
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. Review. — View Citation
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 6 month | |
Secondary | 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). | 6 month | |
Secondary | 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. | 6 month | |
Secondary | 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. |
12 months | |
Secondary | 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. | 12 months | |
Secondary | Immunocytological analysis of the cultured cells. | Cultured cells (Outcome 4) will be analyzed in immunocytology to assess the type of cells (urothelial / smooth muscle / prostatic), the expression and the localization of specific markers (Outcome 2) | 12 months | |
Secondary | RT-qPCR analysis of the cultured cells. | Cultured cells (Outcome 4) will be analyzed in RT-qPCR at each passage to assess evolution during culture. 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) will be measured. | 12 months | |
Secondary | Development of original alginate freezed-dried scaffold | Development of an original scaffold based on sodium alginate hydrogels, followed by freeze-drying to generate porous sponges (at -20°C and -80°C). Analysis of structure, impermeability, ability to be stitched.. |
12 months | |
Secondary | Association of the cultured cells with different scaffolds. Culture of cellularized scaffolds. | Previously cultured and analyzed cells will be associated to different scaffolds. Collagen scaffolds Alginate scaffolds Alginate hydrogels obtained by spray Original alginate freezed-dried scaffold (Outcome 4) Cellularized scaffolds will be cultured at least 28 days using previously described conditions. |
36 months | |
Secondary | Histological analysis of cellularized scaffolds | After association, cellularized scaffolds (Outcome 9) will be cultured at least 28 days. Survival rate using MTT assay will be performed. Histological analysis using standard colorations will be performed to evaluate the appearance of the cellularized scaffold, the location, the appearance and the organization of the cells. |
36 months | |
Secondary | Immunohistological analysis of cellularized scaffolds | After association, cellularized scaffolds (Outcome 9) will be cultured at least 28 days. Immunohistological analysis will be performed to evaluate the expression and location of specific markers (Outcome 2) |
36 months | |
Secondary | RT-qPCR analysis of cellularized scaffolds | After association, cellularized scaffolds (Outcome 9) will be cultured at least 28 days. RT-qPCR will be performed to assess evolution during culture in 3 dimensional conditions. 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) will be measured. |
36 months | |
Secondary | Biophysical analysis of cellularized scaffolds | After association, cellularized scaffolds (Outcome 9) will be cultured at least 28 days. Biophysical analysis on cellularized scaffolds will be done: Transepithelial Electrical Resistance (cellular ability to form an impermeable barrier) Impermeability (ability of the cellularized scaffold to form a water resistant barrier) Ability to be stitched (ability of the cellularized scaffold to be manipulated and stitched) Resistance to urine (ability of the cellularized scaffold to resist to chemical aggression of urine) |
36 months | |
Secondary | Implantation of the cellularized scaffold in Nude mice | Cellularized scaffolds will be implanted in subcutaneous location in Nude mice. Incubation in vivo will be done during at least 28 days. Analysis (histology, immunohistology, RT-qPCR) will be performed after 28 days of incubation to assess the survival of cells and the behavior of the cellularized scaffold in vivo. Signs of necrosis, neoangiogenesis and inflammation will be noted. | 12 months | |
Secondary | Histological analysis of implanted scaffolds | Histological analysis will be performed after 28 days of incubation on implanted scaffolds (Outcome 14) to evaluate the appearance of the cellularized scaffold, the location, the appearance and the organization of the cells. Survival rate using MTT assay will be performed. Signs of fibrosis will be noted. |
12 months | |
Secondary | Immunohistological analysis of implanted scaffolds | Histological analysis will be performed after 28 days of incubation on implanted scaffolds (Outcome 14) to evaluate Immunohistological analysis will be performed to evaluate the expression and location of specific markers (Outcome 2) | 12 months | |
Secondary | RT-qPCR analysis of implanted scaffolds | RT-qPCR analysis will be performed after 28 days of incubation on implanted scaffolds (Outcome 14) to assess evolution during in vivo conditions. 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) will be measured. | 12 months |
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