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Decellularized Extracellular Matrix (ECM)

Decellularization removes cellular material from donor tissue to produce an extracellular-matrix (ECM) scaffold. Sources include human allografts and animal tissues.[1][2] Processing aims to retain useful matrix structure and signals.[1][2]

What the scaffold provides​

A matrix can support host-cell attachment and ingrowth. The result depends on its source, processing, residual cellular or chemical material, mechanical properties and recipient tissue. Remodeling may produce useful tissue, but can also lead to inflammation, fibrosis, contracture or failure.[2][3]

Common sources include porcine small intestinal submucosa (SIS), bladder matrix, dermal matrix and human donor tissues. These are not interchangeable products.

Urethral reconstruction​

The EAU 2026 guideline treats cell-free matrices and cultured oral-mucosa grafts as separate categories.[4]

  • Cell-free matrices (porcine SIS, acellular bladder matrix, acellular dermal matrix) serve as a scaffold for host-cell ingrowth and are available off the shelf. In a small randomized trial (n = 30), urethral patency was 66.6% with acellular bladder matrix and 100% with buccal mucosa graft, and the difference was clearest in an unhealthy urethral bed.[4] Earlier retrospective series reported outcomes of 76% to 92% for porcine SIS and 85.7% for allogeneic acellular dermal matrix, but they differed in stricture location, follow-up and the definition of success; poorer results were reported after previous treatment, in poorly vascularized beds and with longer strictures.[4] A later propensity-matched cohort of 25 SIS and 25 buccal-mucosa bulbar repairs estimated 13-year success at 68% and 83.4%, respectively, with failure defined as any further treatment; follow-up was longer in the SIS group.[5] The guideline advises against cell-free grafts with extensive spongiofibrosis, after failed previous urethroplasty or for stricture length above 4 cm .[4]
  • Cultured autologous oral-mucosa grafts should be used only within clinical trials .[4] In a prospective multicenter study of 99 patients, estimated urethral patency was 67.3% at 12 months and 58.2% at 24 months.[4] In a single-center observational comparison of anterior urethroplasty for strictures longer than 2 cm (failure defined as maximum flow below 15 mL/s or further instrumentation), success was 68.8% with a tissue-engineered oral-mucosa graft (MukoCell, n = 77) and 78.9% with native oral mucosa (n = 76; p = 0.155) at a median follow-up of about 52 months; in the subgroup with prior repeated urethral dilations, success was lower with the engineered graft (31.3% vs 81.3%), and operating time and oral morbidity were lower with it.[6]

Bladder and ureteral replacement​

Identify the exact product, indication and applicable evidence. Autologous gastrointestinal tissue remains the established biomaterial for urinary reconstruction despite its long-term complications, and regenerative biomaterials must show better outcomes than current replacement strategies.[1] For bowel-based options and their limitations, see Bowel Segments.

Practical interpretation​

Look for the actual defect repaired, cell-free versus cell-seeded design, vascular bed, follow-up duration and functional endpoints.[2][3]

References​

1. Davis NF, Cunnane EM, Quinlan MR, et al. Biomaterials and Regenerative Medicine in Urology. Advances in Experimental Medicine and Biology. 2018;1107:189–198. doi:10.1007/5584_2017_139

2. Duan L, Wang Z, Fan S, Wang C, Zhang Y. Research Progress of Biomaterials and Innovative Technologies in Urinary Tissue Engineering. Frontiers in Bioengineering and Biotechnology. 2023;11:1258666. doi:10.3389/fbioe.2023.1258666

3. Sharma S, Basu B. Biomaterials Assisted Reconstructive Urology: The Pursuit of an Implantable Bioengineered Neo-Urinary Bladder. Biomaterials. 2022;281:121331. doi:10.1016/j.biomaterials.2021.121331

4. European Association of Urology. EAU Guidelines on Urethral Strictures. 2026. Chapter 9: Tissue transfer. Guideline text and recommendations.

5. Palminteri E, Toso S, Preto M, et al. "Small intestinal submucosa graft bulbar urethroplasty is a viable technique: results compared to buccal mucosa graft urethroplasty after propensity score matching." World J Urol. 2024;42(1):123. doi:10.1007/s00345-024-04795-8

6. Karapanos L, Knorr V, Halbe L, et al. "Comparison of oral morbidity and mid-term efficacy of anterior urethroplasty using an autologous tissue-engineered graft (MukoCell) versus native oral mucosa graft." Int J Urol. 2023;30(11):1000-1007. doi:10.1111/iju.15247

See also: Synthetic Polymer Scaffolds, Composite Scaffolds, Bowel Segments.