Results of Use of Tissue-Engineered Autologous Oral Mucosa Graft for Urethral Reconstruction: A Multicenter, Prospective, Observational Trial

Abstract

BackgroundHarvest of oral mucosa for urethroplasty due to urethral stricture is associated with donor-site-morbidity. We assessed functionality and safety of an authorized tissue-engineered oral mucosa graft (TEOMG) under routine practice in stricture recurrences of any etiology, location, length and severity (real-world data).Methods99 patients from eight centers with heterogenous urethroplasty experience levels were included in this prospective, non-interventional observational study. Primary and secondary outcomes were success rate (SR) and safety at 12 and 24 months.FindingsAll but one patient had ≥ 1, 77.1% (64 of 83) ≥ 2 and 31.3% (26 of 83) ≥ 4 previous surgical treatments. Pre- and postoperative mean ± SD peak flow rate (Qmax) were 8.3 ± 4.7 mL/s (n = 57) and 25.4 ± 14.7 mL/s (n = 51). SR was 67.3% (95% CI 57.6–77.0) at 12 and 58.2% (95% CI 47.7–68.7) at 24 months (conservative Kaplan Meier assessment). SR ranged between 85.7% and 0% in case of high and low surgical experience. Simple proportions of 12-month and 24-month SR for evaluable patients in all centers were 70.8% (46 of 65) and 76.9% (30 of 39). Except for one patient, no oral adverse event was reported.InterpretationsTEOMG is safe and efficient in urethroplasty.

Regenerative medicine in urology: the future of urinary reconstruction

“…A multicentre, prospective observational trial was performed in Germany in 2017 that investigated a tissue‐engineered oral mucosa graft (MukoCell) . The results of this study demonstrated a recurrent stricture rate of 33% at one year, which is consistent with the reported rates after use of native oral mucosa.…”

Tissue engineering of the urethra: where are we in 2019?

“…Barbagli and Lazzeri concluded 'that by following strict protocol criteria, it is possible to move tissue-engineering technology from the laboratory bench to the bedside'. They did, however, emphasise the importance of an appropriate subsequent study and were justified in taking a cautious approach as the subsequent larger prospective observational multicentre clinical study of 99 patients from eight centres Subsequently showed from this group [39]. They reported success with a heavy reliance on subjective measures and flow rates at 2 years in 98 patients.…”

Characterization of Tissue Engineered Endothelial Cell Networks in Composite Collagen-Agarose Hydrogels

“…Tissue engineering aims to develop in vitro tissues to improve or replace impaired biological tissues in vivo. To date, clinical applications of tissue engineering are limited to tissues which do not require vascularization nor anastomosis [ 1 , 2 , 3 , 4 ]. The 3D engineered tissues exceeding 200 µm (the effective diffusion limit of oxygen), which are densely populated with cells, quickly develop a necrotic core, if they are not vascularized [ 5 ].…”