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Clinical Trial
. 2017 Sep:23:185-192.
doi: 10.1016/j.ebiom.2017.08.014. Epub 2017 Aug 16.

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

Gouya Ram-Liebig  1 , Guido Barbagli  2 , Axel Heidenreich  3 , Dirk Fahlenkamp  4 , Giuseppe Romano  5 , Udo Rebmann  6 , Diana Standhaft  6 , Hermann van Ahlen  7 , Samer Schakaki  7 , Ulf Balsmeyer  4 , Maria Spiegler  8 , Helmut Knispel  8
Affiliations
Clinical Trial

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

Gouya Ram-Liebig et al. EBioMedicine. 2017 Sep.

Abstract

Background: Harvest 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).

Methods: 99 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 24months.

Findings: All 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±4.7mL/s (n=57) and 25.4±14.7mL/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 24months (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.

Interpretations: TEOMG is safe and efficient in urethroplasty.

Keywords: ATMP; Graft; Oral mucosa; Reconstruction; Tissue engineering; Urethra stricture.

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Figures

Fig. 1
Fig. 1
Urethroplasty with the autologous tissue-engineered oral mucosa graft MukoCell®. A small oral mucosa biopsy is taken from the cheek of the patient (A) which is used for the manufacture of the graft. The latter is cut into the desirable size (B), transferred to the opened urethra (C) and sutured as a ventral onlay graft (D). Pre- (E) and postoperative (F) voiding urethrography, before and 3 weeks after the implantation of autologous tissue-engineered oral mucosa graft. The strictured (S) and grafted (G) area are indicated in (E) and (F).
Fig. 2
Fig. 2
Kaplan-Meier plot of re-stricture-free survival. Time calculated from date of urethroplasty surgery. One patient with first assessment after 12 months was excluded from analysis. Urethral strictures of any etiology, location, length and severity were included in the study. Re-stricture-free survival rate, based on uncensored data, using age-related Qmax (Ortega & Pena, 2009) as measure for stricture recurrence.
Fig. 3
Fig. 3
Kaplan-Meier plot of re-stricture-free survival by number of previous surgeries (urethrotomy or urethroplasty). One patient with first assessment after 12 months was excluded from analysis. Urethral strictures of any etiology, location, length and severity were included in the study.
See this image and copyright information in PMC

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