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AUA 2014 – SESSION: TRAUMA/RECONSTRUCTION: TRAUMA & RECONSTRUCTIVE SURGERY III

Abstract MP9-04: Preclinical and clinical examination of tissue-engineered graft for urethral reconstruction (MukoCell®) with regard to its safety

Massimo Lazzeri*, Guido Barbagli, Arezzo, Italy, Dirk Fahlenkamp, Chemnitz, Germany, Giuseppe Romano, Arezzo, Italy, Ulf Balsmeyer, Chemnitz, Germany, Helmut Knispel, Maria-Elsa Spiegeler, Burkard Stuerzebecher, Berlin, Germany, Gouya Ram-Liebig, Dresden, Germany

Introduction and Objectives

MukoCell® is an autologous tissue-engineered oral mucosa graft. The present report sums up MukoCell®s preclinical safety data. Additional reported data of 70 patients, treated with MukoCell®, are also considered with regards to safety analysis.

Methods

For MukoCell® production, patient’s oral mucosa cells were generated from a small oral mucosa biopsy and cultured on the surface of a biocompatible scaffold. The tumorigenic potential of MukoCell® was examined in vivo. For this purpose, cultured cells of 6 human donors were injected by intraperitoneal and subcutaneous route into each of ten immunodeficient athymic nude mice. 4×107 cells ± 2 × 106 cells were injected into each animal on Days 1, 18, 25 and 46 of the study. An additional group consisting of ten animals each received cell culture medium as vehicle control. To examine the potential migration of cells into distant organs, murine MukoCell® constructs from eGFP-transgenic mice were implanted into peritoneal cavity of histocompatible non-transgenic mice and vice versa. The 24 test animals were sacrificed either at weeks 1, 2, 4 or 12 for histological analysis. To investigate the degradation of implanted MukoCell® with time, scaffolds with the size of 0.5 x 1.5 cm were implanted into the peritoneal cavity of 20 female BALBc/C57BL6J mices. Additionally, reported clinical safety data from 70 MukoCell®-treated patients with urethral stricture, which have been recruited in an ongoing observational study with up to 2 year follow-up period, were evaluated on the basis of a pharmacivigilance system. Ethical committee votum was available.

Results

Evaluation of tumorigenity study in nude mice did not reveal macroscopic and microscopic malignancies attributable to MukoCell® in the 60 different examined tissues and organs. Additionally, migration of the transplanted cells into distant organs was excluded at all examined time intervals after implantation of murine homologue of MukoCell®. While the grafts were still present in all 10 animals 9 days after implantation, 6 of 10 grafts were degraded 40 days after implantation in the remaining 10 animals. Reported clinical data of 70 with MukoCell® treated patients demonstrated no peri- or post-operative adverse events related to MukoCell®.

Conclusions

MukoCell® seems to be a safe graft for urethroplasty for patients with urethral stricture. The graft is degrading within a few weeks and hence avoids complication associated with persistent implants.

Date & Time : May 17, 2014 10:30 AM-12:30 PM
Session Title : Trauma/Reconstruction: Trauma & Reconstructive Surgery III
Sources of Funding : MukoCell GmbH

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