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Urethroplasty with MukoCell®

As an alternative to the described methods for urethral reconstruction, the drug MukoCell® was approved in 2013 by the Paul Ehrlich Institute under the number PEI.A.11491.01.1 for advanced therapies (ATMP).

In contrast to the conventional transplantation of oral mucosal tissue in urethroplasty, with MukoCell® only very small pieces of oral mucosa with a size of 0.5 cm²-0.8 cm² are required.1 After outpatient removal of the oral mucosal cells, these are biotechnologically processed and are available three weeks later as a tissue graft. Due to the size of the carrier membrane, the removal of up to two grafts is necessary in individual cases. The number of pieces of oral mucosa removed depends on the length of the stricture. These are implanted precisely into the patient’s urethra and ensure that it is fully functional. An indwelling catheter remains in place for approximately three weeks during healing. Transplantation of the in vitro-produced tissue from autologous oral mucosa represents a promising therapeutic alternative to existing forms of treatment.2.

The procedure has been used very successfully at the University Hospital of Cologne since the beginning of 2016. Currently, three to four procedures for implantation of the tissue graft are performed monthly at the University Hospital. Practical experience with MukoCell® to date supports the efficacy and safety of the treatment.

In a prospective and multi-center observational study (evidence class 2a) initiated by the manufacturer, which will be submitted for publication in February 2017, 99 patients were followed-up. The results of the study show that there is a relationship between intervention outcome and the number of prior surgeries. That is, the earlier treatment with MukoCell® is performed, the more likely the patient is to achieve long-term freedom from symptoms after a single therapy. This contrasts with the alternative of numerous urethral slits, with the high likelihood of a subsequent need for additional urethroplasty.3,4

According to the manufacturer, mild postoperative pain occurred in only 3 of 99 cases during oral mucosal harvest. Therefore, in their summary, the authors recommend considering transplantation of in vitro-derived tissue from autogenous oral mucosa as first-line therapy, depending on the indication.5 With evidence level 2a in the treatment of urethral strictures, the study results represent scientifically high-quality and unique findings, in terms of the level of evidence.

1 Studienreport (Sponsor MukoCell GmbH): Observational Study of the Use of Tissue-engineered Autologous Implants of Oral Mucosa (MukoCell®) in Reconstruction of the Urethra. 2016 (unveröffentlicht).
2

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3 Zugor et al. Offene urethrale Rekonstruktion bei Harnröhrenstrikturen. Urologie. 2014(1): 76-78.
4 Santucci and Eisenberg. Urethrotomy has a much lower success rate than previously reported. The Journal of urology. 2010; 185(5):1859-1862.
5 Studienreport (Sponsor MukoCell GmbH): Observational Study of the Use of Tissue-engineered Autologous Implants of Oral Mucosa (MukoCell®) in Reconstruction of the Urethra. 2016 (unveröffentlicht).