Tissue-engineering can help to overcome problems, associated with tissue limitations for urological reconstruction. MukoCell GmbH’s expertise is in the area of advanced medicinal products, allowing the manufacture of urologic tissue for reconstruction of lower urinary organs. MukoCell ® , the first product in German market from MukoCell GmbH, is an authorized tissue engineered construct and can be used in patients with urethral stricture.
MukoCell® has successfully been used in over 80 patients with bulbar or penile urethral stricture in 8 different urologic clinics. For the production of MukoCell ® , a tiny oral mucosa biopsy was taken from the patient and sent to an advanced pharmaceutical clean room facilities for manufacturing of cell-based medicinal products according to „Good Manufacturing Practice“ (GMP). During three weeks, cells were isolated from the biopsy, expanded and cultured on the surface of a biodegradable scaffold. Patient’s own mucosal construct was then packed in a sterile container and sent to the hospital, where it was implanted into patients, undergoing urethral reconstruction surgery.
After the biopsy harvesting, patients did have no or only minor complain at the oral harvesting site. The urethroplasty with MukoCell ® was performed without intraoperative complications. The patients did not show adverse reactions related to MukoCell ® during the follow up time of up to 2 years. Postoperative radiologic and uroflowmetric analysis showed wide urethral calibers without diverticula, fistula or stricture recurrence in over 70-80% of patients. In these patients, uroflowmetric studies showed adequate flow rates.
Urethral reconstruction can successfully be performed with tissue engineered mucosa in patients with urethral stricture. Postoperative results are promising and allow the avoidance of harvesting large segments of oral mucosa for urethroplasty.