Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 7, 2026
Date Accepted: Jul 31, 2026
Evaluation of the clinical usefulness of a bioartificial urethral substitute generated by tissue engineering: an in vivo study protocol in laboratory rabbits
ABSTRACT
Background:
The recent development of bioartificial tissues by tissue engineering allows the generation of multilayered urethra substitutes potentially useful for the clinical treatment of severe conditions affecting the human urethra.
Objective:
This study aims to evaluate biosafety and efficacy in laboratory animals of a multilayered artificial urethra generated by tissue engineering to determine its clinical potential as advanced therapies medicinal product.
Methods:
Five groups of study have been established, including a positive control group of native animals, a negative control group of animals in which the ventral side of the urethra will be surgically sectioned and left unrepaired, a gold-standard group in which the ventral side of the urethra will be surgically sectioned and repaired with an oral mucosa autograft, an acellular group in which the urethral defect will be repaired using a multilayered fibrin-agarose biomaterial and a group of animals in which a multilayered cellular bioartificial urethra will be used to repair the urethral defect. Animals will be followed for 3 months, and variables related to biosafety, functionality and histological structure of the urethral grafts will be determined.
Results:
This study was approved by the Ethics Committee for Animal Research (Junta de Andalucía), protocol code 17/12/2024/178; date of approval: 20 December 2024). The study began in February 2025, and it is expected to finish by July 2026.
Conclusions:
The present preclinical study will contribute to determining the potential usefulness of these bioartificial tissues as novel advanced therapies medicinal products for clinical use.
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