Vagina reconstruction by decellularization of healthy human vaginal tissue

When a healthy, full-size vagina is absent due to a disorder, various neovagina creation methods are available. Sometimes dilation or stretching of the vagina cavity is sufficient, but generally intestinal or dermal graft tissue is required. However, different inherent tissue properties cause complications. Therefore, when a body part is lost, it should be replaced by a similar material. The use of organ-specific acellular vaginal tissue carries great potential, as the similar architecture and matrix composition make it fit for vagina regeneration. We developed an optimized decellularization protocol for human vaginal tissue and determined suitability as tissue-mimicking scaffold for vagina reconstruction. Histological examination confirmed the preservation of structural features and minimal cellular residue was seen during fluorescence microscopy, DNA and RNA quantification and fragment-length examination. Biomechanical testing showed decreased (P<0,05) strain at rupture (23%), tensile stress (55%) and elastic modulus (68%) after decellularization. Fluorescence microscopy revealed preserved Fibronectin-I/II/III and Laminin-I/II, while Collagen-I and Ficolin-2B were decreased but mostly retained. The absence of cellular residue, minimally altered biomechanical ECM properties and mostly preserved structural proteins, appear to make our decellularized human vaginal matrix a suitable tissue-mimicking scaffold for vagina transplantation when tissue survival through vascularization and innervation are accomplished in the future. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This study did not receive any funding. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: the institutional Medical Ethical Examination Committee of Amsterdam UMC location VU Medical Center gave ethical approval for this work (Amsterdam; IRB approval by METc VUmc registration number 2018/3190, October 2018). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors.