International Policy Framework for Donor Gonadal Tissue Banking and Transplantation: Advancing Endocrine Health, Healthspan and Responsible Reproductive Medicine

Abstract

This policy concept proposes the architecture for a future international framework governing the donation, banking, cross-border transport and potential clinical application of donor ovarian and testicular tissue. Existing regulatory systems address human tissues and cells, transplantation, reproductive cells and autologous fertility preservation. However, they do not provide a dedicated and internationally harmonised pathway for the donation, storage, allocation, transport and transplantation of donor gonadal tissue. The proposed framework places the preservation or restoration of endocrine function, prevention of morbidity associated with hormone deficiency, improvement of quality of life and advancement of healthspan at the centre of future policy development. Reproductive use is treated as a distinct and secondary pathway requiring additional safeguards relating to informed consent, genetic parentage, donor anonymity or identifiability, protection of future offspring and long-term follow-up. The concept covers: • the existing scientific and regulatory position of autologous ovarian and testicular tissue preservation and transplantation in women, men and children; • the regulatory gap concerning donor gonadal tissue; • separate authorisation pathways for endocrine and reproductive applications; • international tissue banks, accreditation, traceability, biovigilance and cross-border cryogenic transport; • medical, infectious-disease, genetic, psychosocial and legal criteria for donors and recipients; • ethical principles, non-commercialisation, equitable access and protection against premature clinical marketing; • recommendations for WHO, ESHRE, ASRM, the European Union and national regulators. The document clearly distinguishes established clinical evidence from experimental procedures and proposed future regulation. Autologous ovarian tissue cryopreservation is recognised as an accepted fertility-preservation technique in appropriate indications, whereas testicular tissue cryopreservation in prepubertal boys remains experimental. Donor gonadal tissue transplantation is not presented as established clinical practice. The concept does not claim that donor gonadal tissue transplantation has been demonstrated to extend human lifespan. Instead, it identifies endocrine function and healthspan as priority research and policy objectives whose long-term effects require prospective clinical evidence. This Zenodo record contains the English and Montenegrin editions of the policy concept. Ovaj policy koncept predlaže arhitekturu budućeg međunarodnog okvira za doniranje, bankiranje, prekogranični transport i moguću kliničku primjenu donorskog ovarijalnog i testikularnog tkiva. Postojeći regulatorni sistemi uređuju ljudska tkiva i ćelije, transplantaciju, reproduktivne ćelije i autologno očuvanje fertiliteta. Međutim, oni ne uspostavljaju poseban i međunarodno harmonizovan put za doniranje, skladištenje, raspodjelu, transport i transplantaciju donorskog gonadalnog tkiva. Predloženi okvir stavlja očuvanje ili obnavljanje endokrine funkcije, prevenciju posljedica hormonskog deficita, unapređenje kvaliteta života i healthspan-a u središte budućeg razvoja politike. Reproduktivna primjena tretira se kao poseban i sekundarni put koji zahtijeva dodatne garancije u pogledu informisanog pristanka, genetskog roditeljstva, anonimnosti ili mogućnosti identifikovanja donora, zaštite budućeg potomstva i dugoročnog praćenja. Koncept obuhvata: • postojeće naučno i regulatorno stanje autolognog očuvanja i transplantacije ovarijalnog i testikularnog tkiva kod žena, muškaraca i djece; • regulatornu prazninu koja se odnosi na donorsko gonadalno tkivo; • odvojene puteve odobravanja za endokrinu i reproduktivnu primjenu; • međunarodne banke tkiva, akreditaciju, sljedivost, biovigilancu i prekogranični kriogeni transport; • medicinske, infektivne, genetske, psihosocijalne i pravne kriterijume za donore i primaoce; • etičke principe, nekomercijalizaciju, pravičan pristup i zaštitu od preuranjenog kliničkog marketinga; • preporuke za WHO, ESHRE, ASRM, Evropsku uniju i nacionalne regulatore. Dokument jasno razdvaja etablirane kliničke dokaze, eksperimentalne postupke i predloženu buduću regulativu. Autologna krioprezervacija ovarijalnog tkiva priznata je kao prihvaćena metoda očuvanja fertiliteta u odgovarajućim indikacijama, dok krioprezervacija testikularnog tkiva kod prepubertetskih dječaka ostaje eksperimentalna. Transplantacija donorskog gonadalnog tkiva ne predstavlja se kao ustanovljena klinička praksa. Koncept ne tvrdi da je dokazano da transplantacija donorskog gonadalnog tkiva produžava životni vijek. Umjesto toga, endokrinu funkciju i healthspan određuje kao prioritetne istraživačke i regulatorne ciljeve čiji dugoročni efekti zahtijevaju prospektivne kliničke dokaze. Ovaj Zenodo zapis sadrži englesku i crnogorsku verziju policy koncepta.