Samantha Bobba1,2, Nick Di Girolamo3, Megan Munsie4, Fred Chen5, Alice Pebay6, Damien Harkin7, Alex Hewitt8, Michael O’Connor9, Samuel McLenachan10, Audra Shadforth7, Stephanie Watson11,12,1
Purpose: A greater understanding of the function and location of ocular stem cells (SCs) has led to rapid advances in possible therapeutic applications. However, ocular SC therapy is associated with sig- niﬁcant technical challenges and potential long-term complications. Whilst other international organisa- tions have developed guidelines regarding the use of ocular SC therapy, a RANZCO position statement does not yet exist. Our purpose was to develop a position statement on the role of ocular SC therapy from an Australian perspective in the context of international advances.
Methods: A systematic literature review of ocular SC therapy was conducted, registered clinical trials reviewed and expert opinions sought. Collated data was used to develop a position statement based on current guidelines whilst also considering activities occurring outside the expected pathways to clinical translation.
Results: This position statement supports advance- ments in knowledge, whilst endeavouring to mini- mise patient harm. The literature suggests that limbal epithelial progenitor cells for ocular surface transplantation are a viable therapy based on Phase I/II clinical trials, and that the development of more robust clinical trials is reasonable. Further pre- clinical evaluation and/or clinical trials of all other cellular-based interventions that rely on induced pluripotent SCs, human embryonic SCs, mesenchy- mal SCs and other potential SC sources are required.
Conclusion: Expert opinion and systematic review of the safety and efﬁcacy of ocular SCs were used to develop a position statement on ocular SC therapy. This has recently been approved by the RANZCO Board as the college’s ﬁrst position statement on the topic.