To the best of our knowledge, this is the first paper reporting the clinical use of stem cells for the corneal stroma.13 Nevertheless, our results should be considered carefully given that this pilot clinical trial is vulnerable to many biases: i.e., small study sample and the unrandomised, unblind trial design. However, we have observed encouraging results that will open a new and very exciting line of research in the coming years.
All patients gained some vision (although not enough to consider it a viable alternative to classical corneal transplantation), and in our small study sample the implantation of autologous mesenchymal stem cells have proven completely safe.
Probably one of the most important findings of this study is that a mild amount of newly formed collagen was generated within the stroma without the induction of any clinically visible stromal haze.
Of course, the study raises many questions regarding this novel therapy: are these findings clinically relevant and can they be enhanced by alternative approaches? Is the therapy able to halt the natural progression of the disease in less advanced cases?
All of these questions will have to be answered by future studies in order to establish whether this new modality of treatment can be accepted in real clinical practice, otherwise it will remain a scientific curiosity.