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Bulgarian Review of Ophthalmology

Experimental considerations and clinical applications of the innovative bioproduct Alloheal

Catherina Meglena Bommert


Aim: The aim of this article is to develop and standardize an implementable algorithm for ex vivo expanding of allogenic limbal epithelial stem cells, applicable in unified transplantation in everyday clinical practice.

Methods: An evaluation of 32 proprietary Alloheal grafts that were manufactured by cultivating limbal epithelial stem cells derived from allogenic corneoscleral donor tissue on cryopreserved and thermolysin-treated amniotic membranes was done. These were spanned within a self-prepared flexible device and an insert ring was constructed to compare and to assess a surgically acceptable modality for transfer.

Result: The time-consuming suturing procedure provided better surgical handling. Considering the importance of reduction of the surgical time, this method was seen as beneficial investment. Its flexibility and adjustability improves surgical handling and the rapid transplantation of a wrinkle-free bioproduct carries a decreased risk of trauma to the cells and/or to the ocular surface. The mean score of Alloheal 5.28 was better when compared with the gold standard in most centers - CellCrown 4.28.

Conclusion: We think that Alloheal is a safe, effective and efficient method, clinically meaningful for future advancement and management of complex anterior surface disorders. Further research and development will be needed for better and even more universal products for corneal regeneration. So far, our proprietary Alloheal is the first biological product at the Bulgarian market. It is not considered a medical device, because of its specific characteristics.


amniotic membrane; bioproduct

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About The Author

Catherina Meglena Bommert
Medical University of Varna

Department of Ophthalmology and Visual Sciences, Faculty of Medicine