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Bulgarian Review of Ophthalmology

Experimental considerations and clinical applications of the innovative bioproduct Alloheal

Catherina Meglena Bommert

Abstract

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.


Keywords

amniotic membrane; bioproduct

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References

Meller D, Pauklin M, Thomasen H, Westekemper H, Steuhl KP. Amniotic membrane transplantation in the human eye. Dtsch Arztebl Int. 2011;108(14):243-8. doi: 10.3238/arztebl.2011.0243.

Mamede AC, Botelho MF, editors. Amniotic membrane: Origin, characterization and medical applications. Springer Netherlands; 2015.

de ROTTH A. Plastic repair of conjunctival defects with fetal membranes. Arch Ophthalmol. 1940;23(3):522-5. doi:10.1001/archopht.1940.00860130586006.

Sorsby A, Symons HM. Amniotic membrane grafts in caustic burns of the eye (burns of the second degree). Br J Ophthalmol. 1946; 30(6):337-45. doi:10.1136/bjo.30.6.337.

Kim JC, Tseng SCG. The effects on inhibition of corneal neovascularization after human amniotic membrane transplantation in severely damaged rabbit corneas. Korean J Ophthalmol. 1995;9(1):32-46. doi: 10.3341/kjo.1995.9.1.32.

Tseng SC, Espana EM, Kawakita T, Di Pascuale MA, Li W, He H, et al. How does amniotic membrane work? Ocul Surf. 2004;2(3):177-87. doi:10.1016/S1542-0124(12)70059-9

Meller D, Pauklin M, Thomasen H, Westekemper H, Steuhl KP. Amniotic Membrane Transplantation in the Human Eye. Dtsch Arztebl Int. 2011;108(14):243-8. doi: 10.3238/arztebl.2011.0243.

Grueterich M, Espana EM, Tseng SC. Ex vivo expansion of limbal epithelial stem cells: Amniotic membrane serving as a stem cell niche. Surv Ophthalmol. 2003;48(6):631-46. doi:10.1016/j.survophthal.2003.08.003.

Jain P, Jhagta H. Limbal stem cell deficiency: A review. J Clin Ophthalmol Res. 2015;3(2):71. doi:10.4103/2320-3897.156582.

Tseng SC, Prabhasawat P, Barton K, Gray T, Meller D. Amniotic membrane transplantation with or without limbal allografts for corneal surface reconstruction in patients with limbal stem cell deficiency. Arch Ophthalmol. 1998; 116(4):431-41. doi:10.1001/archopht.116.4.431.




DOI: http://dx.doi.org/10.14748/bro.v0i3.5547

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About The Author

Catherina Meglena Bommert
Medical University of Varna
Bulgaria

Department of Ophthalmology and Visual Sciences, Faculty of Medicine

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