Efficiency of the cryopreserved allogeneic amniotic membrane transplantation in patients with infectious and neurotrophic keratitis

Most clinical trials demonstrate a rapid decrease in the inflammatory reaction and a fast reepithelialization due to allogeneic amniotic membrane (AM) transplantation in case of severe ulcerative keratitis that may help to avoid an emergency keratoplasty and improves the prognosis of the elective keratoplasty. Therefore, AM transplantation could be a very promising approach to in attenuate inflammation of cornea, to trigger reepitelisation and to preserve health cornea structure without blood vessel growing in patients with infectious and neurotrophic keratitis

Study aim: to evaluate of efficiency and safety of cryopreserved allogeneic amniotic membrane (AM) transplantation in the patients with different corneal pathologies

Primary Endpoint:

  • Еfficiency and safety of cryopreserved allogeneic AM transplantation: assessing by fixing clinical results and reviewing adverse events at 1, 3, 6, 12, 18 and 24 months post-procedure
  • Major adverse events were adjudicated: hospitalization, tumor formation, vision loss

Dosing regimen:Experimental: Keratitis + AM:

Experimental Group 1: Allogeneic AM transplantation

Inlay (graft transplantation) – AM is placed directly on the area of the injured cornea, without covering of the intact area. AM was fixed to the defect by separate sutures 10/0. 2-4 amniotic membrane layers were fixed with interrupted 10/0 sutures to the edge of the corneal defect. As a result, the AM plays the role of a basement membrane, and stimulate the epithelial cells to migrate and crawl forward to the cornea defect

Experimental Group 2: Biological covering with Allogeneic AM

Only (biological covering) – the entire corneal surface, including limbal area, was covered with amniotic membrane and fixed by episcleral interrupted sutures 8/0

By this technique, the amniotic membrane plays primarily the role of a biological contact lens

Experimental Group 3: Combined (sandwich) technique

Sandwich technique is a combination of the previous two, when the amniotic graft was fixed to the corneal defect and covered with amniotic layer using episcleral fixation

No HLA matching or immunosuppression required

Publication:

  • 1. Drozhzhyna G, Sereda K, Vit V, Molchanuk N. Trasplante de membrane amniotica para el tratamiento de queratitis ulcerative recurrente por virus herpes simple. Horiz Med. 2016. 16(3): 79-82.
  • 2. Sereda KV, Drozhzhyna GI, Gaidamaka TB, Vit VV, Shablii VA, Lobintseva GS. Features of influence of cryopreserved human amniotic membrane depending on the type of its fixation on the bacterial keratitis model. Bulletin of Vinnytsya Medical University. 2016. 20(1):21-27. [In Ukrainian]
  • 3. Sereda KV, Drozhzhyna GI, Gaidamaka TB. The effect of different techniques of cryopreserved amniotic membrane transplantation on the repair processes of the cornea on the bacterial keratitis model. Ophthalmology. Eastern Europe. 2016. 6(2):229-239. [In Russian]
  • 4. Sereda K. V. Drozhzhyna G. I., Gaidamaka T. B. Corneal inflammation and proliferative activity of the anterior epithelium cells on the bacterial keratitis model with amniotic membrane transplantation using different types of its fixation. 7th EuCornea Congress. -2016 – Copenhagen. Sept.9. – POS-27146
  • 5. Sereda K. V. Drozhzhyna G. I., Gaidamaka T. B. Corneal inflammation and proliferative activity of the anterior epithelium cells on the bacterial keratitis model with amniotic membrane transplantation using different types of its fixation. Ophthalmologe DOI 10.1007/s00347-016-0324-7. Springer-Verlag Berlin Heidelberg. – 2016 DOG16 28.09.-02.10.2016 DOG.-2016. Berlin. Sept 28 – Oct. 2. PFr03 -983.
  • 6. Sereda K. V. Drozhzhyna G. I., Gaidamaka T. B., Shablii V. A., Lobintseva G. S. Comparative evaluation of amniotic membrane transplantation techniques on the bacterial keratitis model. 6-th EuCornеa Congress Electronic Poster at WSPOS Barcelona 2015 (September 4th – September 6th 2015). P OS -7082.
  • 7. Sereda K.V., Drozhzhyna G. I., Gaidamaka T. B., Shablii V. A., Lobintseva G. S. Сryopreserved amniotic membrane transplantation on the bacterial keratitis model. DerOphthalmologe DOG-Kongress der Deutschen Ophthalmologischen Gesellschaft October 2015 Abstracts zum 113. DOG- Berlin , bis 01. – 04 . October 2015. – V.P. 106. – PFr02-09.
  • 8. Sereda E.V., Drozhzhina G.I., Gaidamaka T.B., Ivanovskaia E.V., Ostashevskii V.L., Ivanova O.N., Kogan B.M. Efficacy of different amniotic membrane transplantation techniques in patients with inflammatory and degenerative pathology of the cornea. Journal of Ophtalmology, 2016, 4: 3-10. [In Russian].

Efficiency of the cryopreserved allogeneic amniotic membrane transplantation in patients with infectious and neurotrophic keratitis

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