View abstract

This abstract is assigned to session AOB Poster session1

Title	Early results of a multicenter clinical trial: Regenerating the anterior cornea through standardized transplantation of limbal epithelial stem cells
Abstract Nr.	1026

Purpose	To report the early results of transplanting non-xenogenic, bioengineerd, composite grafts of cultured limbal epithelial cells on standardized amniotic membranes in patients with limbal stem cell deficiency, in a phase II multicenter clinical trial.
Methods	So far a total of 6 patients with severe limbal stem cell deficiency were transplanted in this phase II multicenter trial. All of the 6 patients suffered from unilateral, total limbal stem cell deficiency. The limbo-amnion grafts were generated by cultivating limbal epithelial stem cells from the contralateral donor eye on a standardized amniotic membrane. The cells were cultured for a period of 2 weeks in a xenogenic-free culture medium and the composite graft was transplanted with a standardized 'no touch' surgical technique.
Results	The mean follow-up of the 6 patients so far is 10 weeks (range 1-19 weeks). Three patients had an improvement in pain and 2 patients reported a slight improvement in photophobia. Two of the 6 patients had a gain in visual acuity from hand movements to finger counting.
Conclusion	In this limited number of patients a functional improvement was achieved. So far, the grafts were well-tolerated, and not associated with side effects. The larger sample size and inclusion of allogenic transplant recipients in this phase II trial will further help ascertain safety and efficacy of a standardized transplantation of limbal epithelial stem cells.

Authors 1

Last name	BEHAEGEL
Initials	J
Department	Dept of Ophthalmology, UZB
City	Brussels

Authors 2

Last name	Ni Dhubhghaill
Initials	S
Department	Dept of Ophthalmology, UZA
City	Antwerp

Authors 3

Last name	Koppen
Initials	C
Department	Dept of Ophthalmology, UZA
City	Antwerp

Authors 4

Last name	Leysen
Initials	I
Department	Dept of Ophthalmology, UZA
City	Antwerp

Authors 5

Last name	Ten Tusscher
Initials	M
Department	Dept of Ophthalmology, UZB
City	Brussels

Authors 6

Last name	Tassignon
Initials	MJ
Department	Dept of Ophthalmology, UZA
City	Antwerp

Authors 7

Last name	Zakaria
Initials	N
Department	Center for Cell Therapy and Regenerative Medicine, UZA
City	Antwerp