Titre | Early results of a multicenter clinical trial: Regenerating the anterior cornea through standardized transplantation of limbal epithelial stem cells |
Abstract Nr. | 1026 |
But | 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. |
Méthodes | 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. |
Résultats | 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. |
Nom | BEHAEGEL |
Initiales | J |
Institut | Dept of Ophthalmology, UZB |
Ville | Brussels |
Nom | Ni Dhubhghaill |
Initiales | S |
Institut | Dept of Ophthalmology, UZA |
Ville | Antwerp |
Nom | Koppen |
Initiales | C |
Institut | Dept of Ophthalmology, UZA |
Ville | Antwerp |
Nom | Leysen |
Initiales | I |
Institut | Dept of Ophthalmology, UZA |
Ville | Antwerp |
Nom | Ten Tusscher |
Initiales | M |
Institut | Dept of Ophthalmology, UZB |
Ville | Brussels |
Nom | Tassignon |
Initiales | MJ |
Institut | Dept of Ophthalmology, UZA |
Ville | Antwerp |
Nom | Zakaria |
Initiales | N |
Institut | Center for Cell Therapy and Regenerative Medicine, UZA |
Ville | Antwerp |