Abstract
Purpose :
Success of a cell therapy for AMD requires safe delivery of iPSC-RPE-patch using a surgical technique that is simple and reproducible. We have developed such a technique in Yucatan mini pigs using standard vitrectomy instruments, a custom injector for delivery of an iPSC-RPE patch and a clamp for temporary closure of the sclerotomy.
Methods :
A four-port pars-plana vitrectomy with posterior vitreous detachment is followed by a posterior retinal detachment and retinotomy. One working port is enlarged to fit the injector and the iPSC-RPE-patch released in the subretinal space using foot pedal control. The sclerotomy is temporally closed using the clamp and a fluid air exchange performed to provide surface tension management and prevent patch migration through the retinotomy. The sclerotomy is sutured under air.
Results :
27 surgeries were performed in 14 animals. 21 surgeries (77.7%) ended up without complications. Most common complications were vitreous hemorrhage, PVR, and retinal detachment. The lightweight ergonomic design of the injector together with the foot pedal control through the viscous fluid injector allowed a smooth delivery of the patch. Temporary closure of the sclerotomy using the custom clamp prevented depressurization of the eye when the injector is withdrawn.
Conclusions :
The surgical technique together with the use of a custom injector and clamp allowed a safe and reproducible delivery of the iPSC-RPE-patch. This technique will be applied in upcoming phase I clinical trial for treating patients with the dry-form of AMD.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.