hESC-RPE can survive for at least 12 months in an immunocompromised animal model. Polarized monolayers of hESC-RPE show improved survival compared to cell suspensions. The lack of teratoma or any ectopic tissue formation in the implanted rats bodes well for similar results with respect to safety in human subjects.
Purpose A subretinal implant termed CPCB-RPE1 is currently being developed to surgically replace dystrophic RPE in patients with dry age-related macular degeneration (AMD) and severe vision loss. CPCB-RPE1 is composed of a terminally differentiated, polarized human embryonic stem cell-derived RPE (hESC-RPE) monolayer pre-grown on a biocompatible, mesh-supported submicron parylene C membrane. The objective of the present delivery study was to assess the feasibility and 1-month safety of CPCB-RPE1 implantation in Yucatán minipigs, whose eyes are similar to human eyes in size and gross retinal anatomy. Methods This was a prospective, partially blinded, randomized study in 14 normal-sighted female Yucatán minipigs (aged 2 months, weighing 24-35 kg). Surgeons were blinded to the randomization codes and postoperative and post-mortem assessments were performed in a blinded manner. Eleven minipigs received CPCB-RPE1 while three control minipigs underwent sham surgery that generated subretinal blebs. All animals except two sham controls received combined local (Ozurdex™ dexamethasone intravitreal implant) and systemic (tacrolimus) immunosuppression or local immunosuppression alone. Correct placement of the CPCB-RPE1 implant was assessed by in vivo optical coherence tomography and postmortem histology. hESC-RPE cells were identified using immunohistochemistry staining for TRA-1-85 (a human marker) and RPE65 (an RPE marker). As the study results of primary interest were nonnumerical no statistical analysis or tests were conducted. Results CPCB-RPE1 implants were reliably placed, without implant breakage, in the subretinal space of the minipig eye using surgical techniques similar to those that would be used in humans. Histologically, hESC-RPE cells were found to survive as an intact monolayer for 1 month based on immunohistochemistry staining for TRA-1-85 and RPE65. Conclusions Although inconclusive regarding the necessity or benefit of systemic or local immunosuppression, our study demonstrates the feasibility and safety of CPCB-RPE1 subretinal implantation in a comparable animal model and provides an encouraging starting point for human studies.
Background Proliferative diabetic retinopathy (PDR) is one of the most common cause of vision loss in diabetic patients, and the incidence age of PDR patients gradually gets younger. This study aims to compare the characteristics of PDR and outcomes following vitrectomy in young and senior patients. Methods This is a retrospective case series study. Data of 116 eyes of 92 patients who underwent vitrectomy for PDR from February 2012 to February 2017 were reviewed, which were divided into young and senior patient groups. All patients were followed up for 24 months at least. Results There were 62.1% of eyes with tractional retinal detachment secondary to PDR in the young patient group, while only 12.1% of eyes in the senior patient group with this surgery indication. (P < 0.001) The best corrected visual acuity increased in 41 eyes (70.7%), stable in 9 eyes (15.5%), and decreased in 8 eyes (13.8%) in young patients at the final follow-up. And it increased in 47 eyes (81.0%), stable in 2 eyes (3.4%), and decreased in 9 eyes (15.5%) in senior patients.(P = 0.085) Postoperative complications mainly included recurrent vitreous hemorrhage (24.1%), retinal detachment (3.4%), neovascular glaucoma (NVG) (27.6%) and nuclear sclerosis (53.4%) in young patients, and it was 19.0, 0.0, 1.7 and 3.4% in senior patients respectively. Conclusion PDR of young patients is more severe than that of senior patients, and vitrectomy is an effective and safe method for PDR treatment. NVG is a main and severe complication besides nuclear sclerosis in young patients, and the incidence of NVG is higher compared to that in senior patients.
Background: To document characteristics and treatments of ocular blast injury from a fire and explosion. Method: Authors retrospectively evaluated 116 patients with 166 eye injuries from six hospitals. Terminology of ocular injury referred to Birmingham Eye Trauma Terminology, and best-corrected visual acuity (BCVA) was categorized with the ocular trauma score (OTS) grading system. Incidence, preoperational and follow-up BCVA, treatment of severe ocular blast injuries were surveyed. Results: Oculoplastic injuries accounted for the majority of eye injuries, while globe injuries were presented in 52 eyes with median baseline OTS 70 ranging from 26 to 100. No endophthalmitis occurred. The mean timing of the first-stage operations was 9.4 ± 6.4 h after blast, while second-stage operations were performed on average 14.7 ± 0.9 days post blast. Final BCVA of 68.8% of eyes achieved 20/200 or better as followed, 7 open globe injuries had a BCVA of no light perception. Additionally, eyes presenting rupture, retinal detachment, vitreous hemorrhage, choroidal injury and initial BCVA less than 20/200 had worse final visual outcomes, while globe penetration was not associated with poor visual acuity. Conclusion: Various ocular injuries were commonly in the casualties of blast, in which open-globe injuries have worst visual prognosis. OTS is a valid approach for evaluation of prognosis and optimizing the therapeutic strategies subsequently in the massive casualty. Intense rescue and careful examination, proper surgery should be performed correctly to rescue patients.
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