Transplantation of autologous ex vivo expanded human conjunctival epithelial cells for treatment of pterygia: A prospective open-label single arm multicentric clinical trial

Abstract

Purpose:To establish the efficacy and safety of ex vivo cultured autologous human conjunctival epithelial cell (hCjEC) transplantation for treatment of pterygia.Methods:Twenty-five patients with pterygia were recruited at different centers across the country. Autologous hCjEC grafts were prepared from conjunctival biopsy specimens excised from the healthy eye and cultured ex vivo on human amniotic membrane mounted on inserts using a unique mounting device. The hCjEC grafts were then transported in an in-house designed transport container for transplantation. Post-surgery, the patients were followed up on days 1, 7, 14, 30, 90, and 180 as per the approved study protocol. Clinical outcomes were assessed by slit lamp examination, visual acuity, imprint cytology, fluorescein/rose bengal staining, Schirmer's test, and photographic evaluation three and 6 months post-transplantation.Results:Two patients were lost to follow-up and final analysis included 23 cases. No recurrence of pterygium was observed in 18 (78.3%) patients; all of these eyes showed a smooth conjunctival surface without epithelial defects. Recurrence was observed in 5 (21.7%) patients at 3 months post-treatment. No conjunctival inflammation, secondary infections or other complications were reported. Adequate goblet cells were present in 19 (82.6%) patients at the site of transplantation.Conclusion:We have, for the 1st time, standardized a protocol for preparing autologous hCjEC grafts that can be safely transported to multiple centers across the country for transplantation. The clinical outcome was satisfactory for treating pterygia.

Optimization of Storage Temperature for Retention of Undifferentiated Cell Character of Cultured Human Epidermal Cell Sheets

“…This study prepares the way for such future work by providing analyses that represent a thorough characterization of stored sheets at each temperature. A future clinical trial might follow a similar design to that recently conducted by Vasania et al 57 , where cultured human conjunctival epithelial cells were transported to four regional centers from a centralized culture facility in India. Transplants were successfully used to treat patients with pterygium following transport 57 .…”

“…A future clinical trial might follow a similar design to that recently conducted by Vasania et al 57 , where cultured human conjunctival epithelial cells were transported to four regional centers from a centralized culture facility in India. Transplants were successfully used to treat patients with pterygium following transport 57 . A trial such as this might employ the optimal conditions outlined in the present study and transport CES for treatment of patients with chronic skin ulcers, which is an operation that can be scheduled in advance.…”

Effect of Transportation on Cultured Limbal Epithelial Sheets for Worldwide Treatment of Limbal Stem Cell Deficiency

“…Vasania et al . found a viability of 78–90% after transport of up to 48 hours for conjunctival tissue 16 . The present study suggests that vigorous shaking does not appear to cause cell death.…”

“…In 2014, Vasania et al . tested an in-house designed transportation container for cultured conjunctival epithelial cell sheets on human amniotic membrane (HAM), with viable, intact epithelial sheets upon arrival and good post-operative outcome for pterygium surgery 16 . Oie et al .…”

Transcriptome Analysis of Cultured Limbal Epithelial Cells on an Intact Amniotic Membrane following Hypothermic Storage in Optisol-GS

“…Oie et al demonstrated that cultured oral mucosal cell sheets retained viability and phenotype following 12 hours transportation in Japan [ 4 ]. Moreover, cultured conjunctival epithelial cells were successfully used for treatment of pterygium in 23 patients following distribution to four eye clinics in India [ 5 ]. Advantages of a standardized short-term storage and transport method for cultured HLEC include provision of a window for sterility and quality assessment, improved surgery logistics, and wider access to treatment.…”