title: Transplantation of Autologous Ex Vivo Expanded Human Conjunctival Epithelial Cells for Treatment of Pterygia: A Prospective Open-label Single Arm Multicentric Clinical Trial.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  We have, for the 1(st) 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.
authors.affiliation: Regenerative Medicine Group, Reliance Life Sciences Pvt. Ltd., Navi Mumbai, Maharashtra, India.
authors.forename: Viraf Sam
authors.initials: VS
authors.lastname: Vasania
authors.affiliation: Regenerative Medicine Group, Reliance Life Sciences Pvt. Ltd., Navi Mumbai, Maharashtra, India.
authors.forename: Aarya
authors.initials: A
authors.lastname: Hari
authors.affiliation: Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Radhika
authors.initials: R
authors.lastname: Tandon
authors.affiliation: Department of Ophthalmology, King Edward Memorial Hospital, Pune, Maharashtra, India.
authors.forename: Sanjay
authors.initials: S
authors.lastname: Shah
authors.affiliation: Laxmi Eye Institute, Panvel, Mumbai, Maharashtra, India.
authors.forename: Suhas
authors.initials: S
authors.lastname: Haldipurkar
authors.affiliation: Dr. Shah's Laser Eye Institute, Kalyan West, Thane, Maharashtra, India.
authors.forename: Smitesh
authors.initials: S
authors.lastname: Shah
authors.affiliation: Regenerative Medicine Group, Reliance Life Sciences Pvt. Ltd., Navi Mumbai, Maharashtra, India.
authors.forename: Shailendra
authors.initials: S
authors.lastname: Sachan
authors.affiliation: Regenerative Medicine Group, Reliance Life Sciences Pvt. Ltd., Navi Mumbai, Maharashtra, India.
authors.forename: Chandra
authors.initials: C
authors.lastname: Viswanathan
keywords: Autologous; Conjunctival Epithelial Cells; Goblet Cells; Human Amniotic Membrane; Multicenter Study; Pterygium