Transplantation of autologous ex vivo expanded human conjunctival epithelial cells for treatment of pterygia: A prospective open-label single arm multicentric clinical trial
Viraf Sam Vasania PhD 1, Aarya Hari MSc 1, Radhika Tandon FRCOphth 2, Sanjay Shah MS 3, Suhas Haldipurkar DOMS 4, Smitesh Shah DOMS 5, Shailendra Sachan MBBS 1, Chandra Viswanathan MD, PhD 1
1 Regenerative Medicine Group, Reliance Life Sciences Pvt. Ltd., Navi Mumbai, Maharashtra, India
2 Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India
3 Department of Ophthalmology, King Edward Memorial Hospital, Pune, Maharashtra, India
4 Laxmi Eye Institute, Panvel, Mumbai, Maharashtra, India
5 Dr. Shah's Laser Eye Institute, Kalyan West, Thane, Maharashtra, India
Regenerative Medicine Group, Reliance Life Sciences Pvt. Ltd., R 282, T. T. C Area of MIDC, Thane Belapur Road, Rabale, Navi Mumbai - 400 701
Source of Support: None, Conflict of Interest: None
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 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.