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R. Tandon, V. Vasania, G. Pujari, S. Sen, T. Agarwal, S. Sharma, B. George; Experience With Using an Outsourcing Model for Limbal Stem Cell Culture and Transplantation in a Tropical Developing Country. Invest. Ophthalmol. Vis. Sci. 2007;48(13):473.
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© ARVO (1962-2015); The Authors (2016-present)
To report the results of working on an outsourcing model for limbal stem cell culture and transplantation (LSCCAT) in a tropical developing country.
To make the expensive and highly technical facility for LSCCAT accessible to more patients, a protocol was devised to first test the logistics in a few centres of excellence. The transport container to be used for transporting limbal biopsy specimens from surgical site to the lab and for delivery of cultured cells to the site for transplantation were designed and limbal stem cell (LSC) culture technique was standardized. Three clinical centres were selected to be serviced by a single culture lab. IRB, regulatory approvals and informed consent were obtained for patients with unilateral LSC deficiency. Surgery and post-operative medication were as per published norms. The experience related to LSCCAT from the most distant center (1400 Km) with most potential for difficulties was analyzed. Limbal biopsy taken from donor eye at the surgical site was transported to the lab; cultured on human amniotic membrane (HAM) and surgery scheduled after optimum growth was confirmed. The graft with cultured cells (ReliNethraTM) was transported in duplicate for transplantation.
16 patients (6-28 years, mean 13.5±6.6) have been recruited and have undergone limbal biopsy and transplantation with cultured cells. Eight have completed 6 mths and 11 have completed 3 mths follow-up. Transit time for shipment of tissue samples from site to lab and from lab to site was 21.04±0.09 hrs and 21.04±0.06 hrs respectively. The time taken for limbal graft to be ready for shipment was 18±0.59 days. Temp maintained during transit was 5.9±1.3OC. Problems encountered were media leakage (1 of 16 biopsies, 1 of 32 cultured grafts) and slippage of the HAM from the supporting ring (2 of 32). Expression of markers p63, Oct-4 and cytokeratin 19 and AE5 were studied in unused duplicate grafts using immunofluorescence. None of the patients had post-op problems following limbal biopsy. No infection was observed in the early post-op period. Two patients had stromal keratitis 6 weeks after transplantation related to early Bandage Contact Lens extrusion, prolonged topical use of fluoroquinolones and topical steroids, successfully managed with emergency corneal grafts.
A LSCCAT service as outlined in this study is logistically feasible and useful.
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