PMID- 27543289 OWN - NLM STAT- MEDLINE DCOM- 20170501 LR - 20191210 IS - 1468-2079 (Electronic) IS - 0007-1161 (Linking) VI - 101 IP - 5 DP - 2017 May TI - Safety outcomes and long-term effectiveness of ex vivo autologous cultured limbal epithelial transplantation for limbal stem cell deficiency. PG - 640-649 LID - 10.1136/bjophthalmol-2015-308272 [doi] AB - PURPOSE: To evaluate the safety and effectiveness of ex vivo autologous cultured limbal stem cell transplantation (CLET). METHODS: We reviewed the clinical records of 59 consecutive patients treated with 65 CLETs. Efficacy was graded 1 year after surgery as successful, partially successful or failed. A safety analysis was performed considering side effects and complications that were recorded during the first year after CLET and those reported later than 1 year, including the events related to subsequent treatments. RESULTS: The mean post-CLET follow-up was 6.0+/-4.1 years. 69% of CLETs had either one or more adverse events (AEs), or adverse drug reactions (ADRs), within 1 year of surgery, with inflammation being the most common (42%), followed by corneal epithelium defects/disepithelialisation (31%), and blood coagula under the fibrin (24%). One year after surgery, 41% of the 59 primary CLET procedures were successful, 39% partially successful and 20% failed. The most common ADRs recorded for the primary unsuccessful CLETs were ulcerative keratitis, melting/perforation, and epithelial defects/disepithelialisation. Six failed CLETs required reconstructive penetrating keratoplasty (PK). Among CLETs with a favourable outcome, 13 underwent corrective PK (mean 4.8+/-3.4 years), and thereafter seven eyes maintained integrity of the corneal epithelium, five showed corneal surface failure, and one had recurrent epithelial defects. Corneal graft rejection episodes were reported in 71% and 58% of patients following corrective or reconstructive PK, respectively. Seven primary CLETs with a favourable outcome worsened thereafter, and the overall 3-year long-term effectiveness was 68%. CONCLUSIONS: This study addresses important issues regarding possible risks associated with disarray of the ocular surface homeostasis following autologous CLET in patients with limbal stem cell deficiency, despite the fact that the majority of patients experienced a favourable long-term benefit. CI - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/. FAU - Fasolo, Adriano AU - Fasolo A AD - Fondazione Banca degli Occhi del Veneto (The Veneto Eye Bank Foundation), Venezia Zelarino, Italy. AD - Department of Neurosciences, Biomedicine, and Movement Sciences, Eye Clinic, AOUI-University of Verona, Italy. FAU - Pedrotti, Emilio AU - Pedrotti E AD - Department of Neurosciences, Biomedicine, and Movement Sciences, Eye Clinic, AOUI-University of Verona, Italy. FAU - Passilongo, Mattia AU - Passilongo M AD - Department of Neurosciences, Biomedicine, and Movement Sciences, Eye Clinic, AOUI-University of Verona, Italy. FAU - Marchini, Giorgio AU - Marchini G AD - Department of Neurosciences, Biomedicine, and Movement Sciences, Eye Clinic, AOUI-University of Verona, Italy. FAU - Monterosso, Cristina AU - Monterosso C AD - Ophthalmology Unit, Ospedale dell'Angelo, ULSS 12 Veneziana, Venezia Zelarino, Italy. FAU - Zampini, Roberto AU - Zampini R AD - Ophthalmology Unit, Ospedale dell'Angelo, ULSS 12 Veneziana, Venezia Zelarino, Italy. FAU - Bohm, Elisabetta AU - Bohm E AD - Ophthalmology Unit, Ospedale dell'Angelo, ULSS 12 Veneziana, Venezia Zelarino, Italy. FAU - Birattari, Federica AU - Birattari F AD - Ophthalmology Unit, Ospedale SS. Giovanni e Paolo, ULSS 12 Veneziana, Venezia, Italy. FAU - Franch, Antonella AU - Franch A AD - Ophthalmology Unit, Ospedale SS. Giovanni e Paolo, ULSS 12 Veneziana, Venezia, Italy. FAU - Barbaro, Vanessa AU - Barbaro V AD - Fondazione Banca degli Occhi del Veneto (The Veneto Eye Bank Foundation), Venezia Zelarino, Italy. FAU - Bertolin, Marina AU - Bertolin M AD - Fondazione Banca degli Occhi del Veneto (The Veneto Eye Bank Foundation), Venezia Zelarino, Italy. FAU - Breda, Claudia AU - Breda C AD - Fondazione Banca degli Occhi del Veneto (The Veneto Eye Bank Foundation), Venezia Zelarino, Italy. FAU - Di Iorio, Enzo AU - Di Iorio E AD - Fondazione Banca degli Occhi del Veneto (The Veneto Eye Bank Foundation), Venezia Zelarino, Italy. AD - Department of Molecular Medicine, University of Padua, Padua, Italy. FAU - Ferrari, Barbara AU - Ferrari B AD - Fondazione Banca degli Occhi del Veneto (The Veneto Eye Bank Foundation), Venezia Zelarino, Italy. FAU - Ferrari, Stefano AU - Ferrari S AD - Fondazione Banca degli Occhi del Veneto (The Veneto Eye Bank Foundation), Venezia Zelarino, Italy. FAU - Meneguzzi, Mauro AU - Meneguzzi M AD - Fondazione Banca degli Occhi del Veneto (The Veneto Eye Bank Foundation), Venezia Zelarino, Italy. FAU - Ponzin, Diego AU - Ponzin D AD - Fondazione Banca degli Occhi del Veneto (The Veneto Eye Bank Foundation), Venezia Zelarino, Italy. LA - eng PT - Evaluation Study PT - Journal Article DEP - 20160819 PL - England TA - Br J Ophthalmol JT - The British journal of ophthalmology JID - 0421041 SB - IM MH - Adult MH - Aged MH - Corneal Diseases/*surgery MH - Epithelial Cells/*transplantation MH - Epithelium, Corneal/*transplantation MH - Eye Burns/surgery MH - Female MH - Humans MH - Keratoplasty, Penetrating MH - Limbus Corneae/*cytology MH - Male MH - Middle Aged MH - Regression Analysis MH - Stem Cell Transplantation/*methods MH - Transplantation, Autologous MH - Visual Acuity MH - Young Adult OTO - NOTNLM OT - Cornea OT - Ocular surface OT - Stem Cells EDAT- 2016/08/21 06:00 MHDA- 2017/05/02 06:00 CRDT- 2016/08/21 06:00 PHST- 2015/12/16 00:00 [received] PHST- 2016/07/11 00:00 [revised] PHST- 2016/07/30 00:00 [accepted] PHST- 2016/08/21 06:00 [pubmed] PHST- 2017/05/02 06:00 [medline] PHST- 2016/08/21 06:00 [entrez] AID - bjophthalmol-2015-308272 [pii] AID - 10.1136/bjophthalmol-2015-308272 [doi] PST - ppublish SO - Br J Ophthalmol. 2017 May;101(5):640-649. doi: 10.1136/bjophthalmol-2015-308272. Epub 2016 Aug 19.