Autologous limbal explant culture therapy product application for bilateral limbal stem cell deficiency
Dilek Dursun Altinors1, Ozlem Barut Selver2,3,4, Mehmet Gurdal2,3, Ege Karslioglu1, Leyla Asena1, Sibel Oto1, Mehmet A. Haberal5.
1Department of Ophthalmology, Baskent University, Ankara, Turkey; 2LimbuStem R&D Health and Consultancy Services, Ege Teknopark, Izmir, Turkey; 3Ocular Surface Research Laboratory, Ege University, Izmir, Turkey; 4Department of Ophthalmology, Ege University, Izmir, Turkey; 5Department of General Surgery, Division of Transplantation, Baskent University, Ankara, Turkey
Introduction: When limbal stem cell deficiency (LSCD) is bilateral, the chance of applying conventional autologous methods disappears, and the clinical success level of allogeneic methods is low. Cultured autologous limbal stem cell transplantation is an important option that offers the chance of effective treatment in such patients.
Purpose: To report the results and clinical findings in a patient with bilateral LSCD treated with autologous cultured limbal stem cell transplantation.
Case Report: A 34-year-old female patient was admitted to our clinic with a history of acid burns in both eyes that occurred 18 months ago. In the ophthalmological examination of the patient, who had undergone human amniotic membrane (hAM) transplantation surgery plenty of times in addition to medical treatment, the best-corrected visual acuity was 0.2 and light perception in the right and left eyes, respectively. On anterior segment examination, the LSCD score according to the global consensus on the LSCD classification published in 2019 was Stage 2B on the right and Stage 3 on the left eye. Limbal explant culture therapy product, commercialized within the scope of the Limbustem-Stembio collaboration, was produced from autologous limbal biopsy tissue taken from right eye using the ex vivo explant culture technique on hAM under Good Manufacturing Practices (GMP) conditions, in 2 weeks. After the product was produced, it was transferred from the laboratory to the operating room. After bleeding control following pannus dissection, the product was transplanted to the ocular surface. After the operation, the patient was monitored by best-corrected visual acuity (BCVA), subjective vision and pain score, and LSCD classification. Topical steroid, antibiotic and cyclosporine treatment were administered. After completing the 3-month early postoperative follow-up period, the patient's BCVA at the last visit increased to 0.4 in the right eye and 0.05 in the left eye. The follow-up of the patient, who is planned to undergo combined cataract and corneal transplantation surgery for the left eye, continues.
Conclusions: These clinical results show that the autologous limbal explant culture product can be used effectively and successfully in selected bilateral LSCD cases.