Volkan Tahmaz1,2,3, Uta Gehlsen1,2,3, Laura Sauerbier1,2,3, Udo Holtick4, Lisa Engel1,2, Stela Radojska5, Viorica-Maria Petrescu-Jipa5, Christof Scheid2,4, Michael Hallek2,3,4, Birgit Gathof2,5, Claus Cursiefen1,2, Philipp Steven1,2,3. 1. Department of Ophthalmology, Medical Faculty, University of Cologne, Cologne, Germany. 2. Competence Center for Ocular GvHD, Medical Faculty, University of Cologne, Cologne, Germany. 3. Cluster of Excellence: Cellular Stress Responses in Aging-Associated Diseases (CECAD), University of Cologne, Cologne, Germany. 4. Department I of Internal Medicine, Medical Faculty, University of Cologne, Cologne, Germany. 5. Institute of Transfusion Medicine, Medical Faculty, University of Cologne, Cologne, Germany.
Abstract
BACKGROUND/AIMS: To analyse patients with chronic ocular graft-versus-host disease (GvHD) under treatment with 100% autologous serum eye drops from a sealed manufacturing system. METHODS: 17 patients with chronic ocular GvHD received 100% autologous serum eye drops from single use vials manufactured in a sealed system. Retrospective analysis included visual acuity, corneal staining, frequency of artificial tears, ocular symptoms by means of a questionnaire and information on subjective side effects and cost compensation. RESULTS: Data of prior to autologous serum eye drops therapy and at a 6-month follow-up were obtained. They demonstrated a significant increase in visual acuity (logMAR oculus dexter/right eye (OD) 0.5±0.32 to 0.4±0.3; oculus sinister/left eye (OS) 0.6±0.35 to 0.3±0.35; p=0.177/0.003) and significant improvement in corneal staining (Oxford grading scheme: OD from 3±1.03 to 2±1.43, OS from 4±1.0 to 2±1.09, p=0.004/0.001) and ocular symptoms (ocular surface disease index: 88±20.59 to 63±22.77; p=0.02). Frequency of artificial tears was reduced and no side effects were reported. Patient satisfaction was 100%, and cost compensation by health insurance reached 80%. CONCLUSIONS: 100% autologous serum eye drops using a sealed manufacturing system were efficient in improving the ocular surface, patient symptoms and visual acuity without side effects. It seems to be safe to use 100% autologous serum despite earlier suspicions regarding immune complex accumulations and exacerbation of ocular surface inflammation. The potential effects of serum levels of systemic immunosuppressives through readministration onto the ocular surface need to be elucidated. 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/.
BACKGROUND/AIMS: To analyse patients with chronic ocular graft-versus-host disease (GvHD) under treatment with 100% autologous serum eye drops from a sealed manufacturing system. METHODS: 17 patients with chronic ocular GvHD received 100% autologous serum eye drops from single use vials manufactured in a sealed system. Retrospective analysis included visual acuity, corneal staining, frequency of artificial tears, ocular symptoms by means of a questionnaire and information on subjective side effects and cost compensation. RESULTS: Data of prior to autologous serum eye drops therapy and at a 6-month follow-up were obtained. They demonstrated a significant increase in visual acuity (logMAR oculus dexter/right eye (OD) 0.5±0.32 to 0.4±0.3; oculus sinister/left eye (OS) 0.6±0.35 to 0.3±0.35; p=0.177/0.003) and significant improvement in corneal staining (Oxford grading scheme: OD from 3±1.03 to 2±1.43, OS from 4±1.0 to 2±1.09, p=0.004/0.001) and ocular symptoms (ocular surface disease index: 88±20.59 to 63±22.77; p=0.02). Frequency of artificial tears was reduced and no side effects were reported. Patient satisfaction was 100%, and cost compensation by health insurance reached 80%. CONCLUSIONS: 100% autologous serum eye drops using a sealed manufacturing system were efficient in improving the ocular surface, patient symptoms and visual acuity without side effects. It seems to be safe to use 100% autologous serum despite earlier suspicions regarding immune complex accumulations and exacerbation of ocular surface inflammation. The potential effects of serum levels of systemic immunosuppressives through readministration onto the ocular surface need to be elucidated. 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/.
Authors: Joseph Pidala; Carrie Kitko; Stephanie J Lee; Paul Carpenter; Geoffrey D E Cuvelier; Shernan Holtan; Mary E Flowers; Corey Cutler; Madan Jagasia; Ted Gooley; Joycelynne Palmer; Tim Randolph; John E Levine; Francis Ayuk; Fiona Dignan; Helene Schoemans; Eric Tkaczyk; Nosha Farhadfar; Anita Lawitschka; Kirk R Schultz; Paul J Martin; Stefanie Sarantopoulos; Yoshihiro Inamoto; Gerard Socie; Daniel Wolff; Bruce Blazar; Hildegard Greinix; Sophie Paczesny; Steven Pavletic; Geoffrey Hill Journal: Transplant Cell Ther Date: 2021-04-06