Gabriel, C; Marks, DC; Henschler, R; Schallmoser, K; Burnouf, T; Koh, MBC
(2023)
Eye drops of human origin-Current status and future needs: Report on the workshop organized by the ISBT Working Party for Cellular Therapies.
Vox Sang, 118 (4).
pp. 301-309.
ISSN 1423-0410
https://doi.org/10.1111/vox.13413
SGUL Authors: Koh, Mickey
Abstract
BACKGROUND AND OBJECTIVES: Serum eye drops (SEDs) are used to treat ocular surface disease (OSD) and to promote ocular surface renewal. However, their use and production are not standardized, and several new forms of human eye drops have been developed. MATERIALS AND METHODS: The International Society for Blood Transfusion Working Party (ISBT WP) for Cellular Therapies held a workshop to review the current types of eye drops of human origin (EDHO) status and provide guidance. RESULTS: The ISBT WP for Cellular Therapies introduced the new terminology 'EDHO' to emphasize that these products are analogous to 'medical products of human origin'. This concept encompasses their source (serum, platelet lysate, and cord blood) and the increasingly diverse spectrum of clinical usage in ophthalmology and the need for traceability. The workshop identified the wide variability in EDHO manufacturing, lack of harmonized quality and production standards, distribution issues, reimbursement schemes and regulations. EDHO use and efficacy is established for the treatment of OSD, especially for those refractory to conventional treatments. CONCLUSION: Production and distribution of single-donor donations are cumbersome and complex. The workshop participants agreed that allogeneic EDHO have advantages over autologous EDHO although more data on clinical efficacy and safety are needed. Allogeneic EDHOs enable more efficient production and, when pooled, can provide enhanced standardization for clinical consistency, provided optimal margin of virus safety is ensured. Newer products, including platelet-lysate- and cord-blood-derived EDHO, show promise and benefits over SED, but their safety and efficacy are yet to be fully established. This workshop highlighted the need for harmonization of EDHO standards and guidelines.
Item Type: |
Article
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Additional Information: |
© 2023 The Authors. Vox Sanguinis published by John Wiley & Sons Ltd on behalf of International Society of Blood Transfusion.
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made. |
Keywords: |
eye drops of human origin, ocular surface disease, serum eye drops, Humans, Ophthalmic Solutions, Tissue Donors, Treatment Outcome, Serum, Dry Eye Syndromes, Serum, Humans, Dry Eye Syndromes, Ophthalmic Solutions, Treatment Outcome, Tissue Donors, eye drops of human origin, ocular surface disease, serum eye drops, 1103 Clinical Sciences, 1116 Medical Physiology, Cardiovascular System & Hematology |
SGUL Research Institute / Research Centre: |
Academic Structure > Institute of Medical & Biomedical Education (IMBE) |
Journal or Publication Title: |
Vox Sang |
ISSN: |
1423-0410 |
Language: |
eng |
Dates: |
Date | Event |
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12 April 2023 | Published | 27 February 2023 | Published Online | 7 February 2023 | Accepted |
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Publisher License: |
Creative Commons: Attribution-Noncommercial-No Derivative Works 4.0 |
PubMed ID: |
36847186 |
Web of Science ID: |
WOS:000940480800001 |
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Go to PubMed abstract |
URI: |
https://openaccess.sgul.ac.uk/id/eprint/116899 |
Publisher's version: |
https://doi.org/10.1111/vox.13413 |
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