Ready-made allogeneic ABO-specific serum eye drops: production from regular male blood donors, clinical routine, safety and efficacy

Lene Holm Harritshøj; Connie Nielsen; Henrik Ullum; Morten Bagge Hansen; Hanne Olsen Julian

doi:10.1111/aos.12386

Ready-made allogeneic ABO-specific serum eye drops: production from regular male blood donors, clinical routine, safety and efficacy

Lene Holm Harritshøj, Connie Nielsen, Henrik Ullum, Morten Bagge Hansen, Hanne Olsen Julian

Institut for Klinisk Medicin

34 Citationer (Scopus)

Abstract

PURPOSE: To overcome problems and delays of the preparation of autologous serum eye drops, a production line of ABO-specific allogeneic serum eye drops from male blood donors was set up in a blood bank. Feasibility, clinical routine, safety and efficacy were evaluated in a cohort of patients with severe ocular surface disorders.

METHODS: Serum was derived from 450 ml whole-blood donations from regular male blood donors, produced and tested according to good manufacturing practice and legislation regulating blood products in Denmark. Serum was diluted to 20% (v/v) with NaCl 0.9%, filtered, bottled, registered and stored at -30°C in the blood bank. Upon request, frozen ABO-identical serum drops in lots of 14 bottles could be provided immediately. Safety and efficacy were evaluated in 34 patients with severe ocular surface disease refractory to conventional medical therapy. Patients were treated six times daily for minimum 2-4 weeks. Objective findings and subjective symptoms were compared between day 0 and after 4 weeks of treatment using the Wilcoxon signed-rank test.

RESULTS: Clinically, no side-effects were observed. In total, 59% of the patients with ocular surface changes improved objectively (slit-lamp examination). Partial or full healing of corneal changes, as well as subjective relief of symptoms, was observed in 16 of 20 patients with keratoconjunctivitis sicca (p < 0.001). The 14 patients with persistent epithelial defect experienced neither objective nor subjective improvements during serum treatment.

CONCLUSION: Ready-made ABO-identical allogeneic serum eye drops were straightforwardly produced, quality-assured and registered as a safe standard blood product for the treatment of certain cases of severe dry eye disease. Therapeutic efficacy was comparable to previous reports on autologous serum drops.

Originalsprog	Engelsk
Tidsskrift	Acta Ophthalmologica
Vol/bind	92
Udgave nummer	8
Sider (fra-til)	783–786
Antal sider	4
ISSN	1755-375X
DOI	https://doi.org/10.1111/aos.12386
Status	Udgivet - 1 dec. 2014

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10.1111/aos.12386

https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/aos.12386

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title = "Ready-made allogeneic ABO-specific serum eye drops: production from regular male blood donors, clinical routine, safety and efficacy",

abstract = "PURPOSE: To overcome problems and delays of the preparation of autologous serum eye drops, a production line of ABO-specific allogeneic serum eye drops from male blood donors was set up in a blood bank. Feasibility, clinical routine, safety and efficacy were evaluated in a cohort of patients with severe ocular surface disorders.METHODS: Serum was derived from 450 ml whole-blood donations from regular male blood donors, produced and tested according to good manufacturing practice and legislation regulating blood products in Denmark. Serum was diluted to 20% (v/v) with NaCl 0.9%, filtered, bottled, registered and stored at -30°C in the blood bank. Upon request, frozen ABO-identical serum drops in lots of 14 bottles could be provided immediately. Safety and efficacy were evaluated in 34 patients with severe ocular surface disease refractory to conventional medical therapy. Patients were treated six times daily for minimum 2-4 weeks. Objective findings and subjective symptoms were compared between day 0 and after 4 weeks of treatment using the Wilcoxon signed-rank test.RESULTS: Clinically, no side-effects were observed. In total, 59% of the patients with ocular surface changes improved objectively (slit-lamp examination). Partial or full healing of corneal changes, as well as subjective relief of symptoms, was observed in 16 of 20 patients with keratoconjunctivitis sicca (p < 0.001). The 14 patients with persistent epithelial defect experienced neither objective nor subjective improvements during serum treatment.CONCLUSION: Ready-made ABO-identical allogeneic serum eye drops were straightforwardly produced, quality-assured and registered as a safe standard blood product for the treatment of certain cases of severe dry eye disease. Therapeutic efficacy was comparable to previous reports on autologous serum drops.",

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author = "Harritsh{\o}j, {Lene Holm} and Connie Nielsen and Henrik Ullum and Hansen, {Morten Bagge} and Julian, {Hanne Olsen}",

note = "{\textcopyright} 2014 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.",

year = "2014",

month = dec,

day = "1",

doi = "10.1111/aos.12386",

language = "English",

volume = "92",

pages = "783–786",

journal = "Acta Ophthalmologica",

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TY - JOUR

T1 - Ready-made allogeneic ABO-specific serum eye drops

T2 - production from regular male blood donors, clinical routine, safety and efficacy

AU - Harritshøj, Lene Holm

AU - Nielsen, Connie

AU - Ullum, Henrik

AU - Hansen, Morten Bagge

AU - Julian, Hanne Olsen

PY - 2014/12/1

Y1 - 2014/12/1

N2 - PURPOSE: To overcome problems and delays of the preparation of autologous serum eye drops, a production line of ABO-specific allogeneic serum eye drops from male blood donors was set up in a blood bank. Feasibility, clinical routine, safety and efficacy were evaluated in a cohort of patients with severe ocular surface disorders.METHODS: Serum was derived from 450 ml whole-blood donations from regular male blood donors, produced and tested according to good manufacturing practice and legislation regulating blood products in Denmark. Serum was diluted to 20% (v/v) with NaCl 0.9%, filtered, bottled, registered and stored at -30°C in the blood bank. Upon request, frozen ABO-identical serum drops in lots of 14 bottles could be provided immediately. Safety and efficacy were evaluated in 34 patients with severe ocular surface disease refractory to conventional medical therapy. Patients were treated six times daily for minimum 2-4 weeks. Objective findings and subjective symptoms were compared between day 0 and after 4 weeks of treatment using the Wilcoxon signed-rank test.RESULTS: Clinically, no side-effects were observed. In total, 59% of the patients with ocular surface changes improved objectively (slit-lamp examination). Partial or full healing of corneal changes, as well as subjective relief of symptoms, was observed in 16 of 20 patients with keratoconjunctivitis sicca (p < 0.001). The 14 patients with persistent epithelial defect experienced neither objective nor subjective improvements during serum treatment.CONCLUSION: Ready-made ABO-identical allogeneic serum eye drops were straightforwardly produced, quality-assured and registered as a safe standard blood product for the treatment of certain cases of severe dry eye disease. Therapeutic efficacy was comparable to previous reports on autologous serum drops.

AB - PURPOSE: To overcome problems and delays of the preparation of autologous serum eye drops, a production line of ABO-specific allogeneic serum eye drops from male blood donors was set up in a blood bank. Feasibility, clinical routine, safety and efficacy were evaluated in a cohort of patients with severe ocular surface disorders.METHODS: Serum was derived from 450 ml whole-blood donations from regular male blood donors, produced and tested according to good manufacturing practice and legislation regulating blood products in Denmark. Serum was diluted to 20% (v/v) with NaCl 0.9%, filtered, bottled, registered and stored at -30°C in the blood bank. Upon request, frozen ABO-identical serum drops in lots of 14 bottles could be provided immediately. Safety and efficacy were evaluated in 34 patients with severe ocular surface disease refractory to conventional medical therapy. Patients were treated six times daily for minimum 2-4 weeks. Objective findings and subjective symptoms were compared between day 0 and after 4 weeks of treatment using the Wilcoxon signed-rank test.RESULTS: Clinically, no side-effects were observed. In total, 59% of the patients with ocular surface changes improved objectively (slit-lamp examination). Partial or full healing of corneal changes, as well as subjective relief of symptoms, was observed in 16 of 20 patients with keratoconjunctivitis sicca (p < 0.001). The 14 patients with persistent epithelial defect experienced neither objective nor subjective improvements during serum treatment.CONCLUSION: Ready-made ABO-identical allogeneic serum eye drops were straightforwardly produced, quality-assured and registered as a safe standard blood product for the treatment of certain cases of severe dry eye disease. Therapeutic efficacy was comparable to previous reports on autologous serum drops.

KW - ABO Blood-Group System

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Blood Banks

KW - Blood Donors

KW - Blood Safety

KW - Corneal Dystrophies, Hereditary

KW - Epithelium, Corneal

KW - Female

KW - Humans

KW - Keratoconjunctivitis Sicca

KW - Male

KW - Middle Aged

KW - Ophthalmic Solutions

KW - Serum

KW - Treatment Outcome

KW - Wound Healing

KW - Young Adult

U2 - 10.1111/aos.12386

DO - 10.1111/aos.12386

M3 - Journal article

C2 - 24629028

SN - 1755-375X

VL - 92

SP - 783

EP - 786

JO - Acta Ophthalmologica

JF - Acta Ophthalmologica

IS - 8

ER -

Ready-made allogeneic ABO-specific serum eye drops: production from regular male blood donors, clinical routine, safety and efficacy

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