Autologous Serum Eyedrops for Ocular Surface Disorders

Geerling, Gerd; Hartwig, D.

doi:10.1007/3-540-31226-9_1

Cited by 12 publications

(21 citation statements)

References 41 publications

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“…In human patients, autologous serum eye drops are most commonly prescribed for severe dry eye and persistent epithelial defects . Several studies have investigated the contamination rate of serum eye drops during the course of treatment in human patients.…”

Section: Discussionmentioning

confidence: 99%

“…and Fonsecaea spp . While there are different protocols for production and storage of serum eye drops, a common recommendation in human medicine appears to be daily dosage vials of serum that can be removed from the freezer and used within 24 hours before being discarded, as this reduces the risk of contamination …”

Section: Discussionmentioning

confidence: 99%

“…Serum and plasma contain macroglobulins, which have been shown to be effective inhibitors of proteases . These blood products also have components such as vitamin A, epitheliotrophic and neurotrophic growth factors, immunoglobulins, and fibronectin that may help promote corneal healing …”

Section: Introductionmentioning

confidence: 99%

“…Contamination risk is likely higher when administering an eye drop to a veterinary patient that has more facial hair and may be uncooperative. This risk is important clinically, as the contaminated product could be detrimental when applied to the ocular surface, especially in the presence of a corneal epithelial defect . One veterinary abstract reported that plasma and serum eye drops are effective for use up to 16 days, with no contamination seen in the laboratory .…”

Section: Introductionmentioning

confidence: 99%

“…neurotrophic growth factors, immunoglobulins, and fibronectin that may help promote corneal healing. 6,7 One major limitation of serum and plasma eye drops used clinically is the risk for microbial contamination. 6 There are currently no standardized protocols for production or storage of these eye drops nor are commercial products available, so clinicians often obtain and bottle serum or plasma from an individual patient, a donor animal, or a blood bank, and no preservatives are added.…”

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confidence: 99%

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Evaluation of microbial contamination of canine plasma eyedropper bottles following clinical use in canine patients

Strauss

Genschel

Allbaugh

et al. 2018

Veterinary Ophthalmology

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

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Evaluation of microbial contamination of canine plasma eyedropper bottles following clinical use in canine patients

Strauss

Genschel

Allbaugh

et al. 2018

Veterinary Ophthalmology

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Detection of systemic immunosuppressants in autologous serum eye drops (ASED) in patients with severe chronic ocular graft versus host disease

Tahmaz

Wiesen

Gehlsen

et al. 2020

Graefes Arch Clin Exp Ophthalmol

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Purpose Chronic graft versus host disease is a major consequence after allogeneic stem cell transplantation (allo-SCT) and has great impact on patients’ morbidity and mortality. Besides the skin, liver, and intestines, the eyes are most commonly affected, manifesting as severe ocular surface disease. Treatment protocols include topical steroids, cyclosporine, tacrolimus, and ASED. Since these patients often receive systemic immunosuppressant therapy from their oncologists, a topical re-administration of these drugs via ASED with potentially beneficial or harmful effects is possible. The purpose of the study was to determine whether and to which extent systemic immunosuppressants are detectable in ASED. Methods A total of 34 samples of ASED from 16 patients with hemato-oncological malignancies after allo-SCT were collected during the manufacturing process and screened for levels of cyclosporine, mycophenolic acid, everolimus, and tacrolimus via liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS). The study followed the tenets of the Declaration of Helsinki and informed consent was obtained from the subjects after explanation of the nature and possible consequences of the study. Results Cyclosporine was found in 18 ASED samples in concentrations ranging from 6.5–105.0 ng/ml (32.0 ± 22.8 ng/ml, mean ± SD). The concentration range of mycophenolic acid in 19 samples was 0.04–25.0 mg/l (4.0 ± 5.4 mg/l, mean ± SD). Everolimus and tacrolimus concentrations were well below the respective limits of quantification (< 0.6 and < 0.5 ng/ml) of the established LC-MS/MS method in all samples. Conclusions Our study suggests that orally administered cyclosporine and mycophenolic acid for the treatment of systemic GvHD, but not everolimus and tacrolimus, are distinctly detectable in ASED in relevant concentrations. It is highly likely that these agents affect topical therapy of ocular GvHD. However, the extent of this effect needs to be evaluated in further studies.

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A Novel Technique of Aseptic Manufacture of Autologous Serum Eye Drops (ASEDs) and Sterility Analysis of the Bottled Ophtioles

Blaser,

Meneau,

Mihic-Probst

et al. 2024

Klin Monbl Augenheilkd

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Purpose To introduce a novel technique of the aseptic manufacture of autologous serum eye drops (ASEDs) with a prefiltered closed system and to analyze the sterility of the produced ophtioles between 2018 and 2022. Methods This is a prospective single-center study conducted at the Department of Ophthalmology at a Swiss University Hospital between 2018 and 2022. For regulatory reasons, closed systems for manufacturing ASEDs are strongly recommended. We attached an upstream sterile filter (Sterivex PES0.22 µm Burlington, USA) to a commercially available closed system (COL System Modena, Italy) for manufacturing ASEDs. The goal of this novel approach was to reduce the microbiological contamination of the donated autologous blood. Using the presented manufacturing method, we are able to produce, on average, 56 ophtioles per batch, containing either 1.45 mL or 2.5 mL of autologous serum per ophtiole. For each batch of ASEDs, we performed a microbiological analysis by automated blood culture testing (BACTEC). This system examines the presence of bacteria and fungi. Results We analyzed all manufactured batches between 2018 and 2022. None of the 2297 batches and the resulting 129 060 ophtioles showed bacterial or mycotic contamination. During the analyzed period, two batches were discarded: one due to fibrin-lipid aggregations, further microbiological and histological work-up excluded any contamination; another due to false-positive HIV in serological testing. Overall, the contamination rate was 0%, and the batch discharge rate was 0.09%. Conclusions The combination of upstream sterile filtration with a commercial closed system for manufacturing ASEDs proved to be effective in ensuring sterility without any contamination over the past 4 years. This is becoming crucial, as the demand for autologous blood products for treating ocular surface disorders, such as refractory dry eyes or nonhealing defects of the corneal epithelium, is on the rise.

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Autologous Serum Eyedrops for Ocular Surface Disorders

Cited by 12 publications

References 41 publications

Evaluation of microbial contamination of canine plasma eyedropper bottles following clinical use in canine patients

Evaluation of microbial contamination of canine plasma eyedropper bottles following clinical use in canine patients

Detection of systemic immunosuppressants in autologous serum eye drops (ASED) in patients with severe chronic ocular graft versus host disease

A Novel Technique of Aseptic Manufacture of Autologous Serum Eye Drops (ASEDs) and Sterility Analysis of the Bottled Ophtioles

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