1 Recommendations
1.1 Holoclar (ex vivo expanded autologous human corneal epithelial cells containing stem cells) is recommended as an option in people with moderate to severe limbal stem cell deficiency after eye burns, only if:
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it is only used to treat 1 eye and
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people have already had a conjunctival limbal autograft or
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there is not enough tissue for a conjunctival limbal autograft or it is contraindicated and
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the company provides it with the discount agreed in the patient access scheme.
Moderate to severe limbal stem cell deficiency is defined by the presence of superficial corneal neovascularisation in at least 2 corneal quadrants, with central corneal involvement, and severely impaired visual acuity.
1.2 Holoclar is recommended in people with moderate to severe limbal stem cell deficiency after eye burns for treating both eyes only:
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in the context of research and
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when there is not enough tissue for a conjunctival limbal autograft.
Such research should be designed to generate robust evidence of the clinical- and cost-effectiveness of Holoclar in treating 2 eyes in people who do not have enough tissue for a conjunctival limbal autograft.
1.3 These recommendations are not intended to affect treatment with Holoclar that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.