Current evidence on the safety and efficacy of tissue-cultured limbal stem cell allograft transplantation for regrowth of corneal epithelium does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research.
Clinicians wishing to use tissue-cultured limbal stem cell allograft transplantation for regrowth of corneal epithelium should take the following actions.
Inform the clinical governance leads in their Trusts.
Ensure that patients understand the uncertainty about the procedure's safety and efficacy, and provide them with clear written information. In addition, use of NICE's information for the public is recommended.
Audit and review clinical outcomes of all patients having tissue-cultured limbal stem cell allograft transplantation for regrowth of corneal epithelium (see section 3.1).
Further research on long-term outcomes and the risks and benefits of long-term systemic immunosuppressant regimes would be useful. The Institute may review the procedure upon publication of further evidence.