There are no data for the use of limbal stem cells in pregnant women.
Animal studies are not available with respect to reproductive toxicity.
As a precautionary measure, and in light of the requirement of the post-operative pharmacological treatment, it is preferable to avoid the implantation of limbal stem cells during pregnancy.
As a precautionary measure, limbal stem cells are not recommended for implant during breast-feeding.
No clinical data on the effects of limbal stem cells implantation on fertility are available.
Limbal stem cells implantation has a major influence on the ability to drive and use machines due to the surgical nature of the underlying procedure for the implantation. Therefore, following treatment with limbal stem cells implantation, driving and using machines must be limited and patients should follow the advice of their treating physician.
The most serious adverse reactions are corneal perforation and ulcerative keratitis, which may occur within the 3 months from limbal stem cells living tissue implantation and are related to the corneal epithelial instability, and syncope vasovagal occurring in the first day after surgery due to eye pain. The most common adverse reactions are eye disorders. The most frequently occurring reaction related to the surgical procedure was conjunctival haemorrhage (5%) which appears mostly during the first day after surgery and tends to be mild in intensity and disappears within a few days without treatment.
Adverse reactions reported in patients implanted with limbal stem cells are provided in the table. The following categories are used to rank the adverse reactions by frequency of occurrence: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping the adverse reactions are presented in the order of decreasing seriousness.
| MedDRA System organ class | Adverse reaction | Frequency |
|---|---|---|
| Infections and infestations | Corneal infection | Uncommon |
| Nervous system disorders | Syncope vasovagal | Uncommon |
| Eye disorders | Blepharitis | Very common |
| Common | ||
| Conjunctival adhesion, conjunctival hyperaemia, corneal oedema, corneal perforation, eye irritation, photophobia | Uncommon | |
| Skin and subcutaneous tissue disorders | Haemorrhage subcutaneous | Uncommon |
| General disorders and administration site conditions | Metaplasia of the implant | Uncommon |
| Injury, poisoning and procedural complications | Suture rupture | Uncommon |
Blepharitis (10.5%), and corneal epithelium defect (3.5%) were the most common individual adverse reactions not related to the surgical procedure. Glaucoma (3.5%) was the most frequent adverse reaction considered related to the corticosteroid treatment. Reports of glaucoma included adverse reactions of intraocular pressure.
There is no information on the safety of limbal stem cells living tissue implantation in children up to 7 years of age and only limited information in patients 8-17 years of age. In the paediatric patients included in the studies HLSTM01 (age 13, 14 and 16 years) and HLSTM02 (age 8 and 14 years) the profile of adverse reactions was not different from the adult population.
There is only limited information in elderly (n=12, >65 years old) and very elderly (n=2, 75-84 years old) patients.
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