ex vivo expanded autologous human corneal epithelial cells containing stem cells at a glance
Medicine class
Autologous cell-based advanced therapy and tissue-engineered product
Licensed use
Moderate to severe limbal stem-cell deficiency in adults after physical or chemical ocular burns
Administration
Patient-specific corneal implant placed surgically by a trained eye surgeon in hospital
Cell source
Healthy limbal tissue collected from the person receiving the implant
What is ex vivo expanded autologous human corneal epithelial cells containing stem cells used for?
Licensed for specialist treatment of adults with moderate to severe limbal stem-cell deficiency caused by ocular burns.
Disease may affect one or both eyes and involves the central cornea, superficial new blood vessels and severely impaired vision.
Enough undamaged limbal tissue must remain for the biopsy used to manufacture the implant.
How does ex vivo expanded autologous human corneal epithelial cells containing stem cells work?
The implanted sheet replaces damaged corneal epithelial cells and lost limbal stem cells. Its stem cells can produce and replenish specialised surface cells, helping establish and maintain a stable corneal epithelium.
How to take ex vivo expanded autologous human corneal epithelial cells containing stem cells
This treatment is not swallowed or self-administered. A surgeon collects healthy limbal tissue; after laboratory expansion, the scarred corneal surface is prepared and the cell sheet is implanted in hospital.
Use prescribed antibiotics and anti-inflammatory treatments as directed after biopsy and implantation.
Do not drive or operate machinery until the surgeon confirms it is safe.
Attend all arranged postoperative eye examinations.
ex vivo expanded autologous human corneal epithelial cells containing stem cells side effects
Common or expected effects
- Eye pain
- Corneal surface defects, abrasion or erosion
- Bleeding on or around the eye surface
- Inflammation of the cornea or eyelids
- Raised pressure inside the eye, sometimes associated with corticosteroid treatment
- Complications related to the eye operation
Get urgent medical advice
- Corneal infection or ulcerative keratitis
- Persistent failure of the corneal surface to heal or implant engraftment failure
- Corneal thinning or perforation
- Fainting associated with severe postoperative eye pain
ex vivo expanded autologous human corneal epithelial cells containing stem cells in pregnancy
There are no clinical pregnancy data. As a precaution, implantation should be avoided during pregnancy, particularly because postoperative medicines are required. Discuss pregnancy or possible pregnancy with the specialist team.
ex vivo expanded autologous human corneal epithelial cells containing stem cells while breastfeeding
Implantation is not recommended while breastfeeding as a precaution. The surgeon should also review medicines required around the procedure.
ex vivo expanded autologous human corneal epithelial cells containing stem cells interactions
Formal interaction studies have not been performed. Some topical products can harm implanted cells or reduce their growth.
Eye drops containing benzalkonium chloride or other preservatives
Can damage exposed corneal epithelial cells and should be avoided around implantation.
Topical lidocaine
Can reduce colony-forming ability and must not be used during the treatment process.
Anaesthetics containing adrenaline
Can reduce colony-forming efficiency and must be avoided.
Common questions about ex vivo expanded autologous human corneal epithelial cells containing stem cells
Answers are fully visible for fast scanning and source review.
What is Holoclar made from?
The recipient’s own corneal epithelial and limbal stem cells, expanded in a laboratory and placed on a fibrin support.
Can it treat both eyes?
The licence includes disease affecting one or both eyes, provided sufficient healthy limbal tissue is available for manufacture.
Can it be given to someone else?
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.