The ophthalmology team of the San Giovanni Addolorata Hospital in Rome performed the innovative surgical treatment on a patient with a very severe bilateral sulphuric acid eye burn
The treatment of lesions of the ocular surface with the grafting of stem cells of the corneal epithelium has been an important focus of cutting-edge research for some years now, as reported in the article 'Regenerative medicine with limbal stem cells: a successful protocol', published in our newspaper by Prof. Graziella Pellegrini.
Now the research has crossed the first clinical milestone with the transplantation of corneal epithelium stem cells, carried out on 19 April 2019 at the UOC of Ophthalmology - Eye Bank of the Azienda Ospedaliera San Giovanni Addolorata, directed by Dr Augusto Pocobelli, on a patient who suffered a very severe bilateral sulphuric acid eye burn in early 2017.
Since then, the Company's ophthalmologists have implemented all the necessary medical and surgical therapies to restore the acute manifestations of the trauma, including multiple conservative surgeries on the facial skin, eyelids and cornea. This made it possible to stabilise the patient's condition so that he was eligible for treatment with a new drug based on corneal epithelial stem cells, approved by the European Medicines Agency in 2015 and available through the NHS since 2017.
The drug has been developed over the past 10 years by a team of Italian researchers from the Centre for Regenerative Medicine (CMR) of the University of Modena and Italian ophthalmologists from various Italian universities and hospitals.
The team includes Prof. Graziella Pellegrini herself, who conceived, together with Prof. De Luca, all the development phases of the stem project and explains: "After developing cell cultures based on epithelial stem cells for the treatment of various pathologies affecting the lining epithelia, from skin for major burns to urethral reconstruction, we discovered that the stem cells that enable the regeneration of the cornea reside in a small area on the border between the cornea (the transparent part at the centre of the eye) and the conjunctiva (the adjacent white part) called limbus.
When thermal or chemical burns of the ocular surface irreversibly damage this reserve of stem cells, the corneal surface, which in a healthy eye is completely renewed every six to nine months, stops regenerating and the conjunctiva gradually begins to cover the cornea with a white patina that makes vision impossible and causes chronic pain and inflammation.
If at least in one of the patient's eyes even a very small residue of limbus undamaged, we are able to reconstruct the epithelium covering the corneal surface in the laboratory, thanks to stem cells collected from a 1-2 mm biopsy2. This flap of epithelium, which resembles a kind of contact lens, is then transplanted into the patient and makes it possible to obtain a cornea stable transparency over time and full recovery of visual capacity, without causing any rejection reaction because it consists of the patient's own cells".
Within this working group, a significant contribution has been made since 2005 by the team of the Ophthalmology Unit - Eye Bank of the Azienda Ospedaliera San Giovanni Addolorata, which carried out the transplantation of a fibrin sheet on the surface of which the patient's autologous stem cells were placed, cultivated in the cell factory of the CMR in Modena.
The therapywhich was first applied on an experimental basis in humans in the 1990s and was recognised as an orphan drug in 2008, may in the near future, thanks to the registration obtained today, be available to all European patients who have suffered accidents at work (e.g. caused by quicklime, solvents or acids), accidents in the home (e.g. eye burns caused by detergents or abrasive agents in adults and children) or, as sadly reported in the news in recent months, in cases of aggression with chemical agents.
The drug, which is extremely expensive, can currently only be dispensed by three centres in Italy.
Dr. Carmelo Chines
Direttore responsabile
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